Registration number: P N001049/03 Trade name: CYCLOFERON® Group name: Meglumina acridone acetate Dosage form: solution for intravenous and intramuscular administration
Composition of the drug Pharmacological properties Indications for use Contraindications
Directions for use and dosage Side effects Interaction with other drugs
Pharmacological properties
Pharmacodynamics
CYCLOFERON® is a low-molecular-weight interferon inducer, which determines a wide range of its biological activity (antiviral, immunomodulatory, anti-inflammatory, etc.).
The main interferon-producing cells after administration of the drug CYCLOFERON® are macrophages, T- and B-lymphocytes. Depending on the type of infection, the activity of one or another part of the immune system predominates. The drug induces high interferon titers in organs and tissues containing lymphoid elements (spleen, liver, lungs), activates bone marrow stem cells, stimulating the formation of granulocytes. CYCLOFERON® activates T-lymphocytes and natural killer cells, normalizes the balance between subpopulations of T-helpers and T-suppressors. Enhances the activity of α-interferons. CYCLOFERON® demonstrates antiviral activity against pathogens of tick-borne encephalitis, influenza, herpes, cytomegalovirus, papilloma virus and other viruses. Preclinical studies have shown that the use of Cycloferon in the early stages of the infectious process leads to a decrease in the viral load (virus titer) in lung tissue. Increases the body's nonspecific resistance to viral and bacterial infections. The drug has been found to be highly effective in complex therapy of acute and chronic bacterial infections (neuroinfections, chlamydia) as a component of immunotherapy. Pharmacokinetics
When the maximum permissible dose is administered, the maximum concentration in the blood is reached after 1–2 hours; after 24 hours the drug is detected in trace amounts. Crosses the blood-brain barrier. The half-life is 4–5 hours. CYCLOFERON® does not have cumulative properties. Does not accumulate in tissues with prolonged use.
Cycloferon
Cycloferon is a domestic antiviral immunomodulatory drug, the active substance of which is meglumine acridone acetate. Being an inducer of endogenous interferon, the drug has a wide range of pharmacological activity. It has been present on the Russian pharmaceutical market for about 20 years, having established itself during this time as an effective, but difficult to use remedy that requires certain knowledge and practical experience from the doctor.
Interferon inducers are synthetic or natural substances that can stimulate the production of interferon in the human body. Introducing into the body not “ready-made” interferon, but substances that help its endogenous synthesis, has undeniable advantages. Thus, interferon formed under the influence of inducers is not endowed with antigenicity. Another important point: with long-term use of exogenous interferon, a number of negative side effects occur, which is not observed when taking interferon inducers. Cycloferon should be recognized as one of the most effective drugs in this group. Cycloferon inhibits the reproduction of influenza viruses types A and B, herpes viruses types I and II (HSV-1 and HSV-2), human immunodeficiency virus, cytomegalovirus, hepatitis B and C virus, human papilloma virus. The antiviral effect of cycloferon is due to stimulation of the reproduction of endogenous interferon and a direct effect on the reproduction of the virus. Such shameless interference of the drug in the “lifestyle” of viruses prevents the inclusion of viral DNA or RNA in the outer shell of the virus, increases the number of defective viral genomes, and reduces cellular protein synthesis induced by the virus. Interferon synthesis under the influence of cycloferon occurs mainly in the spleen, skeletal muscles and lungs. This critical process involves the body's immunocompetent cells, including monocytes, lymphocytes, macrophages and liver sinusoid cells.
The presence of endogenous interferon in the brain indicates the ability of cycloferon to overcome the blood-brain barrier. When the maximum dose of the drug is administered, the peak of its concentration in the blood plasma is observed after 2-3 hours, by the 8th hour it gradually decreases, and after a day only traces of the drug are found in the body, which indicates the absence of a cumulative effect. As a result of many controlled clinical trials of cycloferon, its pronounced immunomodulatory activity was confirmed. The drug has a beneficial effect on the immune status of the body, regulating the synthesis of interferon equally in immunodeficiency states and autoimmune diseases. In this regard, the drug was introduced into the standard treatment of secondary immunodeficiencies. The immunoregulatory properties of cycloferon are realized through the activation of γ-interferon. Against the background of an increase in the concentration of the latter, the drug restores the T-cell component of immunity. Course use of cycloferon works well in patients suffering from chronic and recurrent infectious diseases of both viral and bacterial etiology. It is impossible not to note the effectiveness of the drug in secondary immunodeficiency conditions associated with hepatitis viruses, cytomegalovirus, and herpes viruses. The anti-inflammatory effect of cycloferon is ensured by its ability to suppress the formation of pro-inflammatory cytokines. In addition, the drug restores the sensitivity of cells to immunocorrectors.
Thus, cycloferon is a promising biofunctional drug with a wide range of pharmacological effects, allowing its use both in the treatment and prevention of viral diseases. Due to its good tolerability, it is successfully used in pediatrics, as well as in elderly patients.
Directions for use and doses
In adults
CYCLOFERON® is used intravenously or intramuscularly. For herpes and cytomegalovirus infection, the course of treatment consists of 10 injections of the drug, 250 mg each, with an interval between injections of 48 hours (every other day). A single dose is 250 mg (1 ampoule). The course dose is 2.5 g. Treatment is most effective at the beginning of an exacerbation of the disease.
For neuroinfections, the course of treatment consists of 12 injections of the drug, 250–500 mg each, with an interval between injections of 48 hours (every other day) in combination with etiotropic therapy. A single dose is 250–500 mg (1–2 ampoules). The course dose is 3.0–6.0 g. Repeated courses are carried out as needed. For immunodeficiency conditions, the course of treatment consists of 10 intramuscular injections of the drug, 250 mg each, with an interval between injections of 48 hours (every other day). A single dose is 250 mg (1 ampoule). The course dose is 2.5 g. A repeat course is carried out after 6–12 months.
For chlamydial infection, the course of treatment consists of 10 injections of the drug, 250 mg each, with an interval between injections of 48 hours (every other day). A single dose is 250 mg (1 ampoule). The course dose is 2.5 g. A second course of treatment is carried out after 10–14 days. It is advisable to combine the drug CYCLOFERON® with antibiotics.
In children over 4 years old
CYCLOFERON® is used intramuscularly or intravenously. A single dose is 6–10 mg per 1 kg of body weight.
For herpes infection, the course of treatment consists of 10 injections of the drug with an interval between injections of 48 hours (every other day). If the replicative activity of the virus is maintained, the course of treatment is continued according to the maintenance regimen - administration of the drug once every three days for four weeks.
Cycloferon 125 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration
pharmachologic effect
Immunostimulating agent.
Composition and release form Cycloferon 125 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration
Solution - 1 ml:
- Active ingredients: meglumine acridone acetate* (in terms of acridone acetic acid) - 125 mg;
- Excipients: water for injection - up to 1 ml.
* obtained according to the following recipe: acridoneacetic acid - 125 mg, meglumine (N-methylglucamine) - 96.3 mg.
2 ml - colorless glass ampoules (5) - contour cell packaging (1) - cardboard packs.
2 ml - brown glass ampoules (5) - contour cell packaging (1) - cardboard packs.
Description of the dosage form
The solution for intravenous and intramuscular administration is transparent, yellow.
Directions for use and doses
For adults, Cycloferon® is administered intramuscularly or intravenously 1 time/day according to the basic regimen: every other day. The duration of treatment depends on the disease.
For herpetic and cytomegalovirus infections, the drug is prescribed according to the basic regimen - 10 injections of 250 mg each. The total dose is 2.5 g. Treatment is most effective at the beginning of an exacerbation of the disease.
For neuroinfections, the drug is administered according to the basic regimen. The course of treatment is 12 injections of 250-500 mg in combination with etiotropic therapy. The total dose is 3-6 g. Repeated courses are carried out as needed.
For chlamydial infection, treatment is carried out according to the basic regimen. The course of treatment is 10 injections of 250 mg. Total dose 2.5 g. Repeated course - after 10-14 days. It is advisable to combine Cycloferon with antibiotics.
For acute viral hepatitis A, B, C, D and mixed forms, the drug is administered according to the basic regimen of 10 injections of 500 mg. The total dose is 5 g. In case of prolonged course, a repeat course is carried out after 10-14 days.
For chronic viral hepatitis B, C, D and mixed forms, the drug is administered according to the basic regimen of 10 injections of 500 mg, then according to the maintenance regimen 3 times a week. for 3 months as part of complex therapy. Recommended in combination with interferons and chemotherapy. The course is repeated after 10-14 days.
For HIV infection (stage 2A-2B), the drug is prescribed according to a basic regimen of 10 injections of 500 mg each and then according to a maintenance regimen once every three days for 2.5 months. The course is repeated after 10 days.
For immunodeficiency conditions, the course of treatment consists of 10 intramuscular injections according to the basic regimen in a single dose of 250 mg. The total dose is 2.5 g. A repeat course is carried out after 6-12 months.
For rheumatic and systemic connective tissue diseases, 4 courses of 5 injections are prescribed according to the basic regimen, 250 mg each with a break of 10-14 days. The doctor determines the need for a repeat course individually.
For degenerative-dystrophic diseases of the joints, 2 courses of 5 injections of 250 mg each are prescribed with a break of 10-14 days according to the basic regimen. The doctor determines the need for a repeat course individually.
For children, Cycloferon® is prescribed IM or IV 1 time/day. The daily therapeutic dose is 6-10 mg/kg body weight.
For acute viral hepatitis A, B, C, D and mixed forms, 15 injections of the drug are administered according to the basic regimen. In case of prolonged infection, the course is repeated after 10-14 days.
For chronic viral hepatitis B, C, D, the drug is administered according to a basic regimen of 10 injections and then according to a maintenance regimen 3 times a week for 3 months as part of complex therapy. Use in combination with interferons and chemotherapy is recommended.
For HIV infection (stages 2A-2B), a course of 10 injections is prescribed according to the basic regimen and then according to the maintenance regimen once every 3 days for 3 months. A repeat course is carried out after 10 days.
For herpes infection, a course of 10 injections is carried out according to the basic scheme. If the replicative activity of the virus is maintained, the course of treatment is continued according to a maintenance regimen with administration of the drug once every 3 days for 4 weeks.
Pharmacodynamics
Meglumine acridone acetate is a low-molecular-weight interferon inducer, which determines a wide range of its biological activity (antiviral, immunomodulatory, anti-inflammatory).
The main interferon-producing cells after administration of the drug are macrophages, T- and B-lymphocytes. Depending on the type of infection, the activity of one or another part of the immune system predominates. The drug induces high titers of interferon in organs and tissues containing lymphoid elements (spleen, liver, lungs), activates bone marrow stem cells, stimulating the formation of granulocytes. Cycloferon® activates T-lymphocytes and natural killer cells, normalizes the balance between subpopulations of T-helpers and T-suppressors. Enhances the activity of α-interferons.
Cycloferon® is effective against tick-borne encephalitis, influenza, hepatitis, herpes, cytomegalovirus, human immunodeficiency virus, papilloma virus and other viruses. In acute viral hepatitis, Cycloferon® prevents the disease from becoming chronic.
At the stage of primary manifestations of HIV infection, it helps to stabilize immunity levels.
The drug has been found to be highly effective in the complex treatment of acute and chronic bacterial infections (neuroinfections, chlamydia, bronchitis, pneumonia, postoperative complications, urogenital infections, peptic ulcers) as a component of immunotherapy.
Cycloferon® is highly effective in treating rheumatic and systemic connective tissue diseases, suppressing autoimmune reactions and providing anti-inflammatory and analgesic effects.
Pharmacokinetics
When administered in the maximum permissible dose, Cmax in the blood plasma is achieved after 1-2 hours. After 24 hours, the active substance is detected in trace amounts.
Penetrates through the BBB.
T1/2 is 4-5 hours. With long-term use, accumulation in the body is not observed.
Indications for use Cycloferon 125 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration
As part of complex therapy in adults:
- HIV infection (stages 2A-2B);
- neuroinfections: serous meningitis and encephalitis, tick-borne borelliosis (Lyme disease);
- viral hepatitis A, B, C, D;
- herpetic infection;
- cytomegalovirus infection;
- secondary immunodeficiencies associated with acute and chronic bacterial and fungal infections;
- chlamydial infections;
- rheumatic and systemic connective tissue diseases (rheumatoid arthritis, systemic lupus erythematosus);
- degenerative-dystrophic diseases of the joints (including deforming osteoarthritis).
As part of complex therapy in children:
- viral hepatitis A, B, C, D;
- herpetic infection;
- HIV infection (stages 2A-2B).
Contraindications
- liver cirrhosis in the stage of decompensation;
- children under 4 years of age;
- pregnancy;
- lactation period (breastfeeding);
- hypersensitivity to the components of the drug.
Application Cycloferon 125 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration during pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation (breastfeeding).
Contraindication: children under 4 years of age.
special instructions
For diseases of the thyroid gland, the use of Cycloferon should be carried out under the supervision of an endocrinologist.
When treating influenza and ARVI, in addition to Cycloferon therapy, symptomatic therapy should be carried out.
Impact on the ability to drive vehicles and operate machinery
Cycloferon® does not affect the ability to drive vehicles.
Overdose
There is no information about an overdose of the drug.
Side effects Cycloferon 125 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration
Possible: allergic reactions.
Drug interactions
Cycloferon® is compatible with all drugs used in the treatment of these diseases (including interferons and chemotherapy drugs).
Cycloferon® enhances the effect of interferons and nucleoside analogues.
When used together, Cycloferon® reduces the side effects of chemotherapy and interferon therapy.
Side effect
According to the World Health Organization, undesirable effects are classified according to the frequency of their development as follows: – very common (≥ 1/10); – common (≥ 1/100 – – uncommon (≥ 1/1000 – – rare (≥ 1/10000 – – very rare ( – frequency unknown (cannot be determined from available data). General disorders and administration site conditions: very rarely - chills, fever, pain and redness at the injection site Disorders of the skin and subcutaneous tissues: very rarely - rash, urticaria If any of the undesirable effects indicated in the instructions worsen or you notice any other undesirable effects not listed in the instructions, tell your doctor about this.
Release form
Solution for intravenous and intramuscular administration 125 mg/ml. 2 ml in brown glass ampoules. A self-adhesive label is placed on the ampoule. 5 ampoules are placed in a blister pack made of polymer film. The contour blister packaging is heat-sealed with a cover film or left open. 1 blister pack together with instructions for medical use are placed in a cardboard box. To control the first opening, the side flaps of the package can be sealed with labels.
