MEROPENEM injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Savior Lifetec Corporation

INN (국제 이름):

MEROPENEM

구성:

MEROPENEM 1 g in 30 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Meropenem for Injection is useful as presumptive therapy in the indicated condition (e.g. intra-abdominal infections) prior to the identification of the causative organisms because of its broad spectrum of bactericidal activity. For information regarding use in pediatric patients see Indications and Usage (1.1), (1.2) or (1.3) ; Dosage and Administration (2.3) , Adverse Reactions (6.1) , and Clinical Pharmacology (12.3) . Meropenem for Injection is indicated as a

제품 요약:

Meropenem for Injection is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 20º - 25º C (68º -77º F) [see USP].

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MEROPENEM- MEROPENEM INJECTION
SAVIOR LIFETEC CORPORATION
----------
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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Indications and Usage, Intra-Abdominal Infections, Pediatric Patients
(less than 3 months of age) (1.2) 12/2014
Dosage and Administration, Use in Pediatric Patients (less than 3
months of age) (2.3) 12/2014
INDICATIONS AND USAGE
Meropenem for Injection is a penem antibacterial indicated as single
agent therapy 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
skin and skin structure infections 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)
DOSE (DEPENDENT ON TYPE OF INFECTION)
DOSING INT