Butenaskin

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BUTENASKIN CREAM

Cetylated Fatty Acid Esters, Vitamin E, Tetrahydrocurcumin, Small Peptides.

For Doctors
For patients

Butenafine Hydrochloride 1% w/w in a cream base q.s.
Preservative: Sodium Benzoate IP – 0.2% w/w

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

Butenafine HCl has been shown to be active against most strains of the following microorganisms: Epidermophyton floccosum, Trichophyton mentagrophytes, Trichophyton rubrum, Trichophyton tonsurans.

HIGHLIGHTS (USPs)

Has broad-spectrum fungicidal activity
Proven anti-inflammatory effect
Exerts anti-inflammatory in vivo
Better drug retention
Achieves high concentrations in skin and remains in skin tissue for
prolonged periods (24 hours).
Persistent effect and low relapse rate
Effectiveness persists for at least 4 weeks following the
discontinuation of therapy.
Provides fast symptom relief (within 7 days), with few side effects.

CLINICAL PHARMACOLOGY

Butenafine HCl is a benzylamine derivative with a mode of action similar to that of the allylamine class of antifungal drugs.

Butenafine HCl is hypothesized to act by inhibiting the epoxidation of squalene, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes.

INDICATIONS AND USAGE

Butenafine HCl cream 1.0% is indicated for the topical treatment of superficial dermatophytes like Interdigital tinea pedis (athlete's foot), Tinea corporis
(ringworm) and Tinea cruris (jock itch) due to E.floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans

CONTRAINDICATIONS

Butenafine HCl cream, 1% is contraindicated in individuals who have known or suspected sensitivity to butenafine cream, 1%, or any of its components.

PRECAUTIONS

General
Butenafine HCl Cream, 1% is not for ophthalmic, oral, or intravaginal use. Butenafine Cream, 1% is for external use only. If irritation or sensitivity develops with the use of butenafine cream, 1%, treatment should be discontinued and appropriate therapy instituted.

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

Butenafine cream 1% should not be brought into contact with the eyes, nose, and mouth, and other mucous membranes.

Drug Interactions

Potential drug interactions between Butenafine cream 1%, and other drugs have not been systematically evaluated.

Pregnancy

Pregnancy Category B
There are no adequate and well-controlled studies that have been conducted of topically applied butenafine in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known if butenafine HCl is excreted in human milk. Caution should be exercised in prescribing butenafine cream, 1% to a nursing woman.

Pediatric Use

Safety and efficacy in pediatric patients below the age of 12 years have not been studied.

ADVERSE REACTIONS

Hypersensitive Skin Reactions: In controlled clinical trials only 1%, reported adverse events related to the skin. These included burning/stinging and worsening of the condition. In uncontrolled clinical trials, the most frequently reported adverse events in patients treated with butenafine cream, 1% were: contact dermatitis, erythema, irritation, and itching, each occurring in less than 2% of patients.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Interdigital Tinea Pedis: Butenaskin Cream should be applied twice daily for 7 days or once daily for 4 weeks.

Tinea Corporis or Tinea Cruris: Butenaskin Cream should be applied once daily for two weeks.

1. What is Butenaskin ?
A: It contains butenafine a topical antifungal indicated in fungal infections.

2. What is the active ingredient of Butenaskin?
A: Butenafine Hydrochloride 1% w/w in a cream base q.s.
Preservative: Sodium Benzoate IP – 0.2% w/w

3. How is it available?
A: Butenaskin cream is available in a tube of 15gm.

4. What are its indications or uses of Butenaskin?
A: Indicated for the topical treatment of the following:
Tinea infections like:
Interdigital tinea pedis (athlete's foot)
Tinea corporis (ringworm)
Tinea cruris (jock itch)

5. What is the right dosage?
A: Interdigital tinea pedis: Butenaskin should be applied twice daily for 7
days OR once daily for 4 weeks.
Tinea corporis or tinea cruris: Apply Butenaskin once daily for two weeks.

6. What is to be done in case of a missed dosage?
A: In case you miss a dose, skip the missed dose and proceed with your usual
dose schedule. Do not double dose.

7. What are the precautions while taking the product?
1. Use BUTENASKIN® Cream, 1%, as directed by the physician. The handsshould be washed after applying the medication to the affected area(s). Avoid contact with the eyes, nose, mouth, and other mucous membranes. BUTENASKIN® Cream, 1%, is for external use only.
2. Dry the affected area(s) thoroughly before application, if you wish to apply BUTENASKIN® Cream, 1%, after bathing.
3. 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).
4. Inform the physician if the area of application shows signs of increased irritation, redness, itching, burning, blistering, swelling, or oozing.
5. Avoid the use of occlusive dressings unless otherwise directed by the physician.
6. Do not use this MEDICATION for any disorder other than that for which it was prescribed.

8. Which drugs should be avoided along with it?
A: There are no significant drug interactions with this medicine.

9. Who cannot take the medicine?

Butenaskin Cream 1%, is contraindicated in individuals who have knownor suspected sensitivity to Butenafine or any of the other components of Butenaskin Cream.
Children below the age of 12 years.

10.What is the time of taking the medicine, dosage and the usual duration?
A: Sufficient Butenaskin Cream should be applied to cover affected areas and immediately surrounding skin of patients with interdigital tinea pedis, tinea corporis, and tinea cruris. If a patient shows no clinical improvement after the treatment period, go back to your doctor

11. What are the possible common and rare adverse effects of the medicine?
A: 1% patients reported adverse events related to the skin. These included burning/stinging and worsening of the condition.

12 .How to store the medicine?
A: Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture

13. What is the Price per unit?
A: Butenaskin is available in a tube of 15gm for Rs. 47/-