Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ciclopirox (UNII: 19W019ZDRJ) (ciclopirox - UNII:19W019ZDRJ)
Taro Pharmaceuticals, Inc.
ciclopirox
ciclopirox 10 mg in 0.96 mL
TOPICAL
PRESCRIPTION DRUG
Ciclopirox Shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. Ciclopirox Shampoo is contraindicated in individuals who have shown hypersensitivity to any of its components.
Ciclopirox Shampoo, 1% is supplied in 120 mL plastic bottles (NDC 51672-1351-8). Discard unused product after initial treatment duration. Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CICLOPIROX- CICLOPIROX SHAMPOO TARO PHARMACEUTICALS, INC. ---------- CICLOPIROX SHAMPOO, 1% RX ONLY FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE KEEP OUT OF REACH OF CHILDREN DESCRIPTION Ciclopirox Shampoo 1% contains the synthetic antifungal agent, ciclopirox. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-2, purified water USP, sodium chloride USP and sodium laureth sulfate. Ciclopirox Shampoo is a colorless to yellowish, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1_H_)-pyridone, with the empirical formula C H NO and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: CLINICAL PHARMACOLOGY MECHANISM OF ACTION Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox acts by chelation of polyvalent cations (Fe or Al ), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. PHARMACOKINETICS AND PHARMACODYNAMICS In a study in patients with seborrheic dermatitis of the scalp, application of 5 mL ciclopirox shampoo 1% twice weekly for 4 weeks, with an exposure time of 3 minutes per application, resulted in detectable serum concentrations of ciclopirox in 6 out of 18 patients. The serum concentrations measured throughout the dosing interval on Days 1 and 29 ranged from 10.3 ng/mL to 13.2 ng/mL. Total urinary excretion of ciclopirox was less than 0.5% of the administered dose. CLINICAL STUDIES In two randomized, double-blind clinical trials, patients 16 years and older with seborrheic dermatitis of 12 17 2 3+ 3+ the scalp applied Ciclopirox Shampoo or its vehicle two times per week for 4 weeks. Patients who were immunocompromised, those with psoriasis or atopic dermatitis, women of childbearing potential not using adequ Les hele dokumentet