MEROPENEM injection powder for solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

MEROPENEM (UNII: FV9J3JU8B1) (MEROPENEM ANHYDROUS - UNII:YOP6PX0BAO)

Dostupno od:

Par Pharmaceutical, Inc.

INN (International ime):

MEROPENEM

Sastav:

MEROPENEM 500 mg in 20 mL

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

MEROPENEM- MEROPENEM INJECTION, POWDER, FOR SOLUTION
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEROPENEM FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEROPENEM FOR
INJECTION.
MEROPENEM FOR INJECTION, USP
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Meropenem for injection is a penem antibacterial indicated for the
treatment of:
Complicated skin and skin structure infections (adult patients and
pediatric patients 3 months of age and older only).
(1.1)
Complicated intra-abdominal infections (adult and pediatric patients).
(1.2)
Bacterial meningitis (pediatric patients 3 months of age and older
only). (1.3)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of meropenem for injection and other
antibacterial drugs, meropenem for injection should only be used to
treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for
complicated skin and skin structure infections
(cSSSI) for adult patients. When treating infections caused by
_Pseudomonas aeruginosa_, a dose of 1 gram every 8
hours is recommended. (2.1)
1 gram every 8 hours by intravenous infusion over 15 minutes to 30
minutes for intra-abdominal infections for adult
patients. (2.1)
1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL)
over 3 minutes to 5 minutes for adult patients.
(2.1)
Dosage should be reduced in adult patients with renal impairment.
(2.2)
RECOMMENDED MEROPENEM FOR INJECTION DOSAGE SCHEDULE FOR ADULT PATIENTS
WITH RENAL
IMPAIRMENT
CREATININE CLEARANCE
(ML/MIN)
DO SE
(DEPENDENT ON TYPE OF INFECTION)
DOSING INTERVAL
Greater than 50
Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal)
Every 8 hours
26 to 50
Recommended dose
Every 12 hours
10 to 25
One-half recommended dose
Every 12 hours
Less Than 10
One-half recommended dose
E