MEROPENEM injection, powder, for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

WG Critical Care, LLC

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Meropenem for injection, USP is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species. Meropenem for injection, USP is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli , Klebsiella pneumoniae , Pseudomonas aeruginosa , Bacteroides fragilis , B. thetaiotaomicron , and Peptostreptococcus species. Meropenem for injection, USP is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae , Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae . Meropenem for injection, USP has been found to be effective in eliminating con

Tuoteyhteenveto:

Meropenem for Injection, USP is supplied in 20 mL and 30 mL single-dose 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 to 25ºC (68º to 77ºF) [see USP]. NDC 44567-145-01 500 mg single-dose injection vial NDC 44567-145-10 500 mg single-dose injection vial packaged in carton of 10 NDC 44567-146-01 1 gram single-dose injection vial NDC 44567-146-10 1 gram single-dose injection vial packaged in carton of 10 The container closure is not made with natural rubber latex.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

MEROPENEM- MEROPENEM INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions
Severe Cutaneous Adverse Reactions (5.2) 6/2018
INDICATIONS AND USAGE
Meropenem for injection is a penem antibacterial indicated for the
treatment of:
•
•
•
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
•
•
•
•
RECOMMENDED MEROPENEM FOR INJECTION DOSAGE SCHEDULE FOR ADULT PATIENTS
WITH RENAL
IMPAIRMENT
CREATININE CLEARANCE
(ML/MIN)
DOSE (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
Every 24 hours
•
RECOMMENDED MEROPENEM FOR INJECTION DOSAGE SCHEDULE FOR PEDIATRIC
PATIENTS 3 MONTHS
OF AGE AND OLDER WITH NORMAL RENAL FUNCTION (2.3)
TYPE OF INFECTION
DOSE
(MG/KG)
UP TO A
MAXIMUM DOSE
DOSING INTERVAL
Complicated skin and skin structure*
10
500 mg
Every 8 hours
Intra-abdominal
20
1 gram
Every 8 hours
Meningitis
40
2 gram
Every 8 hours
- Intravenous infusion is to be given over approximately 15 minutes to
30 minutes.
- Intravenous bolus injection (5 mL to 20 mL) is to be given over
approximately 3 minutes to 5 minutes.
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 patie