Full Prescribing Info
Contents
Hydroquinone, tretinoin, fluocinolone acetonide.
Description
Each gram cream contains: Hydroquinone 40 mg; Tretinoin 0.5 mg; Fluocinolone acetonide 0.1 mg.
Action
Pharmacology: Mechanism of Action: Hydroquinoneis classified therapeutically as a depigmenting agent. Tretinoin is classified therapeutically as a keratolytic. Fluocinolone acetonide classified therapeutically as an anti-inflammatory.
One of the components in Quintri cream hydroquinone, is a depigmenting agent, and may influence one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. However, the mechanism of action of the active ingredients in the Quintri cream in the treatment of melasma is unknown.
Indications/Uses
Quintri cream is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
Quintri cream is a combination product containing corticosteroid, retinoid and depigmenting agent, NOT indicated for the maintenance treatment of melasma.
The safety and efficacy of Quintri cream in the treatment of hyperpigmentation conditions, other than melasma of the face have not been studied.
Dosage/Direction for Use
Quintri cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime.
Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry.
Apply a thin film of the cream to the hyperpigmented areas of melasma.
Application of Quintri cream should be kept away from the eyes, nose, or angles of the mouth.
Not using more often than prescribed. Do not use occlusive dressing. If local irritation persists or becomes severe, application of the medication should be discontinued, and the health care provider consulted.
During the day, use a sunscreen of SPF 30 or greater and wear protective clothing such as the use of hat. Patients may use moisturizers and/or cosmetics during the day.
Therapeutic effects may be observed as early as 4 weeks.
Contraindications
Quintri cream is contraindicated in individuals with a history of hypersensitivity, allergy or intolerance to this product or any its components.
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.
Adverse Reactions
Local irritation, such as skin reddening, peeling, mild burning sensation, dryness. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued.
Drug Interactions
Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentration of alcohol and astringent.
Patients are cautioned on concomitant use or medications that are known to be photosensitizing.
Storage
Keep tightly closed. Store below 25°C.
ATC Classification
D11AX11 - hydroquinone ; Belongs to the class of other dermatologicals.
Presentation/Packing
Cream 15 g x 1's.
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