MEROPENEM- meropenem injection, powder, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Sandoz Inc

INN (שם בינלאומי):

MEROPENEM

הרכב:

MEROPENEM 500 mg in 10 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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. Meropenem for Injection is indicated as a single agent therapy for the treatment of complicated skin and skin structure infections due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes , Streptococ

leaflet_short:

Meropenem for Injection is supplied in injection vials containing sufficient meropenem to deliver 500 mg or 1 g for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 15 to 25°C (59 to 77°F) [see USP Controlled Room Temperature]. 500 mg Injection Vial (NDC 0781-3265-95) – 10 vials per carton 1 g Injection Vial (NDC 0781-3267-95) – 10 vials per carton

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

MEROPENEM- MEROPENEM INJECTION, POWDER, FOR SOLUTION
SANDOZ 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
INITIAL U.S. APPROVAL: 1996
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.
RECENT MAJOR CHANGES
Warnings and Precautions, Potential for Neuromotor Impairment (5.10)
INDICATIONS AND USAGE
Meropenem for Injection is a penem antibacterial indicated as single
agent therapy for the treatment of:
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DOSAGE AND ADMINISTRATION
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RECOMMENDED MEROPENEM FOR INJECTION DOSAGE SCHEDULE FOR ADULT PATIENTS
WITH RENAL IMPAIRMENT
CREATININE
CLEARANCE (ML/MIN)
DOSE
(DEPENDENT ON
TYPE OF INFECTION)
DOSING INTERVAL
> 50
Recommended dose (500 mg cSSSI
and 1 g Intra-abdominal)
Every 8 hours
26-50
Recommended dose
Every 12 hours
10-25
One-half recommended dose
Every 12 hours
<10
One-half recommended dose
Every 24 hours
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RECOMMENDED MEROPENEM FOR INJECTION DOSAGE SCHEDULE FOR PEDIATRIC
PATIENTS WITH NORMAL RENAL FUNCTION
TYPE OF INFECTION
DOSE
(M G /KG )
UP TO A
MAXIMUM
DO SE
DOSING
INTE RVAL
Complicated skin and skin structure
10
500 mg
Every 8 hours
Intra-abdominal
20
1 g
Every 8 hours
Me ningitis
40
2 g
Every 8 hours
- Intravenous infusion is to be given over approximately 15 to 30
minutes.
- Intravenous bolus injection (5 to 20 mL) is to be given over
approximately 3-5 minutes.
- There is no experience in pediatric patients with renal impairment.
DOSAGE FORMS AND STRENGTHS
500 mg Injection Vial (3)
1 g Injection Vial (3)
CONTRAINDICATIONS
Complicated skin and skin structure infections (adult patients and
pediatric patients ≥ 3 months only). (1.1)
Complicated