Instruction for use: Neotigason

Active substance Acitretin

ATX code D05BB02 Acitretin

Pharmacological group - dermotropic means

Nosological classification (ICD-10)

L40 Psoriasis

Chronic psoriasis with diffuse plaques, Generalized psoriasis, Psoriasis of the scalp, Psoriasis of the scalp, Generalized form of psoriasis, Psoriasis dermatitis, Psoriasis complicated by erythroderma, Invalidative psoriasis, Isolated psoriatic plaque, Exfoliative psoriasis, Psoriatic Erythroderma, Psoriasis with eczematosis, Hyperkeratosis in psoriasis,Inverse psoriasis,Psoriasis eczematous, Dermatosis of psoriasis, Psoriasis of the genitals, Psoriasis with lesions of hairy areas of skin, Erythrodermal psoriasis, Chronic psoriasis of the scalp, Chronic psoriasis, Ordinary psoriasis, Refractory psoriasis, Kebner phenomenon, Scaly lichen

L43 Red Leaf Flat

Lishay Wilson, Erosive-ulcerative form of red flat lichen, Warty forms of red lichen, Red lichen, Flat lichen, Kebner phenomenon

L53 Other erythematous conditions

Variable erythrokeratodermia, Malignant exudative erythema, Erythema, Erythematous, Erythroderma, Erythema from diapers

Q80.9 Congenital ichthyosis, unspecified

Composition and form of release

1 capsule contains acitretin 10 mg; in a blister pack of 10 pcs., in a cardboard bundle 3, 5 or 10 blisters.

pharmachologic effect

The pharmacological action is antipsoriatic.

Normalizes the processes of renewal, differentiation and keratinization of skin cells.

Pharmacokinetics

It is well absorbed from the gastrointestinal tract, Cmax is reached after 1-4 hours. Bioavailability is about 60% (it increases with admission during or after meals). Well passes into the fabric; binding to plasma proteins - 99%. Penetrates through the placental barrier and into breast milk. Metabolized by isomerization and the formation of glucuronides. T1 / 2 Acitretinum - 50 h, and its main metabolite - 60 h. Within 36 days after discontinuation of treatment, 99% of the drug is excreted in the form of metabolites with urine and bile in equal amounts. In some cases, the body produces etretinate, T1 / 2 of which - about 4 months, i.e. in a similar situation the drug is excreted completely within 2 years after the end of treatment.

Clinical Pharmacology

Treatment is continued until sufficient healing of psoriatic lesions occurs. For violations of keratinization, long-term maintenance therapy is performed using the lowest effective dose (not more than 50 mg / day). In children's practice apply only in cases of ineffectiveness of other methods of treatment.

Indication

Heavy forms of psoriasis, congenital ichthyosis, red hairy pityriasis, Daria's disease.

Contraindications

Hypersensitivity (including and to other retinoids), expressed violations of the kidney and liver, the use of tetracyclines, vitamin A, other retinoids, methotrexate, pregnancy.

Side effects

Development of symptoms of hypervitaminosis A; thinning and peeling of the skin throughout the body, alopecia, fragility of the nails, paronychia, photosensitivity, headache, twilight vision, reversible increase in transaminase and alkaline phosphatase activity in plasma, hypercalcemia, increased triglyceride and plasma cholesterol, bone and muscle pain, hyperostosis and calcification of tissues.

Interaction

Incompatible with tetracyclines, methotrexate, vitamin A and other retinoids. Displaces phenytoin from binding to proteins. Ethanol-containing preparations and beverages lead to the formation of etretinate.

Dosing and Administration

Inside, once a day, with food or with milk. Adults - start with 25-30 mg per day for 2-4 weeks, then - for 25-50 mg for 6-8 weeks, it is possible to increase the maximum daily dose to 75 mg. Children - the initial dose of 500 mcg per kg / day, possibly a short-term increase to 1 mg / kg / day (but not more than 35 mg per day); The maintenance dose is as low as possible.

Overdose

Symptoms: headache, dizziness. Treatment: withdrawal of the drug, symptomatic therapy.

Precautionary measures

It is necessary to monitor liver function (before the start of therapy and every 1-2 weeks for the first 2 months, and then every 3 months, with pathological changes monitored every week, and if the liver function does not return to normal or worsens, the drug is canceled); the concentration of cholesterol and triglycerides in fasting serum, especially in cases of lipid metabolism disorders, diabetes mellitus, obesity, chronic alcoholism, during long-term therapy. Patients with diabetes require glycemic control. Children need to monitor the growth and development of bones. In connection with the teratogenicity of the drug, women of childbearing age should use contraceptive drugs without interruption for 4 weeks before the initiation of therapy, during the course of treatment, and at least 2 years after its termination. Therapy is started on the 2nd or 3rd day of the menstrual cycle. During the treatment, additional pregnancy tests are performed. Nursing mothers must stop breastfeeding.

storage Conditions

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.