Protopic ointment is indicated for the treatment of atopic dermatitis in children from 2 years of age – Protopic ointment 0.03%, in adults and adolescents from 16 years of age – Protopic ointment 0.03% and 0.1%.
Composition
Active ingredient: tacrolimus;
1 g of ointment contains tacrolimus (as monohydrate) 0.3 mg or 1 mg;
Excipients: white soft paraffin, mineral oil, propylene carbonate, white wax, paraffin.
Contraindication
Hypersensitivity to tacrolimus, macrolides or excipients.
Method of application
Protopic ointment should be applied in a thin layer to the affected or most frequently affected areas of the skin. The ointment can be applied to any part of the body (face, neck, etc.), including flexural surfaces. It is necessary to avoid contact of the ointment with mucous membranes. The ointment should be applied under occlusive dressings, as this method of application has not been studied.
Application features
Pregnant women
Should not be used.
Children
Used for children aged 2 years and over.
Drivers
Does not affect.
Overdose
With topical application, overdose is unlikely.
In case of ingestion, it is necessary to take generally accepted measures, including 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 characteristics of the excipients contained in the ointment.
Side effects
During clinical trials, approximately 50% of patients experienced an adverse reaction in the form of skin irritation at the site of application of the ointment. Burning and itching, usually mild to moderate, were common and generally resolved after the first week of treatment. Erythema was a common adverse reaction. Warmth, pain, paresthesia and rash were also common. Alcohol intolerance (facial flushing or skin irritation after drinking alcoholic beverages) was common.
Interaction
Formal drug interaction studies of the topical drug tacrolimus ointment have not been conducted.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Do not use the drug after the expiration date indicated on the package.
Shelf life – 3 years.













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