İHALE DÜNYASI
İHALE DÜNYASI
Dovonex (R) (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D 3 derivative, for topical dermatologic use. Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1?,3?,24-triol monohydrate, with the empirical formula C 27 H 40 O 3 ·H 2 O, a molecular weight of 430.6, and the following structural formula: Calcipotriene monohydrate is a white or off-white crystalline substance. Dovonex (R) Scalp Solution contains calcipotriene monohydrate equivalent to 50 ?g/g anhydrous calcipotriene in a vehicle of isopropanol (51% v/v), propylene glycol, hydroxypropyl cellulose, sodium citrate, menthol and water. image of chemical structure
Dovonex (R) (calcipotriene solution) Scalp Solution, 0.005%, is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Comb the hair to remove scaly debris and after suitably parting, apply Dovonex (R) Scalp Solution, 0.005%, twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Dovonex (R) Scalp Solution, 0.005%, have been demonstrated in patients treated for eight weeks. Keep Dovonex (R) Scalp Solution, 0.005%, well away from the eyes . Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.
Dovonex (R) Scalp Solution, 0.005%, is contraindicated in those patients with acute psoriatic eruptions or a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity.
In controlled clinical trials, the most frequent adverse reactions reported to be related to Dovonex (R) Scalp Solution, 0.005%, use were transient burning, stinging and tingling, which occurred in approximately 23% of patients. Rash was reported in about 11% of patients. Dry skin, irritation and worsening of psoriasis were reported in 1-5% of patients. Skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis were not observed in these studies, but cannot be excluded.
Avoid contact with the eyes or mucous membranes. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas. Drug product is flammable. Keep away from open flame.