Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
cefepime hydrochloride (UNII: I8X1O0607P) (cefepime - UNII:807PW4VQE3)
Cardinal Health
cefepime hydrochloride
cefepime 1 g
PRESCRIPTION DRUG
New Drug Application
MAXIPIME- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION CARDINAL HEALTH ---------- MAXIPIME (CEFEPIME HYDROCHLORIDE, USP) FOR INJECTION FOR INTRAVENOUS OR INTRAMUSCULAR USE To reduce the development of drug-resistant bacteria and maintain the effectiveness of MAXIPIME and other antibacterial drugs, MAXIPIME should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION MAXIPIME (cefepime hydrochloride, USP) is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)- glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1- methylpyrrolidinium chloride, 7 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C H N O S ) per mg, calculated on an anhydrous basis. It is highly soluble in water. MAXIPIME for Injection is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. (See DOSAGE AND ADMINISTRATION.) MAXIPIME is a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C H N O S ). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the constituted solution at 4.0–6.0. Freshly constituted solutions of MAXIPIME will range in color from colorless to amber. CLINICAL PHARMACOLOGY Cefepime is an antibacterial agent belonging to the cephalosporin class of antibacterials with _in vitro_ antibacterial activity against facultative Gram-positive and Gram-negative bacteria. PHARMACOKINETICS The average plasma concentrations of cefepime observed in healthy adult male volunteers Belgenin tamamını okuyun