When should treatment with Tri-Luma® Cream be stopped?
Stop using Tri-Luma
® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) and contact your doctor if you experience:
- Severe or continued irritation, blistering, oozing, scaling, or crusting
- Severe burning or swelling of your skin
- Irritation of your eyes, nose, or mouth
- Any type of breathing problem
- Blue-black coloration on your skin where the cream was applied
If you become pregnant while taking Tri-Luma® Cream, tell your doctor right away. You should discuss the chances that your baby may be harmed. Using Tri-Luma
® Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.
Additionally, Tri-Luma
® Cream is indicated for the short-term (up to 8 week) treatment of moderate to severe melasma of the face.
It is not indicated for long-term use (more than 8 weeks) or for the maintenance of melasma symptoms.
IMPORTANT SAFETY INFORMATION
Tri-Luma
® Cream is indicated for the short-term (8 week) treatment of moderate to severe melasma of the face. Tri-Luma
® Cream should be used with measures for sun avoidance, like using sunscreen of SPF 30 or higher. Tri-Luma
® Cream contains sulfites which may cause severe, life-threatening allergic reactions, so tell your doctor if you are allergic to sulfites. Tri-Luma
® Cream contains hydroquinone, which may cause a gradual blue-black darkening of the skin. If you are pregnant, nursing or trying to become pregnant you should not use Tri-Luma
® Cream. Safety and efficacy have not been established in individuals with darker skin. Reversible HPA axis (adrenal function) suppression may result from exposure to the topical corticosteroid, fluocinolone acetonide, so discontinue use if signs or symptoms of this condition occur. In addition, redness, peeling, burning, dryness and itching may occur. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. Tri-Luma
® Cream should not be used with irritating products such as abrasive cleansers, scrubs, or skin-peeling agents.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit
www.fda.gov/medwatch,
or call 1-800-FDA-1088.
For more information about Tri-Luma
® Cream, please see full
Prescribing Information.