Composition
Active ingredient: glucosaminylmuramyldipeptide (GMDP) – 1,0 mg. Excipients: lactose monohydrate-73.88 mg, sucrose (sugar) – 5.0 mg, potato starch-19.0 mg, methylcellulose-0.12 mg, calcium stearate-1.0 mg
Pharmacological action
Pharmacodynamics
The Active ingredient of Lycopid ® tablets – glucosaminylmuramyldipeptide (GMDP) – is a synthetic analog of the structural fragment of the shell (peptidoglycan) of bacterial cells. GMDP is an activator of innate and acquired immunity, enhances the body’s defense against viral, bacterial and fungal infections; it has an adjuvant effect in the development of immunological reactions.
The biological activity of the drug is realized by binding HMDP to the intracellular NOD2 receptor protein localized in the cytoplasm of phagocytes (neutrophils, macrophages, dendritic cells). The drug stimulates the functional (bactericidal, cytotoxic) activity of phagocytes, enhances their presentation of antigens, proliferation of T-and B-lymphocytes, increases the synthesis of specific antibodies, and helps normalize the balance of Th1/Th2 lymphocytes in the direction of Th1 predominance Pharmacological action is carried out by increasing the production of key interleukins (interleukin-1, interleukin-6, interleukin-12), tumor necrosis factor alpha, interferon gamma, and colony-stimulating factors. The drug increases the activity of natural killer cells.
Lycopide® has low toxicity (LD50 exceeds the therapeutic dose by 106 000 times or more). In the experiment, when administered orally in doses 100 times higher than the therapeutic one, the drug does not have a toxic effect on the central nervous and cardiovascular systems, and does not cause pathological changes in the internal organs. Lycopide® does not have embryotoxic and teratogenic effects, does not cause chromosomal or gene mutations. In experimental studies conducted on animals, data on the antitumor activity of Lycopide® (GMDP) were obtained.
Pharmacokinetics
The oral bioavailability of the drug is 7-13%. The degree of binding to blood albumins is weak. The time to reach the maximum concentration (tmax) is 1.5 hours after use. The half-life (t1 / 2) is 4.29 hours. It does not form active metabolites and is mainly excreted unchanged through the kidneys.
Indications
The drug is used in adults and children (from 3 years of age) in the complex therapy of diseases accompanied by secondary immunodeficiency conditions:
Children
: chronic, recurrent upper and lower respiratory tract infections in the acute and remission stages;
- acute and chronic purulent-inflammatory diseases of the skin and soft tissues (pyoderma, furunculosis, etc. );
- herpetic infection.
Adult
chronic respiratory tract infections;
- acute and chronic purulent-inflammatory diseases of the skin and soft tissues (pyoderma, furunculosis, etc. );
- herpetic infection.
Preventive care (adults)
prevention and reduction of seasonal morbidity of acute respiratory infections and the frequency of exacerbations of chronic diseases of ENT organs, upper and lower respiratory tracts.
Use during pregnancy and lactation
Taking the drug Lycopid ® 1 mg is contraindicated in women during pregnancy and lactation.
Contraindications
Hypersensitivity to glucosaminilmuramildipeptide and other components of the drug;
pregnancy and breastfeeding; autoimmune thyroiditis in the acute phase;
state, accompanied by febrile temperature (>38°C) at the time of taking the drug;
rare inborn errors of metabolism: alactasia, galactosemia, lactase deficiency, lactose intolerance, lack of sucrase/isomaltase, fructose intolerance, glucose-galactose malabsorption;
application in autoimmune diseases is not recommended due to the lack of clinical data.
Side effects
Often (1-10%) – at the beginning of treatment, there may be a short-term increase in body temperature to subfebrile values (up to 37.9°C), which is not an indication for discontinuation of the drug.
Rarely (0.01-0.1%) – a short-term increase in body temperature to febrile values (>38.0°C). When the body temperature rises above 38.0°C, antipyretics can be taken, which does not reduce the pharmacological effects of Lycopid®tablets.
Very rarely (less than 0.01%) – diarrhea.
If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Interaction
The drug increases the effectiveness of antimicrobial drugs, there is a synergy in relation to antiviral and antifungal drugs. Antacids and sorbents significantly reduce the bioavailability of the drug. Glucocorticosteroids reduce the biological effect of Lycopide®.
How to take, course of use and dosage
Lycopide® is administered orally or sublingually on an empty stomach,30 minutes before meals.
If you miss taking the drug, if no more than 12 hours have passed from the scheduled time, you can take the missed dose; if more than 12 hours have passed from the scheduled time of taking, you need to take only the next dose according to the schedule and do not take the missed one.
Dose adjustments in certain groups of patients (elderly, patients with impaired liver function, patients with impaired renal function) not required.
Children:
Acute and chronic purulent-inflammatory diseases of the skin and soft tissues (pyoderma, furunculosis, etc. ): take 1 tablet once a day under the tongue for 10 days.
Chronic, recurrent upper and lower respiratory tract infections (in the acute stage and in remission): Likopid® is taken in 3 courses of 1 tablet 1 time a day under the tongue for 10 days, with a break between courses of 20 days.
Herpes infection: 1 tablet 3 times a day inside or under the tongue for 10 days.
Adults:
Chronic respiratory tract infections: 2 tablets 1 time a day under the tongue for 10 days.
Acute and chronic purulent-inflammatory diseases of the skin and soft tissues (pyoderma, furunculosis, etc. ): Â 2 tablets 2-3 times a day under the tongue for 10 days.
Herpes infection: 2 tablets 3 times a day inside or under the tongue for 10 days.
Prevention (adults):
to prevent or reduce the seasonal incidence of acute respiratory infections and the frequency of exacerbations of diseases of the ENT organs, upper and lower respiratory tracts, Likopid® is taken 1 tablet 3 times a day under the tongue for 10 days.
Precautions for use:
Each Lycopid® 1 mg tablet contains sucrose in an amount of 0.00042 cu (bread units), which should be considered in patients with diabetes mellitus.
Each Likopid® 1 mg tablet contains 0.074 grams of lactose, which should be considered in patients suffering from hypolactasia (lactose intolerance, in which the body has a decrease in the level of lactase-an enzyme necessary for the digestion of lactose).
Overdose
Cases of overdose of the drug are unknown. Based on the pharmacological properties of the drug, in case of overdose, there may be a rise in body temperature to subfebrile (up to 37.9°C) values. If necessary, symptomatic therapy (antipyretics) is carried out, sorbents are prescribed. The specific antidote is unknown.
Description
Round flat-cylindrical tablets of white color with a chamfer.
Special instructions
At the beginning of taking Likopid® 1 mg, symptoms of chronic and latent diseases may worsen, due to the main pharmacological effects of the drug.
Influence on the ability to drive vehicles and mechanisms It does not affect the ability to drive a car or use complex mechanisms.
Form of production
– During production at Peptek JSC: 10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished. 1 or 3 contour cell packages together with instructions for medical use are placed in a pack of cardboard.
– In the production of LLC “SKOPINFARM”: 10 or 15 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished. 1 contour cell pack of 10 tablets or 2 contour cell packs of 15 tablets together with instructions for medical use is placed in a cardboard pack.
Storage conditions
In the original packaging, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.
Shelf
life is 5 years. Do not use after the expiration date.
Active ingredient
Glucosaminylmuramyldipeptide
Dosage form
Tablets
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