Source: FDA, National Drug Code (US) Revision Year: 2019
To reduce the development of drug‑resistant bacteria and maintain the effectiveness of AUGMENTIN (amoxicillin/clavulanate potassium) and other antibacterial drugs, AUGMENTIN 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.
AUGMENTIN is 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, AUGMENTIN should not be used.
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.
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. 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 AUGMENTIN should not be substituted for one 500 mg tablet of AUGMENTIN. Since both the 250 mg and 500 mg tablets of AUGMENTIN 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 AUGMENTIN.
The 250 mg tablet of AUGMENTIN and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable. 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.
Based on the amoxicillin component, AUGMENTIN should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of AUGMENTIN 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 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 |
a Each strength of suspension of AUGMENTIN 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 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 tablet of AUGMENTIN (250/125) versus the 250 mg chewable tablet of AUGMENTIN (250/62.5).
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 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.
Prepare a suspension at time of dispensing as follows: Tap bottle to loosen ALL powder. Measure a total (see Table 2 below for total amount of water for reconstitution) OF WATER. Add approximately ⅔ of the water to the powder. Replace cap and shake VIGOROUSLY. Add remaining water. Replace cap and shake VIGOROUSLY.
Table 2. Amount of Water for Mixing Oral Suspension:
| Strength | Bottle Size | Amount of Water for Contents of Each Teaspoonful (5 mL) | Reconstitution |
|---|---|---|---|
| 125 mg/5 mL | 75 mL | 67 mL | 125 mg amoxicillin and 31.25 mg of clavulamnic as the potassium salt |
| 100 mL | 90 mL | ||
| 150 mL | 134 mL | ||
| 200 mg/5 mL | 50 mL | 50 mL | 200 mg amoxicillin and 28.5 mg of clavulamnic as the potassium salt |
| 75 mL | 75 mL | ||
| 100 mL | 95 mL | ||
| 250 mg/5 mL | 75 mL | 65 mL | 250 mg amoxicillin and 62.5 mg of clavulamnic as the potassium salt |
| 100 mL | 87 mL | ||
| 150 mL | 130 mL | ||
| 400 mg/5 mL | 50 mL | 50 mL | 400 mg amoxicillin and 57.0 mg of clavulamnic as the potassium salt |
| 75 mL | 70 mL | ||
| 100 mL | 90 mL |
Note: 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.
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms1.
Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin/clavulanate potassium.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin/clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin/clavulanate potassium crystalluria.
Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin/clavulanate potassium. Amoxicillin/clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration (2.3)].
Store tablets and dry powder at or below 25°C (77°F).
Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.
Keep out of the reach of children.
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