TSYKLOFERON® (Pills, solution in / and the / m)

Active material: akridonuksusnaya acid
When ATH: L03AX
CCF: The antiviral and immunomodulatory drugs. Inducer of interferon synthesis
ICD-10 codes (testimony): A08, A56.0, A56.1, A60, A69.2, A87, B00, B02, B15, B16, B17.1, B18.1, B18.2, B24, B25, J06.9, J10, M05, M15, M32
When CSF: 09.01.05.02
Manufacturer: POLYSAN NTFF Ltd. (Russia)

Pharmaceutical form, composition and packaging

Pills, enteric coated yellow color, lenticular.

Excipients: potato starch, calcium stearate, a copolymer of methacrylic acid and ethyl acrylate, 1,2-propylene glycol.

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (5) – packs cardboard.

Solution for in / and the / m clear, yellow color.

Excipients: water d / and.

2 ml – ampoule (5) – packings Valium planimetric (1) – packs cardboard.

Pharmacological action

Immunomodulator. Meglumine akridonatsetat is a low molecular weight interferon inducer, which defines a wide range of its biological activity (Antiviral, immunomodulatory, antiinflammatory). Interferonogenic activity of the drug after oral administration is maintained for a 3 d.

The main producers of interferon-cells after treatment are macrophages, T- and B-lymphocytes. The drug induces high titers of interferon in organs and tissues, containing lymphoid elements (spleen, liver, lungs), activates stem cells in the bone marrow, stimulating the formation of granulocytes. Cyclopheron^® activates T-lymphocytes and natural killer cells, It normalizes the balance between subpopulations of T-helper and T-suppressor. Enhances Activity α-interferon.

It has a direct antiviral effect, suppressing the reproduction of the virus in the early stages (1-5 d) infection, reducing the infectivity of progeny virus, resulting in formation of defective viral particles. Increases non-specific resistance of the organism against viral and bacterial infections.

Cyclopheron^® effective against tick-borne encephalitis virus, Flu, hepatitis, Herpes, cytomegalovirus, human immunodeficiency virus, papilloma virus and other viruses. In acute viral hepatitis TSikloferon^® prevents transfer of diseases in the chronic form. At the stage of the primary manifestations of HIV infection helps to stabilize immunity indices.

The high efficacy of the drug in the treatment of acute and chronic bacterial infections (neuroinfection, chlamydioses, bronchitis, pneumonia, postoperative complications, urogenital infections, peptic ulcer) as a component of immunotherapy. Meglumine akridonatsetat shows high efficacy in rheumatic and systemic connective tissue diseases, suppressing autoimmune reactions and providing anti-inflammatory and analgesic effect.

Pharmacokinetics

Pills

After taking the drug inside the maximum permissible dose of C_max plasma levels achieved after 2-3 no, the concentration is gradually reduced to 8 time, through 24 h surfactant is found in trace amounts.

T_1/2 is 4-5 no. When applied at the recommended doses Cycloferon there are no conditions for its accumulation in the body.

Solution for injection

After taking the drug inside the maximum permissible dose of C_max plasma levels achieved after 1-2 no. Through 24 h surfactant is found in trace amounts.

It penetrates through the BBB.

T_1/2 is 4-5 no. With prolonged use of cumulation in the body is not observed.

Testimony

Orally

In the combined therapy Adult :

- Herpes infection;

- Influenza and acute respiratory infections;

- Chronic viral hepatitis B and C;

- Acute intestinal infections;

- Neuroinfection, including serous meningitis, tick borellioz (Lyme disease);

- HIV infection (Step 2A-2B);

- Secondary immunodeficiencies, associated with chronic bacterial and fungal infections.

In the combined therapy older children 4 years:

- Herpes infection;

- Prevention and treatment of influenza and acute respiratory diseases;

- Chronic viral hepatitis B and C;

- Acute intestinal infections;

- HIV infection (Step 2A-2B).

For parenteral administration

In the combined therapy Adult:

- HIV infection (Step 2A-2B);

- Neuroinfection: serous meningitis and encephalitis, tick borellioz (Lyme disease);

- Viral hepatitis A, IN, FROM, D;

- Herpes infection;

- Cytomegalovirus infection;

- Secondary immunodeficiencies, associated with acute and chronic bacterial and fungal infections;

- Chlamydial infections;

- Rheumatic and systemic connective tissue disease (rheumatoid arthritis, systemic lupus erythematosus);

- Degenerative-dystrophic diseases of joints (including deforming osteoarthritis).

In the combined therapy children:

- Viral hepatitis A, IN, FROM, D;

- Herpes infection;

- HIV infection (Step 2A-2B).

Dosage regimen

Inside

Cyclopheron^® take the form of tablets 1 time / day for 30 minutes before eating, without chewing.

Adults at herpes infection the drug is prescribed for 4 tab. an appointment on 1, 2, 4, 6, 8, 11, 14, 17, 20 and 23 d. A course of treatment – 40 tab. Treatment is most effective when the first symptoms of the disease.

At the treatment of influenza and acute respiratory diseases appoint 4 tab. an appointment on 1, 2, 4, 6, 8 d. A course of treatment – 20 tab. Treatment should begin at the first sign of infection. At severe disease take the first reception 6 tab. If necessary, additional symptomatic therapy (antipyretic, painkillers, expectorants).

At chronic viral hepatitis B and C drug taking 4 tab. an appointment on 1, 2, 4, 6, 8, 11, 14, 17, 20 and 23 day of treatment and then the maintenance dose by 4 tab. appointment 1 once every 3 days for 6 months while maintaining the replicating and cytolytic activity to 12 Months. Recommended combination with interferon and antiviral drugs.

IN complex therapy of intestinal infections apply for 2 tab. an appointment on 1, 2, 4, 6, 8, 11, 14, 17, 20 and 23 day. A course of treatment – 20 tab.

At neuroinfections appoint 4 tab. an appointment on 1, 2, 4, 6, 8, 11, 14, 17, 20 and 23 day or more for the maintenance dose 4 tab. appointment 1 once every 3 days for 2.5 Months. A course of treatment – 140 tab.

At HIV infection (Step 2A-2B) the drug is prescribed for 1, 2, 4, 6, 8, 11, 14, 17, 20, 23 day of 4 tab. to receive and carry out further maintenance treatment of 4 tab. 1 once every 3 days for 2.5 Months. A course of treatment – 140 tab. Repeated courses through 2-3 Sun. after the end of the previous 2-3 times.

At immunodeficiency, associated with chronic bacterial and fungal infections appoint 4 tab. first 5 receptions for 1, 2, 4, 6, 8 day and 2 tab. in the following 5 receptions for 11, 14, 17, 20, 23 d. A course of treatment – 30 tab.

Babies Cyclopheron^® appoint the following basic scheme: aged 4-6 years – by 150 mg (1 tab.), aged 7-11 years – by 300 mg (2 tab.), senior 12 years – 450 mg (3 tab.) appointment 1 time / day. A second course is advantageously carried out by 2-3 Sun. after the first year.

At herpes infection take on 1, 2, 4, 6, 8, 11, 14 day treatment. The course of treatment may vary with the severity of the condition and severity of clinical symptoms.

At flu and acute respiratory viral infections drug administered in doses at ages 1, 2, 4, 6, 8, 11, 14, 17, 20, 23 day and then 1 once every 3 day. The course of treatment is from 5 to 15 methods, depending on the severity of the condition and symptoms.

As a means of emergency nonspecific prophylaxis of acute respiratory diseases and flu during the high-rise illness the drug is prescribed in the said age at doses 1, 2, 4, 6, 8 d, Further more 5 time intervals 72 no (3 d).

At chronic hepatitis B and / or C the drug is prescribed in the indicated doses on 1, 2, 4, 6, 8, 11, 14 day and then 1 once every 3 days for 6 months while maintaining the replicating and cytolytic activity to 12 Months. Recommended combination with interferon and antiviral drugs.

At acute intestinal infections the drug is prescribed for 1, 2, 4, 6, 8, 11 day of treatment 1 time / day. A course of treatment – 6-18 tab.

At HIV infection (Step 2A-2B) drug taking in the basic scheme 1, 2, 4, 6, 8, 11, 14, 17, 20 day care, further 1 once every 3 days for 5 Months.

Parenteral administration

Adults Cyclopheron^® injected i / m or / 1 time / day for basic scheme: in one day. The duration of treatment depends on the disease.

At herpes and cytomegalovirus infections the drug is prescribed for the basic scheme – 10 injections 250 mg. Accumulated dose 2.5 g. Treatment is most effective in early disease exacerbation.

At neuroinfections the drug is administered to the standard regimen. A course of treatment – 12 injections 250-500 mg in combination with causal therapy. Accumulated dose 3-6 g. Repeated courses are held as needed.

At Chlamydia infection treatment is carried out to the standard regimen. A course of treatment 10 injections 250 mg. Accumulated dose 2.5 g. A second course – through 10-14 days. It is advisable to mix Cycloferon^® with antibiotics.

At acute viral hepatitis A, IN, FROM, D and mixed forms the drug is administered to the standard regimen 10 injections 500 mg. Accumulated dose – 5 g. When protracted course refresher course conducted by 10-14 days.

At chronic viral hepatitis B, FROM, D and mixed forms the drug is administered to the standard regimen 10 injections 500 mg, Further the maintenance dose 3 twice per week. during 3 Months in the complex therapy. It recommended in combination with interferons and chemotherapy. The repetition rate is passed through 10-14 days.

At HIV infection (Step 2A-2B) the drug is prescribed for the basic scheme 10 injections 500 mg and then the maintenance dose once every three days for the 2.5 Months. The repetition rate is passed through 10 days.

At immunodeficiency treatment consists of 10 Injection / m to base circuit in a single dose 250 mg. Accumulated dose 2.5 g. Repeated courses through 6-12 months.

At rheumatic and systemic connective tissue diseases appointed 4 Course on 5 injections for the standard regimen, by 250 mg with a break 10-14 days. The need for repeated courses of doctor determines individually.

At degenerative joint diseases appointed 2 Course on 5 injections 250 mg with a break 10-14 days to the standard regimen. The need for repeated courses of doctor determines individually.

Babies Cyclopheron^® appoint / m or / 1 time / day. The daily therapeutic dose is 6-10 mg / kg body weight.

At acute viral hepatitis A, IN, FROM, D and mixed forms conduct 15 injections for the standard regimen. In protracted infection rate during repeated after 10-14 days.

At chronic viral hepatitis B, FROM, D the drug is administered to the standard regimen 10 injections and then the maintenance dose 3 once a week for 3 Months in the complex therapy. Recommended use in combination with interferons and chemotherapy.

At HIV infection (Step 2A-2B) prescribe a course of 10 injections for the standard regimen and then the maintenance dose 1 once every 3 days for 3 Months. Repeated courses through 10 days.

At herpes infection a course of 10 injections for the standard regimen. When you save a replicative virus activity treatment continues with the maintenance dose of the drug administration 1 once every 3 days for 4 Sun.

Side effect

Maybe: allergic reactions.

Contraindications

- Cirrhosis decompensated;

- Children up to age 4 years;

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breast-feeding).

Cautions

In diseases of the thyroid gland use Cycloferon^® should be supervised by an endocrinologist.

In the treatment of influenza and acute respiratory viral infections in addition to therapy Tsiklofernom^® should be symptomatic therapy.

Effects on ability to drive vehicles and management mechanisms

Cyclopheron^® It does not influence the ability to drive.

Overdose

At present, cases of drug overdose were reported.

Drug Interactions

Cyclopheron^® compatible with all drugs, used in the treatment of these diseases (incl. with interferon and chemotherapy drugs).

Cyclopheron^® It enhances the action of interferon and nucleoside analogues.

In a joint application TSikloferon^® reduces side effects of chemotherapy and interferon.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. Pills, covered with enteric coating, It should be stored in a dry, dark place at a temperature of 10 ° to 25 ° C. Shelf life - 2 year.

The solution for injection should be stored in a dry, dark place at a temperature from 0 ° to 25 ° C. Freezing of the solution for injection during transport (at subzero temperatures) It does not alter the properties. Thawed at room temperature, the drug maintains its biological and physico-chemical properties. If you change the color of the solution and the formation of a precipitate drug application inadmissible. Shelf life – 3 year.