Licopid® (GMDP) Instruction

International Non-Proprietary Name (INN): glucosaminyl muramyl dipeptide (GMDP)
Dosage form: tablets
Structure
In a 1 mg tablet:
Active ingredient: GMDP – 1.0 mg;
Excipients: lactose monohydrate – 73.88 mg, sugar (sucrose) – 5.0 mg, potato starch – 19.0 mg, methyl cellulose – 0.12 mg, calcium stearate – 1.0 mg.
In a 10 mg tablet:
Active ingredient: GMDP – 10.0 mg;
Excipients: lactose monohydrate – 184.7 mg, sugar (sucrose) – 12.5 mg, potato starch – 40 mg, methyl cellulose – 0.3 mg, calcium stearate – 2.5 mg.
Description
Round flat-cylindrical tablets of white color with a facet.
ATC code: L03A
Pharmacological action: Immunomodulatory


Pharmacodynamics

The active ingredient of Lycopid is glucosaminyl muramyl dipeptide. It is a synthetic analog of the structural fragment of the shell (peptidoglycan) of bacterial cells. GMDP is an activator of congenital and acquired immunity; it enhances the body’s defense against viral, bacterial and fungal infections and has an adjuvant effect in the development of immunological reactions. The biological activity of the drug is realized through the binding of GMDP to 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 their presentation of antigens, the proliferation of T- and B-lymphocytes; it increases the synthesis of specific antibodies and contributes to the normalization of the balance of Th1/Th2 lymphocytes towards the prevalence of Th1. Pharmacological action lies in enhancing the production of key interleukins (interleukin-1, interleukin-6, interleukin-12), necrosis factor of alpha tumors, gamma interferon, and colony-stimulating factors. The drug increases the activity of natural killer cells.

Licopid has low toxicity (LD50 for 1 mg tablets exceeds the therapeutic dose more than 106,000 times, and for 10 mg tablets more than 49,000 times). In experiments with the per os administration in doses 100 times exceeding the therapeutic one, the drug has no toxic effect on the central nervous and cardiovascular systems and it does not cause pathological changes in internal organs. Lycopid does not exercise embryotoxic and teratogenic effects and does not cause chromosomal gene mutations. In experimental studies conducted on animals, Lycopid demonstrated anticancer activity.

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 administration. The half-life (t1/2) is 4.29 hours. The drug does not form metabolites; it is excreted in the unchanged form mainly through the kidneys.

Intended uses

1 mg tablets

The drug is used in adults and children (from 3 years old) in the complex treatment of diseases, accompanied by secondary immunodeficiency conditions.

Adults and children
  • chronic, recurring infections of the upper and lower respiratory tract in exacerbation and remission stages;
  • acute and chronic pyo-inflammatory diseases of skin and soft tissues; (pyoderma, furunculosis, etc.);
  • herpetic infection.

Preventive administration (adults)
  • prevention and reduction of seasonal incidence of acute respiratory infections and the frequency of exacerbations of chronic diseases of the ENT organs and upper and lower respiratory tract.


10 mg tablets

The drug is used in adults in the complex treatment of diseases accompanied by secondary immunodeficiency conditions:

  • acute and chronic pyo-inflammatory diseases of skin and soft tissues, including purulent-septic postoperative complications;
  • sexually transmitted infections (papilloma viral infection, chronic trichomoniasis);
  • herpetic infection (including ophthalmic herpes);
  • psoriasis (including psoriatic arthritis);
  • pulmonary tuberculosis.


Contraindications

  • hypersensitivity to glucosaminyl muramyl dipeptide and other components of the drug;
  • pregnancy and lactation;
  • autoimmune thyroiditis in the acute phase;
  • conditions accompanied by febrile temperature (>38°C or >100.4°F) at the time of taking the drug;
  • rare congenital metabolic disorders: alactasia, galactosemia, lactase deficiency, lactose intolerance, sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
  • administration in autoimmune diseases is not recommended because of the lack of clinical data.


For Licopid in tablets 10 mg, child age under 18 y.o. is also a contraindication.

Dosage and administration

Lycopid is administered orally or sublingually in the fasting state, 30 minutes before meals. If you skip an intake not more than 12 hours ago, you can take the missed dose; if more than 12 hours have passed from the planned time of administration, only the next dose (not the missed one) can be taken according to the scheme.

1 mg tablets

Dose adjustment in certain groups of patients (elderly people, patients with impaired liver function, and patients with impaired renal function) is not required.

Children

Acute and chronic pyo-inflammatory diseases of skin and soft tissues (pyoderma, furunculosis, etc.)
1 tablet 1 time per day under the tongue for 10 days.

Chronic, recurring infections of the upper and lower respiratory tract (in exacerbation and remission stages)
Licopid is taken in 3 courses, 1 tablet 1 time per day under the tongue for 10 days, with a break of 20 days between the courses.

Herpetic infection
1 tablet 3 times a day orally or under the tongue for 10 days.

Adults

Chronic respiratory infections
2 tablets 1 time per day under the tongue for 10 days.

Acute and chronic pyo-inflammatory diseases of skin and soft tissues (pyoderma, furunculosis, etc.)
2 tablets 2-3 times a day under the tongue for 10 days.

Herpetic infection
2 tablets 3 times a day orally or under the tongue for 10 days.

Prevention
1 tablet 3 times a day under the tongue for 10 days to prevent or reduce the seasonal incidence of acute respiratory infections and the exacerbation frequency of the diseases of the ENT organs and upper and lower respiratory tract.

10 mg tablets

For elderly patients, it is recommended to start the treatment with half doses (1/2 of the therapeutic dose), in the absence of side effects the dose is increased to the therapeutic one.

Acute and chronic purulent-inflammatory diseases of skin and soft tissues, including severe course and purulent-septic postoperative complications
10 mg once a day for 10 days.

Herpetic infection (recurrent course, severe forms)
10 mg once a day for 6 days.

Ophthalmic herpes
10 mg 2 times a day for 3 days. After a break of 3 days, the treatment is repeated.

Sexually transmitted infections (papilloma viral infection, chronic trichomoniasis)
In papilloma viral infection: 10 mg once a day for 10 days; in chronic trichomoniasis: 10 mg once a day for 10 days.

Psoriasis
10–20 mg 1 time per day for 10 days, and then five intakes every other day, 10–20 mg 1 time per day. In severe psoriasis and coarse lesion (including psoriatic arthritis): 10 mg 2 times a day for 20 days.

Pulmonary tuberculosis
10 mg once a day for 10 days.

Precaution

Every 1 mg tablet of Licopid contains sucrose in the amount of 0.00042 c.u. (carbohydrate units); every 10 mg tablet of Licopid contains sucrose in the amount of 0.001 c.u., which should be taken into account by patients with diabetes mellitus.

Every 1 mg tablet of Licopid contains 0.074 grams of lactose; every 10 mg tablet of Licopid contains 0.184 grams of lactose, which should be noted by patients suffering from hypolactasia (lactose intolerance, in which the body has a decrease in the level of lactase – an enzyme necessary for digesting lactose).

Elderly patients should take Licopid 10 mg with caution and under the strict supervision of the doctor.

In the beginning of the course of Licopid 10 mg, exacerbation of symptoms of chronic and latent diseases is possible, which is associated with the main pharmacological effects of the drug.

The decision to prescribe Licopid 10 mg to patients with a combination of psoriasis and gout should be made by the doctor, assessing the risk/benefit ratio, as there is a potential risk of exacerbation of gouty arthritis and joint swelling. If the decision is made to prescribe Licopid 10 mg to a patient with a combination of psoriasis and gout, the treatment should be started with low doses. If side effects do not occur, the dose can be increased up to a therapeutic one.

Side effects

Often (1–10%): At the beginning of the treatment with Licopid 1 mg, a short-term increase in the body temperature to subfebrile values (up to 37.9°C or 100.22°F) may be recorded, which is not an indication for the drug withdrawal. When taking Licopid 10 mg, arthralgia (joint pain) and myalgia (muscle pain) may be manifested; at the beginning of the treatment, a short-term increase in the body temperature to subfebrile values (up to 37.9°C or 100.22°F) may be recorded, which is not an indication for the drug withdrawal. Most often, the side effects described above are observed when taking Licopid® tablets in high doses (20 mg).

Rarely (0.01–0.1%): A short-term increase in the body temperature to febrile values (>38.0°C or >100.4°F). If the body temperature rises above 38.0°C (100.4°F), antipyretic drugs may be administered. They do not reduce pharmacological effects of Licopid tablets.

Very rarely (<0.01%): Diarrhea.

If any of the side effects listed in the description aggravate, or if you notice any other side effects not listed in the description, notify your doctor.

Overdose

Cases of overdose have not been reported.

Based on the pharmacological properties of the drug, in case of an overdose, the body temperature can rise up to subfebrile values (37.9°C or 100.22°F). If necessary, symptomatic therapy can be conducted, including antipyretic drugs and sorbent prescription. There is no specific antidote.

Interaction with other drugs

The drug increases the effectiveness of antimicrobials, there is a synergy regarding antiviral and antifungal drugs. Antacids and sorbents significantly reduce the bioavailability of the drug. Glucocorticosteroids reduce the biological effect of Lycopid.

Pregnancy and lactation

Licopid is contraindicated in women during pregnancy and breastfeeding.

Influence on the ability to drive vehicles and operate mechanisms

The drug does not affect the ability to drive vehicles and operate mechanisms.

Storage conditions

Store in a dry, dark place at a temperature not higher than 25°C (77°F). Keep out of the reach of children.

Shelf life

5 years. Do not use after the expiration date.

Manufacturer

Peptek JSC, Russia. https://peptek.company/, www.licopid.ru

Instructions