Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)
THIRTY MADISON INC
TOPICAL
PRESCRIPTION DRUG
Ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ). Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. Ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 71713-097-04). Storage conditions: Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS contact Thirty Madison, Inc. at 1-833-745-3377 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Thirty Madison, Inc. New York, NY 10016 04006149 Rev. 1 11/22
Abbreviated New Drug Application
KETOCONAZOLE- KETOCONAZOLE SHAMPOO, SUSPENSION THIRTY MADISON INC ---------- KETOCONAZOLE SHAMPOO DESCRIPTION KETOCONAZOLE SHAMPOO, 2% FOR TOPICAL APPLICATION ONLY. RX ONLY Ketoconazole shampoo, 2%, is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: sodium laureth sulfate, disodium laureth sulfosuccinate, cocamide diethanolamide, hydrochloric acid, PEG-120 methyl glucose dioleate, imidurea, sodium chloride, sodium hydroxide, fragrance, FD&C red No. 40, and purified water. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3- dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula: CLINICAL PHARMACOLOGY Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by _Pityrosporum orbiculare (Malassezia furfur)_. This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable. Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months). An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of ketoconazole shampoo, 2%, was significantly less than that of 2.5% selenium sulfide shampoo. A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers s Belgenin tamamını okuyun