Imusat film-coated tablets 100 mg No. 10

Instructions for Imusat film-coated tablets 100 mg No. 10

Composition

active ingredient: umifenovir;

1 tablet contains umifenovir 50 mg or 100 mg;

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

Dosage form

Film-coated tablets.

Main physicochemical properties: film-coated tablets, white or white with a creamy tint, biconvex shape.

Pharmacotherapeutic group

Antiviral drugs for systemic use. Other antiviral drugs. ATX code J05A X13.

Pharmacological properties

Pharmacodynamics.

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

Therapeutic efficacy in influenza is manifested in reducing the duration and severity of the disease and its main symptoms, as well as in reducing the frequency of complications associated with influenza.

The drug belongs to low-toxic drugs and has no negative effects on the human body when used in recommended doses.

Pharmacokinetics.

The drug is rapidly absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is reached 1.2 hours after taking a dose of 50 mg, 1.5 hours after taking a dose of 100 mg. The half-life is 17–21 hours. Approximately 40% of the drug is excreted unchanged in the feces (38.9%) and urine (0.12%). During the first day, 90% of the dose is excreted.

Indication

Prevention and treatment of influenza A and B.

Contraindication

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

Interaction with other medicinal products and other types of interactions

No negative effects were detected when the drug interacted with other drugs.

Application features

Use with caution:

elderly patients (since the safety and effectiveness of use in elderly patients have not been sufficiently studied);

patients with impaired liver and kidney function (since pharmacokinetics and safety of use in such patients have not been studied).

There are no data on long-term use of the drug.

Use during pregnancy or breastfeeding

The safety of use during pregnancy or breastfeeding has not been sufficiently studied.

Ability to influence reaction speed when driving vehicles or other mechanisms

At recommended doses, the drug does not affect the reaction rate when driving or working with other mechanisms.

Method of administration and doses

For adults. Take orally before meals. A single dose is 200 mg.

For prevention:

in direct contact with flu patients: 200 mg once a day for 10–14 days;

during the flu epidemic: 200 mg 2 times a week for 3 weeks.

For the treatment of influenza: 200 mg 4 times a day (every 6 hours) for 5 days.

The maximum daily dose is 800 mg.

Children.

Do not use on children.

Overdose

Overdose with the drug has not been observed.

If any undesirable effects occur, you should consult a doctor.

Treatment is symptomatic.

Side effects

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

Immune system: hypersensitivity reactions, including skin redness, itching, rash, urticaria, angioedema.

Expiration date

Tablets of 50 mg - 2 years.

Tablets of 100 mg - 3 years.

Storage conditions

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

Packaging

10 tablets each in a contour cell package; 1 contour cell packaging in a pack.

Leave category. Without a prescription.

Vacation category

Without a prescription.

Producer

PrJSC "Pharmaceutical Company "Darnitsa".

Address

Ukraine, 02093, Kyiv, Boryspilska St., 13.