Ketoconazole

What it is and how it works

Mechanism class: Cytochrome P450 3A4 Inhibitors · Cytochrome P450 3A5 Inhibitors · P-Glycoprotein Inhibitors

Indications

INDICATIONS AND USAGE 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water. One application of the shampoo should be sufficient.

Contraindications

CONTRAINDICATIONS Ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

Pregnancy

Pregnancy: Teratogenic effects: 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.

Storage and supply

HOW SUPPLIED Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 0713-0592-04). Storage conditions: Store at 20ºC to 25ºC (68ºF to 77ºF) . Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc.

Source: Ketoconazole (Ketoconazole) — US FDA prescribing information, 2025-02-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.