Misufer (Capsules) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

J05AX13 (Umifenovir)

Active Substance

Umifenovir (Rec.INN WHO registered)

Dosage Forms

	Misufer	Capsules 100 mg: 10, 20 or 40 pcs.
		Capsules 200 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, with a white body and cap; the capsule contents are a mixture containing granules and powder from white to light yellow in color.

Excipients: microcrystalline cellulose, potato starch, povidone K30, colloidal silicon dioxide (aerosil), calcium stearate, croscarmellose sodium.

Capsule body composition titanium dioxide (E171), gelatin.
Capsule cap composition titanium dioxide (E171), gelatin.

5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.

Capsules hard gelatin, size No. 0, with a white body and cap; the capsule contents are a mixture containing granules and powder from white to light yellow in color.

Excipients: microcrystalline cellulose, potato starch, povidone K30, colloidal silicon dioxide (aerosil), calcium stearate, croscarmellose sodium.

Capsule body composition titanium dioxide (E171), gelatin.
Capsule cap composition titanium dioxide (E171), gelatin.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; other antiviral agents

Pharmacological Action

Antiviral agent. Specifically suppresses influenza A and B viruses, coronavirus associated with severe acute respiratory syndrome.

According to the mechanism of antiviral action, it belongs to fusion inhibitors, interacts with the virus hemagglutinin and prevents the fusion of the viral lipid envelope and cell membranes.

It has a moderate immunomodulatory effect.

It has interferon-inducing activity, stimulates humoral and cellular immune responses, the phagocytic function of macrophages, and increases the body’s resistance to viral infections.

It reduces the frequency of complications associated with viral infection, as well as exacerbations of chronic bacterial diseases.

The therapeutic efficacy in viral infections is manifested in a reduction in the severity of general intoxication and clinical phenomena, a reduction in the duration of the illness, and a decrease in the risk of complications.

It belongs to low-toxicity compounds (LD₅₀ >4 g/kg).

It does not have any negative effects on the human body when taken orally in recommended doses.

Pharmacokinetics

It is rapidly absorbed and distributed throughout organs and tissues.

C_max in blood plasma when taken at a dose of 50 mg is reached after 1.2 hours, at a dose of 100 mg – after 1.5 hours.

It is metabolized in the liver.

T_1/2 is 17-21 hours.

About 40% is excreted unchanged, mainly with bile (38.9%) and in small amounts by the kidneys (0.12%).

90% of the administered dose is excreted within the first 24 hours.

Indications

Prevention and treatment in adults and children: influenza A and B, acute respiratory viral infections (ARVI), severe acute respiratory syndrome (including cases complicated by bronchitis, pneumonia); secondary immunodeficiency states; complex therapy of chronic bronchitis, pneumonia, and recurrent herpetic infection.

Prevention of postoperative infectious complications and normalization of immune status.

Complex therapy of acute intestinal infections of rotavirus etiology in children over 3 years of age.

ICD codes

Dosage Regimen

Take orally before a meal.

For adults and children over 12 years: use the 200 mg capsule strength.

For children aged 6 to 12 years: use the 100 mg capsule strength.

For children aged 3 to 6 years: use the 100 mg capsule strength.

For non-specific prevention of influenza and ARVI during an epidemic: administer 200 mg once daily for 10-14 days.

For post-exposure prevention of influenza and ARVI after contact with patients: administer 200 mg once daily for 10-14 days.

For treatment of influenza and ARVI without complications: administer 200 mg four times daily for 5 days.

For complex therapy of chronic bronchitis, pneumonia, or herpetic infection: administer 200 mg four times daily for 5-7 days, then reduce to 200 mg twice weekly for 4 weeks.

For prevention of postoperative complications: administer 200 mg2 days before surgery, then on the 2nd and 5th days after surgery.

For treatment of acute intestinal rotavirus infections in children: administer a single dose four times daily for 5-7 days.

Adhere strictly to the dosing schedule and complete the full course of therapy.

Adverse Reactions

Rarely allergic reactions.

Contraindications

Children under 3 years of age; hypersensitivity to umifenovir.

Special Precautions

It does not exhibit central neurotropic activity and can be used in medical practice for preventive purposes in practically healthy individuals of various professions, including those requiring increased attention and coordination of movements (vehicle drivers, operators, etc.).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.