Ornidazole

Brands of Ornidazole in Kenya

Dazolic®, Sun Pharma Laboratories Ltd.

Diarobic®, Amol Pharmaceuticals Private Limited

Giro®, Panacea Biotec Ltd.

Granid®, NIC pharma

Ordazole®, Meyer Organics Pvt

Orgyl®, Kusum Healthcare Pvt. Ltd

MOA:

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

PHARMACOKINETICS

Ornidazole is readily absorbed from the gastrointestinal tract and peak plasma concentrations of about 30 mcg per ml have been achieved within 2 hours of a single dose of 1.5g, falling to 9mcg per ml after 24 hours and 2.5 mcg per ml after 48 hours.
The plasma elimination half-life of ornidazole is 12 to 14 hours. Less than 15% is bound to plasma proteins.
It is widely distributed in body tissues and fluids, including the cerebrospinal fluid.
Ornidazole is metabolized in the liver and is excreted in the urine, mainly as conjugates and metabolites, and to a lesser extent in feces. 85% of a single oral dose has been reported to be eliminated within five days,63% in the urine and 22% in feces
Biliary excretion may be important in the elimination of ornidazole and its metabolites.

Indications

• Used in the treatment of severe hepatic and intestinal amoebiasis,giardiasis, trichomoniasis of urogenital tract, and bacterial vaginosis.
• Also used in prophylaxis of susceptible anaerobic infections in dental and gastrointestinal surgery.
• Ordinazole 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 5-7 days
Amoebic Dysentry
Adults: 1.5 g once daily for 3 days
Children: 40mg/kg once daily for 3 days
Giardiasis
Adults: 1.5 g once daily for 1-2 days
Children: 40mg/kg once daily for 2 days
Trichomoniasis
Adults: 1.5g once or 500mg twice daily for 5 days. The sexual partner should be simultaneously treated
Bacterial Vaginosis
Adults: 1.5g once or 500mg twice daily for 5 days
Anaerobic Bacterial Infection
Initiate oral therapy as soon as possible after I.V infusion
Adults: 500mg twice daily for 5 -10 days
Children: 10mg per kg twice daily
Use in 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 fetus/ neonate.

CONTRAINDICATIONS

Hypersensitivity to ornidazole and other imidazoles

DRUG INTERACTIONS

So far with ornidazole, the disulfiram-like reaction has not been reported on the consumption of alcohol.
Some medicines and ornidazole may interfere with each other.
These include:
Warfarin a blood-thinning agent
Vancuronium bromide a muscle relaxant

SIDE EFFECTS

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.

Clinical | Pharmacokinetic data

Legal Status | Dosage forms & Strengths

Drug Indentifiers:

References/ Citation:

• PPB Drugs Retention Register
• Rutgeerts, Paul, et al. “Ornidazole for prophylaxis of postoperative Crohn’s disease recurrence: a randomized, double-blind, placebo-controlled trial.” Gastroenterology 128.4 (2005): 856-861.
• Sköld, M. A. R. I. A. N. N. E., H. A. K. A. N. Gnarpe, and L. Hillström. “Ornidazole: a new antiprotozoal compound for treatment of Trichomonas vaginalis infection.” Sexually Transmitted Infections 53.1 (1977): 44-48.