MENTAX Cream Ref.[9985] Active ingredients: Butenafine

Mentax (butenafine HCl) Cream, 1%, is not for ophthalmic, oral, or intravaginal use.

In controlled clinical trials, 9 (approximately 1%) of 815 patients treated with Mentax Cream, 1%, reported adverse events related to the skin. These included burning/stinging, itching and worsening of the condition. No patient treated with Mentax Cream, 1%, discontinued treatment due to an adverse event. In the vehicle-treated patients, 2 of 718 patients discontinued because of treatment site adverse events, one of which was severe burning/stinging and itching at the site of application.

In uncontrolled clinical trials, the most frequently reported adverse events in patients treated with Mentax Cream, 1%, were: contact dermatitis, erythema, irritation, and itching, each occurring in less than 2% of patients.

In provocative testing in over 200 subjects, there was no evidence of allergic-contact sensitization for either cream or vehicle base for Mentax Cream, 1%.

Mentax Cream, 1%, is for external use only. If irritation or sensitivity develops with the use of Mentax Cream, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by culture on an appropriate medium, [except M. furfur (formerly P. orbiculare)] or by direct microscopic examination of infected superficial epidermal tissue in a solution of potassium hydroxide.

Patients who are known to be sensitive to allylamine antifungals should use Mentax (butenafine HCl) Cream, 1%, with caution since cross-reactivity may occur.

Use Mentax Cream, 1%, as directed by the physician, and avoid contact with the eyes, nose, mouth, and other mucous membranes.

The patient should be instructed to:

• Use Mentax Cream, 1%, as directed by the physician. The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, nose, mouth, and other mucous membranes. Mentax Cream, 1%, is for external use only.
• Dry the affected area(s) thoroughly before application, if you wish to apply Mentax Cream, 1%, after bathing.
• Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after the end of the prescribed treatment period, or sooner, if the condition worsens (see below).
• Inform the physician if the area of application shows signs of increased irritation, redness, itching, burning, blistering, swelling, or oozing.
• Avoid the use of occlusive dressings unless otherwise directed by the physician.
• Do not use this medication for any disorder other than that for which it was prescribed.

Potential drug interactions between Mentax (butenafine HCl) Cream, 1%, and other drugs have not been systematically evaluated.

Teratogenic Effects

Subcutaneous doses of butenafine (dose levels up to 25 mg/kg/day administered during organogenesis) (equivalent to 0.5 times the maximum recommended dose in humans for tinea versicolor based on body surface area comparisons) were not teratogenic in rats. In an oral embryofetal development study in rabbits (dose levels up to 400 mg butenafine HCl/kg/day administered during organogenesis) (equivalent to 16 times the maximum recommended dose in humans for tinea versicolor based on body surface area comparisons), no treatment-related external, visceral, skeletal malformations or variations were observed.

In an oral peri- and post-natal developmental study in rats (dose levels up to 125 mg butenafine HCl/kg/day) (equivalent to 2.5 times the maximum recommended dose in humans for tinea versicolor based on body surface area comparisons), no treatment-related effects on postnatal survival, development of the F1 generation or their subsequent maturation and fertility were observed.

There are, however, no adequate and well-controlled studies that have been conducted with topically applied butenafine in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

It is not known if butenafine HCl is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing Mentax Cream, 1%, to a nursing woman.

Safety and efficacy in pediatric patients below the age of 12 years have not been studied since tinea versicolor is uncommon in patients below the age of 12 years.