DESCRIPTION

WARNING

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.

Oral

Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 1-(beta-hydroxyethyl)-2-methyl-5-nitroimidazole.

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.

I.V. Injection

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.

Topical

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 and antibacterial 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; Orphan Drugs

FDA Drug Class: Antibacterials, Miscellaneous; Antidiarrheals; Antiprotozoals; Dermatologics; Disorders, Acid/Peptic; Gastrointestinal, Miscellaneous; Tetracyclines

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)