Salisia KT Shampoo

Ketoconazole

Salicyclic Acid

Indications

Salisia KT Shampoo is indicated for the treatment of dandruff

Drug Interactions

Ketoconazole: Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated. Coadministrationwith ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur

Mechanism of Action

Ketoconazole: Antifungal Salicylic acid: Keratolytic agent

Drug Use in Pregnancy

Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp. Plasma concentrations of ketoconazole were not detectable after topical administration of Ketoconazole Shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Ketoconazole Shampoo 2% on the whole body. There are no known risks associated with the use of Ketoconazole Shampoo 2% in pregnancy or lactation. With the small amounts of salicylic acid absorbed transdermally, it is unlikely that use will cause any adverse effects. Nursing mothers There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when ketoconazole is administered to a nursing woman.

Drug Use in Pediatric Population

Pediatric Use Safety and effectiveness in children have not been established.