CYCLOFERON - a means of preserving reproductive health

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 injection solution 12.5% ​​2ml No. 5

A country

Russia
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Active substance

Meglumine acridone acetate

Compound

active substance - meglumine acridone acetate in terms of acridone acetic acid - 125 mg.

pharmachologic effect

Pharmacodynamics. Cycloferon is a low-molecular-weight inducer of interferon, which determines a wide range of its biological activity (antiviral, immunomodulatory, anti-inflammatory, etc.). The main interferon-producing cells after the administration of 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 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 alpha interferons. Cycloferon is effective against viruses of 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- infections helps to stabilize immunity parameters. The drug has been found to be highly effective in complex therapy 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 rheumatic and systemic connective tissue diseases, suppressing autoimmune reactions and providing anti-inflammatory and analgesic effects. Pharmacokinetics: When the maximum permissible dose is administered, the maximum concentration in the blood is achieved 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. Does not accumulate in the body with prolonged use.

Indications for use

In adults in complex therapy: HIV - infections (stages 2A - 2B); neuroinfections: serous meningitis and encephalitis, tick-borne borelliosis (Lyme disease); viral hepatitis A, B, C, D; herpes and 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: deforming osteoarthritis, etc. In children in complex therapy: viral hepatitis A, B, C , D;herpetic infection;HIV infection (stages 2A-2B).

Mode of application

1. In adults: Cycloferon is used intramuscularly or intravenously once a day according to the basic regimen: every other day. The duration of the course of treatment depends on the disease.1.1 For herpes and cytomegalovirus infection, the basic regimen is 10 injections of 0.25 g. The total dose is 2.5 g. Treatment is most effective at the beginning of an exacerbation of the disease.1.2 For neuroinfections, the drug is administered according to the basic regimen. The course of treatment is 12 injections of 0.25-0.5 g in combination with etiotropic therapy. The total dose is 3-6 g. Repeated courses as needed. 1.3 For chlamydial infection, administer according to the basic regimen. The course of treatment is 10 injections of 0.25 g. Total dose is 2.5 g. Repeated course of treatment after 10-14 days. It is advisable to combine Cycloferon with antibiotics.1.4 For acute viral hepatitis A, B, C, D and mixed forms, the drug is administered according to the basic scheme of 10 injections of 0.5 g. The total dose is 5.0 g. In case of protracted infection, repeat the course after 10- 14 days. For chronic viral hepatitis B, C, D and mixed forms, the drug is administered according to a basic regimen of 10 injections of 0.5 g each, then according to a maintenance regimen 3 times a week for three months as part of complex therapy. Recommended in combination with interferons and chemotherapy. Repeat the course after 10 - 14 days.1.5 For HIV infection (2A-2B) according to the basic regimen of 10 injections of 0.5 g and then according to the maintenance regimen once every three days for 2.5 months. Repeat the course after 10 days.1.6 For immunodeficiency conditions, the course of treatment is 10 intramuscular injections according to the basic regimen in a single dose of 0.25 g. Total dose is 2.5 g. A repeated course is carried out after 6 - 12 months.1.7 For rheumatic and systemic connective tissue diseases 4 courses of 5 injections according to the basic regimen of 0.25 g with a break of 10-14 days. Repeated course on the recommendation of a doctor.1.8 For degenerative-dystrophic diseases of the joints, 2 courses of 5 injections of 0.25 g each with a break of 10-14 days according to the basic scheme. Repeated course on doctor's recommendation.2. In children: In pediatric practice, Cycloferon is used intramuscularly or intravenously once a day according to the basic regimen: every other day. The daily therapeutic dose is 6-10 mg/kg body weight.2.1 For acute viral hepatitis A, B, C, D and mixed forms, the drug is administered according to the basic scheme of 15 injections. In case of prolonged infection, repeat the course after 10-14 days. 2.2 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 three times a week for three months as part of complex therapy. Recommended in combination with interferons and chemotherapy. 2.3 For HIV infection (stages 2A-2B), a course of 10 injections according to the basic regimen and then according to the maintenance regimen once every three days for three months. Repeated course after 10 days.2.4 For herpetic infection, a course of 10 injections according to the basic regimen. If the replicative activity of the virus is maintained, the course of treatment is continued according to a maintenance regimen with administration once every three days for four weeks.

Interaction

Cycloferon is compatible and goes well with all drugs traditionally used in the treatment of these diseases (interferons, chemotherapeutic drugs, etc.). Enhances the effect of interferons and nucleoside analogues. Reduces the side effects of chemotherapy, interferon therapy.

Side effect

Allergic reactions.

Contraindications

Pregnancy, lactation, hypersensitivity to the components of the drug, decompensated cirrhosis of the liver, children under 4 years of age.

Overdose

There is no information about an overdose of the drug.

special instructions

Cycloferon does not affect the ability to drive vehicles. When treating influenza and respiratory viral infections, symptomatic therapy is carried out. For diseases of the thyroid gland, consultation with an endocrinologist is necessary.

Dispensing conditions in pharmacies

On prescription

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 - a means of preserving reproductive health

S. B. Rybalkin, Candidate of Medical Sciences Regional Center for the Treatment and Prevention of Dermatological and Venereal Diseases, Penza M. G. Romantsov, Doctor of Medical Sciences Yu. V. Aspel, Infectious Diseases Physician of the Polisan Scientific and Technical Foundation, St. Petersburg

Since the beginning of the 90s, there has been an increase in sexually transmitted diseases on the territory of the Russian Federation.

The structure of the incidence of sexually transmitted infections is presented in the figure.

The age structure of those sick with ureaplasmosis, chlamydia and herpes raises some concern, since among the infected people there is a group of teenagers aged 15-19 years.

Therapy for sexually transmitted diseases remains open until recently. Antibacterial drugs and their combinations are widely used; treatment does not always lead to the desired effect, since the pathogen is not eliminated, and dysbacteriosis and immunodeficiency states often develop.

Among the drugs with anti-inflammatory and immunocorrective effects is the domestic low-molecular-weight inducer of endogenous interferon - cycloferon. In recent years, cycloferon has begun to be used for the treatment of various chronic slow viral and bacterial infections.

In this regard, the possibility of using cycloferon topically is of great interest. For this purpose, cycloferon liniment 5% was used.

The drug was administered to 89 patients whose age ranged from 18 to 35 years. The drug was prescribed randomly as patients were admitted. Cycloferon liniment was administered endourethrally in a volume of 5 ml every 24 hours, for a course of treatment from 7 to 11 instillations.

The control group consisted of 85 people who were instilled with saline solution according to a similar scheme against the background of antibacterial therapy.

When studying the tolerability of the drug according to the clinical analysis of the cellular elements of peripheral blood, no significant changes indicating phenomena of intolerance were noted. No changes in the mucous membranes indicating symptoms of irritation or allergization were detected; in isolated cases, administration of the drug to damaged mucous membranes (for gonorrheal urethritis) caused a short-term moderate burning sensation and pain.

Positive dynamics of clinical indicators were noted in patients receiving cycloferon, compared with those receiving standard (antibacterial) therapy. Clinical and instrumental examination showed a significant decrease and/or disappearance of inflammation in the urethra, normalization of erosive lesions of the mucous membranes. Patients stopped complaining of itching and burning.

In the group of patients with chlamydia, improvement was documented by a complex of clinical and laboratory methods in 86.2% of treated patients; in 13.8% of cases, after the end of therapy, elimination of the pathogen did not occur and a repeat course of treatment was required. In the chlamydia + ureaplasmosis group, improvement occurred at the end of treatment in 79.4% of patients. In the third group of patients (chlamydia + trichomoniasis), at the end of treatment, laboratory tests did not identify the causative agent of chlamydia, and the treatment of trichomoniasis required the inclusion of specific therapy. In the fourth group of patients (with ureaplasmosis), the pathogen was not determined in all treated patients, but in 15.6% of patients, during bacterioscopic examination of smears, moderate leukocytosis remained (up to 15-18 in the field of view), they were additionally prescribed Unidox. In patients with gonorrheal urethritis, instillations of liniment caused moderate pain (burning); after four instillations of liniment, gonococci were not detected in smears during bacterioscopic examination, although slight leukocytosis was documented in the smears, which normalized during treatment with Unidox.

In patients with gonorrheal urethritis due to trichomoniasis, the effectiveness of cycloferon was absent even with combined treatment with antibiotics; To achieve a clinical and laboratory effect, it was necessary to include specific agents - trichomonacid drugs.

Thus, summarizing the results of treatment of patients with urogenital infections, it is necessary to note the effectiveness of the use of liniment 5% cycloferon, documented by a complex of clinical and laboratory examination of 74.4-86.2% of treated patients, while a second course of therapy was required in 14-25% of patients.

The effect of antibiotic therapy was noted in all observed groups in 59-63% of patients.
Table 1. Dynamics of laboratory parameters in observed patients

Structure of incidence (%) of infections with sexual transmission, 1996-1998.

Table 2. Indicators of clinical effectiveness of cycloferon liniment, %

Table 3. The effectiveness of therapy with the inclusion of 5% cycloferon in the course of treatment of liniment

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.