Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN - UNII:OBN7UDS42Y)
Ranbaxy Pharmaceuticals Inc.
cephalexin
250 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules and cephalexin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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 eradicati
Cephalexin For Oral Suspension, USP is available in: The 125 mg per 5 mL oral suspension* is pink in color with a strawberry flavor and is available as follows: 100 mL Bottles NDC 63304-958-01 200 mL Bottles NDC 63304-958-02 The 250 mg per 5 mL oral suspension* is pink in color with a strawberry flavor and is available as follows: 100 mL Bottles NDC 63304-959-01 200 mL Bottles NDC 63304-959-02 * After mixing, store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed. Cephalexin Capsules, USP are available in: 250 mg dark green and white, size 2, printed “RX656” on both cap and body. (28s) NDC 63304-656-27 (100s) NDC 63304-656-01 (500s) NDC 63304-656-05 500 mg, dark green and light green, size 0, printed “RX657” on both cap and body. (28s) NDC 63304-657-27 (100s) NDC 63304-657-01 (500s) NDC 63304-657-05 The bottle packages contain desiccant. Dispense in tight, light-resistant container. Store at 20 – 25° C (68 – 77° F). (See USP Controlled Room Temperature).
Abbreviated New Drug Application
CEPHALEXIN- CEPHALEXIN CAPSULE CEPHALEXIN- CEPHALEXIN SUSPENSION RANBAXY PHARMACEUTICALS INC. ---------- CEPHALEXIN CAPSULES, USP AND CEPHALEXIN FOR ORAL SUSPENSION, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules and 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. Each capsule for oral administration, contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1,439 µmol) of cephalexin. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, edible printing ink with black iron oxide, FD&C Green No. 3, FD&C Yellow No. 6, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Also, the 500 mg strength capsule contains FD&C Blue No.1. Aft Leggi il documento completo