MENTAX Cream (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Mylan Pharmaceuticals Inc.

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1. Description

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 ...

2. Clinical Pharmacology

Pharmacokinetics 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 cm²) of 7 subjects, and 20 grams of the cream was ...

3. Indications and Usage

Mentax (butenafine HCl) Cream, 1% is indicated for the topical treatment of the dermatologic infection, tinea (pityriasis) versicolor due to M. furfur (formerly P. orbiculare). Butenafine HCl ...

4. Contraindications

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

5. Warnings

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

6.1. 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 ...

6.2. Information for Patients

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, ...

6.4. Drug Interactions

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

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of Mentax Cream, 1%, have not been conducted. Two in vitro assays (bacterial reverse mutation test and chromosome aberration test in Chinese ...

6.7. Pregnancy

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 ...

6.9. 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.

6.10. 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.

7. Adverse Reactions

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 ...

9. Overdosage

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

10. Dosage and Administration

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 ...

11. How Supplied

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) Mylan Pharmaceuticals Inc., Morgantown, WV 26505, U.S.A. ...

12. Storage and Handling

STORE BETWEEN 5° and 30°C (41° and 86°F). Keep this and all medications out of the reach of children.

13. Clinical Studies

Tinea (pityriasis) versicolor In the following data presentations, patients with tinea (pityriasis) versicolor were studied. The term "Negative Mycology" is defined as absence of hyphae in a KOH ...