ERTAPENEM- ertapenem sodium injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ERTAPENEM SODIUM (UNII: 2T90KE67L0) (ERTAPENEM - UNII:G32F6EID2H)

Available from:

Par Pharmaceutical Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated intra-abdominal infections due to Escherichia coli , Clostridium clostridioforme , Eubacterium lentum , Peptostreptococcus species, Bacteroides fragilis , Bacteroides distasonis , Bacteroides ovatus , Bacteroides thetaiotaomicron , or Bacteroides uniformis . Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae , Streptococcus pyogenes , Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , Bacteroides fragilis , Peptostreptococcus species, Porphyromonas asaccharolytica , or Prevotella bivia . Ertapenem for injection has not been studied in diabetic foot infections with concomitant osteomy

Product summary:

Ertapenem for injection is supplied as a sterile lyophilized powder in single-dose vials containing ertapenem for intravenous infusion or for intramuscular injection as follows: NDC 42023-221-85 in packages of 10 vials. Before reconstitution Do not store lyophilized powder above 25°C (77°F). Reconstituted and infusion solutions The reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection [see Dosage and Administration (2.7)], may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of ertapenem for injection should not be frozen.

Authorization status:

New Drug Application

Summary of Product characteristics

ERTAPENEM- ERTAPENEM SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
PAR PHARMACEUTICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ERTAPENEM FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ERTAPENEM FOR
INJECTION.
ERTAPENEM FOR INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Ertapenem for injection is a penem antibacterial indicated in adult
patients and pediatric patients (3
months of age and older) for the treatment of the following moderate
to severe infections caused by
susceptible bacteria:
Complicated intra-abdominal infections. (1.1)
Complicated skin and skin structure infections, including diabetic
foot infections without osteomyelitis.
(1.2)
Community-acquired pneumonia. (1.3)
Complicated urinary tract infections including pyelonephritis. (1.4)
Acute pelvic infections including postpartum endomyometritis, septic
abortion and post-surgical
gynecologic infections. (1.5)
Ertapenem for injection is indicated in adults for the prophylaxis of
surgical site infection following elective
colorectal surgery. (1.6)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ertapenem for
injection and other antibacterial drugs, ertapenem for injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
susceptible bacteria. (1.7)
DOSAGE AND ADMINISTRATION
DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER
MEDICATIONS. DO NOT USE DILUENTS
CONTAINING DEXTROSE (Α–D–GLUCOSE). (2.1)
Ertapenem for injection should be infused over 30 minutes in both the
Treatment and Prophylactic
regimens. (2.1)
Dosing considerations should be made in adults with advanced or
end-stage renal impairment and those
on hemodialysis. (2.4, 2.5)
Treatment regimen:
Adults and pediatric patients 13 years of age and older. The dosage
should be 1 gram once a day
intravenously or intramuscularly. (2.2)
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