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 Adults
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/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 Patients
Based 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 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.
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.