Trimela 0.01%+4%+0.05% (Cream)

Indications

• Short-term treatment of moderate to severe melasma of the face
• Requirement to avoid sun exposure during treatment
• Use of sunscreen with at least SPF 30
• Treatment after gentle face and neck cleansing
• Usage of moisturizers and cosmetics during the day
• Pediatric use not established

Pharmacology

• Active ingredients: Fluocinolone Acetonide, Hydroquinone, Tretinoin
• Unknown mechanism of action for treating melasma
• Fluocinolone Acetonide classified as an anti-inflammatory
• Hydroquinone classified as a depigmenting agent
• Tretinoin classified as a keratolytic agent

Dosage & Administration

• Once daily application at night
• Application at least 30 minutes before bedtime
• Gentle wash with mild cleanser before application
• Application on hyperpigmented areas of melasma
• Use of sunscreen and protective clothing during the day
• Avoidance of sunlight exposure
• Usage of moisturizers and/or cosmetics during the day
• Safety and effectiveness not established for pediatric use

Interaction

• Avoidance of medicated or abrasive soaps and cleansers
• Avoidance of cosmetics with drying effects
• Avoidance of products with high concentration of alcohol
• Avoidance of astringent & other irritants
• Avoidance of keratolytic drugs
• Avoidance of concomitant use of medications with photosensitizing effects

Contraindications

• Contraindicated in individuals with history of hypersensitivity, allergy, or intolerance to the product or its components

Side Effects

• Possibility of severe allergic reactions
• Potential symptoms include trouble breathing, severe asthma attacks
• Possible skin reactions: mild to moderate redness, peeling, burning, dryness, itching

Pregnancy & Lactation

• Pregnancy Category C
• Teratogenic effects of tretinoin
• Limited information on animal studies and teratogenicity
• No adequate and well-controlled studies in pregnant women
• Caution advised for use during pregnancy and lactation

Precautions & Warnings

• Potential mild to moderate irritation from Hydroquinone and Tretinoin
• Local irritation symptoms may include skin reddening, peeling, mild burning sensation, dryness, pruritus
• Transient skin reddening or mild burning sensation should not preclude treatment
• Discontinuation advised in case of hypersensitivity or chemical irritation
• Systemic absorption of topical corticosteroids may lead to reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression
• Symptoms of Cushing's syndrome, hyperglycemia, and glucosuria may occur with systemic absorption of topical corticosteroid
• Discontinuation recommended if HPA axis suppression is noted

Therapeutic Class

• Hydroquinone Preparations

Storage Conditions

• Store in a cool & dry place
• Protection from light
• Avoid freezing
• Keep out of reach of children

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