Licopid^® (Tablets) Instructions for Use

ATC Code

L03AX (Other immunostimulants)

Active Substance

Glucosaminylmuramyldipeptide (Grouping name)

Clinical-Pharmacological Group

Immunomodulator

Pharmacotherapeutic Group

Immunostimulants; other immunostimulants

Pharmacological Action

Pharmacodynamics

The active substance of Licopid^® tablets – Glucosaminylmuramyldipeptide (GMDP) – is a synthetic analogue of the structural fragment of the envelope (peptidoglycan) of bacterial cells. GMDP is an activator of innate and acquired immunity, enhances the body’s defense against viral, bacterial, and fungal infections; exerts an adjuvant effect in the development of immunological reactions.

The biological activity of the drug is realized through the binding of GMDP to the intracellular receptor protein NOD2, localized in the cytoplasm of phagocytes (neutrophils, macrophages, dendritic cells). The drug stimulates the functional (bactericidal, cytotoxic) activity of phagocytes, enhances antigen presentation by them, proliferation of T- and B-lymphocytes, increases the synthesis of specific antibodies, and contributes to the normalization of the Th1/Th2 lymphocyte balance towards the predominance of Th1. The pharmacological action is carried out by enhancing the production of key interleukins (interleukin-1, interleukin-6, interleukin-12), TNFα, gamma-interferon, colony-stimulating factors. The drug increases the activity of natural killer cells.

Licopid^® has low toxicity (LD₅₀ exceeds the therapeutic dose by 49,000 times or more). In experiments with oral administration at doses 100 times higher than the therapeutic dose, the drug has no toxic effect on the central nervous system and cardiovascular system, and does not cause pathological changes in internal organs.

Licopid^® has no embryotoxic or teratogenic effects and does not cause chromosomal or gene mutations.

In experimental studies conducted on animals, data on the antitumor activity of the drug Licopid^® (GMDP) were obtained.

Pharmacokinetics

The bioavailability of the drug when taken orally is 7-13%. The degree of binding to blood albumin is weak. Time to reach C_max is 1.5 hours after administration. T_1/2 is 4.29 hours. It does not form active metabolites and is excreted mainly by the kidneys unchanged.

Indications

The drug is used in adults in the complex therapy of diseases accompanied by secondary immunodeficiency states

• Acute and chronic purulent-inflammatory diseases of the skin and soft tissues, including purulent-septic postoperative complications;
• Sexually transmitted infections (papillomavirus infection, chronic trichomoniasis);
• Herpetic infection (including in ophthalmoherpes);
• Psoriasis (including psoriatic arthritis);
• Pulmonary tuberculosis.

ICD codes

Dosage Regimen

Tablets

Licopid^® is taken orally or sublingually on an empty stomach, 30 minutes before meals.

If a dose is missed, if less than 12 hours have passed from the scheduled time, the patient can take the missed dose; if more than 12 hours have passed from the scheduled administration time, only the next scheduled dose should be taken and the missed dose should not be taken.

Dose adjustment in specific patient groups (elderly patients, patients with impaired liver function, patients with impaired renal function) is not required.

Children

Acute and chronic purulent-inflammatory diseases of the skin and soft tissues (pyoderma, furunculosis and others) 1 tablet once a day sublingually for 10 days.

Chronic, recurrent infections of the upper and lower respiratory tract (in the acute stage and in the remission stage) Licopid^® is taken in 3 courses of 1 tablet once a day sublingually for 10 days, with a 20-day break between courses.

Herpetic infection 1 tablet 3 times a day orally or sublingually for 10 days.

Adults

Chronic respiratory tract infections 2 tablets once a day sublingually for 10 days.

Acute and chronic purulent-inflammatory diseases of the skin and soft tissues (pyoderma, furunculosis and others) 2 tablets 2-3 times a day sublingually for 10 days.

Herpetic infection 2 tablets 3 times a day orally or sublingually for 10 days.

For the prevention or reduction of seasonal incidence of acute respiratory infections and the frequency of exacerbations of ENT organ diseases, upper and lower respiratory tract diseases 1 tablet 3 times a day sublingually for 10 days.

Adverse Reactions

Common (1-10%) – arthralgias (joint pain), myalgias (muscle pain); at the beginning of treatment, a short-term increase in body temperature to subfebrile values (up to 37.9°C (100.2°F)) may be noted, which is not an indication for drug discontinuation. The side effects described above are most often observed when taking Licopid^® tablets in high doses (20 mg).

Rare (0.01-0.1%) – increase in body temperature to febrile values (>38°C (100.4°F)). If body temperature rises >38°C (100.4°F), antipyretics may be taken, which does not reduce the pharmacological effects of Licopid^® tablets.

Very rare (<0.01%) – diarrhea.

If any of the side effects listed in the instructions worsen, or any other side effects not listed in the instructions are noted, the patient should inform the attending physician.

Contraindications

• Hypersensitivity to glucosaminylmuramyldipeptide and other components of the drug;
• Pregnancy;
• Breastfeeding period;
• Age under 18 years;
• Autoimmune thyroiditis in the acute phase;
• Conditions accompanied by febrile temperature (>38°C (100.4°F)) at the time of drug administration;
• Rare congenital metabolic disorders (alactasia, galactosemia, lactase deficiency, lactose intolerance, sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption);
• Use in autoimmune diseases is not recommended due to the lack of clinical data.

With caution and strictly under medical supervision, Licopid^® 10 mg should be used in elderly patients.

Use in Pregnancy and Lactation

The use of Licopid^® 10 mg is contraindicated in women during pregnancy and breastfeeding.

Pediatric Use

The use of the drug in children and adolescents under 18 years of age is contraindicated.

Geriatric Use

In elderly patients, the drug should be used with caution and strictly under medical supervision.

Special Precautions

At the beginning of Licopid^® 10 mg administration, an exacerbation of symptoms of chronic and latent diseases may occur, which is associated with the main pharmacological effects of the drug.

In elderly individuals, Licopid^® 10 mg is used with caution, strictly under medical supervision. Elderly patients are recommended to start treatment with half doses (1/2 of the therapeutic dose), and in the absence of side effects, increase the drug dose to the necessary therapeutic level.

The decision to prescribe Licopid^® 10 mg tablets to patients with a combination of diagnoses “psoriasis” and “gout” should be made by a doctor when assessing the risk/benefit ratio, due to the potential risk of exacerbation of gouty arthritis and joint swelling. If the doctor decides to prescribe Licopid^® 10 mg tablets in a situation where the patient has both “psoriasis” and “gout”, treatment should be started with low doses, and in the absence of side effects, the dose should be increased to the therapeutic level.

Each Licopid^® 10 mg tablet contains sucrose in an amount of 0.001 XE (bread units), which should be considered in patients with diabetes mellitus.

Each Licopid^® 10 mg tablet contains 0.184 grams of lactose, which should be considered in patients suffering from hypolactasia (lactose intolerance, in which the body has a reduced level of lactase, the enzyme necessary for digesting lactose).

Effect on the ability to drive vehicles and operate machinery

Does not affect the ability to drive vehicles and complex machinery.

Overdose

Cases of drug overdose are unknown.

Symptoms based on the pharmacological properties of the drug, in case of its overdose, an increase in body temperature to subfebrile values (up to 37.9°C (100.2°F)) may be observed.

Treatment if necessary, symptomatic therapy (antipyretics) is carried out, sorbents are prescribed. A specific antidote is unknown.

Drug Interactions

The drug increases the effectiveness of antimicrobial drugs, synergy is noted with antiviral and antifungal drugs.

Antacids and sorbents significantly reduce the bioavailability of the drug.

Corticosteroids reduce the biological effect of the drug Licopid^®.

Storage Conditions

The drug should be stored in the original packaging in a place protected from light, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.