MEROPENEM injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

BluePoint Laboratories

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Meropenem for 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 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 is indicated for the treatment of bacterial meningitis caused by

Termék összefoglaló:

Meropenem for injection 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 20º to 25ºC (68º to 77ºF) [see USP]. 500 mg Injection Vial (NDC 68001-446-29) and packaged in cartons of 10 vials (NDC 68001-446-31). 1 gram Injection Vial (NDC 6800-447-58) and packaged in cartons of 10 vials (NDC 68001-447-57).

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

MEROPENEM- MEROPENEM INJECTION
BLUEPOINT LABORATORIES
----------
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
INDICATIONS AND USAGE
Meropenem for 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 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 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
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 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
26-50
Recommended dose
Every 12 hours
10-25
One-half recommended dose
Every 12 hours
Less than 10
One-half recommended dose
Every 24