Mequinol and tretinoin (topical route)


    Brand Name

    US Brand Name

    Solage


    Description

    Mequinol and tretinoin combination solution is used together with a comprehensive skin care and sun avoidance program 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.

    This medicine is available only with your doctor's prescription.


    Before Using

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

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of Solage® in the pediatric population. Safety and efficacy have not been established..

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Solage® in the elderly.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Aminocaproic Acid
    • Aprotinin
    • Avacopan
    • Carbamazepine
    • Chlortetracycline
    • Clarithromycin
    • Demeclocycline
    • Doxycycline
    • Eravacycline
    • Lymecycline
    • Mavacamten
    • Meclocycline
    • Methacycline
    • Minocycline
    • Omadacycline
    • Oxytetracycline
    • Palovarotene
    • Rolitetracycline
    • Sarecycline
    • Tazemetostat
    • Tetracycline
    • Tigecycline
    • Tranexamic Acid

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Fluconazole
    • Ketoconazole
    • Voriconazole

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Eczema or
    • Frequent exposure to sunlight or sunlamps or
    • Sunburn—May cause or increase skin irritation caused by these conditions.
    • Vitiligo, or a family history—Use of this medicine may cause lightening of areas of the skin that have not been treated.

    Proper Use

    Use this medicine only as directed by your doctor. 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.

    This medicine usually comes with patient information leaflet. Read the instructions carefully and make sure you understand them before using this medicine. If you have any questions, ask your doctor.

    This medicine is for use only in the skin. Do not get any of it in your eyes, nose, mouth, or vagina. Rinse it off right away if it does get on these areas.

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

    To use this medicine:

    • Using the applicator tip, apply enough medicine only to the spots identified by your doctor. Be careful not to get any medicine on the skin surrounding these spots, on your lips, or in your eyes, nose, or mouth. Avoid areas of normally colored skin.
    • Do not shower or bathe for at least 6 hours after applying the medicine.
    • Wait for 30 minutes before applying makeup to any treated area.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For topical dosage form (solution):
      • For age or liver spots:
        • Adults—Apply to the affected areas of the skin two times a day (once in the morning and once in the evening), at least 8 hours apart.
        • Children—Use and dose must be determined by your doctor..

    Missed Dose

    If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

    Storage

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    The product is flammable and should be kept away from fire or excessive heat.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for any unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

    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 doctor 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 (eg, permanents, hair removal products).
    • Skin products that cause sensitivity to the sun (eg, products containing spices or limes).
    • Skin products containing a large amount of alcohol (eg, astringents, shaving creams, after-shave lotions).
    • Skin products that are too drying or abrasive (eg, cosmetics, soaps, or skin cleansers).

    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 sunblock 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 doctor 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.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    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 immediately if any of the following side effects occur:

    More common

    • Burning feeling or stinging skin (severe)
    • itching (severe)
    • peeling of the skin (severe)
    • redness of the skin (severe)

    Less common

    • Large blisters on the skin

    Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Burning feeling, stinging, or tingling of the skin (mild)
    • chapping or slight peeling of the skin (mild)
    • itching (mild)
    • lightening of the skin on or around the treated area
    • redness of the skin (mild)
    • skin irritation
    • unusually warm skin (mild)

    Less common

    • Crusting of the skin
    • dry skin
    • skin rash

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

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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