Amoxicillin Capsule Amoxicillin

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Side Effects & Adverse Reactions

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH AMOXICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin capsules, amoxicillin for oral suspension, or amoxicillin tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below:

Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis.

Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli

Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females).

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple Therapy

Amoxicillin/clarithromycin/lansoprazole

Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

Dual Therapy

Amoxicillin/lansoprazole

Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent 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.

Indicated surgical procedures should be performed.

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History

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Other Information

Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:

The amoxicillin molecular formula is C16H19N3O5S • 3H2O, and the molecular weight is 419.45.

Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.

Capsules

Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide; Capsule contents - cellulose microcrystalline and magnesium stearate.

Meets USP Dissolution Test 2.

Tablets

Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped, unscored and white to yellowish. The 500 mg tablet is embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide.

Powder for Oral Suspension

Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium.

Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.

Sources

Amoxicillin Capsule Amoxicillin Manufacturers

Physicians Total Care, Inc.

Amoxicillin Capsule Amoxicillin | Physicians Total Care, Inc.

Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.
Neonates and Infants Aged ≤12 Weeks (≤3 Months)
Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

Adults and Pediatric Patients >3 Months Infection Severity Usual Adult Dose Usual Dose for Children > 3 months Ear/Nose/
Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
or
20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
or
20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
or
20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.
After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

Larger doses may be required for stubborn or severe infections.
General
It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological followup for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole
The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)
Dual Therapy Amoxicillin/lansoprazole
The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.
Dosing Recommendations for Adults with Impaired Renal Function
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 or 250 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 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.

There are currently no dosing recommendations for pediatric patients with impaired renal function.
Directions for Mixing Oral Suspension
Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL Each teaspoonful (5 mL) will contain 125 mg amoxicillin. 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL Each teaspoonful (5 mL) will contain 200 mg amoxicillin. 250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL Each teaspoonful (5 mL) will contain 250 mg amoxicillin.
400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL Each teaspoonful (5 mL) will contain 400 mg amoxicillin.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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Dr Reddys Laboratories Inc

Amoxicillin Capsule Amoxicillin | Dr Reddys Laboratories Inc

Capsules, and oral suspensions of AMOXICILLIN may be given without regard to meals. The 400-mg suspension, and the 875-mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.
Neonates and Infants Aged ≤12 Weeks (≤3 Months):
Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of AMOXICILLIN is 30 mg/kg/day divided q12h.
Adults and Pediatric Patients >3 Months: Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months† * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or
250 mg every 8 hours 25 mg/kg/day in divided doses
every 12 hours
or
20 mg/kg/day in divided doses
every 8 hours Severe 875 mg every 12 hours or
500 mg every 8 hours 45 mg/kg/day in divided doses
every 12 hours
or
40 mg/kg/day in divided doses
every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or
500 mg every 8 hours 45 mg/kg/day in divided doses
every 12 hours
or
40 mg/kg/day in divided doses
every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or
250 mg every 8 hours 25 mg/kg/day in divided doses
every 12 hours
or
20 mg/kg/day in divided doses
every 8 hours Severe 875 mg every 12 hours or
500 mg every 8 hours 45 mg/kg/day in divided doses
every 12 hours
or
40 mg/kg/day in divided doses
every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or
250 mg every 8 hours 25 mg/kg/day in divided doses
every 12 hours
or
20 mg/kg/day in divided doses
every 8 hours Severe 875 mg every 12 hours or
500 mg every 8 hours 45 mg/kg/day in divided doses
every 12 hours
or
40 mg/kg/day in divided doses
every 8 hours Gonorrhea
Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
50 mg/kg AMOXICILLIN, combined with
25 mg/kg probenecid as a single dose.
NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.
After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)

Larger doses may be required for stubborn or severe infections.
General:
It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:
Triple Therapy: AMOXICILLIN/clarithromycin/lansoprazole

The recommended adult oral dose is 1 gram AMOXICILLIN, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

Dual Therapy: AMOXICILLIN/lansoprazole

The recommended adult oral dose is 1 gram AMOXICILLIN and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.
Dosing Recommendations for Adults with Impaired Renal Function:
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 tablet. 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 less than 10 mL/min. glomerular filtration rate 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.

There are currently no dosing recommendations for pediatric patients with impaired renal function.
Directions for Mixing Oral Suspension:
Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
125 mg/5 mL Bottle Size Amount of Water
Required for Reconstitution 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Each teaspoonful (5 mL) will contain 125 mg amoxicillin. 200 mg/5 mL Bottle Size Amount of Water
Required for Reconstitution 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Each teaspoonful (5 mL) will contain 200 mg amoxicillin. 250 mg/5 mL Bottle Size Amount of Water
Required for Reconstitution 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Each teaspoonful (5 mL) will contain 250 mg amoxicillin. 400 mg/5 mL Bottle Size Amount of Water
Required for Reconstitution 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL Each teaspoonful (5 mL) will contain 400 mg amoxicillin.
After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of adminstration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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Sandoz Inc

Amoxicillin Capsule Amoxicillin | Sandoz Inc

2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity* Usual Adult Dose Usual Dose for Children
> 3 Months† * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract
Mild/Moderate
500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe
875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
or

40 mg/kg/day in divided doses

every 8 hours

Gonorrhea

Acute, uncomplicated

ano-genital and urethral infections in males and females

3 grams as single oral dose

Prepubertal children:

50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
2.3 Dosing for H. pylori Infection
Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information.
2.4 Dosing in Renal Impairment • 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 a 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. 2.5 Directions for Mixing Oral Suspension
Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet 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 Required for Reconstitution
Oral Suspension 125 mg/5 mL

80 mL

55 mL

100 mL

68 mL

150 mL

102 mL

Oral Suspension 200 mg/5 mL

50 mL

34 mL

75 mL

51 mL

100 mL

68 mL

Oral Suspension 250 mg/5 mL

80 mL

55 mL

100 mL

68 mL

150 mL

102 mL

Oral Suspension 400 mg/5 mL

50 mL

34 mL

75 mL

51 mL

100 mL

68 mL

After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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Dava Pharmaceuticals Inc

Amoxicillin Capsule Amoxicillin | Pd-rx Pharmaceuticals, Inc.

For most patients, the recommended dose of Cyclobenzaprine hydrochloride tablets, USP is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of Cyclobenzaprine hydrochloride tablets, USP for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).

Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and PRECAUTIONS Use in the Elderly).

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Teva Pharmaceuticals Usa Inc

Amoxicillin Capsule Amoxicillin | Teva Pharmaceuticals Usa Inc

2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
Infection

Severity*

Usual Adult Dose

Usual Dose for Children > 3 Months†

Ear/Nose/Throat

Skin/Skin Structure

Genitourinary Tract

Mild/Moderate

500 mg every 12 hours
or

250 mg every 8 hours

25 mg/kg/day in divided doses every 12 hours

or

20 mg/kg/day in divided doses

every 8 hours

Severe

875 mg every 12 hours
or

500 mg every 8 hours

45 mg/kg/day in divided doses every 12 hours

or

40 mg/kg/day in divided doses

every 8 hours

Lower Respiratory

Tract

Mild/Moderate or

Severe

875 mg every 12 hours
or

500 mg every 8 hours

45 mg/kg/day in divided doses

every 12 hours

or

40 mg/kg/day in divided doses

every 8 hours

Gonorrhea

Acute, Uncomplicated Ano-Genital and Urethral Infections in Males and Females

3 grams as single oral dose

Prepubertal children:

50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
2.3 Dosing for H. pylori Infection
Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information.
2.4 Dosing in Renal Impairment • 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 a 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. 2.5 Directions for Mixing Oral Suspension
Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet 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

Required for Reconstitution

Oral Suspension 125 mg/5 mL

80 mL

62 mL

100 mL

77 mL

150 mL

113 mL

Oral Suspension 250 mg/5 mL

80 mL

47 mL

100 mL

60 mL

150 mL

90 mL

After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

No Recall