Mometasone (topical application route)


    Brand Name

    US Brand Name

    Elocon

    Canadian Brand Name

    Elocom

    Pms-Mometasone


    Description

    Mometasone topical is used to relieve redness, itching, swelling, or other discomfort caused by certain skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

    This product is available in the following dosage forms:

    • Cream
    • Ointment
    • Lotion
    • Solution

    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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mometasone topical cream and ointment in children 2 years of age and older, and topical lotion in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Use of the topical cream and ointment in children younger than 2 years of age, and the lotion in children younger than 12 years of age, is not recommended.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mometasone topical in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

    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:

    • Cushing's syndrome (adrenal gland disorder) or
    • Diabetes or
    • Hyperglycemia (high blood sugar) or
    • Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.
    • Infection of the skin at or near the place of application or
    • Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

    Proper Use

    It is very important that you 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 unwanted side effects or skin irritation.

    This medicine is for use on the skin only. Do not get it into your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

    This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

    Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.

    Do not use this medicine in the diaper area of an infant. Diapers or plastic pants will increase the amount of medicine absorbed through the skin and cause unwanted side effects.

    To use:

    • Wash your hands with soap and water before and after using this medicine.
    • Apply a thin layer of this medicine to the affected area of the skin. Rub it in or massage it gently.
    • Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
    • If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

    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 redness, itching, and swelling of the skin:
      • For topical dosage forms (cream or ointment):
        • Adults and children 2 years of age and older—Apply to the affected area of the skin once a day.
        • Children younger than 2 years of age—Use is not recommended.
      • For topical dosage form (lotion):
        • Adults and children 12 years of age and older—Apply to the affected area of the skin once a day.
        • Children younger than 12 years of age—Use is not recommended.

    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

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

    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.


    Precautions

    It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

    If your or your child's symptoms do not improve within 2 weeks, or if they become worse, check with your doctor.

    Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

    Check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

    Do not use cosmetics or other skin care products on the treated areas.


    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:

    Less common

    • Burning
    • itching
    • thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)

    Incidence not known

    • Blindness
    • blurred vision
    • change in vision
    • decreased vision
    • dryness
    • eye pain
    • headache
    • irritation
    • loss of vision
    • nausea
    • redness and scaling around the mouth
    • tearing
    • vomiting

    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:

    Less common

    • Acne or pimples
    • burning, itching, and pain in hairy areas, or pus at the root of the hair
    • dry mouth
    • loss of elasticity
    • loss of normal skin markings
    • raised, dark red, and wart-like spots on the skin, especially when used on the face
    • shininess

    Incidence not known

    • Burning and itching of the skin with pinhead-sized red blisters
    • increased hair growth on the forehead, back, arms, and legs
    • lightening of normal skin color
    • lightening of treated areas of dark skin
    • reddish purple lines on the arms, face, legs, trunk, or groin

    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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