Genferon, vaginal and rectal suppositories 55 mg+1000000 me+10 mg 10 pcs

Pharmacological group: immunomodulatory agents, interferons.

ATC code – L03AB05

Pharmacological properties

Immunobiological properties

Henferon^®

Immunobiological properties. GENFERON^® is a combined preparation the action of which is conditioned by its constituent components. It has both local and systemic action.

The preparation Genferon ^{contains recombinant human interferon
alpha-2b produced by Escherichia coli strain which has been genetically engineered with human interferon alpha-2b gene.}

Interferon alpha-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. Immunomodulatory action is first of all manifested by strengthening of cell-mediated reactions of immune system which increases the effectiveness of immune response against viruses, intracellular parasites and cells which have undergone tumor transformation.

This is achieved through activation of CD8+ T-helpers, NK-cells (natural killer cells), increasing differentiation of В-lymphocytes and their production of antibodies, activation of monocytic-macrophage system and phagocytosis as well as increasing the expression of histocompatibility complex type I molecules, which increases the recognition of infected cells by the immune system.

The activation under the influence of interferon of leukocytes contained in all layers of the mucous membrane provides their active participation in the liquidation of pathological foci; besides, due to the influence of interferon the restoration of the production of secretory immunoglobulin A is achieved. Antimicrobial effect is mediated by reactions of the immune system enhanced under the influence of interferon.

Taurine promotes normalization of metabolic processes and tissue regeneration, has a membrane stabilizing and immunomodulatory action. As a strong antioxidant, taurine directly interacts with reactive oxygen species, the excessive accumulation of which contributes to pathological processes.

Taurine helps to preserve the biological activity of interferon, increasing the therapeutic effect of the drug.

Benzocaine (anesthesin) is a local anesthetic. It reduces cell membrane permeability to sodium ions, displaces calcium ions from the receptors located on the inner surface of the membrane, blocks conduction of nerve impulses. Prevents the occurrence of pain impulses in the endings of sensitive nerves and their conduction along the nerve fibers.

It has only local effect without being absorbed into the systemic blood flow.

Pharmacokinetics

In rectal administration of the drug a high bioavailability (more than 80%) of interferon is observed, due to which both local and expressed systemic immunomodulatory effects are achieved; At intravaginal application due to high concentration in the focus 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.

The maximum concentration of interferon in blood serum is achieved 5 hours after administration of the drug. The main way of excretion of α-interferon is renal catabolism. Half-life period is 12 hours, which determines the necessity of using the drug 2 times
a day.

Indications

As part of the complex therapy for infectious and inflammatory diseases of the urogenital tract in adults: Genital herpes, chlamydia, ureaplasmosis, mycoplasmosis, recurrent vaginal candidiasis, gardnerellosis, trichomonosis, papillomavirus infection, bacterial vaginosis, cervical erosion, cervicitis, vulvovaginitis, bartholinitis, adnexitis, prostatitis, urethritis, balanitis, balanopostitis.

In the complex treatment of acute bronchitis in adults.

In the complex treatment of chronic recurrent cystitis of bacterial etiology in adults.

In the complex treatment of chronic endometritis in adults.

Active ingredient

Composition

Active ingredients:

interferon alpha-2b human recombinant (rchIFN-α-2b); taurine0.01 g; benzocaine 0.055 g;

Excipients:

solid fat – q.s. to obtain suppository mass 1.65 g; dextran 60000, 0.0015 g; macrogol 1500, 0.124 g; polysorbate 80, 0.033 g; emulsifier T2, 0.132 g; sodium hydrocitrate, 0.0001 g; citric acid, 0.0015 g; purified water, 0.066 g.

How to take, the dosage

1. Infectious and inflammatory diseases of the urogenital tract in women.

1 suppository (250 000 ME or 500 000 ME or 1 000 000 ME depending on the severity of the disease) vaginally or rectally (depending on the nature of the disease) 2 times daily for 10 days. In protracted forms, 3 times a week, 1 suppository every other day for 1 to 3 months.

In cases of severe vaginal infection it is possible to use 1 suppository 500 000 IU intravaginally in the morning and 1 suppository 1 000 000 IU rectally at night in combination with a suppository containing antimicrobial/fungicidal agents in the vagina.

In order to normalize the indices of local immunity in the treatment of infectious-inflammatory diseases of the urogenital tract in women with gestational age of 13-40 weeks, 1 suppository of 250 000 IU vaginally 2 times daily for 10 days is used.

2. infectious and inflammatory diseases of the urogenital tract in men.

Rectally 1 suppository (500 000 ME or 1 000 000 ME depending on the disease severity) 2 times daily for 10 days.

3. as part of the complex therapy of acute bronchitis in adults.

1 suppository (1 000 000 ME) rectally 2 times a day for 5 days.

4. As part of the complex therapy of chronic recurrent cystitis in adults.

In case of acute relapse it is taken by 1 suppository (1 000 000 ME) rectally 2 times a day for 10 days in combination with the standard course of antibacterial therapy; afterwards 1 suppository (1 000 000 ME) rectally every other day for 40 days to prevent relapse.

5. As part of the complex therapy of chronic endometritis in adults.

Rectally 1 suppository (1 000 000 IU) 2 times a day for 10 days, then 1 suppository (500 000 IU) rectally 2 times a day for 10 days, then rectally 1 suppository (1 000 000 IU) every other day for 10 days.

Interaction

GENFERON® is most effective in combination with drugs (including antibiotics and other antimicrobials) used for the treatment of urogenital diseases. Nonnarcotic analgesics and anticholinesterase medications enhance the effects of benzocaine. Benzocaine reduces the antibacterial activity of sulfonamides.

Special Instructions

To prevent urogenital reinfection, it is recommended to consider concomitant treatment of the sexual partner.

The use of the drug during menstruation is allowed.

The drug GENFERON® does not affect performance of potentially hazardous activities requiring particular attention and quick reactions (driving of vehicles, machinery, etc.).

Contraindications

Individual intolerance to interferon and other substances in the drug.

With caution

Exacerbation of allergic and autoimmune diseases.

Side effects

The drug is well tolerated by patients.

Very rare adverse reactions (<1/10000):

General disorders and disorders at the site of administration

Possible allergic reactions, including local reactions. Continued treatment is possible after consultation with a physician.

Performance of all forms of interferon alfa-2b may occur, such as chills, fever, fatigue, loss of appetite, muscle and headache, joint pain, sweating, and leuko- and thrombocytopenia, but more often if the daily dose is over
10,000,000 IU. No severe adverse events have been observed to date.

As with any interferon alfa-2b drug, a single dose of
500 – 1000 mg of paracetamol may be taken in case of fever after its administration.

Overdose

No cases of overdose with GENFERON® have been reported. In case of accidental simultaneous administration of more suppositories than prescribed by the physician, further administration should be stopped for 24 hours, after which the treatment can be resumed according to the prescribed schedule.

Pregnancy use

It is indicated for the normalization of local immunity parameters during gestational age of 13-40 weeks in the complex therapy of genital herpes, chlamydia, ureaplasmosis, mycoplasmosis, cytomegalovirus infection, papillomavirus infection, bacterial vaginosis in the presence of itching, discomfort and pain in the lower parts of the urogenital tract.

The safety of intravaginal administration of Genferon® 250 000 IU during pregnancy at 13-40 weeks has been proved by clinical trials. The safety of using the drug in the first trimester of pregnancy has not been studied.