Xolegel Information
Xolegel () Indications And Usage
Xolegel () 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 () for treatment of fungal infections have not been established.
Xolegel () Dosage And Administration
Xolegel () is for topical use only, and not for oral, ophthalmic, or intravaginal use.
Xolegel () should be applied once daily to the affected area for 2 weeks.
Xolegel () Dosage Forms And Strengths
Xolegel () is a translucent to clear amber colored gel containing 2% ketoconazole.
Xolegel () Contraindications
Xolegel () Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the 3 safety and efficacy trials, 65 of 933 subjects (7%) experienced at least one treatment-related adverse event. The most common treatment-related adverse reaction was application site burning (4%). Treatment-related application site reactions that were reported in
Xolegel () Drug Interactions
Formal drug interaction studies with Xolegel () have not been performed. Coadministration of oral ketoconazole with CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, lovastatin and atorvastatin, may increase the risk of skeletal muscle toxicity, including rhabdomyolysis. These effects have not been observed with topically administered ketoconazole.
Xolegel () Use In Specific Populations
It is not known whether Xolegel () is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xolegel () is administered to a nursing woman.
If used during lactation and Xolegel () is applied to the chest, care should be taken to avoid accidental ingestion by the infant.
Xolegel () Overdosage
Xolegel () is intended for topical use only.
There has been no experience of overdose with Xolegel () . No incidents of accidental ingestion have been reported. A health care provider or poison control center should be contacted in the event of accidental ingestion.
Xolegel () Description
Xolegel () contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration.
Chemically, ketoconazole is (±)-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, with the molecular formula CHClNO and a molecular weight of 531.43.
Each gram contains: 20 mg ketoconazole USP, dehydrated alcohol (34%), ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C yellow No. 10.
Xolegel () is a smooth, translucent to clear, amber gel.
Xolegel () Clinical Pharmacology
In a pharmacokinetic absorption trial, eighteen subjects, both males and females, with severe seborrheic dermatitis (range 1-14% of body surface area) applied Xolegel () once daily for 2 weeks. The median total amount of gel applied was 4.6 g (range 1.65–46.3 g). Daily doses ranged from 0.05 to 3.47 g. Mean (± standard deviation [SD]) peak plasma levels were 1.35 (± 3.18) ng/mL on Day 7 (range from
The plasma levels from an oral dose of 200 mg ketoconazole taken with a meal are approximately 250 times higher than the resulting plasma levels of ketoconazole following topical application of Xolegel () .
Xolegel () Clinical Studies
Study 1 was a multicenter, double-blind, randomized, vehicle-controlled trial which enrolled 459 subjects 12 years of age and older with moderate to severe seborrheic dermatitis. A total of 229 subjects were treated with Xolegel () , and 230 subjects were treated with vehicle. All subjects were treated once daily for 14 days, and efficacy was assessed at Day 28 (i.e., 2 weeks after end of treatment). Effective Treatment was defined as:
The proportion of subjects effectively treated is shown in Table 1.
Two additional double-blind, randomized, vehicle-controlled, parallel, and multicenter trials that included a total of 316 subjects treated with Xolegel () provided supportive evidence of the efficacy of Xolegel () for treatment of seborrheic dermatitis. Subjects applied either Xolegel () or vehicle study treatment to the affected area(s) once daily for 14 days and were followed through Day 28. Efficacy was assessed by the proportion of subjects who were completely clear at Day 28.
The contribution to efficacy of individual components of the vehicle has not been established.
Xolegel () How Supplied/storage And Handling
Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F).
Contents are flammable.
Keep out of reach of children.
Xolegel () Patient Counseling Information
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