DORIBAX- doripenem powder, for solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Shionogi Inc.

INN (Jina la Kimataifa):

DORIPENEM

Tungo:

DORIPENEM 500 mg in 10 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

DORIBAX ® (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 . DORIBAX ® (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 DORIBAX ® and other antibacterial drugs, DORIBAX ® should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility infor

Bidhaa muhtasari:

DORIBAX ® 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 DORIBAX ® vials   DORIBAX ® should be stored at 25°C (77°F); excursions permitted to 15°–30°C (59° to 86°F) [refer to USP controlled room temperature].

Idhini hali ya:

New Drug Application

Tabia za bidhaa

DORIBAX- DORIPENEM POWDER, FOR SOLUTION
SHIONOGI INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USEDORIBAX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DORIBAX .
DORIBAX (DORIPENEM FOR INJECTION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
DORIBAX
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 DORIBAX
and other
antibacterial drugs, DORIBAX
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 DORIBAX
> 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-administration of DORIBAX
with valproic acid reduces the serum concentration of valproic
acid. Patient