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Hydroquinone
2%
Mometasone furoate
0.1%
Tretinoin
0.025%
Melacare is indicated for the treatment of hyperpigmentation
Occasional hypersensitivity may occur with hydroquinone. Treatment should be limited to relatively small areas of the body at one time since some patients may experience a transient skin reddening and a mild burning sensation. Ochronosis and pigmented colloid milium have been reported following extended use of stronger creams (5% hydroquinone) in a high sunshine climate. Such severe effects are preceded by redarkening of the skin and follow continual administration. Adverse effects with tretinoin include dry skin, peeling, scaling, flaking skin, skin burning sensation, erythema, pruritus, pain on skin and sunburn. Most skin-related adverse reactions first appear during the first two weeks of treatment with Tretinoin, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persist throughout the treatment period. Local adverse reactions reported infrequently with topical dermatalogic corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae. Infections like folliculitis, pruritus, burning sensation at site of application have rarely been observed.
Topical application of hydroquinone produces a reversible depigmentation of the skin by the inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas. Tretinoin is a metabolite of Vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus, but cutaneous levels of Tretinoin in excess of physiologic concentrations occur following application of a Tretinoin-containing topical drug product. Tretinoin reduces pigmentation by inhibiting tyrosinase transcription, as well as by interrupting melanin synthesis. Mometasone furoate exhibits marked anti-inflammatory activity. When used in combination with tretinoin and hydroquinone in the treatment of melasma, corticosteroid suppresses biosynthetic and secretory functions of melanocytes, and thus melanin production, leading to early response in melasma, synergy among the three agents.
Pregnancy Melacare Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Melacare Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. During pregnancy treatment with mometasone should be performed only on the physician’s order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There are no adequate and well-controlled studies with mometasone in pregnant women and therefore the risk of such effects to the human foetus is unknown. Lactation It is not known whether topical administration of hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother. It is not known whether tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tretinoin is administered to a nursing woman. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Paediatric use Melacare cream is not recommended for use in children and adolescents.
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