Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
OrchidPharma Inc
CEPHALEXIN
CEPHALEXIN ANHYDROUS 125 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Cephalexin for Oral Suspension is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . Cephalexin for Oral Suspension is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis . Cephalexin for Oral Suspension is 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 for Oral Suspension is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. Cephalexin for Oral Suspension is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli , Proteus mirabilis , and Klebsiella p
Cephalexin for Oral Suspension, USP, is supplied as follows: The 125 mg/5 mL oral suspension is available as follows 100 - mL Bottles NDC 42043-142-38 200 - mL Bottles NDC 42043-142-58 The 250 mg/5 mL oral suspension is available as follows 100 - mL Bottles NDC 42043-143-38 200 - mL Bottles NDC 42043-143-58 Direction for mixing are included on the label. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Shake well before using. Keep tightly closed. After mixing store in a refrigerator. May be kept for 14 days without significant loss of potency.
Abbreviated New Drug Application
CEPHALEXIN- CEPHALEXIN POWDER, FOR SUSPENSION ORCHIDPHARMA INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CEPHALEXIN FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEPHALEXIN FOR ORAL SUSPENSIONCEPHALEXIN FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 1971 INDICATIONS AND USAGE Cephalexin for Oral Suspension is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: (1) 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) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for Oral Suspension and other antibacterial drugs, Cephalexin for Oral Suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) (1) 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 ) 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 infection type and severity. (2) Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min. (2.3) DOSAGE FORMS AND STRENGTHS For oral suspension: 125mg/5mL and 250mg/5mL (3) (3) CONTRAINDICATIONS Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. (4) (4) WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions: Prior to use, inquire regarding history of Pročitajte cijeli dokument