Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
Blenheim Pharmacal, Inc.
CEPHALEXIN
CEPHALEXIN ANHYDROUS 500 mg
ORAL
PRESCRIPTION DRUG
Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by S. pneumoniae and S. 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 S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis Skin and skin structure infections caused by staphylococci and/or streptococci Bone infections caused by staphylococci and/or P. mirabilis Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae Note - Culture and susceptibility tests should be initiated prior to and during
Cephalexin capsules, USP are available in: The 250 mg capsules are white opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “140” in black ink. They are available as follows: Bottles of 100 NDC 42043-140-01 Bottles of 500 NDC 42043-140-05 The 500 mg capsules are light green opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “141” in black ink. They are available as follows: Bottles of 100 NDC 42043-141-01 Bottles of 500 NDC 42043-141-05 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CEPHALEXIN - CEPHALEXIN CAPSULE BLENHEIM PHARMACAL, INC. ---------- CEPHALEXIN CAPSULES, USP TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF CEPHALEXIN CAPSULES, USP AND OTHER ANTIBACTERIAL DRUGS, CEPHALEXIN CAPSULES, USP 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. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 μmol) or 500 mg (1439 μmol) of cephalexin. The capsules also contain the following inactive ingredients: Croscarmellose Sodium, D & C Yellow No. 10, F D & C Blue No.1, F D & C Yellow No. 6, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Titanium Dioxide. Ink constituents are: Black Iron Oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Shellac and Strong Ammonia Solution. CLINICAL PHARMACOLOGY HUMAN PHARMACOLOGY Cephalexin is acid stable and may be give Διαβάστε το πλήρες έγγραφο