Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
MedVantx, Inc.
ORAL
PRESCRIPTION DRUG
Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Note –Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin 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 capsules, USP are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Cephalexin capsules, USP are available in: The 250 mg capsules are a white to off-white powder filled into size 2 capsules (white opaque and dark green opaque) that are imprinted with identity code “J1” on the dark green opaque cap, and “J1” on the white opaque body in edible black ink. They are available as follows: The 500 mg capsules are a white to off-white powder filled into size 0 capsules (light green opaque and dark green opaque) that are imprinted with identity code "J2” on the dark green opaque cap, and “J2” on the light green opaque body in edible black ink. They are available as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.
Abbreviated New Drug Application
CEPHALEXIN- CEPHALEXIN CAPSULE MEDVANTX, INC. ---------- CEPHALEXIN CAPSULES, USP Rev. 11/10 RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cephalexin capsules, USP are 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: STRUCTURAL FORMULA The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; ie, 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 (1,439 μmol) of cephalexin. The capsules also contain colloidal silicon dioxide, D & C Yellow No. 10, FD & C Blue No. 2, gelatin, magnesium stearate, sodium starch glycolate, 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 approximately 9, 18, and 32 mcg/mL respectively were obtained at 1 Preberite celoten dokument