MEROPENEM AND SODIUM CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

B. Braun Medical Inc.

INN (International Name):

MEROPENEM

Composition:

MEROPENEM 500 mg in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meropenem for Injection and Sodium Chloride Injection 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 and Sodium Chloride Injection 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 and Sodium Chloride Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae . Merope

Product summary:

Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is a flexible dual chamber single-dose container supplied in two concentrations. The diluent chamber contains approximately 50 mL of 0.9% Sodium Chloride Injection USP. After reconstitution, the delivered doses are equivalent to 5002 mg and 12 gram meropenem. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case. Store the unactivated unit at 20°C–25°C (68°F–77°F). Excursion permitted to 15°C-30°C. [See USP Controlled Room Temperature.] Protect from freezing. Use only if prepared solution is clear and free from particulate matter.

Authorization status:

New Drug Application

Summary of Product characteristics

MEROPENEM AND SODIUM CHLORIDE- MEROPENEM AND SODIUM
CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEROPENEM FOR
INJECTION AND SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR MEROPENEM FOR INJECTION AND SODIUM CHLORIDE INJECTION.
MEROPENEM FOR INJECTION AND SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Cutaneous Adverse Reactions (5.2)
1/2020
INDICATIONS AND USAGE
Meropenem for Injection and Sodium Chloride 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 requiring the full adult dose only). (1.1)
Complicated intra-abdominal infections (adult patients and pediatric
patients 3 months of age and
older requiring the full adult dose only). (1.2)
Bacterial meningitis (pediatric patients 3 months of age and older
requiring the full adult dose only).
(1.3)
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP AND
OTHER ANTIBACTERIAL
DRUGS, MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP
SHOULD ONLY BE
USED TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY
SUSPECTED TO BE CAUSED BY
BACTERIA.
DOSAGE AND ADMINISTRATION
Use this formulation of meropenem only in patients who require the
entire 500 mg or 1 gram dose and not
any fraction thereof. (2.1)
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 to 30 minutes for
intra-abdominal infections for
adult patients. (2.1)
Dosage should be