Tacropic
Tacropic: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. For violations of liver function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Tacropic
ATX code: D11AH01
Active ingredient: tacrolimus (tacrolimus)
Manufacturer: Akrikhin, JSC (Russia)
Description and photo updated: 22.11.2018
Prices in pharmacies: from 310 rubles.
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Tacropic is a topical anti-inflammatory agent.
Release form and composition
Dosage form - ointment for external use 0.03% and 0.1%: homogeneous consistency, white or almost white, there may be a weak specific odor (15 g each in aluminum tubes, in a cardboard box 1 tube).
Composition of 1 g of ointment:
- active substance: tacrolimus - 0.3 or 1 mg (in terms of 100% substance);
- auxiliary components: soft white petrolatum, liquid paraffin, emulsion wax, purified water, disodium edetate, macrogol-400, preservative Euxyl PE 9010 (phenoxyethanol - 90%, ethylhexylglycerol - 10%).
Pharmacological properties
Pharmacodynamics
Tacrolimus is a member of the group of calcineurin inhibitors. The mechanism of its action is explained by the ability to bind to a specific cytoplasmic protein immunophilin (FKBP12), which is a cytosolic receptor for calcineurin (FK506), as a result of which a complex is formed, including tacrolimus, calmodulin, calcineurin, calcium and FKBPI2, which inhibits the phosphatase activity. This, in turn, prevents dephosphorylation and translocation of the nuclear factor of activated T cells (NFAT), which is required to initiate the transcription of genes that encode the production of cytokines (IL-2 and interferon-gamma), which are key to the T-cell immune response.
Also, the drug inhibits the transcription of genes encoding the production of tumor necrosis factor (TNF-α), granulocyte-macrophage colony-stimulating factor (GMCSF), IL-3, IL-4 and IL-5 - cytokines that take part in the initial stages of T-lymphocyte activation.
In addition, tacrolimus inhibits the release of inflammatory mediators from mast cells, eosinophils and basophils, decreases the expression of FcɛRI (high-affinity surface receptor for immunoglobulin E) on Langerhans cells, as a result of which their activity and antigen presentation to T-lymphocytes decreases.
The drug does not affect collagen synthesis, and therefore does not cause skin atrophy.
Pharmacokinetics
- absorption: with topical application of tacrolimus, its absorption into the systemic circulation is minimal. In most adult patients and children with atopic dermatitis, after single and repeated use of Tacropic in the form of 0.1% and 0.03% ointments, the plasma concentration of tacrolimus is <1 ng / ml. The degree of systemic absorption depends on the area of the lesion; it decreases as the clinical manifestations of the disease disappear. With prolonged use of the drug (up to 1 year), the accumulation of tacrolimus was not observed in either adults or children;
- distribution: given the low systemic absorption of the drug, high plasma protein binding (> 98.8%) is considered clinically insignificant;
- metabolism: tacrolimus is not metabolized in the skin. If it enters the systemic circulation, the drug undergoes significant metabolism in the liver with the participation of the CYP3A4 isoenzyme;
- Elimination: after repeated use of Tacropic, the half-life is: in adults - 75 hours, in children - 65 hours.
Indications for use
According to the instructions, Takropic is used to treat moderate to severe atopic dermatitis in cases of resistance to other external drugs or the presence of contraindications to their appointment.
Contraindications
- generalized erythroderma;
- serious violations of the epidermal barrier (lamellar ichthyosis, Netherton syndrome, skin manifestations of the graft-versus-host reaction);
- congenital or acquired immunodeficiency;
- pregnancy and the period of breastfeeding;
- age up to 2 years - for ointment 0.03%, age up to 16 years - for ointment 0.1%;
- simultaneous use of immunosuppressive drugs;
- hypersensitivity to any component of the drug or other macrolides.
With care: uncompensated liver failure.
Particular care should be taken if it is necessary to use Tacropic on extensive skin lesions and / or for a long time, especially in children.
Instructions for the use of Tacropic: method and dosage
Tacropic should be applied in a thin layer to the affected area. The drug can be used on any part of the body, including skin folds, neck and face. Do not apply ointment under occlusive dressings, use to treat lesions on mucous membranes.
Children 2-16 years old are prescribed 0.03% ointment. The frequency of applications is 2 times a day. The duration of treatment is no more than 3 weeks. In the future, the frequency of application is reduced to 1 time per day, the therapy is continued until the inflammatory foci are completely cleared.
Teenagers from 16 years old and adults are prescribed 0.1% ointment. The frequency of applications is 2 times a day. As the condition improves, you can reduce the frequency of application of the drug or transfer the patient to 0.03% Tacropic ointment. The therapy is continued until the inflammatory foci are completely cleared.
Tacropic is used for a short or long time in the form of periodically repeated therapeutic courses. As a rule, improvement is noted within 1 week. If there is no positive dynamics after 2 weeks from the start of treatment, the doctor should reconsider the tactics of therapy. The use of the drug is resumed when the first signs of exacerbation of atopic dermatitis appear.
To prevent exacerbations and increase the duration of remission, patients with frequent exacerbations (more than 4 times a year) are recommended to carry out supportive therapy. Its feasibility is assessed based on the effectiveness of the previous treatment with Takropic (2 times a day for up to 6 weeks).
With maintenance therapy, the drug should be applied to areas of the body that are usually affected during an exacerbation of the disease, 2 times a week with an interval of at least 2-3 days, for example, on Tuesday and Friday.
Clinical dynamics are assessed after 12 months, after which the doctor considers the feasibility of continuing preventive therapy. To assess the dynamics in children, the drug is temporarily canceled, after which it is decided whether it is necessary to continue supportive treatment.
Side effects
Most often, Tacropic causes skin irritation at the site of application: itching, redness, burning sensation, pain, rash, paresthesia. These phenomena, as a rule, are moderately expressed and disappear with continued treatment.
Possible side effects:
- local reactions: very often (≥ 1/10) - burning and itching at the site of ointment application; often (from ≥ 1/100 to <1/10) - redness, warmth, rash, irritation, pain in the area of application of the drug; frequency unknown - local edema (at the sites of Tacropic application);
- from the skin and subcutaneous tissues: often - itching, folliculitis; infrequently (from ≥ 1/1000 to <1/100) - acne;
- on the part of metabolism and nutrition: often - alcohol intolerance (flushing of the face or symptoms of skin irritation after drinking alcohol);
- infectious diseases: often - local skin infections of various etiologies (including folliculitis, Kaposi's herpetic eczema, infections caused by viruses of the Herpesviridae family, including Herpes simplex);
- from the nervous system: often - hyperesthesia / paresthesia;
- others: isolated cases - rosacea, malignancy (skin cancer, cutaneous and other types of lymphomas).
Overdose
Overdose cases with topical application of Tacropic are unknown.
If the ointment gets inside, generally accepted measures should be taken, including monitoring the vital functions of the body and the general condition of the patient. It is not recommended to induce vomiting and gastric lavage.
special instructions
During the treatment period, prolonged exposure to the sun should be avoided, tanning beds and PUVA therapy (therapy with ultraviolet A or B rays in combination with psoralen) should be avoided.
Within 2 hours after using the ointment, do not apply emollients to the same skin areas.
Tacropic should not be applied to areas of skin that are considered potentially malignant or precancerous.
Drug-treated areas of the body should not be covered with occlusive dressings or tight, airtight clothing.
Avoid getting the ointment in the eyes and on the mucous membranes. If this happens, rinse them thoroughly and abundantly with water.
After applying the drug, you should wash your hands thoroughly, unless the product is used on the hand area for therapeutic purposes.
Patients with lymphadenopathy should be examined prior to the appointment of Tacropic and periodically during its use. If there is no obvious cause of the disease, or there are symptoms of acute infectious mononucleosis, the drug is not prescribed / canceled.
The efficacy and safety of tacrolimus in infected atopic dermatitis has not been evaluated. If signs of infection are present before the appointment of Tacropic, appropriate therapy is required.
The use of tacrolimus is associated with an increased risk of developing herpes infection. If there are signs of herpes infection, the advisability of prescribing Tacropic is assessed individually, taking into account the ratio of the expected benefits and possible risks.
Influence on the ability to drive vehicles and complex mechanisms
There have been no studies on the effect of tacrolimus on reaction rate and ability to concentrate. Given the external method of using the ointment, the negative effect of the drug on the cognitive and psychophysical functions of a person is unlikely.
Application during pregnancy and lactation
Tacrolimus is contraindicated in pregnant and lactating women.
Pediatric use
Tacropic ointment 0.03% is contraindicated for children under 2 years old, 0.1% ointment for children under 16 years old.
For violations of liver function
The drug should be used with caution in patients with concomitant uncompensated hepatic impairment.
Use in the elderly
There are no peculiarities of using Tacropic in the elderly. If there are no signs of improvement within 2 weeks of treatment, it is necessary to consider changing the therapeutic regimen.
Drug interactions
Since tacrolimus is not metabolized in the skin, the likelihood of clinically significant drug interactions in the skin is excluded.
Given the minimal systemic absorption of tacrolimus, interaction with CYP3A4 inhibitors (eg, diltiazem, ketoconazole, itraconazole, erythromycin) is unlikely, but cannot be completely excluded in patients with erythroderma and / or large lesions.
The effect of Tacropic on vaccination has not been studied. However, there is a potential risk of reducing its effectiveness, therefore, it is recommended to administer the vaccine before starting treatment with tacrolimus or after 14 days after its withdrawal, in the case of a live attenuated vaccine - after 28 days.
Tacropic, used during the administration of the conjugate vaccine against Neisseria meningitidis serotype C, in children 2–11 years old did not affect the primary immune response and the formation of immune memory, humoral and cellular immune responses.
The possibility of using Tacropic concomitantly with other external drugs, immunosuppressants and systemic glucocorticosteroids has not been studied.
Analogs
Tacropic analogs are drugs: Advagraf, Pangraf, Grastiva, Prograf, Redinesp, Protopic, Takrosel, Tacrolimus, Tacrolimus-Teva, Tacrolimus Stada.
Terms and conditions of storage
Keep out of reach of children at temperatures up to 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Tacropic
There are no reviews on Tacropic on specialized medical forums that would help assess the safety and effectiveness of this drug in terms of its practical use. There are reviews about the analogue of Tacropic - Protopic, which contains the same active substance and is also available in the form of 0.03% and 0.1% ointment. They describe the high efficacy of the drug for atopic dermatitis in adults and children, fast action (improvement in the condition is noted after the first use), the absence of side effects, including skin atrophy.
Price for Tacropic in pharmacies
Approximate prices for Tacropic: 0.03% ointment - 597-631 rubles. for 1 tube, ointment 0.1% - 623–662 rubles. for 1 tube.
Tacropic: prices in online pharmacies
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Drug name Price Pharmacy |
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Tacropic 0.1% ointment for external use 15 g 1 pc. 310 RUB Buy |
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Tacropic 0.03% ointment for external use 15 g 1 pc. 546 r Buy |
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Tacropic ointment for external use. approx. 0.03% 15g 571 r Buy |
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Tacropic ointment for external use. approx. 0.1% 15g 602 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
