Instructions for Amiksin IS film-coated tablets 0.125 g No. 3
Composition
active ingredient: tilorone;
1 tablet contains tilorone 0.06 g (60 mg) or 0.125 g (125 mg);
other ingredients:
tablets of 0.06 g: calcium hydrogen phosphate dihydrate, hypromellose (hydroxypropylmethylcellulose), microcrystalline cellulose, povidone, croscarmellose sodium, potato starch, polyethylene glycol (macrogol), talc, colloidal anhydrous silicon dioxide, durin (titanium dioxide (E 171); potassium aluminosilicate (E 555)), synthetic mixed red dye (hypromellose (hydroxypropylmethylcellulose), microcrystalline cellulose, titanium dioxide (E 171), dye ponso 4R lacquer (E 1 132), dye ponso yellow FCF (E 110));
tablets of 0.125 g: calcium hydrogen phosphate dihydrate, hypromellose (hydroxypropylmethylcellulose), microcrystalline cellulose, povidone, croscarmellose sodium, potato starch, polyethylene glycol (macrogol), talc, colloidal silicon dioxide candurin (titanium dioxide (E 171), potassium aluminosilicate (E 555)), yellow FCF dye (E 110).
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated, dark pink (for 60 mg tablets) and orange (for 125 mg tablets) colors, two layers are visible on the break.
Pharmacotherapeutic group
Antivirals for systemic use. Direct-acting antivirals. Tilorone. ATX code J05A X19
Pharmacological properties
Pharmacodynamics.
AMIXIN® IS (tilorone) is an immunomodulatory and antiviral agent. It stimulates the formation of α, β, γ-interferons in the body. The main producers of interferon in response to the administration of the drug 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. It stimulates bone marrow stem cells, depending on the dose, enhances antibody formation, reduces the degree of immunosuppression, restores the ratio of T-suppressors/T-helpers. It is effective against a wide range of viral infections, in particular against influenza viruses, other acute respiratory viral infections, hepatitis A, B, C and herpesviruses. The mechanism of antiviral action is associated with inhibition of translation of virus-specific proteins in infected cells, as a result of which virus reproduction is inhibited.
During animal studies (chicken and duck embryos), high antiviral activity of the drug against the causative agent of highly pathogenic avian influenza (HPAI) strain H5N1 was proven, as well as (in experiments on chickens) significant immunostimulatory and adjuvant activity of antigens.
Pharmacokinetics.
After oral administration, tilorone is rapidly absorbed from the gastrointestinal tract. Bioavailability is 60%. About 80% binds to blood plasma proteins.
The drug is not biotransformed and does not accumulate in the body. It is excreted practically unchanged in feces and urine in a ratio of 7:1. The half-life is 48 hours.
Indication
Adults: treatment of viral hepatitis A, B, C, herpes infection, cytomegalovirus infection, as part of complex therapy of infectious-allergic and viral encephalomyelitis (multiple sclerosis, leukoencephalitis, uveoencephalitis and meningoencephalitis); for the treatment and prevention of influenza and acute respiratory viral infections; to reduce the degree of immunosuppression as part of complex therapy of diseases accompanied by secondary induced immunodeficiencies (caused by exposure to X-rays, cytostatics, surgical interventions, etc.) and requiring immunoprophylaxis. p.) and requiring immunocorrection.
Children from 7 years of age: treatment of influenza and acute respiratory viral infections.
Contraindication
Hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
Compatible with antibiotics and traditional treatments for viral and bacterial diseases.
Use during pregnancy or breastfeeding
There is no experience with the use of the drug during pregnancy or breastfeeding, therefore it should not be used during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
The drug is taken orally after meals.
Adults
Prevention of viral hepatitis A: 125 mg per week for 6 weeks.
Treatment of viral hepatitis A: on the 1st day - 125 mg 2 times, then - 125 mg after 48 hours. Course dose - 1.25 g.
Treatment of acute hepatitis B: in the first 2 days of treatment - 125 mg, then - 125 mg after 48 hours. Course dose - 2 g. In case of a prolonged course of the disease, the course dose can be increased to 2.5 g.
In case of acute hepatitis C: in the first 2 days of treatment - 125 mg, then - 125 mg after 48 hours. Course dose - 2.5 g.
In chronic hepatitis C: in the first 2 days of treatment - 250 mg, then - 125 mg after 48 hours. The course dose at the beginning of treatment is 2.5 g. In the future, the drug is taken at a dose of 125 mg/week. In general, the course dose is 5 g.
In the treatment of influenza and acute respiratory viral infections: in the first 2 days of treatment - 125 mg, then - 125 mg after 48 hours. Course dose - 750 mg.
Prevention of influenza and acute respiratory viral infections: 125 mg once a week for 6 weeks.
For the treatment of herpes, cytomegalovirus infection: in the first 2 days of treatment - 125 mg, then - 125 mg after 48 hours. Course dose - 2.5 g.
To reduce the degree of immunosuppression as part of complex therapy of diseases accompanied by secondary induced immunodeficiencies and requiring immunocorrection: 125-250 mg per week for 6 weeks. The maximum course dose is 1.5 g. Depending on the immunological indicators and the course of the disease, the course of treatment can be repeated with an interval between courses of 4 weeks.
For urogenital and respiratory chlamydia: in the first 2 days of treatment - 125 mg, then - 125 mg after 48 hours. Course dose - 1.25 g.
During complex therapy of neuroviral infections - infectious-allergic and viral encephalomyelitis (multiple sclerosis, leukoencephalitis, uveoencephalitis and meningoencephalitis): in the first 2 days of treatment - 125 mg, then - 125 mg after 48 hours. Course dose - from 1.5 to 1.75 g.
Children from 7 years old
In uncomplicated forms of influenza or acute respiratory viral infections, 60 mg is taken once a day on the 1st, 2nd, and 4th day from the start of treatment. The course dose is 180 mg. In case of complications of influenza or acute respiratory viral diseases, 60 mg is taken once a day on the 1st, 2nd, 4th, and 6th day after the start of treatment. The course dose is 240 mg.
Children.
The medicine is not used in children under 7 years of age.
Overdose
Cases of overdose of the drug AMIXIN® IS are not known.
Adverse reactions
Skin and subcutaneous tissue disorders: allergic reactions, including itching, rash (including urticaria).
On the part of the digestive tract: dyspeptic phenomena (including nausea, heartburn).
Others: short-term fever.
Expiration date
4 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
3 tablets in a blister; one, two or three blisters in a pack. 5 tablets in a blister; two blisters in a pack.
Vacation category
Without a prescription.
Producer
"INTERCHEM" Additional Liability Company.
Location of the manufacturer and address of its place of business.
Ukraine, 65080, Odesa region, Odessa, Lustdorfska road, building 86.
