METRONIDAZOLE injection, solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Baxter Healthcare Corporation

INN (Международно Name):

METRONIDAZOLE

Композиция:

METRONIDAZOLE 500 mg in 100 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Treatment of Anaerobic Bacterial Infections 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, Clostrid

Каталог на резюме:

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: AIN00235 NDC 36000-001-24 - PVC containers 500 mg/100 mL Four groups of 6 bags each are placed in a carton, separated by a divider.  Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and protect from light during storage. Avoid excessive heat. Protect from freezing. 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METRONIDAZOLE- METRONIDAZOLE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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METRONIDAZOLE INJECTION, USP
RX ONLY
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 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 Anhydrous Disodium Hydrogen Phosphate,
USP and
22.9 mg Citric Acid Monohydrate, 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 container is fabricated from a specially formulated plastic.
Metronidazole Injection,
USP is supplied in PVC containers. 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 7.5 mg/k