Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
Teva Pharmaceuticals USA, Inc.
AMOXICILLIN
AMOXICILLIN ANHYDROUS 500 mg
ORAL
PRESCRIPTION DRUG
Amoxicillin Tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Amoxicillin Tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Amoxicillin Tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . Amoxicillin Tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae . Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole: Amoxicillin Tablets, in combination with clar
Amoxicillin Tablets USP are supplied as follows: 500 mg: Film-coated, capsule-shaped, off-white, unscored tablets, debossed with “93” on one side and “2263” on the other side. They are available in bottles of 100 (NDC 0093-2263-01) tablets. 875 mg: Film-coated, capsule-shaped, off-white tablets, scored on one side, debossed with “93” on one side of the score and “2264” on the other side of the score. They are available in bottles of 100 (NDC 0093-2264-01) tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMOXICILLIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN TABLETS. AMOXICILLIN TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1974 INDICATIONS AND USAGE Amoxicillin Tablets are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 to 1.4) 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 tablets and other antibacterial drugs, amoxicillin tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) DOSAGE AND ADMINISTRATION 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) The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. (2.2) Dosing for _H. pylori _Infection: Triple Therapy: 1 gram amoxicillin tablets, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual Therapy: 1 gram amoxicillin tablets and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. (2.3) Reduce the dose in patients with severe renal impairment (GFR < 30 mL/min). (2.4) DOSAGE FORMS AND STRENGTHS Tablets: 500 mg, 875 mg (3) CONTRAINDICATIONS 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 A Read the complete document