Genferon^® light (Spray, Drops, Suppositories) Instructions for Use

ATC Code

L03AB05 (Interferon alfa-2b)

Active Substances

Taurine (Rec.INN)

Interferon alfa-2b (USAN)

Clinical-Pharmacological Group

Interferon. An immunomodulatory drug with antiviral action

Pharmacotherapeutic Group

Immunomodulatory agents, interferons

Pharmacological Action

A combined medicinal product.

Interferon alfa-2b has antiviral, immunomodulatory, antiproliferative, and antibacterial action. The antiviral effect is mediated by the activation of a number of intracellular enzymes that inhibit viral replication. The immunomodulatory effect is manifested primarily by the enhancement of cell-mediated immune system reactions, which increases the effectiveness of the immune response against viruses, intracellular parasites, and cells that have undergone tumor transformation. This is achieved by activating CD8+ T-killers, NK-cells (natural killers), enhancing the differentiation of B-lymphocytes and their antibody production, activating the monocyte-macrophage system and phagocytosis, as well as increasing the expression of major histocompatibility complex type I molecules, which increases the likelihood of infected cells being recognized by immune system cells. The activation of leukocytes contained in all layers of the mucous membrane under the influence of interferon ensures their active participation in the elimination of pathological foci; in addition, under the influence of interferon, the production of secretory immunoglobulin A is restored. The antibacterial effect is mediated by immune system reactions enhanced under the influence of interferon.

Taurine helps to normalize metabolic processes and tissue regeneration, has membrane-stabilizing and immunomodulatory effects. Being a strong antioxidant, Taurine directly interacts with reactive oxygen species, the excessive accumulation of which contributes to the development of pathological processes. Taurine helps to preserve the biological activity of interferon, enhancing the therapeutic effect of this combination.

Pharmacokinetics

With intranasal use of this combination, a high concentration of interferon is created at the site of infection and a pronounced local antiviral and immunostimulating effect is manifested. Systemic absorption is insignificant; with intranasal administration, human recombinant interferon alfa-2b is detected in small amounts in the lung tissue and blood. In the body, biotransformation occurs mainly in the kidneys with a T_1/2 of 5.1 hours. The small amount of this agent that enters the systemic circulation has a systemic immunomodulatory effect.

With rectal administration, high bioavailability (more than 80%) of interferon is noted, due to which both local and pronounced systemic immunomodulatory effects are achieved; with intravaginal application, due to the high concentration at the site of infection and fixation on the cells of the mucous membrane, a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic effect is insignificant due to the low absorption capacity of the vaginal mucosa. C_max of interferon in blood serum is reached 5 hours after administration. The main route of elimination is renal catabolism. T_1/2 is 12 hours.

Indications

For intranasal use: treatment and prevention of influenza and ARVI, other acute respiratory viral infections in adults and children aged from 29 days (in the appropriate dosage form).

For rectal use: as part of complex therapy – for the treatment and prevention of acute respiratory viral infections and other infectious diseases of bacterial and viral etiology in children aged 3 years and older (in the appropriate dosage form).

For vaginal use: treatment of infectious and inflammatory diseases of the urogenital tract in children and women, including pregnant women, against the background of specific therapy prescribed and monitored by a physician.

ICD codes

Dosage Regimen

Spray, Drops, Suppositories

Doses are indicated based on interferon alfa-2b.

Intranasally

Used in the appropriate dosage form for 5 days.

For adults and children over 14 years old, a single dose is 50,000 IU.

For children aged from 29 days to 14 years (in a special dosage form) a single dose is 1,000-2,000 IU.

Rectally or vaginally

The method of administration, dose and treatment regimen depend on age and indications for use.

For children under 7 years old, including infants, a single dose is 125,000 IU.

For adults and children over 7 years old, a single dose is 250,000 IU.

Adverse Reactions

Possible local allergic reactions (burning sensation, itching). These phenomena are reversible and disappear on their own within 72 hours after discontinuation of this agent. Continuation of treatment is possible only after consultation with a doctor.

Contraindications

Hypersensitivity to the components of the combination; newborns from 0 to 28 days.

Use in Pregnancy and Lactation

Rectal and vaginal use in the first trimester of pregnancy is contraindicated.

Intranasal use is allowed throughout the entire period of pregnancy.

There are no restrictions for use during breastfeeding.

Pediatric Use

In children aged from 29 days to 14 years, it is used intranasally in a special dosage form.

Special Precautions

Use intranasally with caution in patients prone to nosebleeds.

Effect on ability to drive vehicles and machinery

The effect of this agent on the performance of potentially hazardous activities requiring special attention and quick reactions has not been studied.

Drug Interactions

Simultaneous use of intranasal vasoconstrictor drugs is not recommended, as this causes additional dryness of the nasal mucosa.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.