FDA label database

DailyMed Label Search

Search official DailyMed labels by brand, generic, ingredient, dosage form, or labeler.

Found 20 DailyMed label results for "amoxicillin"

DailyMed

These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable). AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP, and AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors 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 • Adults and Pediatric Patients > 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours. ( 2.1, 2.2) • 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) • 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/31.25 mg per 5 mL oral suspension is recommended. (2.2) DOSAGE FORMS AND STRENGTHS Formulations and amoxicillin/clavulanate content are: Tablets: 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored. (3) Powder for Oral Suspension: 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per 5 mL (3) Chewable Tablets: 200 mg/28.5 mg, 400 mg/57 mg (3) CONTRAINDICATIONS • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin/clavulanate potassium or to other beta-lactams (e.g., penicillins or cephalosporins) ( 4) • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate potassium. ( 4) WARNINGS AND PRECAUTIONS • Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) if a reaction occurs. ( 5.1) • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. ( 5.2) • Clostridium difficile-associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5.3) • Patients with mononucleosis who receive amoxicillin/clavulanate potassium develop skin rash. Avoid amoxicillin/clavulanate potassium use in these patients. ( 5.4) • 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 TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or [email protected]; or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • Coadministration with probenecid is not recommended. ( 7.1) • Concomitant use of amoxicillin/clavulanate potassium and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2) • Coadministration with allopurinol increases the risk of rash. ( 7.3) • Amoxicillin/clavulanate potassium may reduce efficacy of oral contraceptives. ( 7.4) USE IN SPECIFIC POPULATIONS • Pediatric Use: Modify dose in patients 12 weeks or younger. ( 8.4) • Renal Impairment; Dosage adjustment is recommended for severe renal impairment (GFR< 30 mL/min). ( 2.3, 8.6) See 17 for PATIENT COUNSELING INFORMATION. Revised: 1/2015