METRONIDAZOLE injection, solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

West-ward Pharmaceutical Corp

INN (Международно Name):

METRONIDAZOLE

Композиция:

METRONIDAZOLE 500 mg in 100 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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, Peptost

Каталог на резюме:

Metronidazole Injection, USP is sterile and is supplied in 100 mL single dose plastic containers, each containing an iso-osmotic, buffered solution of 500 mg metronidazole as follows: NDC 0143-9772-26             500 mg/100 mL Two groups of 12 bags each are placed in a carton, separated by a divider. Four cartons are then packed into a shipper. Store at 20°-25°C (68°-77°F) (see USP controlled room temperature). 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 the inner bag firmly. If leaks are found, discard solution as sterility may be impaired. Metronidazole Injection, USP is a ready-to-use iso-osmotic solution. No dilution or buffering is required . Do not refrigerate. Each container of Metronidazole Injection, USP contains 14 mEq of sodium. Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. To open Tear overwrap at the top and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for leaks. Do not add supplementary medication. Preparation for Administration

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METRONIDAZOLE- METRONIDAZOLE INJECTION, SOLUTION
WEST-WARD PHARMACEUTICAL CORP
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METRONIDAZOLE INJECTION
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). Its use,
therefore, should be reserved for the conditions described in the
Indications and Usage section
below.
DESCRIPTION
Metronidazole Injection, USP, is a parenteral dosage form of the
synthetic antibacterial agent 1-(ß-
hydroxyethyl)-2-methyl-5- nitroimidazole.
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 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.
CLINICAL PHARMACOLOGY
Metronidazole is a synthetic antibacterial compound. Disposition of
metronidazole in the body is similar
for both oral and intravenous dosage forms, with an average
elimination half-life in healthy humans of
eight hours.
The major route of elimination of metronidazole an