METRONIDAZOLE injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)

Dostupno od:

Baxter Healthcare Corporation

INN (International ime):

METRONIDAZOLE

Sastav:

METRONIDAZOLE 500 mg in 100 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Metronidazole Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole Injection, USP therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Injection, USP. Metronidazole Injection, USP is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin. Intra-Abdominal Infections , including peritonitis, intra-abdominal abscess and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis , B. distasonis , B. ovatus , B. thetaiotaomicron , B. vulgatus ), Clostridium species, Eubacterium species, Peptococcus species and Peptostreptococcus species. Skin and Skin Structure Infections caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Pept

Proizvod sažetak:

Metronidazole Injection, USP is supplied in 100 mL single dose plastic containers, each containing an iso-osmotic, buffered solution of 500 mg metronidazole as follows: 2B3422 NDC 0338-9541-24 500 mg/100 mL Store at controlled room temperature (77°F or 25°C) and protect from light during storage. Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

Status autorizacije:

New Drug Application

Svojstava lijeka

METRONIDAZOLE- METRONIDAZOLE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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METRONIDAZOLE INJECTION, USP
IN PLASTIC CONTAINER
VIAFLEX PLUS CONTAINER
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Metronidazole Injection, USP and other antibacterial drugs,
Metronidazole Injection, USP
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
WARNING
Metronidazole has been shown to be carcinogenic in mice and rats (see
PRECAUTIONS).
Unnecessary use of the drug should be avoided. Its use should be
reserved for the
conditions described in the INDICATIONS AND USAGE section below.
DESCRIPTION
Metronidazole Injection, USP, is a parenteral formulation of the
synthetic nitroimidazole
antibacterial agent 2-methyl-5-nitro-1_H_-imidazole-1-ethanol.
Metronidazole Injection, USP, in 100 mL VIAFLEX Plus single dose
plastic container, is a
sterile, nonpyrogenic, iso-osmotic, buffered solution of 500 mg
Metronidazole, USP, 790
mg Sodium Chloride, USP, 47.6 mg Dibasic Sodium Phosphate Dried, USP
and 22.9 mg
Citric Acid Anhydrous, USP. Metronidazole Injection, USP has an
osmolarity of 310
mOsmol/L (calc) and a pH of 5.5 (4.5 to 7.0). Each container contains
14 mEq of
sodium.
The plastic container is fabricated from a specially formulated
polyvinyl chloride plastic.
Water can permeate from inside the container into the overwrap in
amounts insufficient
to affect the solution significantly. Solutions in contact with the
plastic container can
leach out certain of its chemical components in very small amounts
within the expiration
period, _e.g.,_ di-2-ethylhexyl phthalate (DEHP), up to 5 parts per
million. However, the
safety of the plastic has been confirmed in tests in animals according
to USP biological
tests for plastic containers as well as by tissue culture toxicity
studies.
CLINICAL PHARMACOLOGY
In patients treated with intravenous metronidazole, using a dosage
regimen of 15 mg/kg
loading dose followed 6 hours later by 7