Augmentin Oral Suspension Dosage

Generic name: AMOXICILLIN 125mg in 5mL, CLAVULANATE POTASSIUM 31.25mg in 5mL
Dosage form: powder, for oral suspension
Drug class: Beta-lactamase inhibitors

Medically reviewed by Drugs.com. Last updated on Apr 17, 2024.

Important Administration Instructions

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.

Adult Patients

See dosing regimens of AUGMENTIN (based on the amoxicillin component) provided in Table 1 below.

Table 1. Dosing Regimens of AUGMENTIN in Adult Patients

TYPE OF INFECTION	DOSING REGIMEN OF Amoxicillin and Clavulanate Potassium
Severe infections and infections of the respiratory tract	one 875 mg tablet a of AUGMENTIN every 12 hours or one 500 mg tablet b,c of AUGMENTIN every 8 hours
Less severe infections	one 500 mg tablet b,c of AUGMENTIN every 12 hours or one 250 mg tablet d of AUGMENTIN every 8 hours

a Adults who have difficulty swallowing may be given the AUGMENTIN 200 mg/28.5 mg per 5 mL suspension or the AUGMENTIN 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.

b Adults who have difficulty swallowing may be given the AUGMENTIN 125 mg/31.25 mg per 5 mL or AUGMENTIN 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet.

c Two AUGMENTIN 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg AUGMENTIN tablet [see Dosage and Administration ( 2.6)] .

d AUGMENTIN 250 mg/125 mg tablet is NOT substitutable with AUGMENTIN 250 mg/62.5 mg chewable tablet [see Dosage and Administration ( 2.6)]

Pediatric Patients

Based on the amoxicillin component, AUGMENTIN should be dosed as follows:

Neonates and Infants Aged less than 12 weeks (less than 3 months): See dosing regimens of AUGMENTIN provided in Table 2 below.

Table 2: Dosing Regimens of AUGMENTIN in Neonates and Infants Aged Less than 12 Weeks (Less than 3 Months)

PATIENT POPULATION

DOSING REGIMEN

AUGMENTIN 125 mg/31.25 mg per 5 mL for oral suspensiona

Neonates and Infants aged less than 12

weeks (less than 3 months)

30 mg/kg/day every 12 hours

a Experience with the AUGMENTIN 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the AUGMENTIN 125 mg/31.25 mg per 5 mL for oral suspension is recommended.

Patients Aged 12 weeks (3 months) and Older and Weighing Less than 40 kg: See dosing regimens provided in Table 3 below.

The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies ( 14.2)] .
The Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg per 5 mL and Amoxicillin and Clavulanate Potassium 400 mg/57 mg per 5 mL) for oral suspension and Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg and Amoxicillin and Clavulanate Potassium 400 mg/57 mg chewable tablets contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions ( 5.7)].

Table 3: Dosing in Patients Aged 12 Weeks (3 Months) and Older and Weighing Less than 40 kg

Table

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 AUGMENTIN 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 AUGMENTIN versus the 250 mg/62.5 mg chewable tablet of AUGMENTIN.

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 (GFR) of less than 30 mL/min should NOT receive the 875 mg dose (based on the amoxicillin component) of AUGMENTIN. See dosing regimens in patients with severe renal impairment provided in Table 4.

Table 4. Dosing Regimens of AUGMENTIN in Patients with Severe Renal Impairment

Patients with Renal Impairment	Dosing Regimen
GFR 10 mL/min to 30 mL/min	500 mg or 250 mg every 12 hours, depending on the severity of the infection
GFR less than 10 mL/min	500 mg or 250 mg every 24 hours, depending on severity of the infection
Hemodialysis	500 mg or 250 mg every 24 hours, depending on severity of the infection Administer an additional dose both during and at the end of dialysis

Directions for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension

Prepare AUGMENTIN for oral suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure a total (see Table 5 below for total amount of water for reconstitution) OF WATER. Add approximately 2/3 of the water to the powder. Replace cap and shake VIGOROUSLY. Add remaining water. Replace cap and shake VIGOROUSLY.

Table 5: Amount of Water for Mixing AUGMENTIN for Oral Suspension

Strength of AUGMENTIN Oral Suspension	Bottle Size	Amount of Water for Reconstitution	Contents of Each Teaspoonful (5 mL)
125 mg/31.25 mg per 5 mL	75 mL 100 mL 150 mL	67 mL 90 mL 134 mL	125 mg of amoxicillin and 31.25 mg of clavulanic acid as the potassium salt

250 mg/62.5 mg per 5 mL	75 mL 100 mL 150 mL	65 mL 87 mL 130 mL	250 mg of amoxicillin and 62.5 mg of clavulanic acid as the potassium salt

Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. Some color change is normal during dosing period.

Switching between Dosage Forms and between Strengths

AUGMENTIN 250 mg/125 mg Tablet is NOT Substitutable with AUGMENTIN 250 mg/62.5 mg Chewable Tablet

The 250 mg/125 mg tablet of AUGMENTIN and the 250 mg/62.5 mg chewable tablet of AUGMENTIN should NOT be substituted for each other and the 250 mg/125 mg tablet of AUGMENTIN should NOT be used in pediatric patients weighing less than 40 kg [see Dosage and Administration ( 2.3)] . The 250 mg tablet of AUGMENTIN and the 250 mg chewable tablet of AUGMENTIN do not contain the same amount of clavulanic acid. The 250 mg tablet of AUGMENTIN contains 125 mg of clavulanic acid whereas the 250 mg chewable tablet of AUGMENTIN contains 62.5 mg of clavulanic acid.

Two AUGMENTIN 250 mg/125 mg Tablets are NOT Substitutable with One 500 mg/125 mg AUGMENTIN Tablet

Two 250 mg/125 mg tablets of AUGMENTIN should NOT be substituted for one 500 mg/125 mg tablet of AUGMENTIN. Since both the 250 mg and 500 mg tablets of AUGMNTIN contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of AUGMENTIN are not equivalent to one 500 mg tablet of AUGMENTIN.