Ornithyl

INSTRUCTIONS for medical use of the medicinal product ORNISTIL (ORNISTIL)

Composition:

Active substance: ornidazole;

100 ml of solution contain 500 mg of ornidazole;

Excipients: sodium chloride, hydrochloric acid, water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear solution, colourless to slightly yellow.

Pharmacotherapeutic group. Antibacterials for systemic use. Other antibacterials. Imidazole derivatives. Ornidazole. ATC code J01X D03.

Pharmacological properties.

Pharmacodynamics.

The mechanism of action of ornidazole is associated with disruption of DNA structure in susceptible microorganisms. Ornidazole is active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), as well as certain anaerobic bacteria such as Bacteroides, Fusobacterium spp.; anaerobic bacteria: Clostridium spp.; sensitive strains of Eubacterium spp.; anaerobic cocci: Peptococcus spp., Peptostreptococcus spp.

It readily penetrates the microbial cell and, by binding to DNA, disrupts the replication process.

Pharmacokinetics.

Ornidazole penetrates well through the blood-brain and placental barriers, enters cerebrospinal fluid and bile; it also passes into breast milk. After intravenous administration at a dose of 15 mg/kg and subsequent administration at a dose of 7.5 mg per 1 kg of body weight every

6 hours, the steady-state concentration ranges from 18–26 μg/mL. Approximately 30–60% of the drug is metabolized in the body via hydroxylation, oxidation, and glucuronidation.

Excretion. Ornidazole is excreted primarily in the urine (60–80%), of which nearly 20% is unchanged, and 6–15% is excreted in feces.

Clinical characteristics.

Indications.

Parenteral administration of the drug is indicated in cases of acute and severe infection or when oral administration is not possible, for the following diseases and conditions:

• anaerobic systemic infections caused by microorganisms sensitive to ornidazole: sepsis, meningitis, peritonitis, postoperative wound infections, septicemia, septic abortion, and endometritis;
• prophylaxis of infections caused by anaerobic bacteria; in surgical procedures (especially operations on the colon and rectum); in gynecological surgeries;
• severe amebic dysentery, all extraintestinal forms of amebiasis, giardiasis, hepatic abscess.

Contraindications.

• Hypersensitivity to the components of the drug or to other nitroimidazole derivatives.
• Central nervous system (CNS) disorders.
• Epilepsy.
• Multiple sclerosis.
• Chronic alcoholism.
• Circulatory disorders, pathological blood disorders or other hematological abnormalities.
• First trimester of pregnancy and breastfeeding period.
• Body weight below 6 kg.

Interaction with other medicinal products and other types of interactions.

Unlike other nitroimidazole derivatives, ornidazole does not inhibit aldehyde dehydrogenase and therefore is compatible with alcohol.

Ornidazole enhances the effect of oral coumarin anticoagulants (warfarin), requiring appropriate dose adjustment.

Ornidazole prolongs the myorelaxant effect of vecuronium bromide.

Concomitant use of phenobarbital and other enzyme inducers reduces the circulation period of ornidazole in blood serum, whereas enzyme inhibitors (e.g., cimetidine) increase it.

When used with other 5-nitroimidazole derivatives, isolated cases of peripheral neuritis, psychic depression, and epileptic-like seizures have been reported.

Special precautions for use.

When exceeding the recommended doses, there is a certain risk of adverse effects in children, patients with liver disease, and patients who abuse alcohol. When using high doses of ornidazole or when treatment lasts longer than 10 days, clinical and laboratory monitoring is recommended.

In patients with a history of blood disorders, monitoring of leukocytes is recommended, especially when repeated courses of treatment are administered.

Exacerbation of disorders of the central or peripheral nervous system may occur during ornidazole therapy. In case of peripheral neuropathy, motor coordination disturbances (ataxia), dizziness, or impaired consciousness, treatment should be discontinued.

Exacerbation of candidiasis may occur, which requires appropriate treatment.

When hemodialysis is performed, the reduced half-life should be taken into account, and additional doses of the drug should be administered before or after hemodialysis.

Concentrations of lithium salts, creatinine, and electrolytes should be monitored during lithium therapy.

The effect of other medicinal products may be enhanced or diminished during ornidazole treatment.

This medicinal product contains 15.39 mmol (or 354 mg)/dose (100 mL) of sodium. Caution is advised when administering to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

Ornidazole is contraindicated during the first trimester of pregnancy. In the second and third trimesters, the drug should be used only when strictly indicated.

If ornidazole use is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Ornidazole may cause symptoms such as drowsiness, muscle rigidity, dizziness, tremor, seizures, coordination disturbances, and temporary loss of consciousness. Patients should take this possibility into account when driving or operating machinery.

Method of Administration and Dosage

The dosage and duration of treatment are determined by a physician depending on the nature of the disease and treatment regimen.

The drug should be administered intravenously over 15–30 minutes.

For anaerobic systemic infections: in adults and children aged 12 years and older, the initial dose is 500–1000 mg administered intravenously, followed by 500 mg every 12 hours or 1000 mg every 24 hours for 5–10 days (stepwise dosage). After the patient's condition has stabilized, switch to oral administration of ornidazole (e.g., 500 mg tablets, 1 tablet every 12 hours).

For children under 12 years of age with body weight exceeding 6 kg, the daily dose should be calculated at 20 mg/kg body weight, divided into 2 doses over 5–10 days.

For prophylaxis of anaerobic infections during surgical procedures: in adults and children aged 12 years and older, administer ornidazole at a dose of 500–1000 mg 30 minutes before surgery.

For prophylaxis of mixed infections, ornidazole should be used in combination with aminoglycosides, penicillin, or cephalosporins. The drugs should be administered separately.

Severe amoebic dysentery, all extraintestinal forms of amoebiasis, giardiasis, liver abscess: for adults and children aged 12 years and older, the first dose is 500–1000 mg, followed by 500 mg every 12 hours for 3–6 days.

For children under 12 years of age with body weight exceeding 6 kg, the daily dose should be calculated at 20–30 mg/kg body weight, divided into 2 doses.

In case of renal impairment, prolong the interval between doses or reduce the single and daily dose of the drug.

Children

Ornidazole is contraindicated in children with body weight less than 6 kg.

Overdose

Symptoms: loss of consciousness, headache, dizziness, tremor, seizures, depression, peripheral neuritis, nausea, vomiting, anorexia; possible exacerbation of symptoms of other adverse reactions.

Treatment: symptomatic; no specific antidote is known. In case of seizures, diazepam should be administered.

Adverse Reactions.

Blood and lymphatic system disorders: signs of bone marrow suppression, moderate leukopenia, neutropenia.

Immune system disorders: hypersensitivity reactions, including anaphylactic shock, angioneurotic edema.

Skin and subcutaneous tissue disorders: skin rashes, urticaria, skin hyperemia, pruritus.

Nervous system disorders: dizziness, somnolence, headache, tremor, muscle rigidity, coordination disturbances, ataxia, seizures, transient loss of consciousness, confusion, signs of sensory or mixed peripheral neuropathy, excitation.

Gastrointestinal disorders: taste disturbances, metallic taste in the mouth, dry mouth, coated tongue, nausea, vomiting, dyspepsia, feeling of heaviness and tenderness in the epigastric region.

Hepatobiliary disorders: hepatotoxicity, changes in liver function tests.

General disorders and administration site conditions: increased body temperature, chills, general weakness, fatigue, dyspnea; changes at the injection site, including pain, redness, burning sensation at the injection site.

Other: darkening of urine color; cardiovascular disorders, including decreased arterial pressure.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Unused medicinal product should be destroyed.

Incompatibility. The drug must not be mixed with other injectable solutions during administration.

Packaging. 100 ml of the drug in a container. One container in a film pouch together with the instructions for medical use in a cardboard box.

Prescription status. Prescription only.

Manufacturer. EuroLife Healthcare Pvt. Ltd.

Manufacturer's address and place of business.

H.No. 520, Bhagwanpur, Roorkee, Haridwar, Uttarakhand, India.

Marketing Authorization Holder. Ananta Medikare Ltd.

Address of the Marketing Authorization Holder and/or its representative.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.