Interferon alfa-2b + Taurine + Benzocaine (Interferonum alpha-2b + Taurinum + Benzocainum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Interferons

Antiviral drugs (excluding HIV)

Included in the formulation
АТХ:

L.03.A.B.05   Interferon alfa-2b

Pharmacodynamics:

Interferon alfa-2b inhibits the replication of viruses, disrupts the synthesis of viral DNA, RNA and viral proteins. The drug increases the phagocytic activity of macrophages, potentiates the cytotoxic effect of lymphocytes. It shows pronounced antitumor activity due to antiproliferative properties. Interferon alfa-2b has antiviral, immunomodulating, antiproliferative and antibacterial action. The antiviral effect is mediated by the activation of a number of intracellular enzymes that inhibit the replication of viruses. Immunomodulatory effect manifested primarily cell-mediated amplification reactions of the immune system, which increases the efficiency of the immune response against viruses, intracellular parasites and cells which have undergone malignant transformation. This is achieved by activation of CD8 + killer T cells, NK-cells (natural killer cells), enhance differentiation of B lymphocytes and antibody production to, activation of monocyte-macrophage system and phagocytosis as well as increasing the expression of molecules of the major histocompatibility complex I type, which increases the likelihood recognition of infected cells by cells of the immune system.Activation under the influence of interferon leukocytes contained in all layers of the mucous membrane, ensures their active participation in the elimination of pathological foci; in addition, due to the influence of interferon achieved restoration of secretory IgA production. Antibacterial effect is mediated by immune system reactions, enhanced by interferon.

Taurine is an amino acid, promotes reparative and regenerative processes, improves energy processes, helps normalize the functioning of cell membranes. Taurine promotes the normalization of metabolic processes and tissue regeneration, has a membrane-stabilizing and immunomodulating effect. Being a strong antioxidant, taurine directly interacts with the active forms of oxygen, the excessive accumulation of which contributes to the development of pathological processes. Taurine promotes the preservation of the biological activity of interferon, enhancing the therapeutic effect of the drug.

Benzocaine has a local anesthetic effect by reducing the permeability of neuronal membranes for sodium ions, and increasing the permeability for potassium ions.Thus, depolarization of the membrane of neurons is inhibited and initiation and conduction of nerve impulses are blocked. Prevents the appearance of painful impulses in the endings of the sensory nerves and their conduction along nerve fibers. Has an exclusively local effect, not absorbed into the systemic circulation.

Pharmacokinetics:

It is used vaginally and rectally, while the drug accumulates in surrounding tissues, providing local action, and also enters the lymphatic system, due to it has a systemic effect.

When rectal administration of the drug high bioavailability (more than 80%) of interferon is noted, in connection with which both local and expressed systemic immunomodulatory effect is achieved; when intravaginal application due to the high concentration in the focus of infection and fixation on the cells of the mucosa, a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic action due to the low absorption capacity of the mucous membrane of the vagina is insignificant. Cmax interferon in the serum is reached 5 hours after the administration of the drug. The main way of excretion is through the kidneys. Half-life is 12 hours, which makes it necessary to use the drug 2 times a day.

Indications:

The drug is used as a complex therapy for the treatment of the following diseases:

- genital herpes;

- ureaplasmosis;

- recurrent vaginal candidiasis;

- trichomoniasis;

- bacterial vaginosis;

- cervicitis;

- bartholinite;

- PGrowth;

- balanitis;

- chlamydia;

- mycoplasmosis;

- gardnerellez;

- papillomavirus infections;

- erosion of the cervix;

- vulvovaginitis;

- adnexitis;

- urethritis;

- balanoposthitis.

ICD-10

I.A30-A49.A49.3   Infection caused by mycoplasma, unspecified

I.A50-A64.A56   Other chlamydial diseases, sexually transmitted diseases

I.A50-A64.A56.0   Chlamydial infections of the lower parts of the genito-urinary tract

I.A50-A64.A56.1   Chlamydial infections of the pelvic organs and other urogenital organs

I.A50-A64.A59   Trichomoniasis

I.A50-A64.A60   Anogenital herpetic viral infection [herpes simplex]

I.A50-A64.A63.8   Other specified diseases, mainly sexually transmitted

I.B35-B49.B37.3   Candidiasis of the vulva and vagina (N77.1 *)

I.B95-B97.B97.7   Papillomaviruses as a cause of diseases classified elsewhere

X.J20-J22.J20   Acute bronchitis

XIV.N30-N39.N30.1   Interstitial cystitis (chronic)

XIV.N30-N39.N30.2   Other chronic cystitis

XIV.N30-N39.N34   Urethritis and urethral syndrome

XIV.N40-N51.N41   Inflammatory diseases of the prostate

XIV.N40-N51.N48.1   Balanoposthitis

XIV.N40-N51.N48.6   Balanitis

XIV.N70-N77.N70   Salpingitis and oophoritis

XIV.N70-N77.N71   Inflammatory diseases of the uterus, except the cervix

XIV.N70-N77.N72   Inflammatory disease of the cervix

XIV.N70-N77.N74.4 *   Inflammatory diseases of female pelvic organs caused by chlamydiae (A56.1 +)

XIV.N70-N77.N75.9   Bartholin gland disease, unspecified

XIV.N70-N77.N76   Other inflammatory diseases of the vagina and vulva

XIV.N80-N98.N86   Erosion and ectropion of the cervix

Contraindications:

Hypersensitivity.

Carefully:

Allergic and autoimmune diseases in the acute stage.

Pregnancy and lactation:

Use during pregnancy is only possible if the potential benefit to the mother exceeds the potential harm to the child.

The application for normalization of the indices of local immunity at the 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 part of the urogenital tract.

Clinical studies have shown the safety of intravaginal application of the drug 250 000 IU at the time of pregnancy 13-40 weeks.

The safety of the drug in the first trimester of pregnancy has not been studied.

Dosing and Administration:

Vaginally, rectally.

1 suppository contains human interferon recombinant alpha-2 250/500 000 IU, taurine 10 mg, benzocaine 55 mg.

For women: 1 suppository intravaginally 2 times a day for 10 days, with a chronic course of the disease - 1 suppository 3 times a week for 1-3 months.

For men: 1 suppository rectally 2 times a day for 10 days.

Infectious and inflammatory diseases of the urogenital tract in women. For 1 suppository (250 000, 500 000 or 1 000 000 IU, depending on the severity of the disease) vaginally or rectally (depending on the nature of the disease) 2 times daily for 10 days. With prolonged forms 3 times a week every other day, one suppository for 1-3 months.

With a pronounced infectious inflammatory process in the vagina, it is possible to use 1 suppository (500,000 IU) intravaginally in the morning and 1 suppository (1 000 000 IU) rectally at night, simultaneously with the introduction into the vagina of a suppository containing antibacterial / fungicidal agents.

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

Infectious and inflammatory diseases of the urogenital tract in men. Rectal by 1 suppository (500,000 IU or 1 000 000 IU depending on the severity of the disease) 2 times a day for 10 days.

Acute bronchitis in adults (as part of complex therapy). For 1 suppository (1 000 000 IU) rectally 2 times a day for 5 days.

Chronic recurrent cystitis in adults (as part of complex therapy). At an exacerbation - on 1 suppository (1 000 000 IU) rectally 2 times a day for 10 days in combination with a standard course of antibiotic therapy, then - 1 suppository (1 000 000 IU) rectally every other day for 40 days in order to prevent relapses.

Side effects:

From the nervous system: headache.

From the side of the circulatory system: thrombocytopenia, and leukopenia.

Other: increased sweating, myalgia, arthralgia, fever, fatigue, loss of appetite, allergic reactions.

Possible local allergic reactions (burning sensation in the vagina).These phenomena are reversible and disappear within 72 hours after discontinuation of administration. Continuation of treatment is possible after consultation with a doctor.

Overdose:

No cases of drug overdose have been reported. If you accidentally inject a larger number of suppositories than prescribed by your doctor, you should stop the further administration for 24 hours, after which the treatment can be resumed according to the prescribed schedule.

Interaction:

Nonsteroidal anti-inflammatory drugs, anticholinesterase drugs - potentiation of the action of benzocaine.

Antibiotics and other antimicrobials - an increase in the effectiveness of the drug.

Vitamin E and C - Strengthening the effect of the drug.

The drug reduces the activity of sulfonamides.

Special instructions:

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

Allowed the use of the drug during menstruation.

Impact on the ability to manage motor transport and other technical devices

The drug does not affect the performance of potentially hazardous activities requiring special attention and quick reactions (vehicle management,machinery and others).

Instructions
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