MEROPENEM injection

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Xellia Pharmaceuticals USA LLC

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 concurren

製品概要:

Meropenem for Injection, USP is supplied as follows: 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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

MEROPENEM- MEROPENEM INJECTION
XELLIA PHARMACEUTICALS USA 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
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.
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
Recom