Tiloram tablets p / o 125mg, No. 10

• As part of complex therapy: viral hepatitis A, B and C;

• infections caused by Herpes simplex viruses type 1 and 2, Varicella zoster, cytomegalovirus;

• infectious-allergic and viral encephalomyelitis (multiple sclerosis, leukoencephalitis, uveoencephalitis);

• urogenital and respiratory chlamydia;

• non-gonococcal urethritis;

• pulmonary tuberculosis.

• Treatment and prevention of influenza and other acute respiratory viral infections.

Tiloron is taken orally, after meals.

• For the treatment of viral hepatitis A - on the first day, 125 mg 2 times, then 125 mg after 48 hours. The course is 1.25 g.

• For the treatment of acute hepatitis B - the first two days, 125 mg each, then 125 mg after 48 hours, for the course of treatment - 2 g.

• With a protracted course of hepatitis B - 125 mg 2 times a day on the first day, then 125 mg every 48 hours. For the course of treatment - 2.5 g.

• In chronic hepatitis B - the initial phase of treatment (2.5 g) - the first two days, 125 mg 2 times a day, then 125 mg after 48 hours. Continuation phase (1.25 g to 2.5 g), 125 mg per week. The course dose of tilorone is from 3.75 g to 5 g, the duration of therapy is 3.5-6 months, depending on the results of biochemical, immunological, morphological studies, reflecting the degree of activity of the process.

• In acute hepatitis C - 125 mg per day for the first 2 days of treatment, then 125 mg every 48 hours. The course of treatment is 2.5 g.

• In chronic hepatitis C - the initial phase of treatment (2.5 g) - the first two days, 125 mg 2 times a day, then 125 mg after 48 hours. Continuation phase (2.5 g), 125 mg per week. The course dose of tilorone is 5 g, the duration of therapy is 6 months, depending on the results of biochemical, immunological, morphological markers of the process activity.

• With the complex therapy of infectious-allergic and viral encephalomyelitis - 125-250 mg per day for the first 2 days of treatment, then 125 mg every 48 hours. The dose is set individually, the course of treatment is 3-4 weeks.

• For the treatment of influenza and other acute respiratory viral infections - 125 mg per day for the first 2 days of treatment, then 125 mg every 48 hours. For the course - 750 mg.

• For the prevention of influenza and other acute respiratory viral infections - 125 mg once a week for 6 weeks. For the course - 750 mg.

• For the treatment of herpes, cytomegalovirus infection - the first two days at 125 mg, then after 48 hours at 125 mg. Heading dose -1.25 - 2.5 g.

• With urogenital and respiratory chlamydia - the first two days, 125 mg, then after 48 hours, 125 mg. Heading dose - 1.25 g.

• With the complex therapy of pulmonary tuberculosis - 250 mg for the first two days of treatment, then 125 mg after 48 hours. Heading dose - 2.5 g.

Composition for one tablet:

active substance: tilorone dihydrochloride (tilorone) -125.0 mg.

auxiliary substances (core) : lactose monohydrate (milk sugar) -101.0 mg, microcrystalline cellulose - 45.0 mg, croscar mellose sodium - 9.0 mg, water - 5.0 mg, povidone-K17 - 12.0 mg, magnesium stearate - 3.0 mg.
excipients (shell) : hypromellose - 5.7 mg, macrogol-4000 - 1.4 mg, titanium dioxide - 2.8 mg, tropeolin-0 dye - 0.1 mg.

• Pregnancy,

• lactation (breastfeeding),

• children under 7 years old,

• hypersensitivity to tilorone.

Trade name of the drug:

Tiloram

International non-proprietary name:

tiloron

Dosage form:

film-coated tablets

Composition:

Composition per tablet:
active substance: tilorone dihydrochloride (tilorone) -125.0 mg.
auxiliary substances (core) : lactose monohydrate (milk sugar) -101.0 mg, microcrystalline cellulose - 45.0 mg, croscar mellose sodium - 9.0 mg, water - 5.0 mg, povidone-K17 - 12.0 mg, magnesium stearate - 3.0 mg.
excipients (shell) : hypromellose - 5.7 mg, macrogol-4000 - 1.4 mg, titanium dioxide - 2.8 mg, tropeolin-0 dye - 0.1 mg.

Description:

round, biconvex film-coated tablets from yellow to orange. On the fracture, two layers are visible - a film shell and an orange core, inclusions of white or orange are allowed.

Pharmacotherapeutic group:

antiviral immunostimulating agent-inducer of interferon formation

Pharmacological properties

Pharmacodynamics
A low molecular weight synthetic interferon inducer that stimulates the formation of alpha, beta and gamma interferons in the body. The main producers of interferon in response to the administration of tilorone are intestinal epithelial cells, hepatocytes, T-lymphocytes, neutrophils and granulocytes. After oral administration, the maximum production of interferon is determined in the sequence intestine - liver - blood after 4-24 hours. Tilorone has an immunomodulatory and antiviral effect. In human leukocytes, it induces the synthesis of interferon. Stimulates bone marrow stem cells, depending on the dose, enhances antibody production, reduces the degree of immunosuppression, restores the ratio of T-suppressors and T-helpers. Effective against various viral infections, including influenza viruses, other acute respiratory viral infections,hepatitis viruses and herpes viruses. The mechanism of antiviral action is associated with inhibition of the translation of virus-specific proteins in infected cells, as a result of which the reproduction of viruses is suppressed.

Pharmacokinetics
After oral administration, it is rapidly absorbed from the gastrointestinal tract. Bioavailability -60%. About 80% of the drug binds to plasma proteins. The drug is excreted practically unchanged through the intestines (70%) and through the kidneys (9%). The half-life is 48 hours. The drug does not undergo biotransformation and does not accumulate in the body.

Indications for use

Treatment and prevention of influenza and other acute respiratory viral infections (ARVI); treatment of viral hepatitis A, B and C; treatment of herpes and cytomegalovirus infections; as part of the complex therapy of infectious-allergic and viral encephalomyelitis (multiple sclerosis, leukoencephalitis, uveoencephalitis, etc.); as part of the complex therapy of urogenital and respiratory chlamydia; in the complex therapy of pulmonary tuberculosis.

Contraindications

hypersensitivity to tilorone and other components of the drug.

• period of pregnancy and lactation.

• children under 18 years of age.

• hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

With caution,
as part of the complex therapy of infectious-allergic and viral encephalomyelitis, the drug is used under the supervision of a physician.

Application during pregnancy and lactation

The safety of use during pregnancy and lactation has not been studied. The drug is contraindicated during pregnancy. If necessary, the appointment of the drug during lactation should stop breastfeeding.

Method of administration and dosage

Tiloron is taken orally, after meals.
For the treatment of viral hepatitis A - on the first day, 125 mg 2 times, then 125 mg after 48 hours. For a course of -1.25 g.
For the treatment of acute hepatitis B - the first two days, 125 mg each, then 125 mg after 48 hours , for a course of treatment - 2 g. With a protracted course of hepatitis B - 125 mg 2 times a day on the first day, then 125 mg every 48 hours. For a course of treatment - 2.5 g. In chronic hepatitis B - the initial phase of treatment (2.5 g) - the first two days, 125 mg 2 times a day, then 125 mg after 48 hours. Continuation phase (1.25 g to 2.5 g), 125 mg per week. The course dose of tilorone is from 3.75 g to 5 g, the duration of therapy is 3.5-6 months, depending on the results of biochemical, immunological, morphological studies, reflecting the degree of activity of the process.
In acute hepatitis C - 125 mg per day for the first 2 days of treatment, then 125 mg every 48 hours. The course of treatment is 2.5 g.
In chronic hepatitis C - the initial phase of treatment (2.5 g) - the first two days, 125 mg 2 times a day, then 125 mg after 48 hours. Continuation phase (2.5 g), 125 mg per week. The course dose of tilorone is 5 g, the duration of therapy is 6 months, depending on the results of biochemical, immunological, morphological markers of the process activity.
With the complex therapy of infectious-allergic and viral encephalomyelitis - 125-250 mg per day for the first 2 days of treatment, then 125 mg every 48 hours. The dose is set individually, the course of treatment is 3-4 weeks. For the treatment of influenza and other acute respiratory viral infections - 125 mg per day for the first 2 days of treatment, then 125 mg every 48 hours. For the course - 750 mg. For the prevention of influenza and other acute respiratory viral infections - 125 mg once a week for 6 weeks. For the course - 750 mg.
For the treatment of herpes, cytomegalovirus infection - the first two days at 125 mg, then after 48 hours at 125 mg. Heading dose -1.25 - 2.5 g. With urogenital and respiratory chlamydia - the first two days at 125 mg, then after 48 hours at 125 mg. Heading dose - 1.25 g. In the complex therapy of pulmonary tuberculosis - 250 mg for the first two days of treatment, then 125 mg after 48 hours. Heading dose - 2.5 g.

Side effect

Allergic reactions, dyspeptic symptoms, short-term chills are possible.

Overdose

Cases of drug overdose are not known.

Interaction with other medicinal products

Compatible with antibiotics and medicines for traditional treatment of viral and bacterial diseases. No clinically significant interaction of tilorone with antibiotics and means of traditional treatment of viral and bacterial diseases, alcohol has been identified.

special instructions

Influence on the ability to drive vehicles and work with mechanisms There is no data on the effect of the drug on the ability to drive a car and engage in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions in recommended doses.

Release form

Film-coated tablets 125 mg. On 6, 10, 12, 18, 20, 24 or 30 tablets in a blister strip packaging from a film of polyvinyl chloride and printed aluminum foil varnished.
6, 10, 12, 18, 20, 24, 30, 50 or 100 tablets in polymer cans or polyethylene terephthalate cans.
One can or 1, 2, 3, 4, 5 or 10 blisters together with instructions for use are placed in a cardboard package (pack).
A complete set of 2 or 3 cardboard packages (packs) in a group packaging (shipping container) made of cardboard is allowed.

Storage conditions

In a dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

3 years.
Do not use after the expiration date.

Vacation conditions

Available without a prescription.

Manufacturer

LLC 'Ozon'