Imustat

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT IMUSTAT (IMUSTAT)

Composition:

Active substance: umifenovir;

1 tablet contains 50 mg or 100 mg of umifenovir;

Excipients: potato starch, methylcellulose, colloidal anhydrous silicon dioxide, calcium stearate, Opadry II 85F White.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets of white or off-white color, biconvex in shape.

Pharmacotherapeutic group. Antiviral agents for systemic use. Other antiviral agents. ATC code J05A X13.

Pharmacological properties.

Pharmacodynamics.

An antiviral agent that specifically inhibits influenza viruses A and B, including highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1). According to its mechanism of antiviral action, it belongs to fusion inhibitors, interacting with viral hemagglutinin and preventing fusion of the viral lipid envelope with cellular membranes.

Therapeutic efficacy in influenza is manifested by reduction in duration and severity of the disease and its main symptoms, as well as by reduction in the frequency of influenza-related complications.

The medicinal product belongs to low-toxicity medicinal agents and has no negative impact on the human body when used at recommended doses.

Pharmacokinetics.

The medicinal product is rapidly absorbed in the gastrointestinal tract. Maximum plasma concentration is reached within 1.2 hours after administration of a 50 mg dose, and within 1.5 hours after administration of a 100 mg dose. The half-life ranges from 17 to 21 hours. Approximately 40 % of the drug is excreted unchanged in feces (38.9 %) and urine (0.12 %). About 90 % of the administered dose is eliminated within the first 24 hours.

Clinical characteristics.

Indications.

Prophylaxis and treatment of influenza A and B.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interactions.

No negative effects have been observed with concomitant use of this medicinal product and other medicinal products.

Special precautions for use.

Use with caution:

• in elderly patients (since safety and efficacy in elderly patients have not been sufficiently studied);
• in patients with impaired liver or kidney function (since the pharmacokinetics and safety of use in such patients have not been studied).

Data on long-term use of the medicinal product are lacking.

Use during pregnancy or breastfeeding.

Safety during pregnancy or breastfeeding has not been sufficiently studied.

Ability to influence reaction rate when driving or operating machinery.

At recommended doses, the medicinal product does not affect reaction speed when driving or operating machinery.

Dosage and Administration.

For use in adults. Take orally before meals. The single dose is 200 mg.

For prophylaxis:

• upon direct contact with influenza patients: 200 mg once daily for 10–14 days;
• during influenza epidemic period: 200 mg twice weekly for 3 weeks.

For treatment of influenza: 200 mg four times daily (every 6 hours) for 5 days.

The maximum daily dose is 800 mg.

Children

Do not use in children.

Overdose.

Overdose of the medicinal product has not been reported.

In case of any adverse events, medical advice should be sought.

Treatment is symptomatic.

Side effects.

Gastrointestinal tract: heartburn, feeling of heaviness in the epigastric region, vomiting.

Immune system: hypersensitivity reactions, including skin redness, itching sensation, rash, urticaria, angioneurotic edema.

Shelf life.

50 mg tablets – 2 years.

100 mg tablets – 3 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging.

50 mg tablets – 10 tablets in a blister pack; 1 blister pack in a carton.

100 mg tablets – 10 tablets in a blister pack; 1, 2, or 4 blister packs in a carton.

Category of release. Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's location and address of business activity.

13, Boryspylska Street, Kyiv, 02093, Ukraine.