$42.60
Treatment of moderate to severe atopic dermatitis to prevent sudden exacerbations of the disease and prolong the duration of periods without exacerbations in patients with a high recurrence rate (4 or more times a year).
Description
Protopic Storage
active substance: tacrolimus;
1 g of ointment contains tacrolimus (as a monohydrate) 1 mg;
Excipients: white soft paraffin, mineral oil, propylene carbonate, white wax, paraffin.
Dosage form
Ointment.
Pharmacological properties
By binding to the specific cytoplasmic protein immunophilin (FKBP12), tacrolimus inhibits calcium-dependent signaling to T lymphocytes, preventing their activation and subsequent synthesis of IL-2, IL-3, IL-4, IL-5 and other cytokines such as GM -CSF, TNF-α and IFN-γ.
In in vitro studies in the skin of a healthy person, tacrolimus inhibited Langerhans cell-mediated stimulation of T lymphocytes. Tacrolimus has also been shown to inhibit the release of inflammatory mediators from mast cells, basophils and eosinophils.
In patients with atopic dermatitis, skin cleansing during tacrolimus ointment treatment was accompanied by a decrease in Fc receptor expression on Langerhans cells and inhibition of their stimulating effect on T lymphocytes.
Tacrolimus in the ointment dosage form does not affect collagen synthesis, thus does not cause skin atrophy.
Indication Protopic
- Treatment of atopic dermatitis in children over 2 years of age – Protopic ointment 0.03%, in adults and adolescents over 16 years – Protopic ointment 0.03% and 0.1%.
- Treatment of exacerbations
Adults and adolescents (over 16 years of age)
Treatment of moderate to severe atopic dermatitis in adults and adolescents (16 years of age and older) who do not respond adequately or are insensitive to traditional treatments, including topical corticosteroids.
Children (from 2 to 16 years old)
Treatment of moderate to severe atopic dermatitis in children aged 2 to 16 years who do not respond adequately to traditional treatments, including topical corticosteroids. - Prevention of exacerbations
Prophylactic treatment of moderate to severe atopic dermatitis to prevent sudden exacerbations and prolongation of exacerbation-free periods in patients with a high recurrence rate (4 or more times per year) who had a primary response to a maximum of 6 weeks of ointment (twice daily). day) – complete, almost complete or insignificant healing of lesions.
Contraindication
Hypersensitivity to tacrolimus, macrolides or excipients.
Method of application and dosage
Protopic ointment should be applied in a thin layer on the affected or most affected areas of the skin. The ointment can be applied to any part of the body (face, neck, etc.), including bending surfaces. It is necessary to avoid getting the ointment on the mucous membranes. The ointment should not be applied under occlusive dressings, as this method of application has not been studied.
Treatment of exacerbations
Protopic can be used both for a short time and for a long period, in the form of repeated courses of therapy. Long-term treatment should not be continuous.
Protopic treatment should be started at the first appearance of symptoms and continued until complete, almost complete or significant disappearance of skin lesions. You need to apply ointment to each damaged area of skin. After that, patients can be transferred to preventive treatment (see below). At the first signs of recurrence of symptoms, treatment should be resumed.
Children aged 2 to 16 years
It is necessary to use a lower concentration ointment (Protopic 0.03%). The course of treatment is twice a day for three weeks. In the future, the frequency of application should be reduced to once a day until the complete disappearance of skin lesions.
Adults and adolescents (over 16 years of age)
Treatment should begin with Protopic 0.1% twice daily and continue until complete disappearance of skin lesions. If symptoms recur, treatment is started again. If the clinical condition allows, it is necessary to try to reduce the frequency of application of the drug or use an ointment of lower concentration (Protopic 0.03%).
As a rule, improvement can be observed during the first week of treatment. If no signs of improvement are observed within two weeks of application of the ointment, other treatment options should be considered.
Elderly patients
No separate studies have been performed in elderly patients. However, clinical experience with patients in this age group shows that no dosage adjustment is required.
Prevention of exacerbations
Patients can be switched to preventive treatment after a 6-week course of ointment treatment with the drug twice a day (until complete, almost complete or significant disappearance of skin lesions). Children aged 2 to 16 years
It is necessary to use a lower concentration ointment (Protopic 0.03%). The ointment should be applied once a day twice a week (for example, on Mondays and Thursdays) to areas of the skin that are most often affected by atopic dermatitis to prevent exacerbations. Between applications of the ointment should take a break of 2-3 days.
After 12 months of application of the ointment, the child should be temporarily suspended to determine the need to continue the course of preventive therapy and to assess the course of the disease.
Adults and adolescents (over 16 years of age)
It is necessary to use Protopic 0.1% ointment. The ointment should be applied once a day twice a week (for example, on Mondays and Thursdays) to areas of the skin that are most often affected by atopic dermatitis to prevent exacerbations. Between applications of the ointment should take a break of 2-3 days.
After 12 months of treatment, the doctor should assess the patient’s condition and decide on further prophylactic treatment, as data on prophylactic treatment lasting more than 12 months are not available.
If there are signs of exacerbation, it is necessary to return to the drug twice a day.
Elderly patients
No separate studies have been performed in elderly patients.
Children
Protopic ointment is used for children over 2 years of age.
Overdose
With topical application, overdose is unlikely.
Upon ingestion, it is necessary to take generally accepted measures, which include control of vital functions of the body and monitoring of the general condition. Stimulation of vomiting or gastric lavage is not recommended due to the peculiarities of excipients containing the ointment.
Side effects:
- Infectious and parasitic diseases: herpetiform eczema, folliculitis, herpes simplex, herpes virus infection, Kaposi’s varicella pustulosis.
- Metabolism and digestion disorders: alcohol intolerance (reddening of the face or skin irritation after drinking alcohol).
- Nervous system disorders: paresthesia and dysesthesia (hyperesthesia, burning sensation).
- Skin and subcutaneous tissue disorders: pruritus.
- General disorders and administration site conditions: burning sensation and itching at the application site.
Expiration date
3 years.
Storage conditions
Store Protopic at a temperature not exceeding 25 ° C out of reach of children.
Do not use the drug after the expiration date indicated on the package.
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