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In the U.S.—

Solagé

• Hypopigmenting agent, topical

Mequinol and Tretinoin (MEC-kwin-all and TRET-i-noyn ) is used to treat areas of the skin that have become darker after repeated exposure to the sun. These areas are called solar lentigines, or age or liver spots.

Mequinol and tretinoin is available only with your doctor's prescription, in the following dosage form:

Topical
• Topical solution (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mequinol and tretinoin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to acitretin, etretinate, isotretinoin, mequinol, tretinoin, or vitamin A preparations. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Mequinol and tretinoin has not been studied in pregnant women. Topical mequinol and tretinoin is not recommended during pregnancy. Topical mequinol and tretinoin may cause fetal harm. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether mequinol and tretinoin passes into the breast milk. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctors.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups. Mequinol and tretinoin should not be used in children.

Older adults— This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines— Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin. When you are using topical mequinol and tretinoin, it is especially important that your health care professional know if you are taking any of the following:

• Fluoroquinolones (ciprofloxacin [e.g., Cipro], enoxacin [e.g., Penetrex], grepafloxacin [e.g., Raxar], levofloxacin [e.g., Levaquin], lomefloxacin [e.g., Maxaquin], norfloxacin [e.g., Noroxin], ofloxacin [e.g., Floxin], sparfloxacin [e.g., Zagam]) or
• Phenothiazines (chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mezoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin]) or
• Sulfonamides (sulfa medicine) or
• Tetracyclines (medicine for infection) or
• Thiazide diuretics (water pills)—These medicines may cause your skin to become more sensitive to light

Other medical problems—The presence of other medical problems may affect the use of mequinol and tretinoin topical solution. Make sure you tell your doctor if you have any other medical problems, especially:

• Eczema or
• Frequent exposure to sunlight or sunlamps or
• Sunburn—Use of this medicine may cause or increase the irritation associated with these conditions
• Vitiligo (or a family history of this condition)—Use of this medicine may cause lightening of areas of the skin that have not been treated

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

Do not use this medicine in or around the eyes or lips, or inside of the nose. Spread the medicine away from these areas when applying. If the medicine accidentally gets on these areas, wash with water at once.

This medicine usually comes with patient directions. Read them carefully before using the medicine.

To use this medicine:

• Using the applicator tip, apply enough mequinol and tretinoin solution to cover the affected areas. Apply only enough medicine to make the lesion appear moist. Avoid areas of normally colored skin.
• You should not shower or bathe for at least 6 hours after applying the medicine.
• Cosmetics may be applied 30 minutes after application of the medicine.

Dosing—

Follow your doctor's orders or the directions on the label. The following information includes usual dose of topical mequinol and tretinoin. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical dosage form (solution):
  • For age or liver spots:
    • Adults —Apply to the affected areas of the skin twice daily, morning and evening, at least 8 hours apart.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light. The product is flammable and should be kept away from fire or excessive heat.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

You may notice redness, stinging, burning or irritation when you first start using this medicine. It may take up to 6 months before you notice full beneficial effects, even if you use the medicine every day. Check with your health care professional at any time skin irritation becomes severe or if your age spots get darker in color.

Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as mequinol and tretinoin topical solution:

• Hair products that are irritating, such as permanents or hair removal products
• Skin products that cause sensitivity to the sun, such as those containing spices or limes
• Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions
• Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers

Using these products along with mequinol and tretinoin may cause mild to severe irritation of the skin. Check with your doctor before using other topical medicines.

Avoid overexposing the treated areas to sunlight, wind, or cold weather. The skin will be more prone to sunburn, dryness, or irritation. Do not use a sunlamp.

Regularly use sunscreen or sunblocking lotions with a sun protection factor (SPF) of at least 15. Also, wear protective clothing and hats, and apply creams, lotions, or moisturizers often.

Check with your doctor any time your skin becomes too dry and irritated. Your health care professional can help you choose the right skin products for you to reduce skin dryness and irritation and may include :

• Taking part in an ongoing program to avoid further damage to your skin from the sun. The program should stress staying out of the sun when possible and wearing proper clothing or hats to protect your skin from sunlight.
• Regular use of oil-based creams or lotions to help to reduce skin irritation or dryness caused by the use of mequinol and tretinoin topical solution.

In some animal studies, mequinol and tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if mequinol and tretinoin topical solution causes skin tumors to develop faster in humans.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Burning feeling or stinging skin (severe);  itching (severe);  peeling of skin (severe);  redness of skin (severe) 
  
  

• Less common
  • Allergic reaction;  large blisters on the skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Burning feeling, stinging, or tingling of skin (mild)—lasting for a short time after first applying the medicine;  itching (mild);  chapping or slight peeling of skin (mild);  lightening of skin around treated area;  lightening of skin on treated area;  redness of skin (mild);  skin irritation;  unusually warm skin (mild) 
  
  

• Less common
  • Crusting of skin;  dry skin;  skin rash 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 04/26/2000