MEROPENEM injection, powder, for solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Eugia US LLC

INN (Международно Name):

MEROPENEM

Композиция:

MEROPENEM 500 mg

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 Haemophilus influenzae, Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae. Meropenem for Injection has been found to be effective in eliminating concurre

Каталог на резюме:

Meropenem for Injection, USP is a sterile, pyrogen-free, white to pale yellow crystalline powder and is supplied in vials containing sufficient meropenem to deliver 500 mg or 1 g for intravenous administration, respectively. Meropenem for Injection, USP is available as follows: 500 mg/vial:       10 Vials in a carton                               NDC 55150-207-20 1 g/vial:       10 Vials in a carton                              NDC 55150-208-30 The dry powder should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stoppers are not made with natural rubber latex.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

MEROPENEM - MEROPENEM INJECTION, POWDER, FOR SOLUTION
EUGIA US 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
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 to 50
Recommended dose
Every 12 hours
10 to 25
One-half recommended dose
Every 12 hours
Less than 10
One-half recommended