Special Precautions
Patient receiving hormonal contraceptives may consider changing to non-hormonal contraceptive measures. Not intended for the maintenance treatment of melasma. Use in darker skin types (Fitzpatrick skin types V and VI) has not been evaluated. Pregnancy and lactation. Patient Counselling Avoid exposure to sunlight and UV light; use sunscreen or wear protective clothing during the day. Do not use occlusive dressings on the affected area. Avoid contact with mucous membranes, eyes, nose, angles of the mouth, and abraded skin. Monitoring Parameters May consider confirming the pregnancy status prior to treatment initiation in women of reproductive potential. Monitor for signs or symptoms of hypothalamic-pituitary-adrenal (HPA) axis suppression.
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Adverse Reactions
Significant: Cutaneous hypersensitivity/contact dermatitis, exogenous ochronosis, Kaposi's sarcoma (prolonged use); systemic effects (e.g. adrenal suppression, manifestations of Cushing's syndrome, hyperglycaemia, glycosuria; visual disturbances (e.g. blurred vision, cataract, glaucoma, central serous chorioretinopathy).
Gastrointestinal disorders: Dry mouth.
General disorders and administration site conditions: Application site reactions (e.g. local irritation, inflammation, erythema, burning sensation, desquamation, dryness, xeroderma, pruritus).
Nervous system disorders: Paraesthesia, hyperaesthesia.
Skin and subcutaneous tissue disorders: Acne, telangiectasia, pigmentary changes, papules, acne-like rash, rosacea, rash, vesicles.
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Drug Interactions
May cause additive photosensitivity when used concomitantly with known photosensitising agents (e.g. glimepiride, chlorpromazine, hydrochlorothiazide).
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CIMS Class
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ATC Classification
L01XF01 - tretinoin
D07AC04 - fluocinolone acetonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases. D10AD01 - tretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne. C05AA10 - fluocinolone acetonide ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures. S01BA15 - fluocinolone acetonide ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye. D11AX11 - hydroquinone ; Belongs to the class of other dermatologicals. S02BA08 - fluocinolone acetonide ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear. |