Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
Preferred Pharmaceuticals Inc.
AMOXICILLIN
AMOXICILLIN ANHYDROUS 875 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 contains 500 mg or 875 mg amoxicillin as the trihydrate. 875 mg Tablet Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side. Bottles of 20 NDC 68788-8977-2 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight container.
Abbreviated New Drug Application
AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED PREFERRED PHARMACEUTICALS 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 RECENT MAJOR CHANGES Indications and Usage, Gonorrhea (1.5) Removed 9/2015 Dosage and Administration, Gonorrhea (2.1) Removed 9/2015 INDICATIONS AND USAGE Amoxicillin tablets are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. • • 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 • • • • 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 to 1.4) In combination for treatment of _H. pylori _infection and duodenal ulcer disease. (1.5) 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 gr Read the complete document