METRONIDAZOLE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 500 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Treatment of Anaerobic 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 therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. Metronidazole 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 B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus s

Product summary:

Metronidazole Injection, USP, sterile, is supplied in 100 mL single dose flexible containers, each containing 500 mg (5 mg/mL) of metronidazole (List 7811). Metronidazole Injection, USP should be stored at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature] and protected from light during storage.

Authorization status:

New Drug Application

Summary of Product characteristics

METRONIDAZOLE- METRONIDAZOLE INJECTION, SOLUTION
HOSPIRA, INC.
----------
METRONIDAZOLE
Injection, USP
500 MG (5 MG/ML)
SINGLE DOSE CONTAINER
FLEXIBLE CONTAINER
FOR INTRAVENOUS INFUSION ONLY
Rx only
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
METRONIDAZOLE AND OTHER ANTIBACTERIAL DRUGS, METRONIDAZOLE 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 sterile, nonpyrogenic, isotonic,
buffered parenteral dosage form of
metronidazole in water for injection.
Each 100 mL contains metronidazole 500 mg (5 mg/mL) and sodium
chloride 790 mg in water for
injection; with dibasic sodium phosphate (anhydrous) 48 mg and citric
acid (anhydrous) 23 mg added as
buffers. The osmolarity of this solution is 314 mOsmol/liter (calc.).
Each 100 mL contains 14 mEq
sodium, pH 5.8 (4.5 ― 7.0).
Metronidazole is classified as a synthetic antibacterial and
antiprotozoal agent and is administered by the
intravenous route.
Metronidazole, USP is chemically designated
2-methyl-5-nitroimidazole-1-ethanol (C H N O ), a
crystalline powder sparingly soluble in water. It has the following
structural formula:
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Water for Injection, USP is chemically designated H O.
6
9
3
3
2
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can
permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution
significantly. Solutions inside the plastic container also can leach
out certain of its chemical
components in very small amounts before the expiration period is
attained. However, the safe