Protopic ointment 0.1% 30g

• Active substance
  • Tacrolimus:
    • In the form of tacrolimus monohydrate - 0.1 g.

• Excipients

  Soft white paraffin, liquid paraffin, propylene carbonate, beeswax white, solid paraffin.

In a tube of 30 g of ointment. In the package 1 tube.

Indications for use:

In adults and in children from 16 years for the treatment of:

• Atopic dermatitis (moderate severity and severe forms) in the case of its resistance to other means of external therapy or the presence of contraindications to such.

Use during pregnancy and lactation:

Contraindicated in pregnancy and lactation.
Contraindications:

• Hypersensitivity to tacrolimus, to excipients, to macrolides.
• Pregnancy.
• Breast-feeding.
• Use in patients with genetic defects of the epidermal barrier, such as:
  • Netherton syndrome.
• With generalized erythroderma due to the risk of a progressive increase in systemic absorption of tacrolimus.
• Use in children and adolescents under 16 years of age.

• Use in patients with decompensated liver failure.
• Use in patients with extensive skin lesions, especially long courses, and in children.

Side effect:

The most frequent adverse reactions are skin irritation symptoms (burning sensation and itching, redness, pain,paresthesias and rash) at the site of application.As a rule, they are moderately expressed and disappear within the first week after the start of treatment.

Alcohol intolerance often occurs (facial flushing or skin irritation symptoms after drinking alcohol).

For the entire period of observation of the drug, isolated cases of rosacea, malignancy (skin and other types of lymphomas, skin cancer) were reported.

In patients using Protopic ointment, there is an increased risk of developing folliculitis, acne and herpes infection.

The frequency of occurrence of adverse reactions are divided into:

• Very frequent (> 1/10).
• Frequent (> 1/100, <1/10).
• Rare (> 1 / 1,000, <1/100).

Within each group, adverse reactions are presented in descending order of importance.

• General disorders and local reactions

  Very frequent - burning and itching at the site of application.

  Frequent - sensation of heat, redness, pain, irritation, rash in the area of ​​application.

• Infections

  Frequent are herpes infections (herpes simplex of the face and lips, Kaposi's varicelliform rash).

• Skin and subcutaneous tissue

  Frequent - folliculitis, itching.

  Infrequent - acne.

• Nervous system

  Frequent - paresthesias, hyperesthesia.

• Metabolism and nutrition

  Frequent - alcohol intolerance (facial flushing or symptoms of skin irritation after drinking alcohol).

Overdose:

• Symptoms: at local application of cases of overdose it was not noted.
• Treatment: when ingested, it is necessary to take generally accepted measures, which include monitoring of vital body functions and monitoring the general condition. Stimulation of vomiting or gastric lavage are not recommended.

Dosage and administration:

Protopic ointment is applied to adults and children over 2 years of age with a thin layer on the affected skin. The drug can be used on any part of the body, including the face and neck, in the area of ​​skin folds. Do not apply the drug to the mucous membranes and under occlusive dressings.

Usually, improvement is observed within one week of the start of therapy.

If there are no signs of improvement on the background of therapy within two weeks, consideration should be given to changing the therapeutic tactics.

• Use in adults and adolescents 16 years and older.

  Treatment should begin with the use of 0.1% Protopic ointment twice a day and continue until complete elimination of the lesions.

  As you improve, you can reduce the frequency of applying 0.1% ointment or switch to using 0.03% Protopic ointment.

  In the case of recurrence of the symptoms of the disease, treatment with 0.1% Protopic ointment should be resumed twice a day. If the clinical picture allows, an attempt should be made to reduce the frequency of use of the drug, or use a lower dosage - 0.03% Protopic ointment.

• Use in the elderly (65 years and older)

  Features of use in the elderly are absent.

• Exacerbations treatment

  Protopic ointment can be used for short or long periods in the form of periodically repeated courses of therapy. Treatment of the affected skin is carried out until the complete disappearance of clinical manifestations of atopic dermatitis.As a rule, improvement is observed during the first week of treatment. If signs of improvement are not observed within two weeks of the start of the use of the ointment, other options for further treatment should be considered. Treatment should be resumed at the first signs of exacerbation of atopic dermatitis.

• Exacerbation prevention

  To prevent exacerbations and increase the duration of remission in patients with frequent (more than 4 times a year) exacerbations of the disease in history, it is recommended supportive therapy with Protopic ointment.

  The feasibility of prescribing maintenance therapy is determined by the effectiveness of previous treatment according to the standard regimen (2 times a day) for no more than 6 weeks.

  With maintenance therapy, Protopic ointment should be applied 2 times a week (for example, on Monday and Thursday) on the skin that is usually affected by exacerbations.

  The time interval between the application of the drug should be at least 2-3 days.

  In adults and adolescents 16 years and older, 0.1% Protopic ointment is used. In children (2 years and older) - 0.03% Protopic ointment. When signs of exacerbation appear, proceed to the usual regimen of treatment with Protopic ointment.

  After 12 months of maintenance therapy, it is necessary to evaluate the clinical dynamics and decide whether to continue the prophylactic use of Protopic Ointment. In children, to evaluate the clinical dynamics, the drug should be temporarily discontinued and then the need to continue maintenance therapy should be considered.

Precautionary measures:

Protopic Ointment should not be used in patients with congenital or acquired immunodeficiencies or in patients who are taking immunosuppressive drugs.

During the application of Protopic ointment, it is necessary to avoid sun exposure to the skin, visits to the tanning salon, UV or B or A UV therapy in combination with psoralen (PUVA therapy).

Protopic Ointment should not be used to treat lesions that are considered potentially malignant or premalignant.

For 2 hours, no emollients can be used on the skin areas on which Protopic ointment has been applied.

The efficacy and safety of Protopic ointment in the treatment of infected atopic dermatitis has not been evaluated. If there are signs of infection before prescribing Protopic ointment, appropriate therapy should be carried out. The use of Protopic ointment may be associated with an increased risk of developing a herpetic infection. If there are signs of herpes infection, it is necessary to individually assess the ratio of the benefits and risks of using Protopic.

In the presence of lymphadenopathy, it is necessary to examine the patient before the start of therapy and observe him during the period of application of the ointment. In the absence of an obvious cause of lymphadenopathy or in the presence of symptoms of acute infectious mononucleosis, it is necessary to stop the use of Protopic ointment.

Avoid getting the ointment in the eyes and mucous membranes (in case of accidental ingestion, the ointment must be carefully removed and / or rinsed with water).

It is not recommended to apply Protopic ointment under occlusive dressings and wear thick, air-tight clothing.

Just as with the use of any other local medicinal product, patients should wash their hands after applying the ointment, unless the ointment is applied to the area of ​​the hands for therapeutic purposes.

Storage conditions:

• Store at a temperature not higher than 25 ° С.