Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
Blenheim Pharmacal, Inc.
AMOXICILLIN
AMOXICILLIN ANHYDROUS 875 mg
ORAL
PRESCRIPTION DRUG
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, Amoxicillin Tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin Tablets, USP are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: – due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. – due to Escherichia coli , Proteus mirabilis , or
Amoxicillin Tablets, USP 875 mg: Each film-coated tablet contains 875 mg amoxicillin as the trihydrate. Film-coated, capsule-shaped, pink tablet is scored on one side and imprinted WW951 on the other side. Store at 20°-25°C (68°-77°F ) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.
Abbreviated New Drug Application
AMOXICILLIN- AMOXICILLIN TABLET, COATED BLENHEIM PHARMACAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE, SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN TABLETS, USP. AMOXICILLIN TABLETS, USP, FOR ORAL ADMINISTRATION RX ONLY INITIAL U.S. APPROVAL: 1974 TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF AMOXICILLIN AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. INDICATIONS AND USAGE Amoxicillin Tablets, USP are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. (1) Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 – 1.5) In combination for treatment of _H. pylori _infection and duodenal ulcer disease. (1.6, 1.7) (1) DOSAGE AND ADMINISTRATION In adults, 750-1750 mg/day in divided doses every 8-12 hours. In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 hours. Refer to full prescribing information for specific dosing regimens. (2.1, 2.2, 2.3) Treatment of gonorrhea is 3 grams as a single oral dose. (2.1) 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, 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) Reduce the dose in patients with severe renal impairment (GFR <30 mL/min). (2.4) DOSAGE FORMS AND STRENGTHS Tablets: 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 read_full_document