Protopic

width = Protopik - dermatological ointment with anti-inflammatory effect for the therapy of atopic dermatitis.

Medication does not affect the condition and production of collagen, so it does not provoke atrophic skin changes. Ointment is intended for external treatment of moderate and severe atopic dermatitis.

With topical application Protopik is minimally absorbed into the systemic bloodstream, its concentration in the blood remains insignificant. With repeated application of the ointment, the half-life of the active substance is: for adults - 75 hours, for children - 65 hours.

Clinical and pharmacological group

Immunosuppressant.

Conditions of leave from pharmacies

It is released on prescription.

Price list

How much is the ointment Protopik in pharmacies? The average price is at the level of700 rubles.

Form of issue and composition

Medicinal form - ointment for external use, 3% and,%: homogeneous, from white to slightly yellowish color (in plastic tubes 10, 30 and 60 g, 1 tube in a pack of cardboard).

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Active substance: tacrolimus (in the form of monohydrate), in 1 g of ointment -, or 1 mg.

Auxiliary components: paraffin liquid, paraffin white soft, paraffin hard, wax bee white, propylene carbonate.

Pharmacological effect

Protopic is an anti-inflammatory ointment whose action is determined by the properties of its main substance, tacrolimus. The compound has the ability to induce reactions that inhibit the production and function of calcineurin.

Simultaneously, tacrolimus neutralizes the activity of substances that provide activation at the initial stage t-lymphocytes, blocks the exit from the mast cells of inflammatory mediators, as well as the release of basophils, eosonophiles.

The components of the ointment with tacrolimus do not affect the synthesis of collagen, and therefore do not provoke a negative change in the dermis.

Indications for use

Why helps? Protopic is an agent for the treatment of moderate and severe atopic dermatitis in the case of insufficient effectiveness of traditional methods of treatment or contraindications to their use.

Contraindications

Ointment Protopik contraindicated:

With lamellar ichthyosis.
Do not apply to children aged 2-16 years,% ointment Protopik.
It is strictly forbidden to put children under 2 years.
In the responses to the Protopack it is said that it is forbidden to use the ointment during pregnancy and lactation.
Do not use if you have a patient with Netherton syndrome or other genetic skin diseases.
If the skin reacts poorly to the ointment.
If patients are hypersensitive to the main and auxiliary components of the drug.

In an additional consultation, patients with hepatic insufficiency, very large lesions of skin, children, as well as those patients who have been using for a long time this preparation.

Use in pregnancy and lactation

Scientifically confirmed data on the hazard or safety of the application Protopika during pregnancy and lactation is not present. However, it is known that Tacrolimus penetrates the placental barrier. Therefore, the appointment of the drug to pregnant women is recommended only in cases where the benefit to the mother exceeds the risk to the fetus. If the drug is still pregnant, it is necessary to monitor the overall condition of the newborn baby and the function of his kidneys.

Tacrolimus is excreted in breast milk. Therefore, when this medication is administered to a nursing mother, breastfeeding is discontinued.

Dosage and route of administration

In the instructions for use, it is indicated that the Protopic is applied externally, applying a thin layer on the affected areas of the skin.

Ointment can be used on any part of the body, on the face and neck, as well as in the areas of skin folds. It is not recommended to apply the drug for occlusive dressings and mucous membranes.

Children from 2 to 16 years should be used, 3% ointment 2 times a day. At a given frequency of application, the duration of treatment should not exceed 21 days. In the future, the frequency of application is reduced to 1 time per day and continues therapy until all lesions are eliminated.

Adults and adolescents over 16 years of age, the ointment is recommended 2 times a day, the treatment lasts until the lesions are completely cleared. When the condition improves, the frequency of application is reduced or used, 3% ointment. If signs of the disease occur repeatedly, resumption of therapy,% of the drug twice a day. But at the first opportunity (taking into account the clinical picture) the frequency of administration is reduced or goes to a lower dosage (3%).

As a rule, improvements are noted already after 7 days after the beginning of the course. In the absence of the expected result during 14 days of therapy, it is necessary to consider the expediency of using Protopika.

Features of the drug in elderly patients (from 65 years and older) are absent.

With exacerbations of atopic dermatitis, the remedy can be used for a short time or for a long time in the form of periodically repeating courses. Treatment continues until the symptoms of the lesion disappear completely. If the therapeutic effect is not observed within 2 weeks of the beginning of the application of the ointment, options for using other drugs should be considered. Therapy is resumed at the first manifestations of exacerbation.

To prolong the period of remission and prevent exacerbations (with the development of the latter more than 4 times a year), it is recommended that Protective therapy be administered. The drug is prescribed only in the case of effective previous treatment according to the standard scheme of its use (2 times a day) for a period not exceeding 6 weeks.

With maintenance therapy on the skin zones, usually affected by exacerbations, ointment is applied 2 times a week. The interval between applications should be at least 2-3 days. Adults and adolescents over 16 years of age use,% ointment, children from 2 years and older -, 3%.

In case of symptoms, exacerbations change to the usual dosing regimen. At the end of 12 months of maintenance treatment, it is required to evaluate the clinical dynamics and to decide whether further preventive use of the ointment is advisable.

In children, the use of the drug is temporarily canceled to assess clinical dynamics and determine whether to continue supporting treatment.

Side effects

Against the background of therapy with Protopik ointment, it is possible to develop negative reactions from various organs and systems, including:

Skin and subcutaneous tissue - inflammation of the hair follicles (folliculitis), itching of the skin, its redness, burning sensation, rarely develops acne (acne) in the application of the drug.
Peripheral nervous system - a violation of the sensitivity of nerve endings (paresthesia, manifested by a feeling of tingling) and a decrease in the sensitivity of the skin (hypoesthesia in the form of numbness).
Infectious complications - a herpetic infection, accompanied by the appearance of burning and small bubbles filled with clear liquid (vesicles).
General reactions and metabolism - alcohol intolerance, consisting in hyperemia (reddening) of the skin of the face area, a feeling of heat and burning after drinking.

In post-reforming studies, single cases of rosacea (pink acne) have been reported, and also malignancy (malignant degeneration) of cells of affected skin areas with the development of cancer, lymphoma skin. The appearance of signs of negative reactions is the reason for stopping the use of Protopik ointment and contacting a doctor.

Overdose

There were no cases of overdose with external application.

If the drug has got inside, you need to monitor vital functions and monitor the overall condition of the patient. Do not induce vomiting or gastric lavage.

special instructions

Immunosuppressive therapy increases the risk of malignant neoplasms. It is recommended to limit insolation and ultraviolet radiation, wear appropriate clothing, use sunscreens with a high protection factor.

In the initial post-transplant period, the following parameters should be regularly monitored: blood pressure, ECG, neurological status and vision, level fasting blood glucose, concentration of electrolytes (especially potassium), indicators of hepatic and renal function, hematologic indices, coagulogram, level proteinemia. In the presence of clinically significant changes, correction of immunosuppressive therapy is necessary.

During the application of tacrolimus, the administration of herbal preparations containing Hypericum perforatum should be avoided, as well as other plant remedies that can cause a decrease (change) in the concentration of tacrolimus in the blood and have an adverse effect on the clinical effect tacrolimus.

With diarrhea, the concentration of tacrolimus in the blood can vary significantly; When diarrhea occurs, careful monitoring of tacrolimus concentrations in the blood is necessary.

Simultaneous use of cyclosporine and tacrolimus should be avoided, and caution should be exercised when treating tacrolimus patients who previously received cyclosporine.

When tacrolimus is used, cases of cardiomyopathy - ventricular hypertrophy or hypertrophy of the parturition of the heart are described. In most cases, myocardial hypertrophy was reversible and was observed with tacrolimus concentrations in the blood exceeding those recommended. Other risk factors are: the presence of a previous heart disease, the use of corticosteroids, hypertension, renal and hepatic dysfunction, infections, hypervolemia, edema. Patients with high risk and receiving intensive immunosuppressive therapy before and after transplantation (after 3 and 9-12 months) should carry out echocardiographic and ECG monitoring. If anomalies are detected, consideration should be given to reducing the dose of tacrolimus or replacing it with another immunosuppressant.

Tacrolimus may induce prolongation of the QT interval. In the treatment of patients with diagnosed congenital syndrome of an extended QT interval or suspected of such a condition, special care should be taken.

In patients receiving immunosuppressants, the risk of opportunistic infections (caused by bacteria, fungi, viruses, protozoa) is increased. Among these infections, nephropathy associated with BV virus is noted, as well as the progressive multifocal leukoencephalopathy (PML) associated with JC virus. Such infections are often associated with deep suppression of the immune system and can lead to severe or fatal outcomes, which must be taken into account when conducting a differential diagnosis in patients with signs of impaired renal function or neurologic symptoms on the background of immunosuppressive therapy.

Patients receiving tacrolimus may develop post-transplant lymphoproliferative diseases (PTLZ) associated with the Epstein-Barr virus. With the simultaneous use of the drug with antilymphocytic antibodies, the risk of PTLZ increases. There is also evidence of an increased risk of PTFE in patients with the Epstein-Barr virus capsid antigen. Therefore, before tacrolimus is used in this group of patients, a serological study should be conducted for the presence of the Epstein-Barr virus capsid antigen. In the process of treatment, it is recommended to carry out careful monitoring for the Epstein-Barr virus by polymerase chain reaction (PCR). Positive PCR for the Epstein-Barr virus can persist for months and by itself is not evidence of PTLZ or lymphoma.

There are reports of the occurrence of the syndrome of reversible posterior encephalopathy with tacrolimus therapy. If the patient taking tacrolimus has symptoms that are characteristic of the syndrome of reversible posterior encephalopathy (headache, mental disorders, convulsions and visual disturbances), it is necessary to conduct a magnetic resonance tomography. When confirming the diagnosis, you should monitor blood pressure, the occurrence of seizures, and immediately stop the systemic administration of tacrolimus. If these measures are taken, this condition is completely reversible in most patients.

Drug Interactions

Tacrolimus is not metabolized in the epidermis, which excludes the risk of drug interactions in the skin. Since systemic absorption of tacrolimus when applied in the form of an ointment is minimal, interaction with inhibitors CYP3A4 (erythromycin, itraconazole, ketoconazole, diltiazem, etc.) when combined with ointment Protopik unlikely. Nevertheless, it is not completely excluded, especially in patients with erythroderma and / or extensive lesions.

Effect of ointment Protopik on the effectiveness of vaccination has not been studied. Because of the potential risk of a decrease in effectiveness, vaccination is performed prior to the application of the ointment or 14 days after the last use of the ointment. Using a live attenuated vaccine, this period is increased to 28 days.

The possibility of a complex ointment application Protopik with other external drugs, immunosuppressants and systemic GCS has not been studied.

Reviews

We picked up some feedback from people who used Protopic ointment:

Natasha. My friend's son has dermatitis. Her doctor advised me to buy this ointment. I come to visit, and the baby is almost without spots of these reds. She at me smeared it or him and very quickly has begun to live. For the price, of course, it is expensive, but it's worth it. Money was spent, but the quality result is guaranteed. Girlfriend is delighted, the child is happy and healthy!
Sasha. The child (5 years old) has atopic dermatitis, which is hard to treat, improvements in diet, and so on. not visible. Hormonal ointments help, but this is a temporary effect. We apply a protopic from last year, smeared a few weeks last winter. Improvements are evident. I try not to look at them. Now in autumn they began to get smeared again, as deterioration began, the protopic practically took everything off for 10 days, I smear a thin layer, but last year's tube ended, a week without this ointment and again redness. Now I'm buying a new tube, as this is the only thing that really helps.
Vera. Treatment for Protopic was successful for my child. The diagnosis was contact dermatitis, presumably on the street sand. They smeared the affected places + took drops of "Fenistil", followed a diet. Some products may provoke further spread of dermatitis. For example, semolina porridge and chicken broth. In the complex, improvement occurred in 5 days. The course was held in 10 days.

In general, reviews about the ointment Protopik can be found very different. As a rule, those who have already tried this tool on themselves, report that it helped them. Nevertheless, very often there are reports that when using the cream there was a strong itching, a feeling of pain, redness and other undesirable manifestations on the skin.

Analogues

Structural analogs for the active substance:

Advagraf;
The festival;
Pantograph;
Prograph;
Redesp;
Tacrolimus;
Tacropic;
Tacrose.

Before using analogues, consult your doctor.

Storage conditions and shelf life

Shelf life of the ointment Protopic is 3 years. It must be stored in the original factory packaging, inaccessible to children at an air temperature of no higher than 25 ° C.