Amoxicillin And Clavulanate Potassium
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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Amoxicillin and clavulanate potassium tablets, USP, for oral suspension, USP, and chewable tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below:
Caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.
Caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.
Caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
Caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.
History
There is currently no drug history available for this drug.
Other Information
Amoxicillin and clavulanate potassium tablets, USP; for oral suspension, USP; and chewable tablets, USP are oral antibacterial combinations consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:
Inactive Ingredients
• Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium. • For Oral Suspension – Aspartame, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (caramel). • Chewable Tablets – Aspartame, banana flavoring, cherry flavoring, colloidal silicon dioxide, FD&C Red No. 40, magnesium stearate, mannitol, and sodium starch glycolate. [ see Warnings and Precautions (5.6)] • Each 200-mg chewable tablet and each 5 mL of reconstituted 200 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassium • Each 400-mg chewable tablet and each 5 mL of reconstituted 400 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassiumSources
Amoxicillin And Clavulanate Potassium Manufacturers
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Proficient Rx Lp
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Amoxicillin And Clavulanate Potassium | Proficient Rx Lp
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.
The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1. Dosing in Patients Aged 12 weeks (3 months) and Older * Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.DOSING REGIMEN
Every 12 hours
Every 8 hours
INFECTION200 mg/5 mL or
400 mg/5 mL
oral suspension*125 mg/5 mL or
250 mg/5 mL
oral suspension*Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day
every 12 hours40 mg/kg/day
every 8 hoursLess severe infections
25 mg/kg/day
every 12 hours20 mg/kg/day
every 8 hoursPatients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250 mg/125 mg) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250 mg/62.5 mg).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2. Amount of Water for Mixing Oral Suspension
Strength
Bottle SizeAmount of
Water for
Reconstitution
Contents of Each
Teaspoonful (5 mL)200 mg/5 mL
100 mL
88 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
100 mL
84 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Proficient Rx Lp
Amoxicillin And Clavulanate Potassium | Proficient Rx Lp
Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500-mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250-mg and 500-mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Amoxicillin and Clavulanate Potassium.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
a Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250-mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Waterfor Reconstitution
Contents of EachTeaspoonful (5 mL)
125 mg/5 mL
75 mL100 mL150 mL
67 mL90 mL134 mL
125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt
200 mg/5 mL
50 mL75 mL100 mL
50 mL75 mL95 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
250 mg/5 mL
75 mL100 mL150 mL
65 mL87 mL130 mL
250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
50 mL75 mL100 mL
50 mL70 mL90 mL
400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Preferred Pharmaceuticals Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals Inc.
Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions of amoxicillin and clavulanate potassium should not be substituted for Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Dosage Pediatric patients 3 months and olderBased on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL Providing 90 mg/kg/day8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and moreExperience with Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL formulation in this group is not available.
AdultsExperience with Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL formulation in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL in place of the 500 mg/125 mg or 875 mg/125 mg tablet of amoxicillin and clavulanate potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL Bottle Size Amount of Water Required for Reconstitution75 mL
67 mL
125 mL
110 mL
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
AdministrationTo minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.
The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1. Dosing in Patients Aged 12 weeks (3 months) and Older * Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.DOSING REGIMEN
Every 12 hours
Every 8 hours
INFECTION200 mg/5 mL or
400 mg/5 mL
oral suspension*125 mg/5 mL or
250 mg/5 mL
oral suspension*Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day
every 12 hours40 mg/kg/day
every 8 hoursLess severe infections
25 mg/kg/day
every 12 hours20 mg/kg/day
every 8 hoursPatients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250 mg/125 mg) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250 mg/62.5 mg).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2. Amount of Water for Mixing Oral Suspension
Strength
Bottle SizeAmount of
Water for
Reconstitution
Contents of Each
Teaspoonful (5 mL)200 mg/5 mL
100 mL
88 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
100 mL
84 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
-
Proficient Rx Lp
Amoxicillin And Clavulanate Potassium | Proficient Rx Lp
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged < 12 weeks (< 3 months)
The recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older
See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
* Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg/5 mL or
400 mg/57 mg/5 mL oral suspension*
125 mg/31.25 mg/5 mL or 250 mg/62.5 mg/5 mL oral suspension*
Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg/5 mL
50 mL
75 mL
100 mL
47 mL
70 mL
93 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg/5 mL
50 mL
75 mL
100 mL
45 mL
67 mL
89 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Amoxicillin and Clavulanate Potassium, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AMOXICILLIN AND CLAVULANATE POTASSIUM contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM should not be substituted for Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage: Pediatric patients 3 months and older:Based on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium
600 mg/42.9 mg per 5 mL
providing 90 mg/kg/day8
3.0 mL twice daily
12
4.5 mL twice daily
16
6.0 mL twice daily
20
7.5 mL twice daily
24
9.0 mL twice daily
28
10.5 mL twice daily
32
12.0 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and more:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in this group is not available.
Adults:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of AMOXICILLIN AND CLAVULANATE POTASSIUM.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral Suspension:Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium (600 mg/5 mL Suspension)Bottle Size
Amount of Water
Required for Reconstitution75 mL
70 mL
125 mL
110 mL
200 mL
180 mL
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist:For patients who wish to alter the taste of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.
Administration:To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Hikma Pharmaceutical
Amoxicillin And Clavulanate Potassium | Hikma Pharmaceutical
Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/ 57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/ 57 mg per 5 mL suspensions of amoxicillin and clavulanate potassium for oral suspension should not be substituted for amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Dosage: Pediatric patients 3 months and older:Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of amoxicillin and
clavulanate potassium for oral
suspension, 600 mg/42.9 mg per
5 mL providing 90 mg/kg/day 8 3.0 mL twice daily 12 4.5 mL twice daily 16 6.0 mL twice daily 20 7.5 mL twice daily 24 9.0 mL twice daily 28 10.5 mL twice daily 32 12.0 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and more:Experience with amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL in this group is not available.
Adults:Experience with amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL in place of the 500-mg or 875-mg tablet of amoxicillin and clavulanate potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS .)
Directions for Mixing Oral Suspension:Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin andand Clavulanate Potassium for oral suspension 600 mg/42.9 mg per 5 mL Bottle Size Amount of Water
Required for Reconstitution 75 mL 66 mL 125 mL 110 mL 200 mL 176 mLEach teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Administration:To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
-
Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Bio Cosmetics
Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.
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Pd-rx Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Pd-rx Pharmaceuticals, Inc.
Primary Hyperaldosteronism.Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
Long Test: Spironolactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short Test: Spironolactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Edema in Adults (Congestive Heart Failure, Hepatic Cirrhosis, or Nephrotic Syndrome).An initial daily dosage of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, spironolactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone has not occurred, a second diuretic that acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of spironolactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone should remain unchanged when other diuretic therapy is added.
Essential Hypertension.For adults, an initial daily dosage of 50 to 100 mg of spironolactone administered in either single or divided doses is recommended. Spironolactone may also be given with diuretics that act more proximally in the renal tubule or with other antihypertensive agents. Treatment with spironolactone should be continued for at least two weeks, since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.
Hypokalemia.Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.
Severe Heart Failure (NYHA class III – IV).Treatment should be initiated with spironolactone 25 mg once daily if the patient’s serum potassium is ≤5.0 mEq/L and the patient’s serum creatinine is ≤ 2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dosage reduced to 25 mg every other day. SeeWARNINGS: Hyperkalemia in Patients with Severe Heart Failure for advice on monitoring serum potassium and serum creatinine.
Primary Hyperaldosteronism.Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
Long Test: Spironolactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short Test: Spironolactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Edema in Adults (Congestive Heart Failure, Hepatic Cirrhosis, or Nephrotic Syndrome).An initial daily dosage of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, spironolactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone has not occurred, a second diuretic that acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of spironolactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone should remain unchanged when other diuretic therapy is added.
Essential Hypertension.For adults, an initial daily dosage of 50 to 100 mg of spironolactone administered in either single or divided doses is recommended. Spironolactone may also be given with diuretics that act more proximally in the renal tubule or with other antihypertensive agents. Treatment with spironolactone should be continued for at least two weeks, since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.
Hypokalemia.Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.
Severe Heart Failure (NYHA class III – IV).Treatment should be initiated with spironolactone 25 mg once daily if the patient’s serum potassium is ≤5.0 mEq/L and the patient’s serum creatinine is ≤ 2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dosage reduced to 25 mg every other day. SeeWARNINGS: Hyperkalemia in Patients with Severe Heart Failure for advice on monitoring serum potassium and serum creatinine.
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Ranbaxy Pharmaceuticals Inc.
Amoxicillin And Clavulanate Potassium | Ranbaxy Pharmaceuticals Inc.
Dosage:
Pediatric Patients:Based on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be dosed as follows:
Neonates and infants aged < 12 weeks (3 months):Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/5 mL formulation in this age group is limited and, thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients aged 12 weeks (3 months) and older INFECTIONS DOSING REGIMEN q12h* q8h 200 mg/5 mL or 400 mg/5 mL oral suspension† 125 mg/5 mL or 250 mg/5 mL oral suspension Otitis media‡, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day q12h 40 mg/kg/day q8h Less severe infections 25 mg/kg/day q12h 20 mg/kg/day q8h*The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.
†Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
‡Duration of therapy studied and recommended for acute otitis media is 10 days.
Pediatric Patients Weighing 40 kg and More:Should be dosed according to the following adult recommendations: The usual adult dose is one amoxicillin 500 mg and clavulanate potassium tablet every 12 hours or one amoxicillin 250 mg and clavulanate potassium tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin 875 mg and clavulanate potassium tablet every 12 hours or one amoxicillin 500 mg and clavulanate potassium tablet every 8 hours. Among adults treated with 875 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin and clavulanate potassium tablets.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Adults:Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The amoxicillin/clavulanate potassium 250 mg tablet and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). Amoxicillin/clavulanate potassium 250 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, amoxicillin/clavulanate potassium 250 mg tablet and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in amoxicillin/clavulanate potassium 250 mg tablet (250/125) versus amoxicillin/clavulanate potassium 250 mg chewable tablet (250/62.5), amoxicillin/clavulanate potassium 250 mg tablet should not be used until the child weighs at least 40 kg and more.
Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin/Clavulanate Potassium for Oral Suspension, 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 47 mL 75 mL 70 mL 100 mL 94 mLEach teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.
Amoxicillin/Clavulanate Potassium for Oral Suspension, 400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 46 mL 75 mL 68 mL 100 mL 90 mLEach teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt.
Note:SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
Administration:Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
-
Physicians Total Care, Inc.
Amoxicillin And Clavulanate Potassium | Physicians Total Care, Inc.
All recommended dosages for Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets are included in this section for informational purposes only. Some of the dosages may not be obtainable with the 400 mg/57mg per 5 mL and 200 mg/28.5 mg per 5 mL strengths of oral suspension or the 400 mg/57 mg and 200 mg/28.5 mg strengths of chewable tablets.
Dosage Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be dosed as follows:
Neonates and Infants Aged Less Than 12 Weeks (3 Months)Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium for oral suspension and chewable tablets is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older INFECTIONS
DOSING
REGIMEN
q12h*
q8h
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral
suspension† 125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral
suspension† Otitis media‡, sinusitis, lower
respiratory tract infections, and
more severe infections 45 mg/kg/day
q12h 40 mg/kg/day
q8h
Less severe infections 25 mg/kg/day
q12h 20 mg/kg/day
q8h * The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.
† Each strength of amoxicillin and clavulanate potassium suspension is available as a chewable tablet for use by older children.
‡ Duration of therapy studied and recommended for acute otitis media is 10 days.
Pediatric Patients Weighing 40 kg and MoreShould be dosed according to the following adult recommendations: The usual adult dose is 1 amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or 1 amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be 1 amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or 1 amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea vs. adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin/clavulanate potassium tablets.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
AdultsAdults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). Amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium, USP 250 mg/62.5 mg chewable tablet, the amoxicillin and clavulanate 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg and more.
DIRECTIONS FOR MIXING ORAL SUSPENSIONPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
AMOXICILLIN AND CLAVULANATE POTASSIUM 200 mg/28.5 mg per 5 mL SUSPENSION Bottle Size Amount of Water Required for Suspension 100 mL 88 mLEach teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.
AMOXICILLIN AND CLAVULANATE POTASSIUM 400 mg/57 mg per 5 mL SUSPENSION Bottle Size Amount of Water Required for Reconstitution 100 mL 84 mLEach teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
AdministrationAmoxicillin and clavulanate potassium for oral suspension and chewable tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension and chewable tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be taken at the start of a meal.
Tablets may be chewed before being swallowed or may be swallowed whole.
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Rebel Distributors Corp.
Amoxicillin And Clavulanate Potassium | Rebel Distributors Corp.
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Physicians Total Care, Inc.
Amoxicillin And Clavulanate Potassium | Physicians Total Care, Inc.
Dosage:
Pediatric Patients:Based on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be dosed as follows:
Neonates and infants aged less than 12 weeks (3 months):Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/5 mL formulation in this age group is limited and, thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients aged 12 weeks (3 months) and older INFECTIONS DOSING REGIMEN q12h* q8h 200 mg/5 mL or 400 mg/5 mL oral suspension† 125 mg/5 mL or 250 mg/5 mL oral suspension Otitis media‡, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day q12h 40 mg/kg/day q8h Less severe infections 25 mg/kg/day q12h 20 mg/kg/day q8h*The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.
†Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
‡Duration of therapy studied and recommended for acute otitis media is 10 days.
Pediatric Patients Weighing 40 kg and More:Should be dosed according to the following adult recommendations: The usual adult dose is one amoxicillin 500 mg and clavulanate potassium tablet every 12 hours or one amoxicillin 250 mg and clavulanate potassium tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin 875 mg and clavulanate potassium tablet every 12 hours or one amoxicillin 500 mg and clavulanate potassium tablet every 8 hours. Among adults treated with 875 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin and clavulanate potassium tablets.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Adults:Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The amoxicillin/clavulanate potassium 250 mg tablet and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). Amoxicillin/clavulanate potassium 250 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, amoxicillin/clavulanate potassium 250 mg tablet and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in amoxicillin/clavulanate potassium 250 mg tablet (250/125) versus amoxicillin/clavulanate potassium 250 mg chewable tablet (250/62.5), amoxicillin/clavulanate potassium 250 mg tablet should not be used until the child weighs at least 40 kg and more.
Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin/Clavulanate Potassium for Oral Suspension, 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 47 mL 75 mL 70 mL 100 mL 94 mLEach teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.
Amoxicillin/Clavulanate Potassium for Oral Suspension, 400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 46 mL 75 mL 68 mL 100 mL 90 mLEach teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt.
Note:SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
Administration:Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
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State Of Florida Doh Central Pharmacy
Amoxicillin And Clavulanate Potassium | State Of Florida Doh Central Pharmacy
Since both the Amoxicillin and Clavulanate Potassium Tablets, 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two Amoxicillin and Clavulanate Potassium Tablets 250 mg/125 mg are not equivalent to one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium); therefore, two Amoxicillin and Clavulanate Potassium Tablets 250 mg/125 mg should not be substituted for one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as thetrihydrate and clavulanic acid, 125 mg, as clavulanate potassium) .
Dosage AdultsThe usual adult dose is one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium) every 12 hours or one Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 875 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium) every 12 hours or one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium) every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult commendations
Due to the different amoxicillin to clavulanic acid ratios in the Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg versus the Amoxicillin and Clavulanate Potassium Chewable Tablet 250 mg/62.5, the Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and Clavulanate Potassium Tablet may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablet is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablet should be taken at the start of a meal.
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State Of Florida Doh Central Pharmacy
Amoxicillin And Clavulanate Potassium | State Of Florida Doh Central Pharmacy
Since both the Amoxicillin and Clavulanate Potassium 250 mg/125 mg and 500 mg/125 mg Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets are not equivalent to one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet; therefore, two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets should not be substituted for one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet.
Dosage AdultsThe usual adult dose is one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet every 12 hours or one Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Amoxicillin and Clavulanate Potassium 875 mg/125 mg Tablet every 12 hours or one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg/125 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/ min. should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the Amoxicillin and Clavulanate Potassium Tablets (250 mg/125 mg) versus the Amoxicillin and Clavulanate Potassium Chewable Tablets (250 mg/62.5 mg), the Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets should not be used until the pediatric patient weighs at least 40 kg or more.
Administration: Amoxicillin and Clavulanate Potassium Tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets should be taken at the start of a meal.
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State Of Florida Doh Central Pharmacy
Amoxicillin And Clavulanate Potassium | State Of Florida Doh Central Pharmacy
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Rebel Distributors Corp.
Amoxicillin And Clavulanate Potassium | Rebel Distributors Corp.
All recommended dosages for Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets are included in this section for informational purposes only. Some of the dosages may not be obtainable with the 400 mg/57mg per 5 mL and 200 mg/28.5 mg per 5 mL strengths of oral suspension or the 400 mg/57 mg and 200 mg/28.5 mg strengths of chewable tablets.
Dosage Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (3 Months)Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium for oral suspension and chewable tablets is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older INFECTIONS DOSING REGIMEN q12h* q8h 200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral
suspension† 125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral
suspension† * The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. † Each strength of amoxicillin and clavulanate potassium suspension is available as a chewable tablet for use by older children. ‡ Duration of therapy studied and recommended for acute otitis media is 10 days. Otitis media‡, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day
q12h 40 mg/kg/day
q8h Less severe infections 25 mg/kg/day
q12h 20 mg/kg/day
q8h Pediatric Patients Weighing 40 kg and MoreShould be dosed according to the following adult recommendations: The usual adult dose is 1 amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or 1 amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be 1 amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or 1 amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea vs. adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin/clavulanate potassium tablets.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
AdultsAdults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). Amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium, USP 250 mg/62.5 mg chewable tablet, the amoxicillin and clavulanate 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg and more.
DIRECTIONS FOR MIXING ORAL SUSPENSIONPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
AMOXICILLIN AND CLAVULANATE POTASSIUM 200 mg/28.5 mg per 5 mL SUSPENSION Bottle Size Amount of Water Required for Suspension 100 mL 88 mLEach teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.
AMOXICILLIN AND CLAVULANATE POTASSIUM 400 mg/57 mg per 5 mL SUSPENSION Bottle Size Amount of Water Required for Reconstitution 100 mL 84 mLEach teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
AdministrationAmoxicillin and clavulanate potassium for oral suspension and chewable tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension and chewable tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be taken at the start of a meal.
Tablets may be chewed before being swallowed or may be swallowed whole.
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Stat Rx Usa Llc
Amoxicillin And Clavulanate Potassium | Stat Rx Usa Llc
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Physicians Total Care, Inc.
Amoxicillin And Clavulanate Potassium | Physicians Total Care, Inc.
Dosage Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium for Oral Suspension should be dosed as follows:
Neonates and infants aged <12 weeks (3 months)Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 250 mg/62.5 mg per 5 mL is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients aged 12 weeks (3 months) and older INFECTIONS DOSING REGIMEN q12h* q8h * *The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) contain aspartame and should not be used by phenylketonurics. † Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. ‡ Duration of therapy studied and recommended for acute otitis media is 10 days. 200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspension† 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspension Otitis media‡, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day q12h 40 mg/kg/day q8h Less severe infections 25 mg/kg/day q12h 20 mg/kg/day q8h Pediatric Patients Weighing 40 kg and MoreShould be dosed according to the following adult recommendations: The usual adult dose is one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250 mg/125 mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for tablets of amoxicillin and clavulanate potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
AdultsAdults who have difficulty swallowing may be given the Amoxicillin and Clavulanate Potassium for Oral Suspension 250 mg/62.5 mg per 5 mL or 125 mg/31.25 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the 250 mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250 mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5), the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg and more.
Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium for Oral Suspension, 250 mg/62.5 mg per 5 mL Bottle Size Amount of Water Required for Reconstitution 75 mL 68 mL 100 mL 86 mL 150 mL 128 mLEach teaspoonful (5 mL) will contain 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt.
Note: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
AdministrationAmoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension should be taken at the start of a meal.
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Rebel Distributors Corp
Amoxicillin And Clavulanate Potassium | Rebel Distributors Corp
All recommended dosages for Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets are included in this section for informational purposes only. Some of the dosages may not be obtainable with the 400 mg/57mg per 5 mL and 200 mg/28.5 mg per 5 mL strengths of oral suspension or the 400 mg/57 mg and 200 mg/28.5 mg strengths of chewable tablets.
Dosage Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (3 Months)Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium for oral suspension and chewable tablets is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older * The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. † Each strength of amoxicillin and clavulanate potassium suspension is available as a chewable tablet for use by older children. ‡ Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTIONS
DOSING REGIMEN q12h* q8h 200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspension† 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspension† Otitis media‡, sinusitis, lower respiratory tract infections, and more severe infections45 mg/kg/day
q12h40 mg/kg/day
q8hLess severe infections
25 mg/kg/day
q12h20 mg/kg/day
q8h Pediatric Patients Weighing 40 kg and MoreShould be dosed according to the following adult recommendations: The usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin/clavulanate potassium tablets.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
AdultsAdults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). Amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium, USP 250 mg/62.5 mg chewable tablet, the amoxicillin and clavulanate 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg and more.
DIRECTIONS FOR MIXING ORAL SUSPENSIONPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
AMOXICILLIN AND CLAVULANATE POTASSIUM 200 mg/28.5 mg per 5 mL SUSPENSION
Bottle SizeAmount of Water
Required for Suspension 100 mL 88 mLEach teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.
AMOXICILLIN AND CLAVULANATE POTASSIUM 400 mg/57 mg per 5 mL SUSPENSION
Bottle Size Amount of Water Required for Reconstitution 100 mL 84 mLEach teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
AdministrationAmoxicillin and clavulanate potassium for oral suspension and chewable tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension and chewable tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be taken at the start of a meal.
Tablets may be chewed before being swallowed or may be swallowed whole.
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Redpharm Drug Inc.
Amoxicillin And Clavulanate Potassium | Redpharm Drug Inc.
Since both the Amoxicillin and Clavulanate Potassium Tablets, 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two Amoxicillin and Clavulanate Potassium Tablets 250 mg/125 mg are not equivalent to one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium); therefore, two Amoxicillin and Clavulanate Potassium Tablets 250 mg/125 mg should not be substituted for one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as thetrihydrate and clavulanic acid, 125 mg, as clavulanate potassium) .
Dosage AdultsThe usual adult dose is one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium) every 12 hours or one Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 875 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium) every 12 hours or one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium) every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of less than 30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult commendations
Due to the different amoxicillin to clavulanic acid ratios in the Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg versus the Amoxicillin and Clavulanate Potassium Chewable Tablet 250 mg/62.5, the Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and Clavulanate Potassium Tablet may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablet is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablet should be taken at the start of a meal.
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Pd-rx Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Pd-rx Pharmaceuticals, Inc.
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Amoxicillin And Clavulanate Potassium | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Since both the Amoxicillin and Clavulanate Potassium 250 mg/125 mg and 500 mg/125 mg Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets are not equivalent to one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet; therefore, two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets should not be substituted for one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet.
Dosage AdultsThe usual adult dose is one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet every 12 hours or one Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Amoxicillin and Clavulanate Potassium 875 mg/125 mg Tablet every 12 hours or one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of less than 30 mL/min. should not receive the 875 mg/125 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/ min. should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the Amoxicillin and Clavulanate Potassium Tablets (250 mg/125 mg) versus the Amoxicillin and Clavulanate Potassium Chewable Tablets (250 mg/62.5 mg), the Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets should not be used until the pediatric patient weighs at least 40 kg or more.
Administration: Amoxicillin and Clavulanate Potassium Tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets should be taken at the start of a meal.
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Aurobindo Pharma Limited
Amoxicillin And Clavulanate Potassium | Aurobindo Pharma Limited
Amoxicillin and clavulanate potassium for oral suspension does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium for oral suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of amoxicillin and clavulanate potassium should not be substituted for amoxicillin and clavulanate potassium for oral suspension as they are not interchangeable.
Dosage: Pediatric patients 3 months and older: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below). This dose provides 6.4 mg/kg/day of the clavulanic acid component.
Body Weight (kg)
Volume of Amoxicillin and Clavulanate Potassium Powder for Oral Suspension providing 90 mg/kg/day
8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and more: Experience with amoxicillin and clavulanate potassium for oral suspension in this group is not available.
Adults: Experience with amoxicillin and clavulanate potassium for oral suspension in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension in place of the 500 mg or 875 mg tablet of amoxicillin and clavulanate potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see WARNINGS and PRECAUTIONS (5)].
Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium for Oral Suspension
Bottle Size
Amount of Water Required for Reconstitution
75 mL
71 mL
125 mL
112 mL
200 mL
176 mL
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist: For patients who wish to alter the taste of amoxicillin and clavulanate potassium for oral suspension, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of amoxicillin and clavulanate potassium for oral suspension. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the five flavors listed above.
Administration: To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal.
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H.j. Harkins Company, Inc.
Amoxicillin And Clavulanate Potassium | H.j. Harkins Company, Inc.
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Amoxicillin And Clavulanate Potassium | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Since both the Amoxicillin and Clavulanate Potassium 250 mg/125 mg and 500 mg/125 mg Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets are not equivalent to one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet; therefore, two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets should not be substituted for one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet.
Dosage AdultsThe usual adult dose is one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet every 12 hours or one Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Amoxicillin and Clavulanate Potassium 875 mg/125 mg Tablet every 12 hours or one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg/125 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/ min. should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the Amoxicillin and Clavulanate Potassium Tablets (250 mg/125 mg) versus the Amoxicillin and Clavulanate Potassium Chewable Tablets (250 mg/62.5 mg), the Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets should not be used until the pediatric patient weighs at least 40 kg or more.
Administration: Amoxicillin and Clavulanate Potassium Tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets should be taken at the start of a meal.
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Dr Reddys Laboratories Inc
Amoxicillin And Clavulanate Potassium | Dr Reddys Laboratories Inc
Amoxicillin and Clavulanate Potassium, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AMOXICILLIN AND CLAVULANATE POTASSIUM contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM should not be substituted for Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage: Pediatric patients 3 months and older:Based on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium
600 mg/42.9 mg per 5 mL
providing 90 mg/kg/day 8 3.0 mL twice daily 12 4.5 mL twice daily 16 6.0 mL twice daily 20 7.5 mL twice daily 24 9.0 mL twice daily 28 10.5 mL twice daily 32 12.0 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and more:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in this group is not available.
Adults:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of AMOXICILLIN AND CLAVULANATE POTASSIUM.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral Suspension:Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium (600 mg/5 mL Suspension) Bottle Size Amount of Water
Required for Reconstitution 75 mL 70 mL 125 mL 110 mL 200 mL 180 mLEach teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist:For patients who wish to alter the taste of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.
Administration:To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Stat Rx Usa Llc
Amoxicillin And Clavulanate Potassium | Stat Rx Usa Llc
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Preferred Pharmaceuticals, Inc
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Medvantx, Inc.
Amoxicillin And Clavulanate Potassium | Medvantx, Inc.
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Unit Dose Services
Amoxicillin And Clavulanate Potassium | Unit Dose Services
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see ). WARNINGS
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Stat Rx Usa Llc
Amoxicillin And Clavulanate Potassium | Stat Rx Usa Llc
Since both the Amoxicillin and Clavulanate Potassium Tablets, 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two Amoxicillin and Clavulanate Potassium Tablets 250 mg/125 mg are not equivalent to one Amoxicillin and Clavulanate Potassium Tablet, 500 mg/125 mg; therefore, two Amoxicillin and Clavulanate Potassium Tablets 250 mg/125 mg should not be substituted for one Amoxicillin and Clavulanate Potassium Tablet, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one Amoxicillin and Clavulanate Potassium Tablet, 500 mg/ 125 mg every 12 hours or one Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Amoxicillin and Clavulanate Potassium Tablet, 875 mg/ 125 mg every 12 hours or one Amoxicillin and Clavulanate Potassium Tablet, 500 mg/ 125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg/125 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations
Due to the different amoxicillin to clavulanic acid ratios in the Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg versus the Amoxicillin and Clavulanate Potassium Chewable Tablet 250 mg/62.5 mg, the Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and Clavulanate Potassium Tablet may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablet is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablet should be taken at the start of a meal.
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Sandoz Inc
Amoxicillin And Clavulanate Potassium | Sandoz Inc
All recommended dosages for Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets are included in this section for informational purposes only. Some of the dosages may not be obtainable with the 400 mg/57 mg per 5 mL and 200 mg/28.5 mg per 5 mL strengths of oral suspension or the 400 mg/57 mg and 200 mg/28.5 mg strengths of chewable tablets.
Dosage Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (3 Months)Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium for oral suspension and chewable tablets is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older * The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. † Each strength of amoxicillin and clavulanate potassium suspension is available as a chewable tablet for use by older children. ‡ Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTIONS
DOSING REGIMEN
q12h*
q8h
200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspension†
125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspension†
Otitis media‡, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day
q12h
40 mg/kg/day
q8h
Less severe infections
25 mg/kg/day
q12h
20 mg/kg/day
q8h
Pediatric Patients Weighing 40 kg and MoreShould be dosed according to the following adult recommendations: The usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin/clavulanate potassium tablets.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
AdultsAdults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). Amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium, USP 250 mg/62.5 mg chewable tablet, the amoxicillin and clavulanate 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg and more.
DIRECTIONS FOR MIXING ORAL SUSPENSIONPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
AMOXICILLIN AND CLAVULANATE POTASSIUM 200 mg/28.5 mg per 5 mL SUSPENSION
Bottle Size
Amount of Water
Required for Suspension
100 mL
88 mL
Each teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.
AMOXICILLIN AND CLAVULANATE POTASSIUM 400 mg/57 mg per 5 mL SUSPENSION
Bottle Size
Amount of Water Required for
Reconstitution
100 mL
84 mL
Each teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
AdministrationAmoxicillin and clavulanate potassium for oral suspension and chewable tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension and chewable tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be taken at the start of a meal.
Tablets may be chewed before being swallowed or may be swallowed whole.
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Sandoz Inc
Amoxicillin And Clavulanate Potassium | Sandoz Inc
Since both the Amoxicillin and Clavulanate Potassium 250 mg/125 mg and 500 mg/125 mg Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets are not equivalent to one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet; therefore, two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets should not be substituted for one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet.
Dosage AdultsThe usual adult dose is one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet every 12 hours or one Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Amoxicillin and Clavulanate Potassium 875 mg/125 mg Tablet every 12 hours or one Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablet every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg/125 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/ min. should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the Amoxicillin and Clavulanate Potassium Tablets (250 mg/125 mg) versus the Amoxicillin and Clavulanate Potassium Chewable Tablets (250 mg/62.5 mg), the Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets should not be used until the pediatric patient weighs at least 40 kg or more.
Administration: Amoxicillin and Clavulanate Potassium Tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets should be taken at the start of a meal.
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Aidarex Pharmaceuticals Llc
Amoxicillin And Clavulanate Potassium | Aidarex Pharmaceuticals Llc
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Pd-rx Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Pd-rx Pharmaceuticals, Inc.
All recommended dosages for Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets are included in this section for informational purposes only. Some of the dosages may not be obtainable with the 400 mg/57mg per 5 mL and 200 mg/28.5 mg per 5 mL strengths of oral suspension or the 400 mg/57 mg and 200 mg/28.5 mg strengths of chewable tablets.
Dosage Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (3 Months)Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium for oral suspension and chewable tablets is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older * Each strength of amoxicillin and clavulanate potassium suspension is available as a chewable tablet for use by older children.INFECTIONS
DOSING REGIMEN q12h q8h 200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspension* 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspension* Otitis media, sinusitis, lower respiratory tract infections, and more severe infections45 mg/kg/day
q12h40 mg/kg/day
q8hLess severe infections
25 mg/kg/day
q12h20 mg/kg/day
q8h Pediatric Patients Weighing 40 kg and MoreShould be dosed according to the following adult recommendations: The usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin/clavulanate potassium tablets.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
AdultsAdults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). Amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium, USP 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium, USP 250 mg/62.5 mg chewable tablet, the amoxicillin and clavulanate 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg and more.
DIRECTIONS FOR MIXING ORAL SUSPENSIONPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
AMOXICILLIN AND CLAVULANATE POTASSIUM 200 mg/28.5 mg per 5 mL SUSPENSION
Bottle SizeAmount of Water
Required for Suspension 100 mL 88 mLEach teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.
AMOXICILLIN AND CLAVULANATE POTASSIUM 400 mg/57 mg per 5 mL SUSPENSION
Bottle Size Amount of Water Required for Reconstitution 100 mL 84 mLEach teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
AdministrationAmoxicillin and clavulanate potassium for oral suspension and chewable tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension and chewable tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension and chewable tablets should be taken at the start of a meal.
Tablets may be chewed before being swallowed or may be swallowed whole.
-
Pd-rx Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Pd-rx Pharmaceuticals, Inc.
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Rebel Distributors Corp
Amoxicillin And Clavulanate Potassium | Rebel Distributors Corp
Dosage: Pediatric Patients:Based on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and infants aged < 12 weeks (3 months):Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients aged 12 weeks (3 months) and older INFECTIONS DOSING REGIMEN q12ha q8h 200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensionb 125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspension Otitis mediac, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day q12h 40 mg/kg/day q8h Less severe infections 25 mg/kg/day q12h 20 mg/kg/day q8ha The q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.
b Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
c Duration of therapy studied and recommended for acute otitis media is 10 days.
Pediatric Patients Weighing 40 kg and More:Should be dosed according to the following adult recommendations: The usual adult dose is one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for tablets of Amoxicillin and Clavulanate Potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Adults:Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250 mg/62.5 mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5), the 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg and more.
Directions for Mixing Oral Suspension:Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium 125 mg/31.25 mg per 5 mL Suspension Bottle SizeAmount of Water
Required for Reconstitution 75 mL 67 mL 100 mL 90 mL 150 mL 134 mLEach teaspoonful (5 mL) will contain 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt.
Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg per 5 mL Suspension Bottle SizeAmount of Water
Required for Reconstitution 50 mL 50 mL 75 mL 75 mL 100 mL 95 mLEach teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.
Amoxicillin and Clavulanate Potassium 250 mg/62.5 mg per 5 mL Suspension Bottle SizeAmount of Water
Required for Reconstitution 75 mL 65 mL 100 mL 87 mL 150 mL 130 mLEach teaspoonful (5 mL) will contain 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt.
Amoxicillin and Clavulanate Potassium 400 mg/57 mg per 5 mL Suspension Bottle SizeAmount of Water
Required for Reconstitution 50 mL 50 mL 75 mL 70 mL 100 mL 90 mLEach teaspoonful (5 mL) will contain 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt.
Note: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
Administration:Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
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Unit Dose Services
Amoxicillin And Clavulanate Potassium | Unit Dose Services
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see ). WARNINGS
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Pd-rx Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Pd-rx Pharmaceuticals, Inc.
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric PatientsPediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
AdministrationAmoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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Apotex Corp.
Amoxicillin And Clavulanate Potassium | Apotex Corp.
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets, USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250-mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.
The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months)
The recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Weighing 40 kg or More
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
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Aurobindo Pharma Limited
Amoxicillin And Clavulanate Potassium | Aurobindo Pharma Limited
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 Adults
2.2 Pediatric Patients
The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
Northstar Rx Llc
Amoxicillin And Clavulanate Potassium | Northstar Rx Llc
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 Adults
2.2 Pediatric Patients
The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Amoxicillin And Clavulanate Potassium | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 Adults
2.2 Pediatric Patients
The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
2.3 Patients with Renal Impairment
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
A-s Medication Solutions Llc
Amoxicillin And Clavulanate Potassium | A-s Medication Solutions Llc
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 Adults
2.2 Pediatric Patients
The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
A-s Medication Solutions Llc
Amoxicillin And Clavulanate Potassium | A-s Medication Solutions Llc
Dosage
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other amoxicillin and clavulanate potassium suspensions. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Body Weight
Pediatric patients 3 months and older
Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
(kg) Volume of Amoxicillin and Clavulanate
Potassium for Oral Suspension,
600 mg/42.9 mg per 5 mL providing
90 mg/kg/day 8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Bottle Size Amount of Water
Pediatric patients weighing 40 kg and more
Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in this group is not available.
Adults
Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500 mg or 875 mg tablet.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Required for Reconstitution 75 mL
71 mL
125 mL
112 mL
200 mL
176 mL
Administration
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.br/>To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Amoxicillin And Clavulanate Potassium | A-s Medication Solutions Llc
INFECTIONS DOSING REGIMEN q 12 h* q 8 h * The q 12 h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q 12 h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.
Dosage
Pediatric Patients
Based on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:
Neonates and infants aged <12 weeks (3 months)
Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided q 12 h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients aged 12 weeks (3 months) and older
† Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
‡ Duration of therapy studied and recommended for acute otitis media is 10 days.
200 mg/28.5 mg per 5 mL
or
400 mg/57 mg per 5 mL
oral suspension†
125 mg/31.25 mg per 5 mL
or
250 mg/62.5 mg per 5 mL
oral suspension
Otitis media‡, sinusitis, lower respiratory tract infections,
and more severe infections
45 mg/kg/day q 12 h
40 mg/kg/day q 8 h
Less severe infections
25 mg/kg/day q 12 h
20 mg/kg/day q 8 h
Amoxicillin and Clavulanate Potassium
Pediatric Patients Weighing 40 kg and More
Should be dosed according to the following adult recommendations: The usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin and clavulanate potassium tablets.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Adults
Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). Amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet, the amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg and more.
Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
200 mg/28.5 mg per 5 mL Suspension Bottle Size Amount of Water
Required for Suspension 50 mL
52 mL
75 mL
73 mL
100 mL
98 mL
Each teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.
Amoxicillin and Clavulanate Potassium
400 mg/57 mg per 5 mL Suspension Bottle Size Amount of Water
Required for Suspension 50 mL
49 mL
75 mL
70 mL
100 mL
94 mL
Each teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt.
Note: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
Administration
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal. -
A-s Medication Solutions Llc
Amoxicillin And Clavulanate Potassium | A-s Medication Solutions Llc
Amoxicillin/clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin/clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin/clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of amoxicillin/clavulanate potassium every 12 hours or one 250 mg tablet of amoxicillin/clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg tablet of amoxicillin/clavulanate potassium every 12 hours or one 500 mg tablet of amoxicillin/clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg tablet.
Two 250 mg tablets of amoxicillin/clavulanate potassium should not be substituted for one 500 mg tablet of amoxicillin/clavulanate potassium. Since both the 250 mg and 500 mg tablets of amoxicillin/clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets are not equivalent to one 500 mg tablet of amoxicillin/clavulanate potassium.
The 250 mg tablet of amoxicillin/clavulanate potassium and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg tablet of amoxicillin/clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg tablet of amoxicillin/clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin/clavulanate potassium should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (< 3 Months): The recommended dose of amoxicillin/clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
* Each strength of suspension of amoxicillin/clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.Table 1: Dosing in Patients Aged 12 Weeks (3 Months) and Older
INFECTION DOSING REGIMEN Every 12 hours Every 8 hours 200 mg/5 mL or 400 mg/5 mL oral suspension* 125 mg/5 mL or 250 mg/5 mL oral suspensiona Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hoursPatients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg tablet of amoxicillin/clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg tablet of amoxicillin/clavulanate potassium (250/125) versus the 250 mg chewable tablet of amoxicillin/clavulanate potassium (250/62.5).
2.3 Patients With Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength Bottle Size Amount of Water for Reconstitution Contents of Each Teaspoonful (5 mL) 200 mg/28.5 mg per 5 mL 100 mL 92 mL 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt 400 mg/57 mg per 5 mL 100 mL 87 mL 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium saltNote: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Amoxicillin And Clavulanate Potassium | A-s Medication Solutions Llc
Dosage
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other amoxicillin and clavulanate potassium suspensions. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Body Weight
Pediatric patients 3 months and older
Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
(kg) Volume of Amoxicillin and Clavulanate
Potassium for Oral Suspension,
600 mg/42.9 mg per 5 mL providing
90 mg/kg/day 8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Bottle Size
Pediatric patients weighing 40 kg and more
Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in this group is not available.
Adults
Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500 mg or 875 mg tablet.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amount of Water
Required for Reconstitution
75 mL
71 mL
125 mL
112 mL
200 mL
176 mL
Administration
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is administered at the start of a meal. -
A-s Medication Solutions Llc
Amoxicillin And Clavulanate Potassium | A-s Medication Solutions Llc
Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500-mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250-mg and 500-mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Amoxicillin and Clavulanate Potassium.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION DOSING REGIMEN Every 12 hours Every 8 hours 200 mg/5 mL or 400 mg/5 mL oral suspensiona 125 mg/5 mL or 250 mg/5 mL oral suspensiona Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hoursa Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250-mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength Bottle Size Amount of Waterfor Reconstitution Contents of EachTeaspoonful (5 mL) 125 mg/5 mL 75 mL100 mL150 mL 67 mL90 mL134 mL 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt 200 mg/5 mL 50 mL75 mL100 mL 50 mL75 mL95 mL 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt 250 mg/5 mL 75 mL100 mL150 mL 65 mL87 mL130 mL 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt 400 mg/5 mL 50 mL75 mL100 mL 50 mL70 mL90 mL 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium saltNote: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Amoxicillin And Clavulanate Potassium | A-s Medication Solutions Llc
Dosage: Pediatric Patients:Based on the amoxicillin component, amoxicillin and clavulanate potassium suspension should be dosed as follows:
Neonates and infants aged < 12 weeks (3 months):Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium suspension is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients aged 12 weeks (3 months) and older INFECTIONS DOSING REGIMEN q12hII II q8h 200 mg/28.5 mg per 5 mL
or 400 mg/57 mg per 5 mL
oral suspension 125 mg/31.25 mg per 5 mL
or 250 mg/62.5 mg per 5 mL
oral suspension Otitis media*** sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day q12h 40 mg/kg/day q8h Less severe infections 25 mg/kg/day q12h 20 mg/kg/day q8hװ װThe q12h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES.) However, the q12 h formulations (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) contain aspartame and should not be used by phenylketonurics.
Pediatric patients weighing 40 kg and more:
***Duration of therapy studied and recommended for acute otitis media is 10 days.Should be dosed according to the following adult recommendations: The usual adult dose is one amoxicillin and clavulanate potassium tablet 500-mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250-mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875-mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500-mg/125 mg every 8 hours. Among adults treated with 875 mg/125 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg/125 mg every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for tablets of amoxicillin and clavulanate potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS .)
Adults:Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500-mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875-mg/125 mg tablet. See dosage recommendations above for children weighing 40 kg or more.
The 250-mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250-mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the 250-mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250-mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5), the 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg and more.
Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Bottle Size Amount of Water Required for Suspension
Amoxicillin and clavulanate Potassium 200 mg/28.5 mg per 5 mL Suspension50 mL
48 mL
75 mL 71 mL 100 mL 95 mLEach teaspoonful (5 mL) will contain 200 mg amoxicillin as the trihydrate and 28.5 mg of clavulanic acid as the potassium salt.
Amoxicillin and clavulanate Potassium 400 mg/57 mg per 5 mL Suspension
Bottle Size Amount of Water Required for Suspension 50 mL 45 mL 75 mL 68 mL 100 mL 90 mLEach teaspoonful (5 mL) will contain 400 mg amoxicillin as the trihydrate and 57 mg of clavulanic acid as the potassium salt.
Note: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
Administration:Amoxicillin and clavulanate potassium for oral suspension, USP, 200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension, USP, 200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, USP, 200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL should be taken at the start of a meal.
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Amoxicillin And Clavulanate Potassium | Aurobindo Pharma Limited
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should not be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet. Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.6)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
2.3 Patients with Renal Impairment
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet.
2.4 Directions for Mixing Oral Suspension
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the dose of amoxicillin and clavulanate potassium tablets 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each
Teaspoonful
(5 mL)
200 mg/28.5 mg per 5 mL
50 mL
75 mL
100 mL
52 mL
73 mL
98 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
50 mL
75 mL
100 mL
49 mL
70 mL
94 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. -
Sandoz Inc
Amoxicillin And Clavulanate Potassium | Sandoz Inc
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged < 12 weeks (< 3 months)
The recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older
See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
* Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg/5 mL or
400 mg/57 mg/5 mL oral suspension*
125 mg/31.25 mg/5 mL or 250 mg/62.5 mg/5 mL oral suspension*
Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg/5 mL
50 mL
75 mL
100 mL
47 mL
70 mL
93 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg/5 mL
50 mL
75 mL
100 mL
45 mL
67 mL
89 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Cbschem Limitd
Amoxicillin And Clavulanate Potassium | Cbschem Limitd
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Medvantx, Inc.
Amoxicillin And Clavulanate Potassium | Medvantx, Inc.
Amoxicillin/clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin/clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin/clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of amoxicillin/clavulanate potassium every 12 hours or one 250 mg tablet of amoxicillin/clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg tablet of amoxicillin/clavulanate potassium every 12 hours or one 500 mg tablet of amoxicillin/clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg tablet.
Two 250 mg tablets of amoxicillin/clavulanate potassium should not be substituted for one 500 mg tablet of amoxicillin/clavulanate potassium. Since both the 250 mg and 500 mg tablets of amoxicillin/clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets are not equivalent to one 500 mg tablet of amoxicillin/clavulanate potassium.
The 250 mg tablet of amoxicillin/clavulanate potassium and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg tablet of amoxicillin/clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg tablet of amoxicillin/clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin/clavulanate potassium should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (< 3 Months): The recommended dose of amoxicillin/clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
* Each strength of suspension of amoxicillin/clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.Table 1: Dosing in Patients Aged 12 Weeks (3 Months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspension*
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg tablet of amoxicillin/clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg tablet of amoxicillin/clavulanate potassium (250/125) versus the 250 mg chewable tablet of amoxicillin/clavulanate potassium (250/62.5).
2.3 Patients With Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg per 5 mL
100 mL
92 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
100 mL
87 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Ranbaxy Pharmaceuticals Inc.
Amoxicillin And Clavulanate Potassium | Ranbaxy Pharmaceuticals Inc.
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium.
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/5 mL and 400 mg/5 mL suspensions of amoxicillin and clavulanate potassium should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Dosage: Pediatric patients 3 months and older: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension,600 mg/42.9 mg per 5 mLproviding 90 mg/kg/day 8 3 mL twice daily 12 4.5 mL twice daily 16 6 mL twice daily 20 7.5 mL twice daily 24 9 mL twice daily 28 10.5 mL twice daily 32 12 mL twice daily 36 13.5 mL twice dailyPediatric patients weighing 40 kg and more: Experience with amoxicillin and clavulanate potassium for oral suspension (600 mg/42.9 mg per 5 mL formulation) in this group is not available.
Adults: Experience with amoxicillin and clavulanate potassium for oral suspension (600 mg/42.9 mg per 5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension (600 mg/42.9 mg per 5 mL) in place of the 500 mg or 875 mg tablet of amoxicillin and clavulanate potassium .
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (See WARNINGS).
Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/42.9 mg per 5 mL) Bottle Size Amount of Water Required for Suspension 50 mL 44 mL 75 mL 65 mL 100 mL 87 mL 125 mL 112 mL 150 mL 129 mL 200 mL 174 mLEach teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Administration: To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mLis administered at the start of a meal.
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West-ward Pharmaceutical Corp
Amoxicillin And Clavulanate Potassium | West-ward Pharmaceutical Corp
Amoxicillin and clavulanate potassium suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium suspension should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250-mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.
The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium suspension should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium suspension 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hours regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hours suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION DOSING REGIMEN Every 12 hours Every 8 hours 200 mg/5 mL or 400 mg/5 mL oral suspensiona 125 mg/5 mL or 250 mg/5 mL oral suspensiona Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hoursa Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water for Reconstitution Contents of Each Teaspoonful (5 mL) 200 mg/5 mL 50 mL
75 mL
100 mL 48 mL
71 mL
95 mL 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt 400 mg/5 mL 50 mL
75 mL
100 mL 45 mL
68 mL
90 mL 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium saltNote: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Clinical Solutions Wholesale
Amoxicillin And Clavulanate Potassium | Apotheca Company
DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
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Physicians Total Care, Inc.
Amoxicillin And Clavulanate Potassium | Physicians Total Care, Inc.
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.
The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1. Dosing in Patients Aged 12 weeks (3 months) and Older * Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.DOSING REGIMEN
Every 12 hours
Every 8 hours
INFECTION200 mg/5 mL or
400 mg/5 mL
oral suspension*125 mg/5 mL or
250 mg/5 mL
oral suspension*Otitis media, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day
every 12 hours40 mg/kg/day
every 8 hoursLess severe infections
25 mg/kg/day
every 12 hours20 mg/kg/day
every 8 hoursPatients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250 mg/125 mg) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250 mg/62.5 mg).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2. Amount of Water for Mixing Oral Suspension
Strength
Bottle SizeAmount of
Water for
Reconstitution
Contents of Each
Teaspoonful (5 mL)200 mg/5 mL
100 mL
88 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
100 mL
84 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Clinical Solutions Wholesale
Amoxicillin And Clavulanate Potassium | Clinical Solutions Wholesale
Amoxicillin and Clavulanate Potassium, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AMOXICILLIN AND CLAVULANATE POTASSIUM contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM should not be substituted for Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage: Pediatric patients 3 months and older:Based on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium
600 mg/42.9 mg per 5 mL
providing 90 mg/kg/day8
3.0 mL twice daily
12
4.5 mL twice daily
16
6.0 mL twice daily
20
7.5 mL twice daily
24
9.0 mL twice daily
28
10.5 mL twice daily
32
12.0 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and more:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in this group is not available.
Adults:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of AMOXICILLIN AND CLAVULANATE POTASSIUM.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral Suspension:Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium (600 mg/5 mL Suspension)Bottle Size
Amount of Water
Required for Reconstitution75 mL
70 mL
125 mL
110 mL
200 mL
180 mL
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist:For patients who wish to alter the taste of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.
Administration:To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Morton Grove Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Morton Grove Pharmaceuticals, Inc.
Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions of amoxicillin and clavulanate potassium should not be substituted for Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Dosage Pediatric patients 3 months and olderBased on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL Providing 90 mg/kg/day 8 3 mL twice daily 12 4.5 mL twice daily 16 6 mL twice daily 20 7.5 mL twice daily 24 9 mL twice daily 28 10.5 mL twice daily 32 12 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and moreExperience with Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL formulation in this group is not available.
AdultsExperience with Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL formulation in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL in place of the 500 mg/125 mg or 875 mg/125 mg tablet of amoxicillin and clavulanate potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 47 mL 75 mL 67 mL 100 mL 87 mL 125 mL 110 mL 150 mL 128 mL 200 mL 175 mLEach teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
AdministrationTo minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Clinical Solutions Wholesale
Amoxicillin And Clavulanate Potassium | Clinical Solutions Wholesale
Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500-mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250-mg and 500-mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Amoxicillin and Clavulanate Potassium.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
a Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250-mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Waterfor Reconstitution
Contents of EachTeaspoonful (5 mL)
125 mg/5 mL
75 mL100 mL150 mL
67 mL90 mL134 mL
125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt
200 mg/5 mL
50 mL75 mL100 mL
50 mL75 mL95 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
250 mg/5 mL
75 mL100 mL150 mL
65 mL87 mL130 mL
250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
50 mL75 mL100 mL
50 mL70 mL90 mL
400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Aidarex Pharmaceuticals Llc
Amoxicillin And Clavulanate Potassium | Aidarex Pharmaceuticals Llc
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should not be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet. Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.6)].
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
2.3 Patients with Renal Impairment
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet.
2.4 Directions for Mixing Oral Suspension
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the dose of amoxicillin and clavulanate potassium tablets 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each
Teaspoonful
(5 mL)
200 mg/28.5 mg per 5 mL
50 mL
75 mL
100 mL
52 mL
73 mL
98 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
50 mL
75 mL
100 mL
49 mL
70 mL
94 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. -
Aidarex Pharmaceuticals Llc
Amoxicillin And Clavulanate Potassium | Aidarex Pharmaceuticals Llc
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should not be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet. Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.6)].
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
2.3 Patients with Renal Impairment
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet.
2.4 Directions for Mixing Oral Suspension
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the dose of amoxicillin and clavulanate potassium tablets 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each
Teaspoonful
(5 mL)
200 mg/28.5 mg per 5 mL
50 mL
75 mL
100 mL
52 mL
73 mL
98 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
50 mL
75 mL
100 mL
49 mL
70 mL
94 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. -
Aidarex Pharmaceuticals Llc
Amoxicillin And Clavulanate Potassium | Aidarex Pharmaceuticals Llc
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should not be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet. Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.6)].
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
2.3 Patients with Renal Impairment
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet.
2.4 Directions for Mixing Oral Suspension
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the dose of amoxicillin and clavulanate potassium tablets 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each
Teaspoonful
(5 mL)
200 mg/28.5 mg per 5 mL
50 mL
75 mL
100 mL
52 mL
73 mL
98 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
50 mL
75 mL
100 mL
49 mL
70 mL
94 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. -
Aidarex Pharmaceuticals Llc
Amoxicillin And Clavulanate Potassium | Aidarex Pharmaceuticals Llc
Amoxicillin and Clavulanate Potassium, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AMOXICILLIN AND CLAVULANATE POTASSIUM contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM should not be substituted for Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage: Pediatric patients 3 months and older:Based on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium
600 mg/42.9 mg per 5 mL
providing 90 mg/kg/day 8 3.0 mL twice daily 12 4.5 mL twice daily 16 6.0 mL twice daily 20 7.5 mL twice daily 24 9.0 mL twice daily 28 10.5 mL twice daily 32 12.0 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and more:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in this group is not available.
Adults:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of AMOXICILLIN AND CLAVULANATE POTASSIUM.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral Suspension:Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium (600 mg/5 mL Suspension) Bottle Size Amount of Water
Required for Reconstitution 75 mL 70 mL 125 mL 110 mL 200 mL 180 mLEach teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist:For patients who wish to alter the taste of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.
Administration:To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Aidarex Pharmaceuticals Llc
Amoxicillin And Clavulanate Potassium | Aidarex Pharmaceuticals Llc
Amoxicillin and Clavulanate Potassium, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AMOXICILLIN AND CLAVULANATE POTASSIUM contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM should not be substituted for Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage: Pediatric patients 3 months and older:Based on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium
600 mg/42.9 mg per 5 mL
providing 90 mg/kg/day 8 3.0 mL twice daily 12 4.5 mL twice daily 16 6.0 mL twice daily 20 7.5 mL twice daily 24 9.0 mL twice daily 28 10.5 mL twice daily 32 12.0 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and more:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in this group is not available.
Adults:Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of AMOXICILLIN AND CLAVULANATE POTASSIUM.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral Suspension:Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium (600 mg/5 mL Suspension) Bottle Size Amount of Water
Required for Reconstitution 75 mL 70 mL 125 mL 110 mL 200 mL 180 mLEach teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist:For patients who wish to alter the taste of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.
Administration:To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Sandoz Inc
Amoxicillin And Clavulanate Potassium | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
2.1 Important Administration InstructionsLevetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution) and renal function.
Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.
When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.
2.2 Partial Onset Seizures Adults 16 Years and OlderIn clinical trials, daily doses of 1000 mg, 2000 mg and 3000 mg, given as twice daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.
Treatment should be initiated with a daily dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
Pediatric PatientsDosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
4 Years to < 16 Years: Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
For levetiracetam tablet dosing in pediatric patients weighing 20 kg to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).
Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients
The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:
2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic EpilepsyTreatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.
2.4 Primary Generalized Tonic-Clonic Seizures Adults 16 Years and OlderTreatment should be initiated with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
Pediatric Patients Ages 6 to < 16 YearsTreatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.
2.5 Adult Patients with Impaired Renal FunctionLevetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
Then CLcr is adjusted for body surface area (BSA) as follows:
Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function
Group
Creatinine Clearance
(mL/min/1.73m2)Dosage (mg)
Frequency
Normal
> 80
500 to 1500
Every 12 hours
Mild
50 to 80
500 to 1000
Every 12 hours
Moderate
30 to 50
250 to 750
Every 12 hours
Severe
< 30
250 to 500
Every 12 hours
ESRD patients using dialysis
---
500 to 10001
Every 24 hours1
1 Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.
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Sandoz Inc
Amoxicillin And Clavulanate Potassium | Sandoz Inc
Amoxicillin and Clavulanate Potassium Extended Release Tablets should be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance. Amoxicillin and Clavulanate Potassium Extended Release Tablets are not recommended to be taken with a high‑fat meal, because clavulanate absorption is decreased. [see Clinical Pharmacology (12.3)].
2.1 AdultsThe recommended dose of Amoxicillin and Clavulanate Potassium Extended Release Tablets is 4,000 mg/250 mg daily according to the following table:
Indication
Dose
Duration
Acute bacterial sinusitis
2 tablets q12h
10 days
Community‑acquired pneumonia
2 tablets q12h
7-10 days
Tablets of Amoxicillin and Clavulanate Potassium Tablets (250 mg or 500 mg) CANNOT be used to provide the same dosages as Amoxicillin and Clavulanate Potassium Extended Release Tablets. This is because Amoxicillin and Clavulanate Potassium Extended Release Tablets contains 62.5 mg of clavulanic acid, while the Amoxicillin and Clavulanate Potassium 250-mg and 500-mg tablets each contain 125 mg of clavulanic acid. In addition, the Extended Release Tablet provides an extended time course of plasma amoxicillin concentrations compared to immediate-release tablets. Thus, two Amoxicillin and Clavulanate Potassium 500-mg tablets are not equivalent to one Amoxicillin and Clavulanate Potassium Extended Release tablet.
Scored Amoxicillin and Clavulanate Potassium Extended Release Tablets are available for adult patients who have difficulty swallowing. The scored tablet is not intended to reduce the dosage of medication taken; as stated in the table above, the recommended dose of Amoxicillin and Clavulanate Potassium Extended Release Tablets is two tablets twice a day (every 12 hours).
2.2 Renally Impaired PatientsThe pharmacokinetics of Amoxicillin and Clavulanate Potassium Extended Release Tablets have not been studied in patients with renal impairment. Amoxicillin and Clavulanate Potassium Extended Release Tablets are contraindicated in patients with a creatinine clearance of <30 mL/min and in hemodialysis patients [see Contraindications (4)].
2.3 Hepatically Impaired PatientsHepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see Warnings and Precautions (5.3)].
2.4 Pediatric UsePediatric patients who weigh 40 kg or more and can swallow tablets should receive the adult dose [see Use in Specific Populations (8.4)].
2.5 Geriatric UseNo dosage adjustment is required for the elderly [see Use in Specific Populations (8.5)].
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Proficient Rx Lp
Amoxicillin And Clavulanate Potassium | Proficient Rx Lp
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 Adults
2.2 Pediatric Patients
The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.
b Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensionaOtitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
Morton Grove Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Morton Grove Pharmaceuticals, Inc.
Amoxicillin and Clavulanate Potassium for Oral Suspension 250 mg/62.5 mg per 5 mL may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension 250 mg/62.5 mg per 5 mL is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension 250 mg/62.5 mg per 5 mL should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg suspension or the 400 mg/57 mg suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium.
The 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium and the 250 mg /62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium for Oral Suspension 250 mg/62.5 mg per 5 mL should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 250 mg/62.5 mg per 5 mL is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older INFECTION DOSING REGIMEN Every 12 hours Every 8 hours 200 mg/28.5 mg per 5 mL or 400 mg/57mg per 5 mL oral suspension* 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspension* * Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days. Otitis mediab†, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hoursPatients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet (250/125) versus the 250-mg chewable tablet of (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water for Reconstitution Contents of Each Teaspoonful (5 mL) Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. 250 mg/5 mL 75 mL
100 mL
150 mL 68 mL
86 mL
128 mL 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt -
Proficient Rx Lp
Amoxicillin And Clavulanate Potassium | Proficient Rx Lp
Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be substituted for one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet. Since both the 250 mg/125 mg and 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium for Oral Suspension should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (< 3 Months): The recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
* Each strength of suspension of Amoxicillin and Clavulanate Potassium for Oral Suspension is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.Table 1: Dosing in Patients Aged 12 Weeks (3 Months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL
oral suspension*125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL
oral suspensionaOtitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets (250/125) versus the 250 mg/62.5 mg Amoxicillin and Clavulanate Potassium Tablets (Chewable) (250/62.5).
2.3 Patients With Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg per 5 mL
100 mL
92 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
100 mL
87 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Amoxicillin and clavulanate potassium suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium suspension should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250-mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.
The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium suspension should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months) : The recommended dose of amoxicillin and clavulanate potassium suspension 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older : See dosing regimens provided in Table 1. The every 12 hours regimen is recommended as it is associated with significantly less diarrhea [ see Clinical Studies (14.2) ]. However, the every 12 hours suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [ see Warnings and Precautions (5.6) ]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTIONDOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.Patients Weighing 40 kg or More : Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral SuspensionStrength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/5 mL
50 mL
75 mL
100 mL48 mL
71 mL
95 mL200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
50 mL
75 mL
100 mL45 mL
68 mL
90 mL400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Northstar Rx Llc
Amoxicillin And Clavulanate Potassium | Northstar Rx Llc
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should not be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet. Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.6)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
2.3 Patients with Renal Impairment
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet.
2.4 Directions for Mixing Oral Suspension
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the dose of amoxicillin and clavulanate potassium tablets 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each
Teaspoonful
(5 mL)
200 mg/28.5 mg per 5 mL
50 mL
75 mL
100 mL
52 mL
73 mL
98 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
50 mL
75 mL
100 mL
49 mL
70 mL
94 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. -
Dr. Reddy’s Laboratories Inc
Amoxicillin And Clavulanate Potassium | Dr. Reddy's Laboratories Inc
Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500-mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250-mg and 500-mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Amoxicillin and Clavulanate Potassium.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION DOSING REGIMEN Every 12 hours Every 8 hours 200 mg/5 mL or 400 mg/5 mL oral suspensiona 125 mg/5 mL or 250 mg/5 mL oral suspensiona Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hoursa Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250-mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength Bottle Size Amount of Waterfor Reconstitution Contents of EachTeaspoonful (5 mL) 125 mg/5 mL 75 mL100 mL150 mL 67 mL90 mL134 mL 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt 200 mg/5 mL 50 mL75 mL100 mL 50 mL75 mL95 mL 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt 250 mg/5 mL 75 mL100 mL150 mL 65 mL87 mL130 mL 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt 400 mg/5 mL 50 mL75 mL100 mL 50 mL70 mL90 mL 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium saltNote: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Northwind Pharmaceuticals. Llc
Amoxicillin And Clavulanate Potassium | Northwind Pharmaceuticals. Llc
VIEW THE MANUFACTURER'S COMPLETE DRUG INFORMATION AT THE FDA SITE:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=963e7bea-ff5d-420a-9cb2-e4aefb534b33
DOSAGE AND ADMINISTRATION
Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be substituted for one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet. Since both the 250 mg/125 mg and 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, Amoxicillin and Clavulanate Potassium for Oral Suspension should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (< 3 Months): The recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets (250/125) versus the 250 mg/62.5 mg Amoxicillin and Clavulanate Potassium Tablets (Chewable) (250/62.5).
2.3 Patients With Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Teva Pharmaceuticals Usa Inc
Amoxicillin And Clavulanate Potassium | Teva Pharmaceuticals Usa Inc
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium.. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions should notbe substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage: Pediatric patients 3 months and older: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below). This dose provides 6.4 mg/kg/day of the clavulanic acid component.
BodyWeight (kg)
Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Powder for Oral Suspension providing 90 mg/kg/day
8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and more:Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in this group is not available.
Adults:Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500 mg or 875 mg tablet.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see WARNINGS and PRECAUTIONS (5)].
Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Powder for Oral Suspension
Bottle Size
Amount of Water Required for Reconstitution
75 mL
68 mL
125 mL
108 mL
200 mL
170 mL
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist: For patients who wish to alter the taste of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 ml, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the five flavors listed above.
Administration: To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Hikma Pharmaceutical
Amoxicillin And Clavulanate Potassium | Actient Pharmaceuticals, Llc
Prior to initiating, Striant confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
2.1 Dosage InformationThe recommended dosage for Striant is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart).
To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured at 4 to 12 weeks after initiation of therapy to ensure proper serum testosterone concentrations are achieved. Striant therapy should be discontinued if serum testosterone concentrations are consistently outside of the normal range (300 to 1050 ng/dL) despite the use of one buccal system applied twice daily.
2.2 Administration InstructionsStriant should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Striant should be rotated to alternate sides of the mouth.
Upon opening the packet, the rounded side surface of the buccal system should be placed against the gum and held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion. Striant is designed to stay in position until removed. If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old buccal system should be removed and a new one applied.
If the buccal system falls out of position within the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours then continue with the next regularly scheduled dosing.
Patients should take care to avoid dislodging the buccal system. Patients should check to see if Striant is in place following consumption of food or alcoholic/non-alcoholic beverages. Striant should not be chewed or swallowed. To remove Striant, gently slide it downwards from the gum toward the tooth to avoid scratching the gum. The Striant buccal system should be removed before routine morning and evening oral care is performed, followed by application of a new buccal system.
2.1 Dosage InformationThe recommended dosage for Striant is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart).
To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured at 4 to 12 weeks after initiation of therapy to ensure proper serum testosterone concentrations are achieved. Striant therapy should be discontinued if serum testosterone concentrations are consistently outside of the normal range (300 to 1050 ng/dL) despite the use of one buccal system applied twice daily.
2.2 Administration InstructionsStriant should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Striant should be rotated to alternate sides of the mouth.
Upon opening the packet, the rounded side surface of the buccal system should be placed against the gum and held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion. Striant is designed to stay in position until removed. If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old buccal system should be removed and a new one applied.
If the buccal system falls out of position within the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours then continue with the next regularly scheduled dosing.
Patients should take care to avoid dislodging the buccal system. Patients should check to see if Striant is in place following consumption of food or alcoholic/non-alcoholic beverages. Striant should not be chewed or swallowed. To remove Striant, gently slide it downwards from the gum toward the tooth to avoid scratching the gum. The Striant buccal system should be removed before routine morning and evening oral care is performed, followed by application of a new buccal system.
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Teva Pharmaceuticals Usa Inc
Amoxicillin And Clavulanate Potassium | Teva Pharmaceuticals Usa Inc
Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be substituted for one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet. Since both the 250 mg/125 mg and 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium for Oral Suspension should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (< 3 Months): The recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
* Each strength of Amoxicillin and Clavulanate Potassium for Oral Suspension is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.Table 1: Dosing in Patients Aged 12 Weeks (3 Months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL
oral suspension*125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL
oral suspension*Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets (250/125) versus the 250 mg/62.5 mg Amoxicillin and Clavulanate Potassium Tablets (Chewable) (250/62.5).
2.3 Patients With Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg per 5 mL
100 mL
92 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
100 mL
87 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Northstar Rx Llc
Amoxicillin And Clavulanate Potassium | Phibro Animal Health
Mixing Directions—Swine
Stafac 50 Type A Medicated Article must be thoroughly mixed in the feed to assure even distribution. Determine the appropriate amount of Stafac 50 required from the table below. Dilute Stafac 50 with a portion of one of the feed ingredients (enough to make a quantity equal to 10 lb per ton) before final mixing.
Swine
Required level of virginiamycin activity per ton of Type C Medicated Feed (complete feed)
Required amount of Stafac 50 per ton of Type C Medicated Feed (complete feed)
Amount of virginiamycin activity provided to animal per lb of body weight per day
Continuous Feed Programs From Weaning to Market Weight
Weaning to 120 lb
Increased rate of weight gain and improved feed efficiency
10 g
90 g
120 lb to market weight
Increased rate of weight gain
Improved feed efficiency
5-10 g
5 g
45-90 g
45 g
Treatment of swine dysentery in nonbreeding swine weighing over 120 lb
100 g for
2 weeks
2 lb
2.27 mg
Treatment and control of swine dysentery in swine weighing up to 120 lb
100 g for 2 weeks followed by 50 g
2 lb
1 lb
2.27 mg
1.14 mg
Aid in control of swine dysentery in swine weighing up to 120 lb
For use in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred
25 g
8 oz
0.57 mg
CAUTION: Not for use in breeding swine over 120 lbs.
Mixing Directions—Poultry
Mix 1 lb of Stafac 50 with 9 lb of feed ingredients to make 10 lb of an intermediate mix to contain 5 g/lb virginiamycin. Add 1 lb of the intermediate feed premix for each 5 g of virginiamycin needed to medicate a ton of feed.
Poultry
Required level of virginiamycin activity per ton of Type C Medicated Feed (complete feed)
Required amount of Stafac 50 per ton of Type C Medicated Feed (complete feed)
For use in broiler chickens
Increased rate of weight gain
5-15 g
45-135 g
Improved feed efficiency
5 g
45 g
Prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin
20 g
180 g
Not for Use in Laying Chickens
For use in growing turkeys
Increased rate of weight gain and improved feed efficiency
10-20 g
90-180 g
Feed Continuously as Sole Ration
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Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be substituted for one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet. Since both the 250 mg/125 mg and 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium for Oral Suspension should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (< 3 Months): The recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
* Each strength of suspension of Amoxicillin and Clavulanate Potassium for Oral Suspension is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.Table 1: Dosing in Patients Aged 12 Weeks (3 Months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL
oral suspension*125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL
oral suspensionaOtitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets (250/125) versus the 250 mg/62.5 mg Amoxicillin and Clavulanate Potassium Tablets (Chewable) (250/62.5).
2.3 Patients With Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg per 5 mL
100 mL
92 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
100 mL
87 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
-
Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500-mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250-mg and 500-mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Amoxicillin and Clavulanate Potassium.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
a Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250-mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Waterfor Reconstitution
Contents of EachTeaspoonful (5 mL)
125 mg/5 mL
75 mL100 mL150 mL
67 mL90 mL134 mL
125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt
200 mg/5 mL
50 mL75 mL100 mL
50 mL75 mL95 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
250 mg/5 mL
75 mL100 mL150 mL
65 mL87 mL130 mL
250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
50 mL75 mL100 mL
50 mL70 mL90 mL
400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
-
Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 Adults
2.2 Pediatric Patients
The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.
b Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensionaOtitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500-mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250-mg and 500-mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Amoxicillin and Clavulanate Potassium.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
a Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250-mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Waterfor Reconstitution
Contents of EachTeaspoonful (5 mL)
125 mg/5 mL
75 mL100 mL150 mL
67 mL90 mL134 mL
125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt
200 mg/5 mL
50 mL75 mL100 mL
50 mL75 mL95 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
250 mg/5 mL
75 mL100 mL150 mL
65 mL87 mL130 mL
250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
50 mL75 mL100 mL
50 mL70 mL90 mL
400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
-
Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
2.2 Pediatric Patients
Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should not be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet. Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.Based on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.6)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspensiona125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspensionaOtitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
2.3 Patients with Renal Impairment
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet.
2.4 Directions for Mixing Oral Suspension
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the dose of amoxicillin and clavulanate potassium tablets 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral SuspensionStrength
Bottle Size
Amount of Water for Reconstitution
Contents of Each
Teaspoonful
(5 mL)200 mg/28.5 mg per 5 mL
50 mL
75 mL
100 mL52 mL
73 mL
98 mL200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
50 mL
75 mL
100 mL49 mL
70 mL
94 mL400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. -
Preferred Pharmaceuticals, Inc.
Amoxicillin And Clavulanate Potassium | Preferred Pharmaceuticals, Inc.
Dosage
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other amoxicillin and clavulanate potassium suspensions. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Body Weight
Pediatric patients 3 months and older
Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
(kg) Volume of Amoxicillin and Clavulanate
Potassium for Oral Suspension,
600 mg/42.9 mg per 5 mL providing
90 mg/kg/day8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL
Pediatric patients weighing 40 kg and more
Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in this group is not available.
Adults
Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500 mg or 875 mg tablet.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.Bottle Size
Amount of Water
Required for Reconstitution75 mL
71 mL
125 mL
112 mL
200 mL
176 mL
Administration
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is administered at the start of a meal. -
Medsource Pharmaceuticals
Amoxicillin And Clavulanate Potassium | Medsource Pharmaceuticals
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 Adults
2.2 Pediatric Patients
The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)] . However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics .
b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or
400 mg/57 mg per 5 mL oral suspension a
125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL oral suspension a
Otitis media b, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
Proficient Rx Lp
Amoxicillin And Clavulanate Potassium | Proficient Rx Lp
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged < 12 weeks (< 3 months)
The recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older
See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
* Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg/5 mL or
400 mg/57 mg/5 mL oral suspension*
125 mg/31.25 mg/5 mL or 250 mg/62.5 mg/5 mL oral suspension*
Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg/5 mL
50 mL
75 mL
100 mL
47 mL
70 mL
93 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg/5 mL
50 mL
75 mL
100 mL
45 mL
67 mL
89 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
-
Blenheim Pharmacal, Inc.
Amoxicillin And Clavulanate Potassium | Blenheim Pharmacal, Inc.
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged < 12 weeks (< 3 months)
The recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older
See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies ( 14.2) ].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
* Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg/5 mL or
400 mg/57 mg/5 mL oral suspension *
125 mg/31.25 mg/5 mL or 250 mg/62.5 mg/5 mL oral suspension *
Otitis media †, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral SuspensionPrepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg/5 mL
50 mL
75 mL
100 mL
47 mL
70 mL
93 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg/5 mL
50 mL
75 mL
100 mL
45 mL
67 mL
89 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
-
Lek Pharmaceuticals, D.d.
Amoxicillin And Clavulanate Potassium | Lek Pharmaceuticals, D.d.
Amoxicillin and clavulanate potassium tablets, USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets, USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets, USP should be taken at the start of a meal.
2.1 AdultsThe usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium tablets, USP should not be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium tablets, USP. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium tablets, USP contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium tablets, USP.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium tablets, USP and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium tablets, USP and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium tablets, USP contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric PatientsBased on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months)
The recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older
See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see CLINICAL STUDIES (14.2)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
* Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg/5 mL or
400 mg/57 mg/5 mL oral suspension*
125 mg/31.25 mg/5 mL or 250 mg/62.5 mg/5 mL oral suspension*
Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium tablets, USP should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium tablets, USP (250/125) versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium tablets, USP (250/62.5).
2.3 Patients with Renal ImpairmentPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
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