Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
Preferred Pharmaceuticals, Inc.
CEPHALEXIN
CEPHALEXIN ANHYDROUS 500 mg
ORAL
PRESCRIPTION DRUG
Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis. Cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes . Cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. Cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli , Proteus mirabilis , and Klebsiella pneumoniae . To reduce the development of drug-resist
Cephalexin capsules, USP are available in: 500 mg Capsule Dark green opaque/light green opaque size “0” hard gelatin capsule filled with off white granular powder and imprinted with “A 43” on dark green opaque cap and “500 mg” on light green opaque body with black ink Bottle of 6 – 68788-9404-5 Bottle of 12 – 68788-9404-1 Bottle of 20 – 68788-9404-2 Bottle of 21 – 68788-9404-7 Bottle of 28 – 68788-9404-8 Bottle of 30 – 68788-9404-3 Bottle of 40 – 68788-9404-4 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, light-resistant container.
Abbreviated New Drug Application
CEPHALEXIN- CEPHALEXIN CAPSULE PREFERRED PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CEPHALEXIN CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEPHALEXIN CAPSULES CEPHALEXIN CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1971 INDICATIONS AND USAGE Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: • • • • • To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) DOSAGE AND ADMINISTRATION Adults and patients at least 15 years of age The usual dose is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered (2.1) Pediatric patients (over 1 year of age) • • • • • DOSAGE FORMS AND STRENGTHS Capsules: 250 mg and 500 mg (3) CONTRAINDICATIONS Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. (4) WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AUROBINDO PHARMA USA, INC. AT 1-866-850-2876 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH . Respiratory tract infection (1.1) Otitis media (1.2) Skin and skin structure infections (1.3) Bone infections (1.4) Genitourinary tract infections (1.5) Otitis media: 75 to 100 mg/kg in equally divided doses every 6 hours (2.2) All other indications: 25 to 50 mg/kg given in equally divided doses (2.2) In severe infections: 50 to 100 mg/kg may be administered in equally divided doses (2.2) Duration of therapy ranges from 7 to 14 days depending on the infecti Belgenin tamamını okuyun