Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
Imipenem (UNII: 71OTZ9ZE0A) (IMIPENEM ANHYDROUS - UNII:Q20IM7HE75)
Cardinal Health
Imipenem
IMIPENEM ANHYDROUS 500 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
IMIPENEM AND CILASTATIN- IMIPENEM AND CILASTATIN SODIUM INJECTION, POWDER, FOR SOLUTION CARDINAL HEALTH ---------- IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.) 451205B/Revised: September 2012 To reduce the development of drug-resistant bacteria and maintain the effectiveness of imipenem and cilastatin for injection (I.V.) and other antibacterial drugs, imipenem and cilastatin for injection (I.V.) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. FOR INTRAVENOUS INJECTION ONLY DESCRIPTION Imipenem and Cilastatin for Injection, USP (I.V.) is a sterile formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I), with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is a potent broad spectrum antibacterial agent for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by _Streptomyces cattleya_. Its chemical name is (5_R_,6_S_)-3-[[2-(formimidoylamino)ethyl]thio]-6- [(_R_)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off- white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C H N O S•H O, and its structural formula is: Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (_Z_)- 7[[(_R_)-2-amino-2-carboxyethyl]thio]-2-[(_S_)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C H N O SNa, and its structural formula is: Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solu Läs hela dokumentet