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.
This monograph contains full prescribing information for metronidazole
tablets and gel. Information for metronidazole intravenous injection is
provided in the following sections:
DESCRIPTION, INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION.
Metronidazole is an oral synthetic antiprotozoal and antibacterial agent,
Metronidazole tablets contain 250 mg or 500 mg of metronidazole. Inactive
ingredients include cellulose, FD&C Blue No. 2 Lake, hydroxypropyl
cellulose, hydroxypropyl methylcellulose, polyethylene glycol, stearic
acid, and titanium dioxide.
Metronidazole HCl Sterile IV and Metronidazole Sterile IV, are parenteral
dosage forms of the synthetic antibacterial agents
1-(beta-hydroxyethyl)-2-methyl-5 -nitroimidazole hydrochloride and
1-(beta-hydroxyethyl)-methyl- 5-nitroimidazole, respectively.
Each single-dose vial of lyophilized Metronidazole IV contains sterile,
nonpyrogenic Metronidazole HCl, equivalent to 500 mg metronidazole, and
415 mg mannitol.
Each Metronidazole IV RTU (Ready-To-Use) 100-ml single-dose plastic
container contains a sterile, nonpyrogenic, isotonic, buffered solution of
500 mg metronidazole, 47.6 mg sodium phosphate, 22.9 mg citric acid, and
790 mg sodium chloride in Water for Injection USP. Metronidazole IV RTU
has a tonicity of 310 mOsm/L and a pH of 5 to 7. 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-ethyhexyl phthalate (DEHP), up to 5 parts per million.
However, the safety of the plastic has been confirmed in tests in animal
according to USP biological tests for plastic containers as well as by
tissue culture toxicity studies.
Metronidazole Gel contains metronidazole, USP, at a concentration of 7.5
mg per gram (0.75%) in a gelled, purified water solution, containing
methyl and propyl parabens, propylene glycol, carbomer 940, and edetate
Metronidazole is classified therapeutically as an antiprotozoal
and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-