Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
IMIPENEM (UNII: 71OTZ9ZE0A) (IMIPENEM ANHYDROUS - UNII:Q20IM7HE75), CILASTATIN SODIUM (UNII: 5428WXZ74M) (CILASTATIN - UNII:141A6AMN38)
Fresenius Kabi USA, LLC
IMIPENEM
IMIPENEM ANHYDROUS 250 mg in 20 mL
INTRAVENOUS
PRESCRIPTION DRUG
Imipenem and Cilastatin for Injection, USP (I.V.) for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains of Staphylococcus aureus (penicillinase-producing isolates), Acinetobacter species, Enterobacter species, Escherichia coli , Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella species, Serratia marcescens . Imipenem and Cilastatin for Injection, USP (I.V.) is indicated for the treatment of urinary tract infections (complicated and uncomplicated) caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Enterobacter species, Escherichia coli , Klebsiella species, Morganella morganii , Proteus vulgaris , Providencia rettgeri ,
Imipenem and Cilastatin for Injection, USP (I.V.) is supplied as a sterile powder mixture in single-dose vials containing imipenem (anhydrous equivalent) and cilastatin (free acid equivalent) as follows: Before Reconstitution: Imipenem and Cilastatin for Injection, USP (I.V.) sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
IMIPENEM AND CILASTATIN- IMIPENEM AND CILASTATIN SODIUM INJECTION, POWDER, FOR SOLUTION IMIPENEM AND CILASTATIN - IMIPENEM AND CILASTATIN SODIUM INJECTION, POWDER, FOR SOLUTION FRESENIUS KABI USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.). IMIPENEM AND CILASTATIN FOR INJECTION, USP, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1985 INDICATIONS AND USAGE Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. ( 1.1) Urinary tract infections. ( 1.2) Intra-abdominal infections. ( 1.3) Gynecologic infections. ( 1.4) Bacterial septicemia. ( 1.5) Bone and joint infections. ( 1.6) Skin and skin structure infections. ( 1.7) Endocarditis. ( 1.8) Limitations of Use: Imipenem and Cilastatin for Injection, USP (I.V.) is not indicated in patients with meningitis because safety and efficacy have not been established ( 1.9). Imipenem and Cilastatin for Injection, USP (I.V.) is not recommended in pediatric patients with CNS infections because of the risk of seizures ( 1.9). Imipenem and Cilastatin for Injection, USP (I.V.) is not recommended in pediatric patients weighing less than 30 kg with impaired renal function ( 1.9). Usage: To reduce the development of drug resistant bacteria and maintain the effectiveness of Imipenem and Cilastatin for Injection, USP (I.V.) and other antibacterial drugs, Imipenem and Cilastatin for Injection, USP (I.V.) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria ( 1.10). DOSAGE AND ADMINISTRATION The dosage of Imipenem and Cilastatin for Injection (I.V.) in adult Прочитајте комплетан документ