Dosage and Administration, Gonorrhea (2.1) Removed 9/2015

Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.

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Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 to 1.4)

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In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) and other antibacterial drugs, amoxicillin capsules, amoxicillin for oral suspension, and amoxicillin tablets (chewable) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)

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In adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients > 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.1, 2.2, 2.3)

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The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. ( 2.2)

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Dosing for H. pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.3)

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Reduce the dose in patients with severe renal impairment (GFR < 30 mL/min). ( 2.4)

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Capsules: 250 mg, 500 mg ( 3)

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Powder for Oral Suspension: 125 mg/5 mL, 250 mg/5 mL ( 3)

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Tablets (Chewable): 125 mg, 250 mg ( 3)

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History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins) ( 4)

WARNINGS AND PRECAUTIONS

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Anaphylactic Reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with supportive measures. ( 5.1)

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Clostridium difficile Associated Diarrhea (ranging from mild diarrhea to fatal colitis): eva luate if diarrhea occurs. ( 5.2)

The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets (chewable) or oral suspension were diarrhea, rash, vomiting, and nausea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin. ( 7.1)

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Concomitant use of amoxicillin 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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Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4)

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Pediatric: Modify dose in patients 12 weeks or younger (≤ 3 months). ( 8.4)