MEROPENEM injection

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Gland Pharma Limited

INN (Isem Internazzjonali):

MEROPENEM

Kompożizzjoni:

MEROPENEM 500 mg in 20 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Meropenem for Injection, USP is supplied as follows: NDC                           Meropenem for Injection, USP                                Package Factor 68083-146-10              500 mg Injection Vial                                                 10 vials per carton 68083-147-10              1 gram Injection Vial                                                  10 vials per carton Meropenem for Injection, USP is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

MEROPENEM - MEROPENEM INJECTION
GLAND PHARMA LIMITED
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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, USP 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 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, USP and other antibacterial drugs, Meropenem for Injection,
USP should only be used to treat or
prevent infections that are proven or strongly suspected to be caused
by susceptible bacteria. (1)
DOSAGE AND ADMINISTRATION
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 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, USP 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