Incepta Pharmaceuticals Ltd.
Trimela is indicated for Melasma
Precautions and warnings
Cream contains hydroquinone and tretinoin that may cause mild to moderate irritation such as skin reddening, peeling, mild burning sensation, dryness, and pruritus. 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.
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 Cushingâ€™s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, Cream should be discontinued.
The most frequently reported events were erythema, desquamation, burning, itching, irritation, dryness, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and skin atrophy at the site of application. The majority of these events were mild to moderate in severity.
Medicated or abrasive soaps & cleansers, soaps & cosmetics w/ drying effects, products w/ high conc of alcohol & astringent, & other irritants or keratolytic drugs. Medications w/ photosensitizing effects.
A history of hypersensitivity, allergy, or intolerance to this product or any of its components.
Mode of actions
Fluocinolone acetonide is a synthetic fluorinated corticosteroid that is used topically for its anti-inflammatory, anti-pruritic and vasoconstrictive properties. Hydroquinone is used as a depigmenting agent. Tretinoin is a retinoid that is appears to stimulate mitosis, increases turnover of follicular epithelial cells and reduces their cohesiveness.
Dosage & Administration
It should be applied at least 30 minutes before bedtime. A thin film of the cream should be applied to the hyperpigmented areas of melasma including about Â½ inch of normal appearing skin surrounding each lesion.
Cream is for short-term (up to 8 weeks) treatment of moderate to severe melasma of the face. It is not for long-term (more than 8 weeks) or maintenance (continuous) treatment of melasma.
Pregnancy & Lactation
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks