IMIPENEM AND CILASTATIN- imipenem and cilastatin sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IMIPENEM (UNII: 71OTZ9ZE0A) (IMIPENEM ANHYDROUS - UNII:Q20IM7HE75), CILASTATIN SODIUM (UNII: 5428WXZ74M) (CILASTATIN - UNII:141A6AMN38)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ,

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IMIPENEM AND CILASTATIN- IMIPENEM AND CILASTATIN SODIUM INJECTION,
POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
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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
patients should be based on
suspected or confirmed pathogen susceptibility ( 2.1).
For ad