AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S ,5 R ,6 R )-6-[( R )-(-)-2-Amino-2-( p -hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia...

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AUGMENTIN is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. ca...

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Augmentin for Oral Suspension, USP: 125 mg/31.25 mg per 5 mL : Banana-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 125 mg of amoxicillin as the trihydrate and 31.25 mg of clavulanic acid as the potassium salt). 250 mg/62.5 mg per 5 mL : Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 250 mg of amoxicillin as the trihydrate and 62.5 mg of clavulanic acid as the potassium salt). For Oral Suspension: 125 mg/31.25 mg per...

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Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on the amoxicillin component. Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended. 2.1 Important Administration Inst...

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History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AUGMENTIN or to other beta‑lactams (e.g., penicillins or cephalosporins). History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN. 4.1 Serious Hypersensitivity Reactions AUGMENTIN is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta‑lactam antibacterial drug...

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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 symptoms 1 . Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium. Crystalluria, in some cases leading to r...

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Serious (including fatal) hypersensitivity reactions: Discontinue AUGMENTIN if a reaction occurs. Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses. Drug-induced enterocolitis syndrome (DIES) has been reported with use of Amoxicillin, A componet of Augmentin. If this occures, discontinue AUGMENIN and institute appropriate therapy Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in pati...

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Co‑administration with probenecid is not recommended. Concomitant use of AUGMENTIN and oral anticoagulants may increase the prolongation of prothrombin time.( 7.2 ) Co-administration with allopurinol increases the risk of rash. AUGMENTIN may reduce efficacy of oral contraceptives. 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with AUGMENTIN may result in increased and prolonged blood concentrations...

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8.1 Pregnancy Teratogenic Effects : Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to AUGMENTIN. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximate...

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