Brand Name

    US Brand Name

    Altreno

    Atralin

    Avita

    Refissa

    Renova

    Retin-A

    Retin-A Micro

    Tretin-X

    Canadian Brand Name

    Rejuva-A

    Stieva-A Cream

    Stieva-A Cream Forte

    Stieva-A Gel

    Stieva-A Solution

    Vitamin A Acid


    Description

    Tretinoin is used to treat acne or other skin diseases as determined by your doctor. It works partly by keeping skin pores clear.

    One of the tretinoin creams is used to treat fine wrinkles, dark spots, or rough skin on the face caused by the damaging rays of the sun. It works by lightening the skin, replacing older skin with newer skin, and slowing down the way the body removes skin cells that may have been harmed by the sun. Tretinoin works best when used within a skin care program that includes protecting the treated skin from the sun. However, it does not completely or permanently erase these skin problems or greatly improve more obvious changes in the skin, such as deep wrinkles caused by the sun or the natural aging process.

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

    This product is available in the following dosage forms:

    • Gel/Jelly
    • Cream
    • Lotion

    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 tretinoin in children younger than 9 years of age. 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 tretinoin 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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:

    • Dermatitis, seborrheic (dandruff) or
    • Eczema (skin problem) or
    • Fish allergy or
    • Sunburn—Use with caution. May cause or increase skin irritation, itching, or other skin problems.

    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 should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    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 it accidentally gets on these areas, wash with water at once.

    Before applying tretinoin, wash the skin with a mild soap or cleanser and warm water by using the tips of your fingers. Then gently pat dry. Do not scrub your face with a sponge or washcloth. Wait 20 to 30 minutes before applying this medicine to make sure the skin is completely dry. Applying tretinoin to wet skin can irritate it.

    To use the cream, gel, or lotion form of this medicine:

    • Apply just enough medicine to very lightly cover the affected areas, and rub in gently but well. A pea-sized amount is enough to cover the whole face.
    • You may need to use a moisturizer while you are using the lotion.

    To use the liquid form of this medicine:

    • Using your fingertips, gauze pad, or cotton swab, apply enough tretinoin solution to cover the affected areas. If you use a gauze pad or a cotton swab for applying the medicine, avoid getting it too wet. This will help prevent the medicine from running into areas not intended for treatment.

    After applying the medicine, wash your hands to remove any medicine that might remain on them.

    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 acne:
      • For topical dosage forms (cream, gel, or liquid):
        • Adults—Apply to the affected area(s) of the skin once a day, at bedtime.
        • Children— Use and dose must be determined by your doctor.
      • For topical dosage form (lotion):
        • Adults and children 9 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day.
        • Children younger than 9 years of age— Use and dose must be determined by your doctor.
    • For fine wrinkles, dark spots, or rough skin caused by the sun:
      • For topical dosage form (cream):
        • Adults younger than 50 years of age—Apply to the affected area(s) of the skin once a day, at bedtime.
        • Adults 50 years of age and older—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take 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. Do not double doses.

    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.

    Do not freeze.

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


    Precautions

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

    During the first 3 weeks you are using tretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. It may take longer than 12 weeks before you notice full improvement of your acne, even if you use the medicine every day. Check with your doctor if skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

    You should avoid washing the skin treated with tretinoin for at least 1 hour after applying it.

    Avoid using any topical medicine on the same area within 1 hour before or after using tretinoin. Otherwise, tretinoin may not work properly or skin irritation might occur.

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

    • Any other topical acne product or skin product containing a peeling agent (eg, benzoyl peroxide, resorcinol, salicylic acid, or sulfur).
    • Hair products that are irritating, such as permanents or hair removal products.
    • Skin products that cause sensitivity to the sun, including those containing spices or limes.
    • Skin products containing a large amount of alcohol (eg, 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 tretinoin may cause mild to severe irritation of the skin. Although skin irritation can occur, some doctors sometimes allow benzoyl peroxide to be used with tretinoin to treat acne. Usually tretinoin is applied at night so that it does not cause a problem with any other topical products that you might use during the day. Check with your doctor before using topical medicines with tretinoin.

    During the first 6 months of use, avoid overexposing the treated areas to sunlight, wind, or cold weather. The skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks. However, you should not stop using this medicine unless the skin irritation becomes too severe. Do not use a sunlamp.

    To help tretinoin work properly, 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 at 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 the following:

    • For patients using tretinoin for the treatment of acne:
      • Regular use of water-based creams or lotions helps to reduce skin irritation or dryness that may be caused by the use of tretinoin.
    • For patients using tretinoin for the treatment of fine wrinkling, dark spots, and rough skin caused by the sun:
      • This medicine should be used as part of an ongoing program to avoid further damage to your skin from the sun. This program includes staying out of the sun when possible or wearing proper clothing or hats to protect your skin from sunlight.
      • Regular use of oil-based creams or lotions helps to reduce skin irritation or dryness caused by the use of tretinoin.

    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, stinging, peeling, redness, or unusual dryness of the skin (severe)

    Less common

    • Dryness, pain, redness, irritation, or peeling at the application site

    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, itching, stinging, scaling, or redness of the skin
    • chapping or slight peeling of the skin (mild)
    • darkening of the skin
    • lightening of normal skin color
    • lightening of treated areas of dark skin
    • redness of skin (mild)
    • unusual dryness of skin (mild)
    • unusually warm skin (mild)

    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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