fluocinolone/tretinoin/hydroquinone

Fluocinolone/tretinoin/hydroquinone is a combination medication used for short-term treatment of melasma, a skin disorder that causes patches of dark skin discoloration to appear on the face, particularly on the cheeks and forehead.

Melasma occurs more commonly in women, often with pregnancy or the use of contraceptives or hormones. Fluocinolone/tretinoin/hydroquinone helps lighten the dark skin patches and is used in addition to measures to avoid sun exposure, including the use of sunscreens.

The three drugs in the combination work in different ways to treat melasma:

• Fluocinolone: Fluocinolone is a topical corticosteroid that reduces inflammation and itching and constricts swollen blood vessels in the skin. Fluocinolone works by suppressing the synthesis and release of inflammatory chemicals including histamine, kinins, prostaglandin and liposomal enzymes.
• Tretinoin: Tretinoin is a vitamin A derivative that helps in loosening and shedding of dead skin cells, and increasing the turnover of skin cells.
• Hydroquinone: Hydroquinone inhibits the synthesis of melanin, the pigment that causes dark skin color, by interfering with metabolic processes in melanocytes, the cells that produce melanin.

• Do not use fluocinolone/tretinoin/hydroquinone in patients with hypersensitivity to any component of the formulation.
• Fluocinolone/tretinoin/hydroquinone cream contains sodium metabisulfite that may cause allergic reactions in some people, including asthma episodes or serious life-threatening reactions (anaphylaxis). In case of such reactions, discontinue the drug immediately and institute appropriate treatment.
• Hydroquinone in the formulation can cause gradual blue/black darkening of the skin (ochronosis), particularly in dark-skinned people, but may occur in light-skinned people as well. Discontinue the drug immediately if ochronosis develops.
• The corticosteroid fluocinolone in the formulation may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which can cause insufficiency of cortisol, the stress hormone. Systemic absorption of corticosteroids can cause excessive cortisol levels, and associated conditions such as Cushing’s syndrome, hyperglycemia, and glucosuria. Children are more at risk for systemic absorption.
• Fluocinolone/tretinoin/hydroquinone can cause mild to moderate local skin reactions including irritation, peeling, dryness, and itching. Skin reactions may be aggravated by the concurrent use of abrasive soaps and cleansers, skin care products with drying and astringent effects, or other topical medications that can irritate the skin.
• Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma, a type of cancer.
• The safety and efficacy of fluocinolone/tretinoin/hydroquinone treatment have not been studied in darker skin, it may cause excessive bleaching.
• The safety and efficacy of fluocinolone/tretinoin/hydroquinone in the treatment of hyperpigmentation conditions other than facial melasma have not been studied.
• Fluocinolone/tretinoin/hydroquinone is meant for short-term treatment and not for maintenance treatment of melasma.

Common side effects of fluocinolone/tretinoin/hydroquinone include:

• Skin redness (erythema)
• Peeling skin (desquamation)
• Burning
• Dry skin (xeroderma)
• Itching (pruritus)
• Acne vulgaris
• Spider veins (telangiectasia)
• Skin irritation
• Changes in skin pigmentation (dyschromia)
• Small bumps in the skin (papules)
• Fluid-filled blisters (vesicles)
• Rash
• Acne-like rash
• Rosaceae
• Abnormal skin sensations (paresthesia)
• Reduced skin sensation (hypoesthesia)
• Dry mouth (xerostomia)

Less common side effects of fluocinolone/tretinoin/hydroquinone include:

• Inflammation of follicles (folliculitis)
• Acneiform eruptions
• Reduced skin pigmentation (hypopigmentation)
• Skin inflammation around the mouth (perioral dermatitis)
• Allergic contact dermatitis
• Secondary infection
• Sweat rash/prickly heat (miliaria)
• Loss of skin tissue (skin atrophy)
• Stretch marks (striae)
• Blue-black discoloration of the skin (ochronosis)
• Suppression of the stress axis (hypothalamic-pituitary-adrenal [HPA] axis) that reduces the production of the cortisol stress hormone
• Cushing’s syndrome, a disorder caused by excessive cortisol production due to systemic absorption of the corticosteroid

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Cream

• 0.01%/0.05%/4%/30 g

Adult:

Melasma

• Indicated for short-term treatment of moderate to severe melasma
• Apply to face at night, at least 30 minutes before bedtime
• Wash face gently before application; rinse and pat dry
• Apply a thin film of Tri-Luma to the hyperpigmented area and ½ inch surrounding skin
• Do not use an occlusive dressing

Pediatric:

• Safety and efficacy not established

Overdose

• Overdose of fluocinolone/tretinoin/hydroquinone is unlikely to result from topical application.
• Oral ingestion of the drug may be harmful, there is no information on symptoms or treatment.
• Report your symptoms to Poison Control in the event of accidental ingestion.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of fluocinolone/tretinoin/hydroquinone include:
  • aldesleukin
  • aminolevulinic acid (systemic)
  • multivitamins/fluoride (with A, D, E)
  • multivitamins/minerals (with A, D, E, K)
  • multivitamins/minerals (with A, E, no iron)
• Fluocinolone/tretinoin/hydroquinone has no listed serious interactions with other drugs.
• Moderate interaction of fluocinolone/tretinoin/hydroquinone include:
  • aminolevulinic acid (topical)
  • methoxsalen (systemic)
  • porfimer
  • verteporfin

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

• There are no adequate and well-controlled studies on the topical use of fluocinolone/tretinoin/hydroquinone in pregnant women. Clinical trials were conducted only after a negative pregnancy test, however, some women became pregnant during treatment, but most of the pregnancy outcomes are unknown.
• Fluocinolone/tretinoin/hydroquinone cream should be used during pregnancy only if the potential benefits outweigh the potential risks to the fetus.
• It is not known if topical administration of fluocinolone/tretinoin/hydroquinone can result in sufficient systemic absorption to be present in breastmilk. Use the cream with caution in nursing mothers and avoid letting the breastfed infant come into contact with the cream.

• Use fluocinolone/tretinoin/hydroquinone cream exactly as prescribed. Do not use for any skin disorder other than that for which it is prescribed.
• Do not apply excessive quantities and avoid prolonged use. Wash your hands after each application.
• Switch to nonhormonal contraceptives while on fluocinolone/tretinoin/hydroquinone treatment.
• Avoid contact with eyes, nose, angles of the mouth, mucous membrane, and open wounds.
• Avoid exposure to ultraviolet light and sunlight, including sunlamps, by using protective clothing and sunscreen.
• Use moisturizer after washing the face in the morning to prevent skin dryness.
• Discontinue use and consult with your physician if you develop hypersensitive reactions.
• Local irritation and other skin reactions may occur temporarily. Stop use and seek medical attention if you have persistent irritation, blistering, burning, and swelling, or allergic contact dermatitis.
• Store safely out of reach of children.
• In case of oral ingestion or overdose, contact your physician or Poison Control.