DORIPENEM- doripenem powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DORIPENEM (UNII: BHV525JOBH) (DORIPENEM - UNII:BHV525JOBH)

Available from:

Apotex Corp.

INN (International Name):

DORIPENEM

Composition:

DORIPENEM 250 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doripenem for Injection is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus, and Peptostreptococcus micros . Doripenem for Injection is indicated as a single agent for the treatment of complicated urinary tract infections, including pyelonephritis caused by Escherichia coli including cases with concurrent bacteremia, Klebsiella pneumoniae , Proteus mirabilis , Pseudomonas aeruginosa , and Acinetobacter baumannii . To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doripenem for Injection and other antibacterial drugs, Doripenem for Injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility infor

Product summary:

Doripenem for Injection is supplied as single use type 1 clear glass vials containing 250 mg or 500 mg (on an anhydrous basis) of sterile doripenem powder. Vials are packaged individually and in cartons containing 10 vials. Storage of Doripenem for Injection vials Doripenem for Injection should be stored at 25°C (77°F); excursions permitted to 15°–30°C (59° to 86°F) [refer to USP controlled room temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

DORIPENEM- DORIPENEM POWDER, FOR SOLUTION
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DORIPENEM FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DORIPENEM FOR
INJECTION.
DORIPENEM FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
Doripenem for Injection is a penem antibacterial indicated in the
treatment of the following infections caused by designated
susceptible bacteria:
Complicated intra-abdominal infections ( 1.1)
Complicated urinary tract infections, including pyelonephritis ( 1.2)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Doripenem for Injection and other
antibacterial drugs, Doripenem for Injection should be used only to
treat or prevent infections that are proven or strongly
suspected to be caused by bacteria. ( 1.3)
DOSAGE AND ADMINISTRATION
500 mg every 8 hours by intravenous infusion administered over one
hour for patients ≥18 years of age. ( 2.1)
Dosage in patients with impaired renal function ( 2.2):
CRCL (ML/MIN)
RECOMMENDED DOSE OF DORIPENEM FOR INJECTION
> 50
No dosage adjustment necessary
≥ 30 to ≤ 50
250 mg IV (over 1 hour) every 8 hours
> 10 to < 30
250 mg IV (over 1 hour) every 12 hours
DOSAGE FORMS AND STRENGTHS
250 mg single use vial or 500 mg single use vial of sterile doripenem
powder for reconstitution ( 3)
CONTRAINDICATIONS
Patients with known serious hypersensitivity to doripenem or to other
drugs in the same class or patients who have
demonstrated anaphylactic reactions to beta-lactams ( 4)
WARNINGS AND PRECAUTIONS
Increased mortality in ventilator-associated bacterial pneumonia
patients. Doripenem is not indicated for ventilator-
associated bacterial pneumonia ( 5.1)
Serious hypersensitivity (anaphylactic) reactions have been reported
with carbapenems and other beta-lactams ( 5.2)
Seizures have been reported with carbapenems, including doripenem (
5.3)
It has been shown that co-administratio