Ornidazole


Generic Medicine Info
Indications and Dosage
Oral
Amoebic dysentery
Adult: 1,500 mg as a single daily dose in the evening for 3 days. Patients weighing >60 kg: 1,000 mg bid for 3 days.
Child: ≤35 kg: 40 mg/kg as a single daily dose for 3 days; >35 kg: Same as adult dose.

Oral
Giardiasis
Adult: 1,500 mg as a single daily dose in the evening for 1-2 days.
Child: ≤35 kg: 40 mg/kg as a single daily dose for 1-2 days; >35 kg: Same as adult dose.

Oral
Prophylaxis of postoperative anaerobic bacterial infections
Adult: 1,500 mg 12 hours prior to surgery, then 500 mg 12 hourly for 3-5 days postoperatively.

Oral
Amoebiasis
Adult: 500 mg bid for 5-10 days.
Child: ≤35 kg: 25 mg/kg as a single daily dose for 5-10 days; >35 kg: Same as adult dose.

Oral
Trichomoniasis
Adult: Acute cases: 1,500 mg as a single dose to be given in the evening. Chronic cases: 500 mg bid for 5 days. Treat sexual partners concomitantly.
Child: 25 mg/kg as a single dose.
Renal Impairment
Patients receiving haemodialysis: Give an additional dose of 500 mg (if the daily dose is 2 g daily) or 250 mg (if the daily dose is 1 g daily) before each dialysis.
Hepatic Impairment
Severe: Double the interval between doses.
Administration
Should be taken with food.
Contraindications
Hypersensitivity.
Special Precautions
Patient with CNS disease (e.g. multiple sclerosis, epilepsy). Patient undergoing haemodialysis. Hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Blood and lymphatic system disorders: Rarely, leucopenia.
Ear and labyrinth disorders: Very rarely, vertigo.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, epigastric discomfort, dry mouth. Rarely, impaired sense of taste.
General disorders and administration site conditions: Fatigue.
Hepatobiliary disorders: Jaundice.
Investigations: Abnormal LFT.
Metabolism and nutrition disorders: Loss of appetite.
Nervous system disorders: Very rarely, somnolence, headache, dizziness, tremor, rigidity, coordination impairments, seizures, temporary loss of consciousness, sensory or mixed peripheral neuropathy.
Skin and subcutaneous tissue disorders: Rarely, pruritus and skin reactions.
Patient Counseling Information
This drug may cause somnolence, dizziness, or temporary loss of consciousness, if affected, do not drive or operate machinery.
Drug Interactions
Potentiates the effect of coumarin-type oral anticoagulants. Prolongs the muscle relaxant effect of vecuronium bromide.
Food Interaction
Disulfiram-like reaction (e.g. flushing, tachycardia) may occur when taken concomitantly with alcohol.
Action
Description: Ornidazole, a 5-nitroimidazole derivative, acts via a mechanism that involves preactivation by reduction of the nitro group and production of toxic derivatives and radicals. It is effective against protozoa, such as Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia (Giardia intestinalis), and certain anaerobic bacteria, such as Bacteroides and Clostridium spp., Fusobacterium spp., and anaerobic cocci.
Pharmacokinetics:
Absorption: Rapidly absorbed. Time to peak plasma concentration: Within 3 hours.
Distribution: Widely distributed in body fluids and tissues, including the CSF. Plasma protein binding: Approx 13%.
Metabolism: Metabolised in the liver.
Excretion: Via urine (4% as unchanged drug). Elimination half-life: Approx 13 hours.
Chemical Structure

Chemical Structure Image
Ornidazole

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 28061, Ornidazole. https://pubchem.ncbi.nlm.nih.gov/compound/Ornidazole. Accessed May 26, 2022.

Storage
Store at ≤30°C. Protect from light.
MIMS Class
Antiamoebics / Other Antibiotics
ATC Classification
J01XD03 - ornidazole ; Belongs to the class of imidazole derivative antibacterials. Used in the systemic treatment of infections.
P01AB03 - ornidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.
References
Marcus Y, Tal N, Ronen M et al. The Drug Ornidazole Inhibits Photosynthesis in a Different Mechanism Described for Protozoa and Anaerobic Bacteria. Biochem J. 2016 Dec;473(23):4413-4426. doi: 10.1042/BCJ20160433. Accessed 11/03/2022. PMID: 27647935

Anon. Ornidazole. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/03/2022.

Buckingham R (ed). Ornidazole. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/03/2022.

Preston CL (ed). Ornidazole Drug Interactions. Stockley’s Drug Interactions [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/03/2022.

Teva Pharma (New Zealand) Limited. Arrow - Ornidazole, 500 mg, Film Coated Tablet data sheet 18 October 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 09/03/2022.

Disclaimer: This information is independently developed by MIMS based on Ornidazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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