Metronidazole (Flagyl) - Product information and Uses

Metronidazole is a nitroimidazole antibiotic medication which is used to treat as well as prevent infections caused by anaerobic bacteria and protozoa. Metronidazole is an antibiotic, amebicide, and antiprotozoal. Metronidazole is marketed by Pfizer in US under the brand name Flagyl and by Sanofi-Aventis globally under the same brand name.
Metronidazole (Flagyl) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Metronidazole - Availability And Packaging

Metronidazole is available as Flagyl Tablets which is packaged in 200 mg and 400 mg tablets. Flagyl tablets contain 200 mg or 400 mg of metronidazole USP respectively.

Uses Of Flagyl Tablets (Metronidazole)

Flagyl Tablets (Metronidazole) are used for the treatment of the following infections:
Symptomatic Trichomoniasis:
Flagyl Tablets are indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures.
Asymptomatic Trichomoniasis:
Flagyl Tablets are indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.
Treatment of Asymptomatic Consorts: T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously with Flagyl Tablets if the organism has been found to be present, in order to prevent reinfection of the partner.
Although the decision to treat an asymptomatic male partner who has a negative culture or for whom no culture has been attempted is an individual one, there is evidence that a woman may become reinfected if her consort is not treated. In any case, the consort should be treated with Metronidazole (Flagyl Tablets) in cases of reinfection.
Amebiasis:
Flagyl Tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Flagyl therapy does not obviate the need for aspiration or drainage of pus.
Anaerobic Bacterial Infections:
Flagyl 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 the event of a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection have to be used in addition to Metronidazole (Flagyl) therapy.

Flagyl Tablets (Metronidazole) - Dosage

The dosage of Flagyl tablets for certain indications is given below. The dosage should be individualized as per the requirement of the individual patient. Please consult your doctor for exact dosing instructions.
Trichomoniasis:
In Female Adult Patients:
One-day treatment - two grams of Flagyl, given either as a single dose or in two divided doses of one gram each, given in the same day.
Seven-day course of treatment - 250 mg three times daily for seven consecutive days.
Pregnant patients should not be treated during the first trimester.
Amebiasis:
Recommended Adults Dosage:
For acute intestinal amebiasis (acute amebic dysentery): 750 mg of Metronidazole orally three times daily for 5 to 10 days.
For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.
Pediatric patients: 35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.
Anaerobic Bacterial Infections:
In the treatment of most serious anaerobic infections, FLAGYL I.V. (metronidazole hydrochloride) or FLAGYL I.V. RTU® (metronidazole) is usually administered initially.
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period. The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.

Flagyl Tablets (Metronidazole) - Contraindications

Flagyl Tablets are contraindicated in individuals with a hypersensitivity to metronidazole or other nitroimidazole derivatives or any inactive ingredient present in Flagyl Tablets. Metronidazole is also contraindicated in female patients with trichomoniasis during the first trimester of pregnancy.

Side Effects of Metronidazole (Flagyl)

Common side effects that occur in 1% or more of the patients undergoing systemic metronidazole therapy include nausea, diarrhea, and/or metallic taste in the mouth.
Thrombophlebitis may occur in patients administered Metronidazole intravenously. Rarely occuring side effects include hypersensitivity reactions (rash, itch, flushing, fever), headache, dizziness, vomiting, glossitis, stomatitis, dark urine, and/or paraesthesia.

Overdosage and Overdose Symptoms of Flagyl Tablets (Metronidazole)

Single oral doses of metronidazole (Flagyl Tablets), up to 15 g, have been reported in suicide attempts and accidental overdoses. Overdose symptoms that were reported included nausea, vomiting, and ataxia.
A specific antidote for Flagyl overdose is not available. Treatment therefore consists of symptomatic and supportive therapy.

Additional Information

Additional Info: Prescribing Information