Melacare, Hydroquinone Tretionoin Mometasone Furoate Cream Patient information sheet

 

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory.

Hydroquinone/ Tretionoin/ Mometasone Furoate Cream MELACARE

COMPOSITION

Hydroquinone USP 2% w/w

Tretinoin USP 0.025%- w/w

Mometasone Furoate USP 0.1% w/w

 

PHARMACOLOGY

Hydroquinone is classified therapeutically as a depigmenting agent.

Tretinoin is all- trans -retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. Tretinoin is classified as a keratolytic agent. Mometasone furoate is a synthetic corticosteroid with antiĀ­-inflammatory activity.

The combination agents in Melacare act by inhibiting one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. It a\so effects the formation of melanization and degradation of melanosomes and eventually causes necrosis of the whole melanocytes. The hyperpigmented areas fade rapidly than surrounding normal skin; 80% of patients with melasma may note some improvement within 8 week period.

 

INDICATIONS

Melacare Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as cholasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.

 

CONTRAINDICATIONS

Phor history or allergic reaction to Hydroquinone. Tretinoin and Mometasone.

The safety of Me\acare during pregnancy and children (12 years and under) has not been established.

Caution to be exercised when Melacare is administered to nursing woman.

 

PRECAUTIONS

Strictly For External use only.

Important to avoid contact with eye and mucous membranes. Exposure to sunlight or UV light will cause repigmentation of bleached area.

 

ADVERSE REACTIONS

The adverse reactions reported are dryness, Assuring of paranasal and infraorbital areas, erythema and stinging. Occasional hypersensitivity (Localised contact dermatitis) may develop. If this occurs, the medication should be discontinued and the Physician notified immediately.

 

DIRECTION FOR USE

Melacare should be applied preferably once daily in the evening. Duration of application would be decided by the physician depending upon the response.

 

STORAGE

Store in a dry, well-ventilated p\ace at a temperature not exceeding 30C. Protect from light. Do not freeze.

Keep tube tightly closed after use. Keep out of the reach of children.

 

PRESENTATION

15 g Cream available in laminated tube.

Manufactured in India by :

A janta pharma limited

Ajanta House, Charkop, Kandivli (W), Mumbai400 067.