They arise from the antibacterial and antiparasitic activity of ornidazole and its pharmacokinetic characteristics. They take into account both the clinical studies to which this medicine has given rise and its place in the range of anti-infective products currently available.

They are limited to infections caused by germs defined above as sensitive:

• Amoebiasis;
• Urogenital trichomoniasis;
• Giardia;
• Curative treatment of medico-surgical infections with sensitive anaerobic germs;
• Preventive treatment of infections with sensitive anaerobic germs during surgical operations with a high risk of occurrence of this type of infection;
• Relay of injectable treatments for infections with sensitive anaerobic germs, for curative or preventive purposes.

Official recommendations regarding the appropriate use of antibacterials should be taken into account.

Amebiasis

• Adults: 1000 to 1500 mg per day.
• Children: 30 mg/kg/day.

In hepatic amoebiasis, at the abscess stage, the evacuation of the abscess must be carried out in conjunction with treatment with ornidazole.

Trichomoniasis

• Either 1000 mg per day in two doses for 5 days, or 1500 mg in a single dose after the evening meal ("minute" treatment).

Giardiasis

• Adults: 1000 mg per day.
• Children: 30 mg/kg/day.

Treatment of anaerobic germ infections (first line or relay therapy)

• Adults: 1000 mg/day to 1500 mg/day.
• Children: 20 to 30 mg/kg/day.

Prevention of postoperative infections with anaerobic germs (first line or as a relay treatment)

• Adults: preoperative: 500 mg approximately 12 hours before the intervention, postoperative: 500 mg every 12 hours for 3 days (possible injection relay).
• Children: same protocol at a dosage of 20 to 30 mg/kg/day.

Warnings

• Interrupt treatment in case of ataxia, dizziness or mental confusion;
• Take into account the risk of worsening of the neurological state in patients with severe central, peripheral, fixed or progressive neurological disorders.

Precautions for use

• Control the leukocyte formula in the event of a history of blood dyscrasia, or of high-dose treatment and/or prolonged treatment;
• This product belongs to the family of nitro-5-imidazole why cases of potentiation with vecuronium (non-depolarizing neuromuscular blocking) were reported

Association not recommended:

+ Alcohol

Avoid taking alcoholic beverages and drugs containing alcohol: antabuse effect (heat, redness, vomiting, tachycardia).

Association to take into account:

+ Fluorouracil (and by extrapolation, tegafur and capecitabine)

Increase in the toxicity of fluorouracil by reduction of its clearance. Particular monitoring of the association with coumarin-type anticoagulants, although the potentiation of the anticoagulant effect has not been observed with ornidazole.

Special problems of INR imbalance

Many cases of increased activity of oral anticoagulants have been reported in patients receiving antibiotics. The marked infectious or inflammatory context, age and general condition of the patient appear to be risk factors. In these circumstances, it seems difficult to draw a line between the infectious pathology and its treatment in the occurrence of the INR imbalance. However, certain classes of antibiotics are more involved: these include fluoroquinolones, macrolides, cyclins, cotrimoxazole and certain cephalosporins.

The administration of ornidazole during pregnancy and lactation is to be avoided in the absence of exploitable clinical and experimental data.

Patients should be warned of the potential risk of dizziness and confusion and should be advised not to drive or use machines if this type of disorder occurs.

Rarely: nausea, gastralgia, ataxia, dizziness, headache, mental confusion, rashes.

Very rare cases of hepatitis have been reported.

At high dosage or in case of prolonged treatment: leukopenia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

•    Saudi Arabia

The National Pharmacovigilance Center (NPC)

Fax: + (966-11) 2057662

Call NPC at: + (966-11) 2038222, Exts: 2317-2356-2340.

SFDA Call Center: 19999

e-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

•    Other GCC States

Please contact the relevant competent authority

Not applicable.

Pharmacotherapeutic group: other antibacterials, ATC code P01AB03 (P: Pest control products, insecticides and repellents).

Ornidazole is an anti-infective from the nitro-5-imidazole family.

Spectrum of antimicrobial activity

The critical concentrations separate the sensitive strains from the strains of intermediate sensitivity and the latter, resistant: S≤ 4 mg/l and R> 4 mg/l.

The prevalence of acquired resistance can vary depending on geography and time for some species. It is therefore useful to have information on the prevalence of local resistance, especially for the treatment of severe infections. These data can only provide guidance on the probabilities of the sensitivity of a bacterial strain to this antibiotic.

When the variability in the prevalence of resistance in France is known for a bacterial species, it is indicated in the table below

Absorption

Absorption is rapid. The maximum plasma concentration is reached in 2 to 3 hours after oral administration.

Distribution

After oral administration of a single 750 mg dose of ornidazole, the maximum plasma concentration is 11 µg/ml. The plasma half-life is 12 to 14 hours.

Ornidazole diffuses throughout the body, passes into the CSF and the placenta.

Binding to plasma proteins is less than 15%.

Biotransformation

Ornidazole is metabolized by the liver to 95% Five free or glucuro- and sulfo-conjugate metabolites are identified.

Excretion

Ornidazole is eliminated mainly in the form of inactive metabolites, via the kidneys (65%) and the bile.

Ornidazole has been shown to be carcinogenic in animals, the relevance of these results in humans is unknown.

Tablet core:

•    Maize starch

•    Hypromellose

•    Microcrystalline cellulose

•    Magnesium stearate

Tablets coat:

•    Opadry White

Not applicable.

Do not store above 30°C.

Store in the original package in order to protect from light.

PVC/PVDC blisters with aluminum foil in a cardboard box.

Pack size: 10 Film-coated tablets.

No special requirements.