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Description
REGISTRATION NUMBER:
TRADE NAME means:Kagocel® (Kagocel®)
INTERNATIONAL NON-PATENT NAME: no.
CHEMICAL NAME: The sodium salt of the copolymer (1 → 4) - 6- 0-carboxymethyl -β-D-glucose, (1 → 4) - β-D-glucose and (21 → 24) -2,3,14,15, 21,24, 29,32-octahydroxy-23- (carboxymethoxymethyl) -7, 10-dimethyl-4, 13-di (2-propyl) - 19,22,26,30,31 - pentaoxaheptacyclo [23.3.2.21616.20.05 .28.08.27.09.18.012.17] dotiaconth-1,3,5 (28), 6,8 (27), 9 (18), 10, 12 (17), 13,15-decaene.
DOSAGE FORM: Tablets.
COMPOSITION: Active Substance:Kagocel® 12 mg. Excipients: potato starch - 10 mg, calcium stearate - 0.65 mg, Ludipress (composition: lactose monohydrate, povidone (Kollidon 30), crospovidone (Kollidon CL)) to obtain a tablet weighing 100 mg.
DESCRIPTION: Tablets from white with a brownish tinge to light brown color round biconvex with splashes of brown color.
Pharmacotherapeutic group: Antiviral agent.
ATH CODE: [J05AX]
Release form
Pharmacological effect
The main mechanism of actionKagotsela® is the ability to induce the production of interferon.Kagocel® causes the formation in the human body of the so-called late interferons, which are a mixture of α- and β-interferons with high antiviral activity.Kagocel® causes the production of interferon in virtually all cell populations involved in the antiviral response of the body: T-and B-lymphocytes, macrophages, granulocytes, fibroblasts, endothelial cells. When ingested a single doseKagotsela® serum interferon titer reaches maximum values after 48 hours. Interferon response of the body to the introductionKagotsela® characterized by prolonged (up to 4-5 days) circulation of interferon in the bloodstream. Dynamics of accumulation of interferon in the intestine when administeredKagotsela® does not coincide with the dynamics of circulating interferon titers. In serum, interferon production reaches high values only 48 hours after ingestion.Kagotsela®while in the intestine the maximum of interferon production is observed already after 4 hours.
Kagocel®When administered in therapeutic doses, non-toxic, does not accumulate in the body. The drug does not have mutagenic and teratogenic properties, is not carcinogenic and does not possess embryotoxic action.
The most effective treatmentKagocelom® is achieved with its appointment no later than the 4th day from the onset of acute infection.For prophylactic purposes, the drug can be used at any time, including immediately after contact with the pathogen.
Pharmacokinetics
24 hours after administrationKagocel® accumulates mainly in the liver, to a lesser extent in the lungs, thymus, spleen, kidneys, lymph nodes. Low concentration is noted in adipose tissue, heart, muscles, testicles, brain, blood plasma. Low contentKagotsela® in the brain due to the high molecular weight of the drug, impeding its penetration through the blood-brain barrier. In the blood plasma, the drug is mainly in a bound form.
With daily multiple injectionsKagotsela® the volume of distribution varies widely in all studied organs. Especially pronounced accumulation of the drug in the spleen and lymph nodes. When ingested, about 20% of the administered dose of the drug enters the general circulation. The absorbed drug circulates in the blood, mainly in the form associated with macromolecules: with lipids - 47%, with proteins - 37%. The unbound portion of the drug is about 16%.
Excretion: the drug is excreted from the body mainly through the intestines: 7 days after the administration 88% of the administered dose is excreted from the body, including 90% through the intestine and 10% by the kidneys. No breath detected in exhaled air.
Indications
Kagocel® used in adults and children aged 3 years as a preventive and therapeutic agent for influenza and other acute respiratory viral infections (ARVI), as well as a therapeutic tool for herpes in adults.
Contraindications
- Pregnancy and lactation;
- Age up to 3 years;
- Hypersensitivity to the drug;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Precautionary measures
The effect of the drug on the ability to drive vehicles, mechanisms has not been studied.
Use during pregnancy and lactation
Due to the lack of necessary clinical dataKagocel® It is not recommended to take during pregnancy and lactation.
Dosage and administration
Inside, regardless of the meal.
For the treatment of influenza and SARS, adults are prescribed in the first two days - 2 pills 3 times a day, and in the next two days - one tablet 3 times a day.A total of 18 pills per course, course duration - 4 days.
Prevention of influenza and acute respiratory viral infections in adults is carried out in 7-day cycles: two days - 2 pills 1 time per day, 5 days break, then repeat the cycle. The duration of the prophylactic course is from one week to several months.
For the treatment of herpes in adults, 2 pills are prescribed 3 times a day for 5 days. A total of 30 pills per course, course duration - 5 days.
For the treatment of influenza and ARVI, children aged 3 to 6 years old are prescribed in the first two days — 1 tablet 2 times a day, and in the next two days, one tablet 1 time a day. Total for the course - 6 pills, the duration of the course - 4 days.
For the treatment of influenza and ARVI, children aged 6 years and older are prescribed in the first two days - 1 tablet 3 times a day, and in the next two days - one tablet 2 times a day. Total for the course - 10 pills, the duration of the course - 4 days.
Prevention of influenza and ARVI in children aged 3 years is carried out in 7-day cycles: two days - 1 tablet 1 time per day, 5 days break, then repeat the cycle. The duration of the prophylactic course is from one week to several months.
Side effects
Allergic reactions may develop.
If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects not mentioned in the instructions,notify your doctor.
Overdose
In case of accidental overdose, it is recommended to prescribe a heavy drink, cause vomiting.
Interaction with other drugs
Kagocel® It is well combined with other antiviral drugs, immunomodulators and antibiotics (additive effect).
special instructions
To achieve a therapeutic effectKagotsela® should begin no later than the fourth day from the onset of the disease.
Storage conditions
4 years.
After the expiration date indicated on the package, the drug should not be used.
STORAGE CONDITIONS
In the dark place at a temperature of no higher than 25 C.
Keep out of the reach of children