Ornigel

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ORNIGIL® (ORNIGIL)

Composition:

active substance: ornidazole;

1 ml of solution contains 5 mg of ornidazole;

excipients: sodium chloride, water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless or pale yellow liquid.

Pharmacotherapeutic group. Antibacterial agents for systemic use. Imidazole derivatives. Ornidazole. ATC code J01X D03.

Pharmacological properties.

Pharmacodynamics.

Ornigil® is an antibiotic derivative of 5-nitroimidazole with antibacterial activity similar to that of metronidazole and other 5-nitroimidazoles.

It is effective against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), as well as certain anaerobic bacteria such as Gardnerella vaginalis, Bacteroides and Clostridium spp., Fusobacterium, and anaerobic cocci. It exerts antiprotozoal activity against Balantidium coli, Blastocystis hominis, Trichomonas vaginalis, Trichomonas foetus, Giardia intestinalis, and Entamoeba histolytica.

In terms of its mechanism of action, Ornigil® is a DNA-targeting agent with selective activity against microorganisms possessing enzymatic systems capable of reducing the nitro group and catalyzing the interaction of ferredoxin-group proteins with nitro compounds. After penetrating the microbial cell, the drug's mechanism of action involves the reduction of the nitro group by microbial nitroreductases and the activity of the already reduced nitroimidazole. The reduction products form complexes with DNA, leading to DNA degradation and disruption of DNA replication and transcription processes. Additionally, the drug's metabolites exhibit cytotoxic properties and interfere with cellular respiration.

Pharmacokinetics.

Following intravenous infusion at an initial dose of 15 mg/hour and subsequent administration at 7.5 mg/kg body weight every 6 hours, the maximum steady-state concentration reaches 26 μg/mL, while the minimum concentration is 18 μg/mL. Ornidazole distributes into various tissues and biological fluids of the body, including bile, saliva, pleural, peritoneal, and cerebrospinal fluid (approximately 43% of the plasma concentration), vaginal secretions, bone tissue, liver, and erythrocytes. Plasma protein binding is less than 20%. Ornidazole crosses the placental barrier and is excreted into breast milk. Approximately 30–60% of the drug is metabolized in the body via hydroxylation, oxidation, and glucuronidation. The main metabolite (2-hydroxymetronidazole) also possesses antiprotozoal and antibacterial activity. Ornidazole is primarily excreted in urine (60–80%), partially in bile, both in unchanged form and as metabolites, over 5 days following a single dose.

Clinical characteristics.

Indications.

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

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

Contraindications.

• Hypersensitivity to the components of the drug or to other nitroimidazole derivatives.
• Organic diseases of the central nervous system.
• Epilepsy, multiple sclerosis.
• Circulatory disorders, pathological blood disorders or other hematological abnormalities.
• Chronic alcoholism.

Interaction with other medicinal products and other types of interactions.

Ornidazole potentiates the effect of oral anticoagulants of the coumarin group, requiring appropriate dose adjustment. Ornidazole prolongs the muscle-relaxant effect of vecuronium bromide.

The concentration of the drug is reduced when used concomitantly with microsomal enzyme inducers (phenobarbital, rifampicin) and increased when used concomitantly with inhibitors of hepatic microsomal systems, particularly H₂-receptor blockers (cimetidine).

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

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

Special precautions for use

When exceeding the recommended doses, there is a certain risk of adverse effects in children and in patients with liver disease or those 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, leukocyte monitoring is recommended, especially during repeated courses of treatment.

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

Exacerbation of candidiasis may occur, which may require appropriate treatment.

In patients undergoing hemodialysis, a reduced elimination half-life should be taken into account, and additional doses of the drug should be administered before or after hemodialysis.

Lithium, creatinine, and electrolyte concentrations should be monitored during concomitant lithium therapy.

The effect of other medicinal products may be increased or decreased during ornidazole treatment.

This medicinal product contains 15.4 mmol (or 354.2 mg)/dose (100 mL) of sodium. Caution is advised when administering to patients on a controlled sodium diet.

Use during pregnancy or breastfeeding

Ornigil® is contraindicated during the first trimester of pregnancy. In the second and third trimesters, the drug should be prescribed only if clearly indicated.

If use of Ornigil® is necessary during lactation, breastfeeding should be discontinued.

Ability to influence reaction speed when driving or operating machinery

Ornidazole may cause symptoms such as drowsiness, muscle rigidity, dizziness, tremor, seizures, impaired coordination, or transient loss of consciousness. These potential effects should be considered in patients driving or operating machinery.

Administration and Dosage

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

For systemic anaerobic infections: In adults and children aged 12 years and older, the initial dose is 500–1000 mg, followed by 500 mg every 12 hours or 1000 mg every 24 hours for 5–10 days (stepwise dosing). Once 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 two doses, administered over 5–10 days.

For prophylaxis of anaerobic infections during surgical procedures: In adults and children aged 12 years and older, administer Ornihil® intravenously at a dose of 500–1000 mg half an hour before surgery.

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

Severe amebic dysentery, all extraintestinal forms of amebiasis, 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, administer Ornihil® at a dose of 20–30 mg/kg body weight, divided into two doses.

The duration of treatment is determined by the physician depending on the nature of the disease.

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

Adverse reactions.

Blood and lymphatic system disorders: bone marrow suppression manifestations, 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, excitement.

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; administration site reactions, including pain, redness, burning sensation at the injection site.

Other: darkening of urine color, cardiovascular disorders, including arterial hypotension.

Shelf life. 2 years.

Storage conditions.

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

Do not freeze. Keep out of reach of children.

Incompatibility.

The solution must not be mixed with other medicinal products.

Packaging.

100 ml or 200 ml in glass bottles.

Prescription category. Prescription only.

Manufacturer: LLC "Yuria-Pharm".

Manufacturer's address and location of business activity: 108, Kozbirska St., Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.