देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
Preferred Pharmaceuticals Inc.
AMOXICILLIN
AMOXICILLIN ANHYDROUS 500 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USP and other antibacterial drugs, amoxicillin capsules, 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 capsules, 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 Ent
Amoxicillin Capsules, USP contains 500 mg amoxicillin as the trihydrate. NDC # 68788-8972-2
Abbreviated New Drug Application
AMOXICILLIN- AMOXICILLIN CAPSULE PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMOXICILLIN CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN CAPSULES, USP. AMOXICILLIN CAPSULES, USP INITIAL U.S. APPROVAL: 1974 TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF AMOXICILLIN CAPSULES, USP AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN CAPSULES, USP SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. INDICATIONS AND USAGE Amoxicillin Capsules, USP are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. • • DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • ADVERSE REACTIONS THE MOST COMMON ADVERSE REACTIONS (> 1%) OBSERVED IN CLINICAL TRIALS OF AMOXICILLIN CAPSULES, TABLETS OR ORAL SUSPENSION WERE DIARRHEA, RASH, VOMITING, AND NAUSEA. (6.1)TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CITRON PHARMA LLC. AT 1-855-5-CITRON (1-855-524-8766) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.G O V/MEDWATCH. DRUG INTERACTIONS 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) 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) 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 give पूरा दस्तावेज़ पढ़ें