FLUOCINOLONE TRETINOIN HYDROQUINONE – TOPICAL Tri-Luma side effects medical uses and drug

FLUOCINOLONE TRETINOIN HYDROQUINONE - TOPICAL Tri-Luma side effects medical uses and drug

Tri-Luma – Treatment for Melasma

Medication Uses How To Use Side Effects Precautions Drug Interactions Overdose Notes Missed Dose Storage USES: This combination medication treats melasma on the face. Melasma is a condition characterized by dark patchy areas on the skin, especially on the cheeks and forehead. It sometimes occurs with hormonal changes. Tri-Luma contains 3 different medications. Hydroquinone is a reversible skin bleaching agent. Tretinoin is a retinoid that increases skin shedding. Fluocinolone is a medium strength corticosteroid that reduces swelling, itching, and redness. Tri-Luma may improve melasma but is not a cure. Continued exposure to melasma triggers, such as sunlight or estrogen-type birth control hormones, may cause it to return. HOW TO USE: Before starting treatment, read the Patient Information Leaflet provided by your pharmacist. If you have any questions, consult your doctor or pharmacist. Before using, apply a small amount of the medicine to an unbroken area of skin and check for any serious side effects within 24 hours. If the test area becomes itchy, red, puffy, or blistering, do not use Tri-Luma and contact your doctor. If there is only mild redness, treatment with Tri-Luma may begin. Gently wash your face and neck with a mild soapless cleanser before applying Tri-Luma. Rinse and pat dry the skin. Apply a thin layer of medication, including about 1/2 inch (1.5 centimeters) of normal-appearing skin around the affected area, once daily 30 minutes before bedtime or as directed by your doctor. Rub the medication gently and completely into the skin. Do not cover the area unless directed to do so by your doctor. Tri-Luma may increase skin sensitivity to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen of SPF 30 or greater and wear protective clothing on the treated areas of skin when outdoors, even on cloudy or hazy days. If you experience dry skin from using Tri-Luma, use a skin moisturizer in the morning after washing your face. You may also use a moisturizer and cosmetics during the day while using Tri-Luma. Avoid getting Tri-Luma in your eyes, nose, or mouth. If it comes into contact with these areas, flush with plenty of water. Seek medical attention promptly if severe irritation occurs. Use Tri-Luma regularly to get the most benefit from it. It may take up to 4 weeks to see significant improvement. However, long-term use (over 8 weeks) without stopping for short periods is not recommended. Inform your doctor if your condition persists or worsens after 4 weeks of treatment.

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SIDE EFFECTS: Mild burning, stinging, redness, dryness, or acne may occur. If any of these effects persist or worsen, notify your doctor or pharmacist. Remember that your doctor has prescribed Tri-Luma because the benefits outweigh the risk of side effects. Many people using Tri-Luma do not experience serious side effects. Seek immediate medical attention if any unlikely but serious side effects occur, such as blistering, skin cracking/shedding, "spider veins" (telangiectasia), stretch marks, other skin discoloration (besides melasma), "hair bumps" (folliculitis), blue-black darkening of the skin, numbness/tingling of hands/feet, increased pain/touch sensitivity. Rarely, excessive absorption of Tri-Luma through the skin may occur, leading to side effects of too much corticosteroid. These side effects are more likely in children and people who use Tri-Luma for a long time or over large areas of the skin. Seek medical attention immediately if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. A severe allergic reaction to Tri-Luma is rare but requires immediate medical attention if symptoms such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or difficulty breathing develop. This is not a complete list of possible side effects. Notify your doctor or pharmacist of any other effects not listed above. In the US, contact your doctor or the FDA at 1-800-FDA-1088. In Canada, contact your doctor or Health Canada at 1-866-234-2345. PRECAUTIONS: Before using Tri-Luma, tell your doctor or pharmacist if you are allergic to it or other corticosteroids (e.g., hydrocortisone, prednisone) or if you have any other allergies. Tri-Luma may contain inactive ingredients, such as sulfites, that can cause allergic reactions or other problems. Talk to your pharmacist for more information. Before using Tri-Luma, disclose your medical history to your doctor or pharmacist, particularly if you have asthma, open sores or broken skin (especially on the face or hands), or other skin conditions (e.g., eczema, psoriasis). Excessive skin bleaching may occur in some cases, leading to an undesirable cosmetic effect in individuals with darker skin. Ask your doctor or pharmacist for more details. Long-term use of corticosteroid medications can make it more difficult for your body to respond to physical stress. Inform your doctor or dentist about your use of Tri-Luma before undergoing surgery or emergency treatment or if you experience a serious illness/injury. Children may be more sensitive to the effects of excessive corticosteroid medication. Although it is highly unlikely to occur with corticosteroids applied to the skin, Tri-Luma may temporarily slow down a child’s rate of growth with prolonged use. However, it should not affect final adult height. Monitor your child’s height periodically. Tri-Luma is not recommended for use during pregnancy. One of the medications in Tri-Luma (tretinoin) has caused harm to unborn babies when taken orally. Discuss the risks and benefits with your doctor. It is unknown whether these drugs pass into breast milk when applied topically. Consult your doctor before breastfeeding. Avoid skin-to-skin contact with your infant in areas where Tri-Luma has been applied.

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DRUG INTERACTIONS: Inform your doctor or pharmacist of all prescription and nonprescription/herbal products you use before using Tri-Luma, especially other medicated skin products (e.g., soaps, cleansers, skin medications, skin-drying cosmetics), hormone-based birth control products (e.g., birth control pills, hormone implants), and cosmetic products or drugs that increase the skin’s sensitivity to the sun (e.g., tanning products, tetracycline antibiotics, quinolone antibiotics such as ciprofloxacin). This document does not contain a complete list of possible interactions. Therefore, before using Tri-Luma, notify your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share the list with your doctor and pharmacist. OVERDOSE: Tri-Luma may be harmful if swallowed or in cases of overdose. If you suspect swallowing or overdose, seek immediate medical attention. US residents can contact their local poison control center at 1-800-222-1222. Canadian residents can call a provincial poison control center. NOTES: Do not share Tri-Luma with others. This medication is prescribed only for your current condition. Do not use it for another skin problem unless instructed to do so by your doctor. A different medication may be necessary. Periodic laboratory and/or medical tests, such as adrenal gland function tests, may be performed to monitor your progress or check for side effects, especially if you use Tri-Luma for an extended time or apply it over large areas of the body. Consult your doctor for more details. Inform all your doctors about your use or prior use of Tri-Luma because it contains a corticosteroid. MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up. STORAGE: Store Tri-Luma in the refrigerator. Do not freeze. Keep all medications out of the reach of children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard expired or unused Tri-Luma. Consult your pharmacist or local waste disposal company for more information on how to safely discard the product. Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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