Xolegel® (ketoconazole) Pregnancy C

How Supplied:

2% gel, 15 g

Indications and Usage:

XOLEGEL® Gel is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. Safety and efficacy of XOLEGEL® Gel for treatment of fungal infection have not been established.

Prescribing Instructions:

Prescribing Information Instructions [PDF]

Side Effects and Contraindications:

The most common treatment-related adverse events to XOLEGEL® Gel observed in clinical trials (incidence >1%) were application site burning (4.2%) and headache (1.1%). XOLEGEL® Gel is contraindicated in those patients with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity is noted. XOLEGEL® (ketoconazole) Gel, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. Safety and efficacy of XOLEGEL® Gel for treatment of fungal infections have not been established. XOLEGEL® Gel is contraindicated in those patients with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity is noted. Avoid fire, flame, or smoking during and immediately following application of XOLEGEL® Gel. XOLEGEL® Gel is for topical use only, and not for ophthalmic, oral, or intravaginal use. XOLEGEL® Gel may be irritating to mucous membranes. Contact with eyes, nostrils, and mouth should be avoided. The most common treatment-related adverse events to XOLEGEL® Gel observed in clinical trials (incidence >1%) were application site burning (4.2%) and headache (1.1%). Hepatitis and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.

Company:

Aqua Pharmaceuticals
610-644-7000
aquapharm.com