RiteMED Metronidazole

Each tablet contains: Metronidazole, USP 500 mg.

Amebicide/Antiprotozoal.
Pharmacology: Metronidazole is a 5-nitro-imidazole derivative with activity against anaerobic bacteria and protozoa. Metronidazole is readily absorbed following administration by mouth and bioavailability approaches 100%. Peak plasma concentrations of approximately 5 and 10 mcg per mL are achieved, usually within 1 to 2 hours, after single doses of 250 and 500 mg respectively.
Metronidazole is widely distributed. It appears in most body tissues and fluids including bile, bone, breast milk cerebral abscesses, cerebrospinal fluid, liver and liver abscesses, saliva, seminal fluid, and vaginal secretions, and achieves concentrations similar to those in plasma. It also crosses the placenta and rapidly enters the fetal circulation. No more than 20% is bound to plasma proteins.
Metronidazole is metabolized in the liver by side chain oxidation and glucuronide formation. The elimination half-life of Metronidazole is about 8 hours; that of the hydroxy metabolite slightly longer. The half-life of Metronidazole is reported to be longer in neonates and in patients with severe hepatic impairment; that of the hydroxy metabolite is prolonged in patients with substantial renal impairment. The majority of the dose of Metronidazole is excreted in the urine, mainly as metabolites; a small amount appears in the feces.

In the treatment of susceptible protozoal infections and in the treatment and prophylaxis of anaerobic bacterial infections.

In Intestinal Amoebiasis: Adult: 400 mg to 800 mg three times a day for 5 to 10 days.
Children: 35 mg to 50 mg per kg body weight daily in three divided doses for 5 to 10 days.
In Trichomoniasis: Usual Adult Dose: A single dose of 2 g or 600 mg to 1 g in two to three divided doses for 7 days. Or, as prescribed by the physician.

This product has shown to be carcinogenic in mice and possibly in rats. Unnecessary use of the drug should therefore be avoided.

Should not be used in patients with peripheral neuropathy; transient epileptiform seizures and leucopenia, also should be avoided during first trimester of pregnancy and lactation.

The adverse effects of Metronidazole are generally dose-related. The most common are gastrointestinal disturbances, especially nausea and unpleasant metallic taste, furred tongue, glossitis and stomatitis, weakness, dizziness, ataxia, headache, drowsiness, insomnia, and changes in mood or mental state such as depression or confusion have also been reported. Skin rashes, urticaria, and pruritus occur occasionally and erythema multiforme, angioedema and anaphylaxis have been reported rarely. Other side effects include urethral discomfort and darkening of the urine.

Store at temperatures not exceeding 30°C.

Antiamoebics

P01AB01 - metronidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.

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