IMIPENEM AND CILASTATIN injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

WG Critical Care, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Imipenem and Cilastatin for Injection, USP 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 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, USP is indicated for the treatment of intra-abdominal infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus ep

Product summary:

Imipenem and Cilastatin for Injection, USP is supplied as a sterile powder mixture in single-dose vials containing imipenem (anhydrous equivalent) and cilastatin (free acid equivalent) as follows: 500 mg imipenem equivalent and 500 mg cilastatin equivalent, and 20 mg sodium bicarbonate as a buffer: NDC 44567-705-01 single-dose vial NDC 44567-705-10 carton of 10 Before Reconstitution: Imipenem and Cilastatin for Injection, USP dry powder should be stored at 20°C to 25°C (68°F 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
WG CRITICAL CARE, LLC
----------
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
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:
•
•
•
•
•
•
•
•
Limitations of Use:
•
•
•
Usage:
To reduce the development of drug resistant bacteria and maintain the
effectiveness of Imipenem and
Cilastatin for Injection, USP and other antibacterial drugs, Imipenem
and Cilastatin for Injection, USP
should be used only to treat infections that are proven or strongly
suspected to be caused by bacteria
(1.10).
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
For Injection: Imipenem and Cilastatin for Injection, USP is a sterile
powder mixture for reconstitution in
single-dose containers including vials containing:
•
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)
Imipenem and Cilastatin for Injection, USP is not indicated in
patients with meningitis because safety
and efficacy have not been established (1.9).
Imipenem and Cilastatin for Injection, USP is not recommended in
pediatric patients with CNS
infections because of the risk of seizures (1.9).
Imipenem and Cilastatin for Injection, USP is not recommended in
pediatric patients weighing less
than 30 kg with impaired renal