Butenaskin BM

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BUTENASKIN BM CREAM

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

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COMPOSITION

Butenafine 1% + Betamethasone dipropionate 0.05 %

DESCRIPTION

Butenaskin-BM contains two compounds:

a synthetic corticosteroid (betamethasone dipropionate)
a synthetic antifungal agent (butenafine)

which target different aspects of fungal infection. Butenafine targets the cause of the infection by inhibiting the growth of fungus on the skin, whereas betamethasone reduces fungal infction symptoms such as itching, swelling, and redness.

HIGHLIGHTS (USPs)

In inflamed fungal infections, Butenaskin BM resolves symptoms rapidly by combining

Broad-spectrum Antifungal, Butenafine which has better drug retention, Proven anti-inflammatory effect, Persistent effect and low relapse rate
Powerful anti-inflammatory betamethasone dipropionate.

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.

Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of Betamethasone.

Betamethasone dipropionate is effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, anti-pruritic, and vasoconstrictive actions. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

INDICATIONS AND USAGE

BUTENASKIN-BM Cream is indicated in patients 12 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes,and Trichophyton rubrum.

CONTRAINDICATIONS

BUTENASKIN-BM Cream is contraindicated in patients who are sensitive to Butenafine, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

PRECAUTIONS

General

Butenaskin BM Cream, 1% is for external use only. If irritation or sensitivity develops with the use of Butenaskin BM cream, 1%, treatment should be discontinued and appropriate therapy instituted.

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions, which augment systemic absorption, include use over large surface areas, prolonged use, and use under occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

Drug Interactions

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

Pregnancy

There are no adequate and well-controlled studies that have been conducted of topically applied Butenafine BM 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 BM 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 may be seen
Blistering
Itching
Peeling
Skin eruptions
Rash

OVERDOSAGE

Over dosage in humans has not been reported to date.

DOSAGE AND ADMINISTRATION

In the treatment of interdigital tinea pedis, Butenaskin BM should be applied twice daily for 7 days or once daily for 4 weeks. Patients with tinea corporis or tinea cruris should apply Butenaskin-BM once daily for two weeks.

The use of BUTENASKIN-BM Cream for longer than 4 weeks is not recommended for any condition.

1. What is Butenaskin BM?
A: It contains a topical combination of butenafine an antifungal and bethamethasone dipropionate, a corticosteroid for the treatment of inflamed Tinea infections.

2. What is the active ingredient ?
A: Butenafine hydrochloride - 1% w/w
Betamethasone dipropionate - 0.05 % w/w

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

4. What are its indications or uses?
A: Butenaskin BM is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis.

5. What is the right dosage?
A: Interdigital tinea pedis: Butenaskin BM should be applied twice daily for 7 days or once daily for 4 weeks.
Tinea corporis or Tinea cruris: Butenaskin-BM should be applied once daily for two weeks.
The use of BUTENASKIN-BM Cream for longer than 4 weeks is not recommended for any condition

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

7. What are the precautions while taking the product?
A:Use BUTENASKIN BM ® 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. BUTENASKIN BM® Cream, 1%, is for external use only.
Dry the affected area(s) thoroughly before application, if you wish to apply BUTENASKIN BM® 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

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

9. Who cannot take the medicine?
A: Patients who are sensitive to Butenafine hydrochloride or betamethasone dipropionate or other corticosteroids or imidazoles, or to any ingredient in these preparations. Butenaskin BM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Caution should be exercised when topical corticosteroids are administered to a nursing woman.
Children below the age of 12 years.

10.What are the possible common and rare adverse effects of the medicine?
A: Blistering, Hives, Infection, Irritated skin, Itching, Peeling, Skin eruptions and rash, Tingling sensation etc.

11.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.

12. What is the Price per unit?
A: Butenaskin BM is available in a tube of 15gm for Rs. 52/-