Trimela Cream

Indications

This cream is specifically formulated for the short-term management of moderate to severe melasma on the face. It is crucial to minimize sun exposure during treatment. Always apply a broad-spectrum sunscreen with an SPF of 30 or higher.

• Important: Consult a registered healthcare professional before using this medication.

Pharmacology

This cream combines three potent active ingredients: Fluocinolone Acetonide, Hydroquinone, and Tretinoin, all recognized for their efficacy in treating melasma. While the precise mechanism of action for these ingredients in melasma treatment is not fully understood, their roles are distinct. Fluocinolone Acetonide serves as a topical corticosteroid with anti-inflammatory properties. Hydroquinone acts as a depigmenting agent, potentially disrupting the tyrosine-tyrosinase pathway involved in melanin production. Tretinoin functions as a keratolytic agent, aiding in skin cell turnover.

Dosage & Administration

Apply this cream once nightly, ensuring it is done at least 30 minutes before bedtime. Start by gently cleansing the face and neck with a mild cleanser, then rinse and pat the skin dry. Use a thin layer of the cream on the affected melasma areas, extending to about half an inch of healthy skin around each spot. Gently massage it into the skin. During the day, be diligent about using sunscreen and wearing protective clothing to avoid sun exposure. Patients may continue to use moisturizers and cosmetics as needed.

Pediatric Use: The safety and effectiveness of this cream have not been evaluated in pediatric patients.

• Important: Consult a registered healthcare professional before using this medication.

Interactions

Avoid using medicated, abrasive soaps, or cleansers that may dry the skin, as well as cosmetics containing high alcohol concentrations, astringents, or other irritants. Also, refrain from using medications that can cause photosensitivity concurrently with this cream.

Contraindications

This cream is contraindicated for individuals with a known hypersensitivity or allergic reaction to any of its components.

Side Effects

Some patients may experience severe allergic reactions, including difficulty breathing or asthma exacerbations. Common side effects during treatment may include mild to moderate skin redness, peeling, burning sensations, dryness, or itching.

Pregnancy & Lactation

Pregnancy Category C: This cream contains Tretinoin, which is a teratogen associated with risks such as embryo-fetal death, altered fetal development, congenital malformations, and possible neurological deficits. Animal studies on teratogenicity are inconclusive due to challenges in ensuring relevant dosing comparisons. Adequate and well-controlled studies in pregnant women are lacking. This cream should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.

Lactation: Systemically administered corticosteroids can be present in breast milk. It is uncertain whether topical application of this cream could lead to sufficient systemic absorption to yield detectable levels of Fluocinolone Acetonide, Hydroquinone, or Tretinoin in human milk. Caution is advised when administering this cream to nursing mothers.

Precautions & Warnings

This cream contains Hydroquinone and Tretinoin, which may cause mild to moderate irritation at the application site. Expect local reactions such as skin redness, peeling, a mild burning sensation, dryness, and itching. Temporary skin reddening or a mild burning sensation does not necessitate discontinuation of treatment. If any symptoms suggest hypersensitivity or significant irritation occur, discontinue use immediately. The corticosteroid Fluocinolone Acetonide present in this cream can be absorbed systemically, potentially leading to reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, with risks of glucocorticosteroid insufficiency upon treatment withdrawal. Symptoms like Cushing’s syndrome, hyperglycemia, and glucosuria may arise from systemic absorption. If HPA axis suppression is identified, discontinue use. Recovery of HPA axis function typically occurs after stopping topical corticosteroids.

Therapeutic Class

Hydroquinone Preparations

Storage Conditions

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