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Miracute

Miraflash Nigeria Limited
8, Success Estate, Off Brentfield Avenue, Oke-Afa , Magboro,Ogun State, Nigeria.
Email: miraflashnigerialtd@yahoo.com
Tel: 08052006942, 08023299813, 08023513047
Website: http://miraflash.com

Brand Name

Miracute

Manufacturer

Alpa Laboratories Limited.
33/2, A. B. Road, Pigdamber 453 446

Therapeutic Class

Anti-infective/Corticosteroid combinations, Skin

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Cream (NRN: A4-4800 ): Beclomethasone Dipropionate BP 0.025% w/w; Gentamicin Sulphate BP 0.1 %w/w; Clotrimazole BP 1 % w/w; Methyl paraben 0.15%; Propyl paraben 0.05% (As Preservative)

Pack Size: 30 gm Tube in unit carton.

miracute cream

Pharmacology

Betamethasone Dipropionate is one of a group of medicines catted topical corticosteroids. These medicines are used on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.

Clotrimazole is a topical anti-fungal medicine. It is used to treat some fungal infections of the skin.

Gentamicin sulphate is a water-soluble antibiotic of the aminoglycoside group which has shown activity against a wide variety of pathogenic gram negative and gram-positive bacteria.

Indications

It is a topical steroid preparation. It is used for Short-term topical treatment of tinea infections due to Trichophyton rubrum; T.mentagrophytes; Epidermophyton floccusum and Microsporum canis; candidiasis due to Candida albicans.

Contra-indications

Miracute cream is contraindicated in those patients with a history of sensitivity to any of its components or to other corticosteroids or imidazoles.

Precautions/Warnings

Local and systemic toxicity is common especially following long continued use on large areas of damaged skin and in flexures. If used in children or on the face, courses should be limited to 5 days. MIRACUTE CREAM SHOULD NOT BE USED WITH OCCLUSIVE DRESSING. FOR EXTERNAL USE ONLY

Interactions

There are no known interactions.

PREGNANCY:

There is inadequate evidence of safety in pregnancy. Clotrimazole has shown no teratogenic effect in animals but is fetotoxic at high oral doses.

Adverse Effects

A few people may find that they suffer from some of the following side effects after using Lotriderm: burning and stinging; rash; swelling and other skin infections.

In addition, the following side effects have been reported to occur following the use of other medicines containing either clotrimazole or betamethasone dipropionate: redness, stinging, blistering, peeling, swelling, itching, burning, skin rash, dryness of the skin, inflammation of the hair follicles; excessive hair growth; darkening of the skin; allergic skin reactions; dermatitis around the mouth; other skin infections, thinning of the skin and red marks.

Dosage & Administration

For adults and children over the age of 12 years a layer of cream should be gently massaged into the affected and surrounding skin areas twice a day, in the morning and evening.

OVERDOSE:

Acute overdosage with topical application of MIRACUTE cream is unlikely and would not be expected to lead to a life-threatening situation: however topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

Toxic effects are unlikely to occur following accidental ingestion of MIRACUTE cream. Signs of toxicology appearing after such accidental ingestion should be treated symptomatically.

Storage/Handling Recommendations

Keep in a cool place. Protect from light. Keep the tube tightly closed. Keep out of reach of children; FOR EXTERNAL USE ONLY

Review Date

2017-05-05 08:34:44