Quintri Special Precautions

Quintri cream a combination drug product containing corticosteroid, retinoid and depigmenting agent, is not indicated for the maintenance treatment of melasma. After achieving control with Quintri cream some patients may be managed with other treatment instead of triple therapy with Quintri cream.
Because melasma usually recurs upon discontinuation of Quintri cream patients need to avoid sunlight exposure, use sunscreen of SPF 30 or greater, wear protective clothing and change to non-hormonal forms of birth control, if hormonal methods are used.
Quintri cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people.
Quintri cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, whose occurrence should prompt discontinuation of therapy. The majority of patients developing this condition are black, but it may also occur in Caucasians and Hispanics.
The safety and efficacy of Quintri cream in patients skin types V and VI have not been studied.
The safety and efficacy of Quintri cream in pregnant women and nursing mothers have not been established.
Exposure to sunlight, or ultraviolet light should be avoided. Patients who are consistently exposed to sunlight or skin irritants either through their work environment of habits should exercise particular caution. Sunscreen and protective covering (such as the use of a hat) over the treated areas should be used. Sunscreen use is an essential aspect of melasma therapy, as even minimal sunlight sustains melanocytic activity.
Weather extremes, such as heat or cold; may be irritating to patients treated with Quintri cream. Because of the drying effect of this medication, a moisturizer may be applied to the face in the morning after washing.
Application of Quintri cream should be kept away from the eyes, nose, or angles of the mouth, because the mucosa is much more sensitive than the skin to the irritant effect. If local irritation persists or becomes severe, application of the medication should be discontinued, and the health care provider consulted. Allergic contact dermatitis, blistering, crusting, and severe burning or swelling of the skin and irritation of the mucous membranes of the eyes, nose, and mouth require medical attention.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.
Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator.
Mutagenicity studies were not conducted with this combination of active ingredients. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen.
Pregnancy: Teratogenic effects: Quintri cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. There are no adequate and well controlled studies in pregnant women. Quintri cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.