ORNIM-500 Tablet

Use in the treatment of severe hepatic and intestinal amoebiasis, giardiasis, trichomoniasis of uro-genital tract and bacterial vaginosis. Also used in the treatment and prophylaxis of susceptible anaerobic infections in dental and gastrointestinal surgery. Ornidazole is also advocated in the management of H.pylori duodenal ulcer in combination with other drugs.

Dosage and Administration

Amoebiasis

Adults: 500mg twice daily for 5-7 days.

Children: 25mg/kg once daily for 5-10 days.

Amoebic dysentery

Adults: 1.5g once daily for 3 days.

Children: 40mg/kg once daily for 3 days.

Giardiasis

Adults: 1.5g once daily for 1-2 days

Children: 40mg/kg for 2 days.

Trichomoniasis

Adults: 1.5g once or 500mg twice daily for 5 days. Sexual partner should be simultaneously treated.

Bacterial vaginosis

Adults: 1.5g once or 500mg once daily for 5-7 days.

Anaerobic bacterial infections

Initiate oral therapy as soon as possible after I.V. infusion.

Adults: 500mg twice daily for 5-10 days.

Children: 10mg/kg twice daily.

Hypersensitivity to ornidazole and other imidazoles.

The most frequently encountered side effect is dizziness, alone or in combination with other adverse reactions. The other side effects occurring to a lesser extent are nausea, pyrosis, intestinal spasms and metallic taste. Vertigo, fatigue and other discomforts such as loose stools, insomnia, skin rash and headache have also been reported.

So far with ornidazole, disulfiram like reaction has not been reported on consumption of alcohol.

Pregnancy

There is no evidence of ornidazole accumulation when used in pregnant women. Therefore, dosage regimen of ornidazole requires no adjustment during pregnancy. However, adequate clinical trials have not been conducted. Ornidazole should be prescribed only if the potential benefit justifies the potential risk to foetus/neonate.

Special precautions are required in case of ataxia, vertigo, mental confusion and patients with neurological diseases. There is need for adjustment of dosage and dosage interval in patients with hepatic impairment. Modification of the usual dosage is not necessary in patients of renal failure however, additional post haemodialysis dose may be required in patients undergoing this procedure.

Its antimicrobial activity is due to the reduction of the nitro group to a more reactive amine that attacks microbial DNA, inhibiting further synthesis and causing degradation of existing DNA.