Melatrin Cream

(Fluocinolone Acetonide, Hydroquinone & Tretinoin)

Skin Preparation


Presentation

Melatrin® Cream: Fluocinolone Acetonide USP 0.01%, Hydroquinone USP 4% and Tretinoin USP 0.05% in a hydrophilic cream base for topical application.


Description 

Melatrin® Cream contains three active ingredients Fluocinolone Acetonide, Hydroquinone and Tretinoin. All of them are used to treat melasma. However, the mechanism of action of the active ingredients in Melatrin® Cream in the treatment of melasma is unknown but Fluocinolone Acetonide is a corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. Hydroquinone is classified therapeutically as a depigmenting agent, which may interrupt one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. Tretinoin is classified therapeutically as a keratolytic agent.


Indications


Melatrin® Cream is indicated for the short-term treatment of moderate to severe melasma of the face, after starting the treatment avoid presence of sun. Use asunscreen of at least SPF 30 or more.


Dosage & Administration

Melatrin® Cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma including about 1/2 inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. During the day, use a sunscreen and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.


Side Effects


A very few patients may get severe allergic reactions from Melatrin® Cream. They may have trouble breathing or severe asthma attacks. While patients use Melatrin® Cream, skin may develop mild to moderate redness, peeling, burning, dryness or itching.



Precautions


Melatrin® Cream contains Hydroquinone and Tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued. Melatrin® Cream also contains the corticosteroid Fluocinolone Acetonide. 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 by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of Melatrin® Cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.


Contraindications


Melatrin® Cream is contraindicated in individuals with a history of hypersensitivity, allergy or intolerance to this product or any of its components.


Use in Pregnancy & Lactation


Pregnancy Category C: Melatrin® Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations and potential neurologic deficits. It is difficult to interpret the animal studies on teratogenicity with Melatrin® Cream, because the availability of the dermal applications in these studies cannot be assured and comparison with clinical dosing is not possible. There are no adequate and well-controlled studies in pregnant women. Melatrin® Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Corticosteroids, when systemically administered, the drug appear in human milk. It is not known whether topical application of Melatrin® Cream could result in sufficient systemic absorption to produce detectable quantities of Fluocinolone Acetonide, Hydroquinone or Tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when Melatrin® Cream is administered to nursing women.


Commercial Packaging


Melatrin® Cream: Each carton contains a tube of 30 g cream, an insert and an usage guideline.



Patient Information


Melatrin Cream (Fluocinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05%) should always be used as instructed by your doctor. To use this medicine correctly,please follow the steps below :


Apply Melatrin Cream at night, at least 30 minutes before bedtime.


Step-1 : Gently wash your face with a mild cleanser.


Step-2 : Rinse and pat your skin dry. Put a small amount (pea sized or ½ inch or less) of Melatrin Cream on your finger tip. Apply a thin coat onto the discolored spot(s), including about ½ inch of normal skin surrounding the affected area.


Step-3 : Rub the medicine lightly and uniformly on your skin. The medicine should become invisible almost at once. If you can still see it, you are using too much.


Step-4 : Keep the medicine away from the corners of your nose, mouth, eyes and open wounds. Spread it away from those areas when applying it.


Step-5 : Wash your face gently with water in the next morning.


Step-6 : Use a sunscreen of at least SPF 30 during day time over the treated area. You can also use an umbrella. Always try to avoid the exposure of sunlight.


Step-7 : You may also use a moisturizer and cosmetics during the day.


Do not use more Melatrin Cream or apply it more often than recommended by your doctor. Too much Melatrin Cream may irritate your skin and won't give you faster or better result.


Drug Interaction


Avoid use of medicated or abrasive soaps, cleansers, soaps, cosmetics with drying effects, products with high concentration of alcohol, astringent & other irritants or keratolytic drugs. Also avoid concomitant use of medications with photosensitizing effects.


Pediatric use


Safety and effectiveness of Melatrin® Cream in pediatric patients have not been established.


Storage


Store in a cool & dry place, protected from light. Do not freeze. Keep out of reach of children.