Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
CEFACLOR (UNII: 69K7K19H4L) (CEFACLOR ANHYDROUS - UNII:3Z6FS3IK0K)
Bryant Ranch Prepack
CEFACLOR
CEFACLOR ANHYDROUS 250 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
CEFACLOR- CEFACLOR CAPSULE BRYANT RANCH PREPACK ---------- CEFACLOR CAPSULES, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor and other antibacterial drugs, cefaclor should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cefaclor is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The molecular formula for cefaclor is C H ClN O S•H O and the molecular weight is 385.82. MOLECULAR FORMULA Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain black iron oxide, croscarmellose sodium, FD&C Red No. 3, FD&C Blue No. 2, gelatin, magnesium stearate, corn starch, and titanium dioxide. The color of the capsule powder is white to off white. CLINICAL PHARMACOLOGY Cefaclor is well absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food; however, when it is taken with food, the peak concentration achieved is 50% to 75% of that observed when the drug is administered to fasting subjects and generally appears from three fourths to 1 hour later. Following administration of 250- mg, 500-mg, and 1-g doses to fasting subjects, average peak serum levels of approximately 7, 13, and 23 mcg/mL respectively were obtained within 30 to 60 minutes. Approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours, the greater portion being excreted within the first 2 hours. During this 8-hour period, peak urine concentrations following the 250-mg, 500-mg, and 1-g doses were approximately 600, 900, and 1,900 mcg/mL, respectively. The serum half-life in normal subjects is 0.6 to 0.9 hour. In patients with reduced renal function, the serum half-life of cefaclor is slightly prolonged. In those with complete abs Aqra d-dokument sħiħ