ORNIDA Tablet

Ornidazole is effective in the treatment of anaerobic infections of trichomoniasis, amoebiasis, giardiasis and non specific vaginitis and in surgical antibiotic prophylaxis.

Dosage and administration

Adults:

Amoebiasis: 1.5g daily as a single dose for 3 days or 1g daily for 10days. Patients with amoebic dysentery and amoebic liver abscess, ornidazole may be given by intravenous infusion in a dose of 0.5g to 1.0g initially, followed by 0.5g every 12 hours for 3-6 days; the children’s dose is 20-30mg/kg daily.

Amoebic liver abscess: Single day treatment with 2g dose (1g morning and 1g evening).

Giardiasis; 1-1.5g single dose for 1-2 days; the children’s dose is 30-40mg/kg daily.

Trichomoniasis: Single dose of 1-1.5g or single oral dose of 1g plus 500mg vaginally. 5 day courses of ornidazole 0.5g twice daily by mouth are also used. Sexual partners should be treated concomitantly. The children’s dose is 15mg/kg as a single dose by mouth.

Paediatric:

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

Amoebic dysentery: 40mg//kg/day for 3 days.

For the treatment of anaerobic bacterial infections, ornidazole is given by intravenous infusion in an initial dose for 5-10 days; oral therapy with 0.5g every 12 hours should be substituted as soon as possible. Children may be given 10mg/kg intravenously every 12 hours for 5-10 days.

Administration in hepatic impairment: In view of the prolonged half life and reduced clearance of ornidazole reported in patients with hepatic dysfunction the interval between doses should be doubled in patients with severe hepatic impairment.

Administration in renal impairment: The elimination of ornidazole is reported to largely unaltered in patients with impaired renal function. Dosage adjustment is therefore usually unnecessary, although patients receiving haemodialysis should a given a supplemental dose equivalent to one half of usual dose before dialysis.

Hypersensitivity to the drug or any of its components.

Ornidazole should be administered after meals or with food to lessen gastro-intestinal disturbances.

CNS effects (dose related include headache, lassitude, dizziness and fatigue). GI effects, though less frequently reported include nausea, vomiting, diarrhea, epigastric distress, anorexia, dry mouth; occasionally bitter metallic taste, skin rash, leukopenia.

Ethanol (See the package insert about the details.)

Pregnancy

There are no adequate and well controlled studies in pregnant women.

Nursing Mothers

It is not known whether ornidazole is excreted in the human milk.

Periodic assessment of the organ system functions, including hematopoietic and hepatic, is advisable during prolong therapy.

Ornidazole is a 5-nitroimidazole that is active against protozoa and anaerobic bacteria and is used in the management of susceptible protozoal (Amoeba) and anaerobic bacterial infections.

Ornidazole rapidly diffuse into the protozoal/bacterial cells, nitro group accept the electron as result the chemically active intermediate is formed. This intermediate acts on the cell DNA protein and membrane. This results into the cell death.