IMIPENEM AND CILASTATIN- imipenem and cilastatin 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:

Hospira, Inc.

INN (International Name):

IMIPENEM

Composition:

IMIPENEM ANHYDROUS 250 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Imipenem and Cilastatin for Injection (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 (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 , Pseudomonas aeruginosa. Imipenem and Cilastatin for Injection (I.V.) is indicated for the treatment of intra-abdominal infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococ

Product summary:

Imipenem and Cilastatin for Injection (I.V.) is supplied as a sterile powder mixture in single-dose vials containing imipenem (anhydrous equivalent) and cilastatin sodium as follows: Before Reconstitution: The dry 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 INJECTION, POWDER,
FOR SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMIPENEM AND CILASTATIN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IMIPENEM AND CILASTATIN FOR
INJECTION.
IMIPENEM AND CILASTATIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1985
RECENT MAJOR CHANGES
Dosage and Administration (2.5)
8/2018
INDICATIONS AND USAGE
Imipenem and Cilastatin for Injection (I.V.) 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 (I.V.) is not indicated in
patients with meningitis because safety and efficacy have
not been established (1.9).
Imipenem and Cilastatin for Injection (I.V.) is not recommended in
pediatric patients with CNS infections because of
the risk of seizures (1.9).
Imipenem and Cilastatin for Injection (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 (I.V.) and other antibacterial drugs, Imipenem and
Cilastatin for Injection (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 adult patients with norm