Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Cephalexin (UNII: OBN7UDS42Y) (Cephalexin - UNII:OBN7UDS42Y)
Carlsbad Technology, Inc.
Cephalexin
Cephalexin 125 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Cephalexin for oral suspension is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis Genitourinary tract infections, including acute prostatitis, caused by
Cephalexin For Oral Suspension, USP, is a white to off-white powder with strawberry flavor. After reconstitution a pink colored suspension is formed with strawberry flavor and is available in: The 125 mg per 5 mL oral suspension is available as follows: The 250 mg per 5 mL oral suspension is available as follows: After mixing, store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CEPHALEXIN- CEPHALEXIN SUSPENSION CARLSBAD TECHNOLOGY, INC. ---------- CEPHALEXIN FOR ORAL SUSPENSION USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D- α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C H N O S•H O and the molecular weight is 365.41. Cephalexin has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3- position. After mixing, each 5 mL of cephalexin for oral suspension, USP, will contain cephalexin monohydrate equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. The suspensions also contain the following inactive ingredients: strawberry powder, methylcellulose, sodium lauryl sulfate, sucrose and FD&C Red No. 40. Cephalexin for oral suspension, USP is a white to off-white powder with strawberry flavor. After reconstitution a pink colored suspension is formed with strawberry flavor. CLINICAL PHARMACOLOGY HUMAN PHARMACOLOGY Cephalexin is acid stable and may be given without Baca dokumen lengkap