País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
TYA Pharmaceuticals
CEPHALEXIN
CEPHALEXIN ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by and . (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.) Streptococcus pneumoniae Streptococcus pyogenes Otitis media due to , , , , and . Streptococcus pneumoniae Haemophilus influenzae Staphylococcus aureus Streptococcus pyogenes Moraxella catarrhalis Skin and skin structure infections caused by and/or . Staphylococcus aureus Streptococcus pyogenes Bone infections caused by and/or .
NDC:64725-0121-1 in a BOTTLE of 100 CAPSULES
Abbreviated New Drug Application
CEPHALEXIN- CEPHALEXIN CAPSULE TYA PHARMACEUTICALS ---------- CEPHALEXIN CAPSULES USP RX ONLY 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 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 -phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3- position. _D_ Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide. CLINICAL PHARMACOLOGY HUMAN PHARMACOLOGY: Cephalexin is acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of appro Llegiu el document complet