Index of drugs

Different clinical forms of acne (with the exception of rosacea): acne vulgaris, mixed forms of acne, acne with blackheads and microtorbids. Other forms of acne (secondary acne): acne induced by drugs, e.g. corticosteroids and barbiturates; professional acne, induced by substances that cause blackheads, i.e. oils, halogen hydrocarbon derivatives (chlorine acne). Favre and Racouchot's disease: nodular degeneration of the elastic tissue with cysts and comedones. Due to the concentration of tretinoin and the composition of excipients, the preparation should be used primarily in patients with particularly delicate and thin skin or in patients with a fair complexion.

1 g of cream contains 0.5 mg of tretinoin. The cream contains butylated hydroxyanisole (E 320), butylated hydroxytoluene (E 321), polyoxylated hydrogenated castor oil, sorbic acid and methyl parahydroxybenzoate (E 218).

Anti-acne preparation for external use, a derivative of vitamin A. Tretynoin causes deep metabolic changes in the keratinizing epithelium. Increases epithelial cell proliferative activity and cell differentiation (keratinization and keratosis). The degree of penetration of tretinoin into the body varies depending on the duration of treatment, the area of ​​treated skin and is small after applying therapeutic doses on the skin. Retinoic acid is rapidly metabolised (48 h).

Hypersensitivity to tretinoin or to any of the excipients. acute inflammation of the skin, including peridural dermatitis. Pregnancy. Do not use in women who plan to become pregnant.

Particular caution is recommended when other preparations are used concurrently, especially those that cause exfoliation: sulfur-based skin products, resorcinol, benzoyl peroxide or salicylic acid; medicated soaps or soaps and products for cleansing the skin which cause exfoliation; soaps and cosmetics that strongly dry the skin; preparations for use on the skin with a high alcohol content (lotions with astringent, perfumes, toilet waters and lotions used before shaving and / or after shaving). If the patient has been using epidermal exfoliation before starting treatment, treatment with tretinoin should only be started after healing of skin lesions. Due to the risk of additional irritation, avoid exposure to sunlight, lamps emitting ultraviolet radiation (eg UV lamps, solariums) and X-rays. In patients with sunburn, the preparation should not be used until the symptoms of burns disappear. Patients who, due to the nature of their work, are exposed to significant exposure to solar radiation, have a family predisposition to sunburn, or patients who are sensitive to solar radiation, should exercise extreme caution. If severe irritation occurs at the site of administration, it is recommended to use the product less frequently or to discontinue tretinoin for several days. Avoid contact with the eyes, mouth, nostrils and mucous membranes. In the event of contact with the preparation, these places should be immediately rinsed thoroughly with water. Tretinoin should not be used on injured skin. Do not clean the application areas of the cream more than twice a day. These places should be dried without rubbing them. Due to the content of butylhydroxyanisole and butylhydroxytoluene, hydrogenated polyoxylated oleic acid and sorbic acid, the preparation may cause a local skin reaction (eg contact dermatitis) or irritation of the eyes and mucous membranes. Due to the content of methyl parahydroxybenzoate, the drug may cause allergic reactions (possible late-type reactions).

The preparation is contraindicated in pregnancy and in women who are planning pregnancy. Oral tretinoin has teratogenic effects.In animal studies conducted to assess the toxicity of tretinoin after development into dermal skin, its action has been shown to be limited to delaying the ossification process, which may not be a direct effect but a result of toxicity in the female. Women of childbearing potential should be warned about the risk to the fetus if pregnancy occurs while using tretinoin and the need to use effective contraception during treatment. If a pregnancy is suspected, a pregnancy test with a sensitivity of at least 50 mIU / ml of human chorionic gonadotropin (hCG) should be performed within 2 weeks before starting treatment. The test result must be negative. It is not known whether tretinoin is excreted in human milk, a danger for newborns and children can not be ruled out. Breast-feeding should be discontinued during treatment.

Very common: reactions at the application site (erythema, dry skin, peeling skin, burning), severity of acne lesions. Frequency unknown: skin discoloration. Periodic acne changes may occur. Existing comedones or papules may turn into purulent pustules before being cured. Both skin irritation and pustular discharge can be seen as a worsening of the clinical picture of the disease, but in most cases they are associated with the treatment.

Locally, on the skin. Before use, perform a sensitivity test on a small area of ​​the skin (flake test) to ensure that the product is well tolerated by the patient. The cream is applied to the affected skin area once a day before bedtime. Before applying the drug, thoroughly clean and dry the skin. In the case of severe skin irritation, especially at the beginning of treatment, the drug should be used once every two days. If no local irritation has been observed at the beginning of treatment, there is a possibility of increasing the frequency of use up to twice daily. The duration of treatment should be from 8 to 12 weeks while maintaining the same dosing schedule. Irritation of the skin at the beginning of treatment (about the 2nd week) is caused by exacerbation of acne lesions, due to the intensification of inflammation in comedones located in the deeper layers of the skin, treated with the preparation. This reaction is not an adverse reaction and can not be the basis for changing the frequency of use. The improvement occurs gradually and is clearly visible from the sixth week of treatment. In maintenance therapy, the preparation is used 2 to 3 times a week for several months. The drug should be discontinued gradually.