HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN.
AUGMENTIN® (amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets
Initial U.S. Approval: 1984
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
AUGMENTIN is a combination penicillin-class antibacterial and beta‑lactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections (1.1)
Acute bacterial otitis media (1.2)
Sinusitis (1.3)
Skin and skin structure infections (1.4)
Urinary tract infections (1.5)
DOSAGE AND ADMINISTRATION
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Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours. (2.1, 2.2)
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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. (2.2)
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Neonates and infants < 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. (2.2)
DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin/clavulanate content are:
Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored. (3)
Powder for Oral Suspension: 125 mg/31.25 mg per 5 mL, 200 mg/28.5 mg per 5 mL, 250 mg/62.5 mg per 5 mL, 400 mg/57 mg per 5 mL (3)
Chewable Tablets: 125 mg/31.25 mg, 200 mg/28.5 mg, 250 mg/62.5 mg, 400 mg/57 mg (3)
CONTRAINDICATIONS
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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) (4)
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History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN. (4)
WARNINGS AND PRECAUTIONS
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Serious (including fatal) hypersensitivity reactions: Discontinue AUGMENTIN if a reaction occurs. (5.1)
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Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. (5.2)
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Clostridium difficile-associated diarrhea (CDAD): eva luate patients if diarrhea occurs. (5.3)
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Patients with mononucleosis who receive AUGMENTIN develop skin rash. Avoid AUGMENTIN use in these patients. (5.4)
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Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. (5.5)
ADVERSE REACTIONS
The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%),vomiting (1%) and vaginitis (1%) (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Co‑administration with probenecid is not recommended. (7.1)
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Concomitant use of AUGMENTIN and oral anticoagulants may increase the prolongation of prothrombin time. (7.2)
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Coadministration with allopurinol increases the risk of rash. (7.3)
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AUGMENTIN may reduce efficacy of oral contraceptives. (7.4)
USE IN SPECIFIC POPULATIONS
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Pediatric Use: Modify dose in patients 12 weeks or younger. (8.4)
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Renal impairment; Dosage adjustment is recommended for severe renal impairment (GFR< 30mL/min). (2.3, 8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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*:
1.1 Lower Respiratory Tract Infections
caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, AUGMENTIN should not be used.
2 DOSAGE AND 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.
2.1 Adults
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 AUGM
