Ornidazole


Full Prescribing Info
Dosage/Direction for Use

Oral
Amoebiasis
Adult: 0.5 g bid for 5-10 days.
Child: 25 mg/kg as a single daily dose for 5-10 days.
Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic impairment:
Severe: Double the interval between doses.

Oral
Amoebic dysentery
Adult: 1.5 g as a single daily dose for 3 days. Alternatively for patients >60 kg: 1 g bid for 3 days.
Child: 40 mg/kg daily.
Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic impairment:
Severe: Double the interval between doses.

Oral
Giardiasis
Adult: 1-1.5 g as a single daily dose for 1-2 days.
Child: 30-40 mg/kg daily.
Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic impairment:
Severe: Double the interval between doses.

Oral
Trichomoniasis
Adult: 1.5 g as a single daily dose or 0.5 g bid for 5 days. Treat sexual partners concomitantly.
Child: 25 mg/kg as a single dose.
Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic impairment:
Severe: Double the interval between doses.

Intravenous
Severe amoebic dysentery
Adult: Initially, 0.5-1 g infusion followed by 0.5 g every 12 hrs for 3-6 days.
Child: 20-30 mg/kg body wt daily.
Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic impairment:
Severe: Double the interval between doses.
Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Intravenous
Amoebic liver abscess

Adult: Initially, 0.5-1 g infusion followed by 0.5 g every 12 hrs for 3-6 days.
Child: 20-30 mg/kg body wt daily.
Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic impairment:
Severe: Double the interval between doses.
Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Intravenous
Anaerobic bacterial infections

Adult: Initially, 0.5-1 g followed by 1 g daily as a single dose or in 2 divided doses for 5-10 days. Doses to be given via infusion. Substitute with 500 mg every 12 hr orally as soon as possible.
Child: 10 mg/kg every 12 hr for 5-10 days.
Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic impairment:
Severe: Double the interval between doses.
Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Intravenous
Prophylaxis of postoperative anaerobic bacterial infections

Adult: 1 g by IV about 30 minutes before surgery.
Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic impairment:
Severe: Double the interval between doses.
Reconstitution: Dilute to a concentration of ≤5 mg/ml.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to ornidazole or to other nitroimidazole derivatives.
Special Precautions
Renal and hepatic impairment. CNS diseases e.g. epilepsy or multiple sclerosis. May impair ability to drive or operate machinery. Pregnancy and lactation.
Adverse Reactions
Somnolence, headache, nausea, vomiting, dizziness, tremor, rigidity, poor coordination, seizures, tiredness, vertigo, temporary loss of consciousness and signs of sensory or mixed peripheral neuropathy, taste disturbances, abnormal LFTs, skin reactions.
Drug Interactions
Potentiates effect of coumarin-type oral anticoagulants. Prolongs the muscle-relaxant effect of vecuronium bromide.
Action
Ornidazole is a 5-nitroimidazole derivative active against protozoa and anaerobic bacteria. It is converted to reduction products that interact with DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms.
Absorption: Readily absorbed (oral and intravaginal); peak plasma concentrations after 2 hr (oral), 12 hr (intravaginal).
Distribution: Body tissues and fluids (wide), CSF. Protein-binding: <15%.
Metabolism: Hepatic.
Excretion: Via urine (as conjugates and metabolites), via faeces (small amounts); 12-14 hr (elimination half-life).
ATC Classification
G01AF06 - ornidazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
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.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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