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butenafine hydrochloride

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Overview

What is MENTAX?

Mentax Cream, 1%, contains the synthetic antifungal agent, butenafine hydrochloride. Butenafine is a member of the class of antifungal compounds known as benzylamines which are structurally related to the allylamines.

Butenafine HCl is designated chemically as N-4--butylbenzyl-N-methyl-1-naphthalenemethylamine hydrochloride. The compound has the molecular formula CHN•HCl, a molecular weight of 353.93, and the following structural formula:

Butenafine HCl is a white, odorless, crystalline powder. It is freely soluble in methanol, ethanol, and chloroform, and slightly soluble in water. Each gram of Mentax Cream, 1%, contains 10 mg of butenafine HCl in a white cream base of purified water USP, propylene glycol dicaprylate, glycerin USP, cetyl alcohol NF, glyceryl monostearate SE, white petrolatum USP, stearic acid NF, polyoxyethylene (23) cetyl ether, benzyl alcohol NF, diethanolamine NF, and sodium benzoate NF.



What does MENTAX look like?



What are the available doses of MENTAX?

Sorry No records found.

What should I talk to my health care provider before I take MENTAX?

Sorry No records found

How should I use MENTAX?

Mentax (butenafine HCl) Cream, 1% is indicated for the topical treatment of the dermatologic infection, tinea (pityriasis) versicolor due to (formerly P. orbiculare). Butenafine HCl cream was not studied in immunocompromised patients. (See .)

Patients with tinea (pityriasis) versicolor should apply Mentax Cream, 1%, once daily for two weeks. Sufficient Mentax Cream should be applied to cover affected areas and immediately surrounding skin of patients with tinea versicolor. If a patient shows no clinical improvement after the treatment period, the diagnosis and therapy should be reviewed.


What interacts with MENTAX?

Mentax (butenafine HCl) Cream, 1%, is contraindicated in individuals who have known or suspected sensitivity to Mentax Cream, 1%, or any of its components.



What are the warnings of MENTAX?

Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.


What are the precautions of MENTAX?

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General

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 (formerly )] 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.

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Information for Patients

The patient should be instructed to:

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Drug Interactions

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

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Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of Mentax Cream, 1%, have not been conducted. Two assays (bacterial reverse mutation test and chromosome aberration test in Chinese hamster lymphocytes) and one study (rat micronucleus bioassay) revealed no mutagenic or clastogenic potential for butenafine.

In subcutaneous fertility studies conducted in rats at dose levels up to 25 mg/kg/day (0.5 times the maximum recommended dose in humans for tinea versicolor based on body surface area comparisons), butenafine did not produce any adverse effects on male or female fertility.

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Pregnancy

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.

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Nursing Mothers

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.

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Pediatric Use

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.


What are the side effects of MENTAX?

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%.


What should I look out for while using MENTAX?

Mentax (butenafine HCl) Cream, 1%, is contraindicated in individuals who have known or suspected sensitivity to Mentax Cream, 1%, or any of its components.

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


What might happen if I take too much MENTAX?

Overdosage of butenafine HCl in humans has not been reported to date.


How should I store and handle MENTAX?

Mentax (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:15-gram tube (NDC 0378-6151-46)30-gram tube (NDC 0378-6151-49)STORE BETWEEN 5° and 30°C (41° and 86°F).Keep this and all medications out of the reach of children.Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.REVISED NOVEMBER 2013029.7Mentax (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:15-gram tube (NDC 0378-6151-46)30-gram tube (NDC 0378-6151-49)STORE BETWEEN 5° and 30°C (41° and 86°F).Keep this and all medications out of the reach of children.Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.REVISED NOVEMBER 2013029.7Mentax (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:15-gram tube (NDC 0378-6151-46)30-gram tube (NDC 0378-6151-49)STORE BETWEEN 5° and 30°C (41° and 86°F).Keep this and all medications out of the reach of children.Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.REVISED NOVEMBER 2013029.7Mentax (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:15-gram tube (NDC 0378-6151-46)30-gram tube (NDC 0378-6151-49)STORE BETWEEN 5° and 30°C (41° and 86°F).Keep this and all medications out of the reach of children.Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.REVISED NOVEMBER 2013029.7Mentax (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:15-gram tube (NDC 0378-6151-46)30-gram tube (NDC 0378-6151-49)STORE BETWEEN 5° and 30°C (41° and 86°F).Keep this and all medications out of the reach of children.Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.REVISED NOVEMBER 2013029.7Mentax (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:15-gram tube (NDC 0378-6151-46)30-gram tube (NDC 0378-6151-49)STORE BETWEEN 5° and 30°C (41° and 86°F).Keep this and all medications out of the reach of children.Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.REVISED NOVEMBER 2013029.7Mentax (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:15-gram tube (NDC 0378-6151-46)30-gram tube (NDC 0378-6151-49)STORE BETWEEN 5° and 30°C (41° and 86°F).Keep this and all medications out of the reach of children.Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.REVISED NOVEMBER 2013029.7