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butenafine hydrochloride
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?
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What should I talk to my health care provider before I take MENTAX?
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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
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
In one study conducted in healthy subjects for 14 days, 6 grams of Mentax Cream, 1%, was applied once daily to the dorsal skin (3,000 cm) of 7 subjects, and 20 grams of the cream was applied once daily to the arms, trunk and groin areas (10,000 cm) of another 12 subjects. After 14 days of topical applications, the 6-gram dose group yielded a mean peak plasma butenafine HCl concentration, Cmax of 1.4 ± 0.8 ng/mL, occurring at a mean time to the peak plasma concentration, Tmax, of 15 ± 8 hours, and a mean area under the plasma concentration-time curve, AUC of 23.9 ± 11.3 ng-hr/mL. For the 20-gram dose group, the mean Cmax was 5.0 ± 2.0 ng/mL, occurring at a mean Tmax of 6 ± 6 hours, and the mean AUC was 87.8 ± 45.3 ng-hr/mL. A biphasic decline of plasma butenafine HCl concentrations was observed with the half-lives estimated to be 35 hours and > 150 hours, respectively.
At 72 hours after the last dose application, the mean plasma concentrations decreased to 0.3 ± 0.2 ng/mL for the 6-gram dose group and 1.1 ± 0.9 ng/mL for the 20-gram dose group. Low levels of butenafine HCl remained in the plasma 7 days after the last dose application (mean: 0.1 ± 0.2 ng/mL for the 6-gram dose group, and 0.7 ± 0.5 ng/mL for the 20-gram dose group). The total amount (or % dose) of butenafine HCl absorbed through the skin into the systemic circulation has not been quantitated. It was determined that the primary metabolite in urine was formed through hydroxylation at the terminal -butyl side-chain.
In 11 patients with tinea pedis, butenafine HCl cream, 1%, was applied by the patients to cover the affected and immediately surrounding skin area once daily for 4 weeks, and a single blood sample was collected between 10 and 20 hours following dosing at 1, 2 and 4 weeks after treatment. The plasma butenafine HCl concentration ranged from undetectable to 0.3 ng/mL.
In 24 patients with tinea cruris, butenafine HCl cream, 1%, was applied by the patients to cover the affected and immediately surrounding skin area once daily for 2 weeks (mean average daily dose: 1.3 ± 0.2 g). A single blood sample was collected between 0.5 and 65 hours after the last dose, and the plasma butenafine HCl concentration ranged from undetectable to 2.52 ng/mL (mean ± SD: 0.91 ± 0.15 ng/mL). Four weeks after cessation of treatment, the plasma butenafine HCl concentration ranged from undetectable to 0.28 ng/mL.
Non-Clinical Toxicology
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.
Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir ointment 5%.
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.
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%.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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