Interferon alfa-2b + Taurine - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

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. Immunomodulatory effect is manifested primarily by the intensification of cell-mediated immune system reactions, which increases the effectiveness of the immune response against viruses, intracellular parasites and cells that underwent tumor transformation. This is achieved by activating CD8 + T-killers, NK cells (natural killers), enhancing the differentiation of B-lymphocytes and their production of antibodies, activation of the monocyte-macrophage system and phagocytosis, as well as increasing the expression of the molecules of the main histocompatibility complex of type I, which increases the probability 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 - a sulfur-containing amino acid that forms in the body during the conversion of cysteine. Promotes reparative and regenerative processes, improves energy processes, helps normalize the functioning of cell membranes. 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.

Due to the properties of the inhibitory neurotransmitter GABA release modulation occurs, epinephrine, prolactin and other hormones, the regulation of responses to them; normalization of the functions of cell membranes, activation of energy and metabolic processes, preservation of the electrolyte composition of the cytoplasm due to the accumulation of K⁺ and Ca²⁺ and improve the conditions for carrying out a nerve impulse.

Pharmacokinetics:

Suppositories rectal or vaginal

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 cells of the mucous membrane of the vagina, 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. C_max 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.

Spray nasal

With intranasal application due to the high concentration in the focus of infection, a pronounced local antiviral and immunostimulating effect is achieved.

Systemic absorption of the drug is insignificant - low bioavailability medicinal product when administered intranasally, is associated with the functioning of a specific family of proteins of 25 proteins,which form part of the mucous membrane of the nasal cavity and control the transport of all molecular and cellular objects that penetrate the mucosa.

At the same time, a certain amount of the drug enters the systemic circulation, thereby achieving a systemic immunomodulatory effect.

Indications:

Vaginal or rectal suppositories

- as a component of complex therapy - treatment acute respiratory viral infections and other infectious diseases of bacterial and viral etiology in children;

- treatment of infectious and inflammatory diseases of the urogenital tract in children and women, including pregnant women.

Spray nasal dosed

- prevention and treatment of influenza and acute respiratory viral infections in adults and children older than 14 years.

ICD-10

X.J00-J06 Acute respiratory infections of the upper respiratory tract

X.J00-J06.J06.9 Acute upper respiratory tract infection, unspecified

X.J10-J18.J10 Influenza caused by an identified influenza virus

X.J10-J18.J11 Influenza, virus not identified

Contraindications:

Vaginal or rectal suppositories

- individual intolerance to interferon and other substances that make up the drug;

- I trimester of pregnancy.

Spray nasal dosed

- hypersensitivity to interferon alpha-2b or other components of the drug;

- children's age till 14 years.

Carefully:

Suppositories vaginal or rectal: exacerbation of allergic and autoimmune diseases.

Spray nasal dosed: patients with nasal bleeding.

Pregnancy and lactation:

Vaginal or rectal suppositories

Clinical studies have shown the efficacy and safety of the drug in women at 13-40 week pregnancy. Application in the first trimester of pregnancy is contraindicated. Has no restrictions to use during lactation.

Spray nasal dosed

Allowed to be used throughout the period of pregnancy.

Dosing and Administration:

1 dose of the drug contains interferon alfa-2b 10 000 IU and taurine 0.8 mg.

Age from 29 days to 11 months 29 days - 1 drop 5 times a day.

Age from 1 to 3 years - 2 drops 3-4 times a day.

Age from 3 to 14 years - 2 drops 4-5 times a day.

Suppositories vaginal or rectal: vaginally, rectally.

The method of administration, dosage and duration of the course depend on the age, the specific clinical situation and are determined by the attending physician.In adults and children older than 7 years, the drug is used in a dosage of 250,000 IU interferon alfa-2b on the suppository. In children under 7 years of age, it is safe to use the drug at a dosage of 125,000 IU interferon alfa-2b on the suppository. Women who are on the 13-40 week pregnancy, the drug is used at a dose of 250 000 IU interferon alfa-2b on the suppository.

Recommended doses and treatment regimens

Acute respiratory viral infections and other acute diseases of viral nature in children: 1 suppository rectally 2 times a day with a 12-hour interval in parallel with the main therapy for 5 days. If symptoms persist, the course of treatment is repeated after a 5-day interval.

Chronic infectious and inflammatory diseases of viral etiology in children: 1 suppository rectally 2 times a day with a 12-hour interval simultaneously with standard therapy for 10 days. Then within 1-3 months - 1 suppository rectally at night every other day.

Acute infectious-inflammatory diseases of the urogenital tract in children: 1 suppository rectally 2 times a day with a 12-hour interval for 10 days.

Infectious and inflammatory diseases of the urogenital tract in pregnant women: 1 suppository vaginally 2 times a day with a 12-hour interval for 10 days.

Infectious and inflammatory diseases of the urogenital tract in women: 1 suppository (250 000 IU) vaginally or rectally (depending on the nature of the disease) 2 times a day with a 12-hour interval for 10 days. With prolonged forms 3 times a week every other day, one suppository for 1-3 months.

Spray nasal dosed: intranasally, by aerosol administration of 1 dose (1 dose = 1 short press on the dispenser).

At the first sign of the disease, the drug is administered intranasally for 5 days at a single dose (one push on the dispenser) in each nasal passage 3 times a day (one dose of approximately 50,000 IU interferon alfa-2b, daily should not exceed 500 000 IU).

When in contact with a sick person acute respiratory viral infection and / or when supercooled, the drug is administered according to the indicated scheme 2 times a day for 5-7 days. If necessary, preventive courses are repeated.

Side effects:

Vaginal or rectal suppositories

The drug is well tolerated by patients. Possible local allergic reactions (sensation of itching and burning 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.

To date, no serious or life-threatening side effects have been observed. There may be phenomena that occur when all types of interferon alfa-2b are used, such as chills, fever, fatigue, loss of appetite, muscle and headaches, joint pain, sweating, and leuko- and thrombocytopenia, but more often they occur at a significant exceeding daily dose of more than 10 000 000 IU. In these cases it is advisable to consult a doctor in order to decide whether to cancel the drug or to reduce the dose.

As for any other interferon alpha preparation, in the case of an increase in temperature after its administration, paracetamol can be given once a dose of 500-1000 mg for adults and 250 mg for children.

Spray nasal dosed

Side effects were not observed.

Overdose:

Vaginal or rectal suppositories

Cases of drug overdose are not registered. 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 scheme.

Spray nasal dosed

No cases of drug overdose have been reported.

Interaction:

Do not use simultaneously with vasoconstrictor intranasal preparations.

Vaginal or rectal suppositories

The drug is most effective as a component of complex therapy. When combined with antibacterial, fungicidal and antiviral drugs, a mutual potentiation of the action is observed, which allows achieving a high total therapeutic effect.

Spray nasal dosed

Not noted.

Special instructions:

After instillation it is recommended to massage the wings of the nose with your fingers for several minutes to distribute the drug evenly in the nasal cavity.

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 (management of vehicles, machinery, etc.).

Instructions

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