Augmentin Chewable Dosage

Generic name: amoxicillin and clavulanate potassium
Dosage form: tablets, chewable and powder, for suspension

Dosage

Pediatric Patients

Based on the amoxicillin component, AUGMENTIN 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 AUGMENTIN 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/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
INFECTIONS	q12ha	q8h
	200 mg/5 mL or 400 mg/5 mL oral suspensionb	125 mg/5 mL or 250 mg/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 q8h

a 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 AUGMENTIN 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 tablet of AUGMENTIN every 12 hours or one 250-mg tablet of AUGMENTIN every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of AUGMENTIN every 12 hours or one 500-mg tablet of AUGMENTIN 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 tablets of AUGMENTIN.

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 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of AUGMENTIN contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the 250-mg tablet of AUGMENTIN 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 the 250-mg tablet of AUGMENTIN (250/125) versus the 250-mg chewable tablet of AUGMENTIN (250/62.5), the 250-mg tablet of AUGMENTIN 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.

AUGMENTIN 125 mg/5 mL Suspension
Bottle Size	Amount of Water Required for Reconstitution
75 mL	67 mL
100 mL	90 mL
150 mL	134 mL

Each teaspoonful (5 mL) will contain 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt.

AUGMENTIN 200 mg/5 mL Suspension
Bottle Size	Amount of Water Required for Reconstitution
50 mL	50 mL
75 mL	75 mL
100 mL	95 mL

Each teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt.

AUGMENTIN 250 mg/5 mL Suspension
Bottle Size	Amount of Water Required for Reconstitution
75 mL	65 mL
100 mL	87 mL
150 mL	130 mL

Each teaspoonful (5 mL) will contain 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt.

AUGMENTIN 400 mg/5 mL Suspension
Bottle Size	Amount of Water Required for Reconstitution
50 mL	50 mL
75 mL	70 mL
100 mL	90 mL

Each 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

AUGMENTIN may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when AUGMENTIN is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, AUGMENTIN should be taken at the start of a meal.

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