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
is provided in the following sections: DESCRIPTION, INDICATIONS
AND USAGE, DOSAGE AND ADMINISTRATION.
Metronidazole is an oral
Metronidazole tablets contain 250 mg
or 500 mg of metronidazole.
Inactive ingredients include cellulose,
FD&C Blue No. 2 Lake, hydroxypropyl cellulose, hydroxypropyl
glycol, stearic acid, and titanium
Metronidazole HCl Sterile IV
and Metronidazole Sterile IV, are parenteral dosage forms of the
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,
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 disodium.
Metronidazole is classified therapeutically as an antiprotozoal
agent. Chemically, metronidazole
is named 2-methyl-5- nitro-1H-Imidazole-1-ethanol.
CATEGORIES, BRAND NAMES
CATEGORIES: Abscess, Abdominal; Abscess, Hepatic;
Abscess, Lung; Abscess, Pulmonary; Amebiasis; Endocarditis; Endometritis;
Helicobacter Pylori; Infection, Bone; Infection, Gynecologic; Infection,
Intra-abdominal; Infection, Joint; Infection, Local; Infection,
Respiratory Tract; Infection, Skin; Meningitis; Peritonitis; Pneumonia;
Prophylaxis, Perioperative; Septicemia; Sexually Transmitted Diseases;
Trichomoniasis; Vaginosis, Bacterial; Pregnancy Category B; FDA
Approved 1980 Feb; WHO Formulary;
FDA Drug Class: Antibacterials, Miscellaneous; Antidiarrheals;
Antiprotozoals; Dermatologics; Disorders, Acid/Peptic; Gastrointestinal,
BRAND NAMES: Acromona; Amibazol; Amiyodazol;
Anaerobex; Anerobia; Apo-Metronidazole; Arcazol;
Arilin; Ariline; Asiazole; Asuzol; Camezol;
Clont; Debetrol; Deflamon; Elyzol; Fladex;
Flagenase; Flagyl; Flagyl 375; Flasinyl; Fossyol;
Frotin; Fulikan; Fuzuzin; Klion; Medai;
Melis; Metarsal; Metizol; Metro IV; Metrocream; Metrogel;
Metrogyl; Metrolag; Metrolex; Metromidol; Metronidazole
IV; Metronidazol McKesson; Metroxyn; Metroxyn
500; Metrozin; Metrozine; Metrozole; Metryl;
Nalox; Nida; Nitrozol; Noritate; Norstene;
Novazole; Novonidazole; Protostat; Rozagel;
Rozex; Rozex Gel; Satric; Servizol; Servizole;
Supplin; Takimetol; Trichex; Trichozole;
Tricowas B; Tricowas-B; Trikacide; Trofonil;
Vaginyl; Vagitrix; Vagyl; Zadstat
(Foreign brand names outside U.S. in italics)
COST OF THERAPY: $0.83 (Baterial Vaginosis; Tablet;
500 mg; 2/day; 7 days)