MEROPENEM injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

INN (International Name):

MEROPENEM

Composition:

MEROPENEM 500 mg in 20 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meropenem for injection (I.V.) 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 (I.V.) 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 (I.V.) is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae,  Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae . Meropenem for injection (I.V.) has been found to be effective in eliminating

Product summary:

Meropenem for injection, USP (I.V.) 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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 500 mg Injection Vial (NDC 68001-323-29) [Cartons of 10 - NDC 68001-323-31] 1 gram Injection Vial (NDC 68001-324-58) [Cartons of 10 - NDC 68001-324-57]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEROPENEM- MEROPENEM INJECTION, POWDER, FOR SOLUTION
BLUEPOINT LABORATORIES
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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
Warning and Precautions,
INDICATIONS AND USAGE
Meropenem for injection (I.V.) 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 (I.V.) and
other antibacterial drugs, meropenem for injection (I.V.) 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 (I.V.) DOSAGE SCHEDULE FOR ADULT
PATIENTS WITH RENAL IMPAIRMENT
CREATININE CLEARANCE
(ML/MIN)
DOSE (DEPENDENT ON TYPE OF
INFE C TIO N)
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
Pediatric patients 3 months of age and older.
RECOMMENDED MEROPENEM FOR INJECTION (I.V.) DOSAGE SCHEDULE FOR
PEDIATRIC PATIENTS 3 MONTHS OF AGE AND
OLDER WITH NORMAL RENAL FUNCTION (2.3)
TYPE OF INFECTION
DOSE
(M G /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
Me ningitis
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.
- There is no experience in pediatric patients with renal impairment.
*20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every
8 hours is r