Mometasone furoate ointment usp 0 1

Contents

Elocon Ointment

Brand Names: Elocon

Generic Name: mometasone topical

  • What is mometasone topical (Elocon)?
  • What are the possible side effects of mometasone topical (Elocon)?
  • What is the most important information I should know about mometasone topical (Elocon)?
  • What should I discuss with my healthcare provider before using mometasone topical (Elocon)?
  • How should I use mometasone topical (Elocon)?
  • What happens if I miss a dose (Elocon)?
  • What happens if I overdose (Elocon)?
  • What should I avoid while using mometasone topical (Elocon)?
  • What other drugs will affect mometasone topical (Elocon)?
  • Where can I get more information (Elocon)?

What is mometasone topical (Elocon)?

Mometasone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation.

Mometasone topical (for the skin) is used to treat the symptoms of certain skin conditions, such as pain, redness, warmth, swelling, or itching.

Mometasone topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of mometasone topical (Elocon)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe skin irritation;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or
  • high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor.

Mometasone topical can affect growth in children and should not be used long-term.

Common side effects may include:

  • red or pus-filled bumps on your skin;
  • acne; or
  • mild itching, tingling, or burning.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mometasone topical (Elocon)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Why do dermatologists suggest mometasone furoate cream for acne and black spots, if it is dangerous to use on the face?

Very uncommonly might be prescribed for severe inflammatory lesions or to tackle untoward reactions of procedures like chemical peel, for short duration. No dermatologist would prescribe it for acne or spots per se.

Unfortunately steroid containing creams are misused by many as a fairness creams. It leads to adverse effects. Steroid Dependant/Damaged Face (TSDF) is a difficult to treat skin problem arising due to misuse of steroidal creams on face.

Above picture is adverse effects of steroidal combination cream due to self treatment of ringworm in thighs and groin area.

Steroidal creams cause skin thinning, changes in local blood vessels, redness, stretchmarks depending upon their potency (strong/mild) and duration of application. Some are reversible, some are permanent. Also worse part is steroid dependance, meaning rebound of symptoms like itching, burning, redness are worse when person stops applying them. And person has to use steroidal cream in incremental dosage to control this rebound.

Dermatologists always discourage use of steroidal combination creams (Dermi5, ClobateGM, Pentaderm etc) for treatment of skin infections, unless specifically required in select patients.

Elocon

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion.

If HPA axis suppression is noted, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios .

If irritation develops, ELOCON Cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of ELOCON Cream should be discontinued until the infection has been adequately controlled.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of ELOCON Cream. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from ELOCON Cream on a mcg/m² basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from ELOCON Cream on a mcg/m² basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from ELOCON Cream, on a mcg/m² basis).

Use In Specific Populations

Teratogenic Effects – Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Therefore, ELOCON Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from ELOCON Cream on a mcg/m² basis.)

In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from ELOCON Cream on a mcg/m² basis.)

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from ELOCON Cream on a mcg/m² basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from ELOCON Cream on a mcg/m² basis.)

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from ELOCON Cream on a mcg/m² basis.)

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when ELOCON Cream is administered to a nursing woman.

ELOCON Cream may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of ELOCON Cream have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.

In a pediatric trial, 24 atopic dermatitis subjects, of whom 19 subjects were age 2 to 12 years, were treated with ELOCON Cream once daily. The majority of subjects cleared within 3 weeks.ELOCON Cream caused HPA axis suppression in approximately 16% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 41% (range 15%-94%). The criteria for suppression were: basal cortisol level of ≤ 5 mcg/dL, 30-minute post-stimulation level of ≤ 18 mcg/dL, or an increase of < 7 mcg/dL. Follow-up testing 2 to 4 weeks after trial completion, available for 5 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population .

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

ELOCON Cream should not be used in the treatment of diaper dermatitis.

Clinical studies of ELOCON Cream included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

  • Take care to avoid getting the cream or ointment in your eyes, mouth or nose. Rinse with cold water if accidental contact occurs.
  • Wash your hands thoroughly after applying Elocon, unless the hands are the area being treated.
  • Don’t cover the area being treated with airtight dressings such as bandages or other dressings unless directed by a doctor, as these increase the absorption of the medicine into the body and so increase the risk of side effects. If your doctor has advised you to use dressings with Elocon, you should cleanse the skin before applying the cream or ointment under a fresh dressing. Be aware that nappies and waterproof pants can act as an airtight dressing and can increase the absorption of the medicine.
    • You should continue using Elocon for as long as your doctor has prescribed. However, if you’re using it on a child, it should preferably not be used for more than one to two weeks at a time. Always follow the instructions given by your doctor. If your skin condition has not improved after two weeks of treatment you should consult your doctor.
    • Don’t use Elocon more often or for longer than advised by your doctor.
    • If you think the area of skin you are treating has become infected you should stop using Elocon and consult your doctor.

    Who shouldn’t use Elocon cream or ointment?

    • Elocon cream and ointment are not licensed for children under two years of age.
    • Don’t apply Elocon to broken or ulcerated skin or open wounds, or areas of skin affected by any of the following conditions:
      • Viral skin infections, such as chickenpox, shingles, cold sores, herpes simplex, warts or verrucas.
      • Bacterial skin infections, such as impetigo.
      • Fungal skin infections, such as thrush, ringworm, athlete’s foot.
      • Acne.
      • Acne rosacea.
      • Inflammatory rash around the mouth (perioral dermatitis).
      • Itchy skin where there is no inflammation.
      • Widespread plaque psoriasis.
      • Genital itching.
      • Nappy rash.
    • Don’t use Elocon if you’re allergic to any of its ingredients. Check the ingredients listed in the leaflet that comes with the medicine if you know you have specific allergies.
    • Never use Elocon cream or ointment as a moisturiser.

    Can I use Elocon while pregnant or breastfeeding?

    • Not unless you’ve discussed this with your doctor.
    • Studies in animals have shown that corticosteroids applied to the skin of pregnant animals can cause abnormalities in the development of the foetus, such as cleft palate or slowed growth of the baby in the womb. Studies in animals do not necessarily relate to effects in humans, but there may be a small risk of such effects if enough steroid is absorbed through the skin into the bloodstream of pregnant women. Similarly, if enough steroid is absorbed through the skin of breastfeeding women it could potentially pass into breast milk.
    • If your doctor says you can use Elocon while pregnant or breastfeeding you should not use it on large areas of skin, underneath airtight dressings, or for prolonged periods of time. This will minimise any absorption of the steroid. If you need to apply Elocon to your breasts don’t do this shortly before giving a feed. Ask your doctor or pharmacist for further information.

    What are the possible side effects of Elocon?

    Medicines and their possible side effects can affect individual people in different ways. Potent topical corticosteroids like Elocon have more potential to cause side effects than milder steroids. However, when applied sparingly, no more more than once a day, as directed by your doctor, side effects are still rare.

    Side effects are more likely if you use Elocon on extensive areas of skin, broken or raw skin, delicate areas of skin like the face, areas of skin that rub together like armpits or skin folds, or if you use it underneath airtight dressings or for long periods of time.

    The following side effects are known to be associated with topical corticosteroids. Just because a side effect is stated here doesn’t mean that all people using Elocon will experience that or any side effect.

    • Skin irritation, eg redness, rash, itching or burning on application, or allergic inflammation of the skin (contact dermatitis). Stop using Elocon and consult your doctor if you think you have experienced a reaction or your skin condition appears to be getting worse.
    • Spread or worsening of untreated skin infections.
    • Thinning of the skin.
    • Reduced skin pigmentation.
    • Stretch marks (striae).
    • Groupings of fine blood vessels becoming prominent under the skin (telangiectasia).
    • Excessive hair growth (hypertrichosis).
    • Acne.
    • On rare occasions enough corticosteroid may be absorbed to have side effects on other parts of the body, for example a decrease in the production of natural hormones by the adrenal glands or Cushing’s syndrome. You can read more about the possible side effects of topical corticosteroids here.
    • If you experience any changes in your vision while using Elocon, such as blurred vision, you should tell your doctor.

    Read the leaflet that comes with the medicine, or talk to your pharmacist or doctor if you want any more information about the possible side effects of Elocon. If you think you have experienced a side effect, did you know you can report this using the yellow card website?

    Can I use Elocon with other medicines?

    Make sure your doctor or pharmacist know if you’re already using any other medicines, particularly if you’re already using any other corticosteroid medicines (including those bought without a prescription like nasal sprays for hay fever) before you start using Elocon.

    If you need to use other topical medicines on the same area of skin it’s recommended that you leave several minutes between applying each product. This is to allow each product time to be absorbed and avoid them mixing on the skin.

    If you also use a moisturiser it’s best to apply it about 30 minutes before applying Elocon. This will help soften the skin and improve the absorption of the corticosteroid. If you apply a moisturiser just before or after applying Elocon this can dilute the corticosteroid and potentially make it less effective.

    What other medicines contain mometasone?

    • Elocon scalp lotion.

    Mometasone cream and ointment are also available without a brand name, ie as the generic medicine.

    As mometasone reduces inflammation it is also found in various other medicines that are used to treat inflammatory conditions in other parts of the body. These include Asmanex twisthaler for asthma and Nasonex nasal spray for hay fever.

    Last updated 21.12.2017

    Helen Marshall, BPharm, MRPharmS Helen Marshall, BPharm, MRPharmS A UK registered pharmacist with a background in hospital pharmacy.

  • Unless advised to do so by your doctor, do not apply a bandage or dressing to the area being treated, as this will increase absorption of the preparation and increase the risk of side-effects.
  • Continue to use mometasone until the flare-up has gone, and then stop it. A course of treatment for 7-14 days is often sufficient. If your symptoms have not improved after this time (or if they get worse), speak again with your doctor for further advice. Topical corticosteroids like mometasone should not be used for long periods of time or on large areas of the body.
  • After you finish using mometasone, continue to use your moisturiser every day. This will help to prevent a further flare-up. Your doctor may also prescribe a less potent steroid cream for you to use when needed.
  • Can mometasone cause problems?

    Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. You can reduce the risk of side-effects from mometasone, by applying the preparation thinly, no more than once a day, and to the affected areas only.

    Side-effects of mometasone skin preparations What can I do if I experience this?
    Burning or smarting These may occur in the first few days but usually get better after this
    Thinning of the skin, permanent stretchmarks, allergic contact dermatitis, acne, rosacea, and hair growth at the site of application These would normally only affect you if you use mometasone for long periods of time
    Mometasone may get through your skin and into your bloodstream This usually causes no problem unless you use mometasone regularly on large areas of your skin

    If you experience any other symptoms which you think may be due to mometasone, speak with your doctor or pharmacist for further advice.

    How to store mometasone

    • Keep all medicines out of the reach and sight of children.
    • Store in a cool, dry place, away from direct heat and light.

    Important information about all medicines

    Make sure that the person prescribing this medicine knows about any other medicines that you are taking or using. This includes medicines you buy and herbal and homeopathic medicines.

    Before using this medicine tell your doctor if you have ever had an allergic reaction after taking or using any medicine.

    Never use more than the prescribed dose. If you suspect that someone has swallowed some of the medicine by accident, contact the accident and emergency department of your local hospital for advice.

    If you are having an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking or using.

    If you buy any medicines check with a pharmacist that they are safe to take with your other medicines.

    This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

    Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

    If you have any questions about this medicine ask your pharmacist.

    Mometasone skin cream, lotion, or ointment

    What is this medicine?

    MOMETASONE (moe MET a sone) is a corticosteroid. It is used to treat skin problems that may cause itching, redness, and swelling.

    This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

    COMMON BRAND NAME(S): Elocon

    What should I tell my health care provider before I take this medicine?

    They need to know if you have any of these conditions:

    • acne or rosacea

    • any type of active infection

    • large areas of burned or damaged skin

    • skin wasting or thinning

    • an unusual or allergic reaction to mometasone, steroids, other medicines, foods, dyes, or preservatives

    • pregnant or trying to get pregnant

    • breast-feeding

    How should I use this medicine?

    This medicine is for external use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Apply a thin film to the affected area and rub in gently. Do not bandage or wrap the skin being treated unless directed to do so by your doctor or health care professional. Do not use on healthy skin or over large areas of skin. Do not get this medicine in your eyes. If you do, rinse it out with plenty of cool tap water. Use your doses at regular intervals. Do not use your medicine more often than directed or for a longer period of time than ordered by your doctor or health care professional. To do so may increase the chance of side effects.

    Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply. Do not use this medicine on the diaper area of a child. Diapers or plastic pants are considered air tight bandages and may increase the amount of medicine that is absorbed and increase the risk of serious side effects.

    Elderly patients are more likely to have damaged skin through aging, and this may increase side effects. This medicine should only be used for brief periods and infrequently in older patients.

    Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

    NOTE: This medicine is only for you. Do not share this medicine with others.

    What if I miss a dose?

    If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

    What may interact with this medicine?

    Interactions are not expected. Do not use any other skin products without telling your doctor or health care professional.

    This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

    What should I watch for while using this medicine?

    Tell your doctor or health care professional if your symptoms do not get better within 2 weeks.

    This medicine may increase your risk of getting an infection. Tell your doctor or health care professional if you are around anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

    What side effects may I notice from receiving this medicine?

    Side effects that you should report to your doctor or health care professional as soon as possible:

    • painful, red, pus filled blisters in hair follicles

    • severe burning and continued itching of the skin

    • thinning of the skin with easy bruising

    Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

    • burning, itching, or irritation of the skin

    • increased redness or scaling of the skin

    This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Where should I keep my medicine?

    Keep out of the reach of children.

    Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) away from heat and direct light. Do not freeze. Throw away any unused medicine after the expiration date.

    NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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    SIDE EFFECTS

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

    In controlled clinical trials involving 812 subjects, the incidence of adverse reactions associated with the use of ELOCON Ointment was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Cases of rosacea associated with the use of ELOCON Ointment have been reported.

    The following adverse reactions were reported to be possibly or probably related to treatment with ELOCON Ointment during a clinical study in 5% of 63 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 1; an unspecified skin disorder, 1; and a bacterial skin infection, 1. The following signs of skin atrophy were also observed among 63 subjects treated with ELOCON Ointment in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness, 1.

    Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings.

    Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

    Read the entire FDA prescribing information for Elocon Ointment (Mometasone Furoate Ointment)

    Mometasone Cream

    Generic Name: mometasone furoate
    Dosage Form: cream

    Medically reviewed by Drugs.com. Last updated on May 1, 2019.

    • Overview
    • Side Effects
    • Dosage
    • Professional
    • Interactions
    • More

    Indications and Usage for Mometasone Cream

    Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.

    Mometasone Cream Dosage and Administration

    Apply a thin film of mometasone furoate cream, 0.1% to the affected skin areas once daily. Mometasone furoate cream, 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of mometasone furoate cream, 0.1% have not been established in pediatric patients below 2 years of age; use in this age group is not recommended . Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary . Do not use mometasone furoate cream, 0.1% with occlusive dressings unless directed by a physician. Do not apply mometasone furoate cream, 0.1% in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing. Avoid contact with eyes. Wash hands after each application. Avoid use on the face, groin, or axillae. Mometasone furoate cream, 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

    Dosage Forms and Strengths

    Cream, 0.1%. Each gram of Mometasone Furoate Cream USP, 0.1% contains 1 mg of mometasone furoate, USP in a white to off-white, uniform and smooth cream.

    Contraindications

    Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

    Warnings and Precautions

    Effects on Endocrine System

    Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion. If HPA axis suppression is noted, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios .

    ​5.2 Ophthalmic Adverse Reactions

    ​Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroids, including the topical mometasone products . ​Avoid contact of mometasone furoate cream with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

    Allergic Contact Dermatitis

    If irritation develops, mometasone furoate cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

    Concomitant Skin Infections

    If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate cream should be discontinued until the infection has been adequately controlled.

    Adverse Reactions

    Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of mometasone furoate cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of mometasone furoate cream have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of mometasone furoate cream was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis. The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate cream during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with mometasone furoate cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.

    Postmarketing Experience

    Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings. Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

    Drug Interactions

    No drug-drug interaction studies have been conducted with mometasone furoate cream.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m2 basis.) In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m2 basis.) In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m2 basis.) When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m2 basis.)

    Nursing Mothers

    Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate cream is administered to a nursing woman.

    Pediatric Use

    Mometasone furoate cream may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of mometasone furoate cream have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. In a pediatric trial, 24 atopic dermatitis subjects, of whom 19 subjects were age 2 to 12 years, were treated with mometasone furoate cream once daily. The majority of subjects cleared within 3 weeks. Mometasone furoate cream caused HPA axis suppression in approximately 16% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after trial completion, available for 5 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population . Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Mometasone furoate cream should not be used in the treatment of diaper dermatitis.

    Geriatric Use

    Clinical studies of mometasone furoate cream included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

    Overdosage

    Topically applied mometasone furoate cream can be absorbed in sufficient amounts to produce systemic effects .

    Mometasone Cream Description

    Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity.

    Mometasone furoate, USP is a white to off-white powder, soluble in acetone and methylene chloride.

    Each gram of Mometasone Furoate Cream USP, 0.1% contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax.

    Mometasone Cream – Clinical Pharmacology

    Mechanism of Action

    Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

    Pharmacodynamics

    Studies performed with mometasone furoate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids. In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The cream was applied without occlusion to at least 30% of the body surface. The results showed that the drug caused a slight lowering of adrenal corticosteroid secretion . Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. Mometasone furoate cream was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). In approximately 16% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate cream. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the subjects, demonstrated suppressed HPA axis function in one subject, using these same criteria .

    Pharmacokinetics

    The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.4% of the applied dose of mometasone furoate cream enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

    Nonclinical Toxicology

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate cream. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m2 basis). Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes. In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream, on a mcg/m2 basis).

    Clinical Studies

    The safety and efficacy of the mometasone furoate cream for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis. A total 366 subjects (12 to 81 years of age), of whom 177 received mometasone furoate cream and 181 subjects received vehicle cream, were evaluated in these trials. Mometasone furoate cream or the vehicle cream were applied once daily for 21 days. The two trials showed mometasone furoate cream is effective in the treatment of psoriasis and atopic dermatitis.

    How Supplied/Storage and Handling

    Mometasone furoate cream USP, 0.1% is a white to off-white, uniform and smooth cream and is supplied in 15 g (NDC 16714-974-01) and 45 g (NDC 16714-974-02) tubes.

    Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Avoid excessive heat.

    Patient Counseling Information

    Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following: • Use mometasone furoate cream as directed by the physician. It is for external use only. • Avoid contact with the eyes. • Advise patients to report any visual symptoms to their healthcare providers. • Do not use mometasone furoate cream on the face, underarms, or groin areas unless directed by the physician. • Do not use mometasone furoate cream for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician. • Report any signs of local adverse reactions to the physician. • Advise patients not to use mometasone furoate cream in the treatment of diaper dermatitis. Do not apply mometasone furoate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing. • Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Do not use other corticosteroid-containing products with mometasone furoate cream without first consulting with the physician.

    Manufactured for:

    Northstar Rx LLC

    Memphis, TN 38141.

    Manufactured by:

    Glenmark Pharmaceuticals Ltd.
    Village: Kishanpura, Baddi Nalagarh Road,
    Dist: Solan, Himachal Pradesh – 173205, India.

    May 2019

    Patient Information

    Mometasone Furoate (moe-MET-a-sone-FYOOR-oh-ate)

    Cream, 0.1%

    Important information: Mometasone furoate cream is for use on skin only. Do not use mometasone furoate cream in your eyes, mouth, or vagina.

    What is Mometasone furoate cream?

    • Mometasone furoate cream is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 2 years of age and older. • It is not known if mometasone furoate cream is safe and effective for use in children under 2 years of age. • Mometasone furoate cream should not be used in children under 2 years of age. • It is not known if mometasone furoate cream is safe and effective for use in children longer than 3 weeks.

    Do not use mometasone furoate cream if you are allergic to mometasone furoate or any of the ingredients in mometasone furoate cream, 0.1%. See the end of this leaflet for a complete list of ingredients in mometasone furoate cream.

    Before using mometasone furoate cream, tell your healthcare provider about all your medical conditions, including if you:

    • have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. • are pregnant or plan to become pregnant. It is not known if mometasone furoate cream will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if mometasone furoate cream passes into your breast milk.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.

    How should I use mometasone furoate cream?

    • Use mometasone furoate cream exactly as your healthcare provider tells you to use it. • Apply a thin film of mometasone furoate cream to the affected skin area 1 time each day. • Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment. • Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. • Mometasone furoate cream should not be used to treat diaper rash or redness. Do not apply mometasone furoate cream in the diaper area if wearing diapers or plastic pants. • Avoid using mometasone furoate cream on the face, groin, or underarms (armpits). • Wash your hands after applying mometasone furoate cream.

    What are the possible side effects of mometasone furoate cream?

    Mometasone furoate cream may cause serious side effects, including:

    • Mometasone furoate cream can pass through your skin. Too much mometasone furoate cream passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. • Vision problems. Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate cream. • Skin problems. Skin problems may happen during treatment with mometasone furoate cream, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate cream and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate cream.

    The most common side effects of mometasone furoate cream include burning, itching, and thinning of the skin (atrophy). These are not all the possible side effects of mometasone furoate cream.

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

    How should I store mometasone furoate cream?

    • Store mometasone furoate cream at room temperature between 68°F to 77°F (20°C to 25°C). • Keep mometasone furoate cream and all medicines out of the reach of children.

    General information about the safe and effective use of mometasone furoate cream.

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate cream for a condition for which it was not prescribed. Do not give mometasone furoate cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate cream that is written for health professionals.

    What are the ingredients in mometasone furoate cream, 0.1%?

    Active ingredient: mometasone furoate

    Inactive ingredients: aluminum starch octenyl succinate (Dry-Flo Plus(Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax.

    Manufactured for:

    Northstar Rx LLC

    Memphis, TN 38141.

    Manufactured by:

    Glenmark Pharmaceuticals Ltd.

    Village: Kishanpura, Baddi Nalagarh Road,

    Dist: Solan, Himachal Pradesh – 173205, India.

    May 2019

    This Patient Information has been approved by the U.S. Food and Drug Administration.

    Package/Label Display Panel

    NDC 16714-974-01

    Mometasone Furaoate Cream USP, 0.1%

    MOMETASONE FUROATE
    mometasone furoate cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16714-974
    Route of Administration TOPICAL DEA Schedule
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MOMETASONE FUROATE (MOMETASONE) MOMETASONE FUROATE 1 mg in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALUMINUM STARCH OCTENYLSUCCINATE
    HEXYLENE GLYCOL
    HYDROGENATED SOYBEAN LECITHIN
    PHOSPHORIC ACID
    WATER
    TITANIUM DIOXIDE
    PETROLATUM
    WHITE WAX
    Packaging
    # Item Code Package Description
    1 NDC:16714-974-01 15 g in 1 TUBE
    2 NDC:16714-974-02 45 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078541 09/17/2019

    Labeler – NORTHSTAR RX LLC (830546433)

    Establishment
    Name Address ID/FEI Operations
    Glenmark Pharmaceuticals Limited 676115028 ANALYSIS(16714-974), MANUFACTURE(16714-974)
    Establishment
    Name Address ID/FEI Operations
    Sterling Spa 338689703 API MANUFACTURE(16714-974)

    NORTHSTAR RX LLC

    Medical Disclaimer

    More about mometasone topical

    • Side Effects
    • During Pregnancy
    • Dosage Information
    • Drug Interactions
    • Compare Alternatives
    • Pricing & Coupons
    • En Español
    • 68 Reviews
    • Drug class: topical steroids

    Consumer resources

    • Mometasone topical
    • Mometasone (Topical)
    • Mometasone Topical application (Advanced Reading)

    Professional resources

    • Mometasone Furoate topical (AHFS Monograph)
    • Mometasone (Topical) (Wolters Kluwer)
    • Mometasone Lotion (FDA)
    • Mometasone Ointment (FDA)

    Other brands: Elocon

    Related treatment guides

    • Eczema
    • Psoriasis
    • Atopic Dermatitis
    • Dermatitis

    Order mometasone furoate – Mometasone Cream – FDA prescribing information, side effects and uses

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    INVESTIGATION

    Action of topical mometasone on the pigmented halos of micrografting in patients with vitiligo

    Ação da mometasona tópica nos halos pigmentares de microenxertia em vitiligo

    Karine Dantas Diógenes SaldanhaI; Carlos D’Apparecida Santos Machado FilhoII; Francisco Macedo PaschoalIII

    IDermatologist – Master in health sciences by the Faculdade de Medicina do ABC (FMABC) – Santo André (SP), Brazil
    IILecturer by the Faculdade de Medicina ABC – Director of the Discipline of Dermatology of the Faculdade de Medicina do ABC (FMABC) – Santo André (SP), Brazil
    IIIPhD in Health Sciences by the Faculdade de Medicina of the Universidade de São Paulo (USP) – Assistant Professor of the Discipline of Dermatology of the Faculdade de Medicina do ABC (FMABC) – Santo André (SP), Brazil

    Mailing address

    ABSTRACT

    BACKGROUND: Vitiligo is a prevalent skin pigmentation disorder worldwide. The treatments available still offer limited results to some patients. For patients with clinically stable vitiligo, melanocyte transplantation is an appropriate treatment option, and the technique of autologous punch grafting shows good repigmentation.
    OBJECTIVE: To evaluate the effect of topical mometasone on the halos of repigmentation after autologous punch grafting in patients with clinically stable vitiligo.
    METHODS: Between 2009 and 2010, 11 patients with clinically stable vitiligo (7 generalized, 2 focal and 2 segmental) underwent autologous punch grafting in the achromic patches. According to the clinical type of vitiligo, patients were instructed to use the corticosteroid ointment during 6 months, only on a few grafted lesions. In the first month, the mometasone ointment was used twice a day and after that just once. They were reassessed 1, 3 and 6 months after the procedure. Grafted halos were photographed and recorded using the software fotofinder. After 6 months, all the treated and untreated areas of the repigmentation halos were measured and analyzed comparatively.
    RESULTS: The median area of the repigmentation halos after 6 months of treatment with mometasone was larger (25,96 mm2 ) than the one of the untreated halos (13,86 mm2 ), showing a statistically significant difference (p = 0,026).
    CONCLUSION: In this study, the use of mometasone ointment increased the area of the repigmentation halos after punch grafting. However, this should be further investigated in larger samples in order to validate this positive action in the treatment of stable vitiligo.

    Keywords: Glucocorticoids; Transplantation; Vitiligo

    RESUMO

    FUNDAMENTOS: Vitiligo é um transtorno de pigmentação freqüente na população mundial. Seu tratamento ainda oferece resultados limitados em alguns pacientes. Nos casos de vitiligo estável clinicamente, o transplante de melanócitos tornase uma opção terapêutica, sendo a técnica de enxertos autólogos por punch empregada com boa resposta na repigmentação. OBJETIVOS: Estudar a ação do corticoesteróide tópico mometasona sobre halos de repigmentação após enxertos autólogos por punch em pacientes com vitiligo estável clinicamente.
    MÉTODOS: Entre 2009 e 2010, 11 pacientes com vitiligo estável (7 do tipo generalizado, 2 focal e 2 segmentar) foram submetidos a enxertos autólogos por punch nas máculas acrômicas. Conforme o tipo clínico do vitiligo, os pacientes eram orientados a aplicar pomada de mometasona por 6 meses em lesões enxertadas selecionadas individualmente. No primeiro mês, a aplicação era 2 vezes ao dia e nos demais, apenas uma vez ao dia. Eram reavaliados nos meses 1, 3 e 6 após enxertos cujos halos eram fotografados e registrados pelo software fotofinder. No fim do 6̊mês, todas as áreas dos halos de repigmentação com e sem mometasona foram mensuradas e analisadas comparativamente.
    RESULTADOS: A mediana da área dos halos de repigmentação após os 6 meses com mometasona foi superior (25,96 mm2 ) comparada àquela sem mometasona (13,86 mm2 ), com diferença estatisticamente significante (p=0,026).
    CONCLUSÃO: Em nossa casuística, o uso da mometasona tópica determinou incremento dos halos de repigmentação após enxertia. A amplificação da amostra se faz necessária em estudos posteriores a fim de ratificar esta ação positiva da mometasona no tratamento do vitiligo estável.

    Palavras-chave: Glucocorticóides; Transplante; Vitiligo

    INTRODUCTION

    Vitiligo affects approximately 1% of the population worldwide. It is a pigmentation disorder characterized by achromic patches that, depending on the body region affected, can be classified as localized (focal, segmental) or generalized (totalis, universal).1 Also, depending on its clinical activity, vitiligo can be divided into stable and unstable.

    Vitiligo results from disrupted epidermal melanization and its etiology has not been defined.2 Autotoxic damage or intrinsic changes to the endoplasmic reticulum with melanocyte destruction, pathological changes in fine nerve endings, neuropeptide disturbances and imbalance of humoral and cellular immune response are well documented as participants in the pathogenesis of vitiligo.3 However, the sequence of these events leading to depigmentation has not been yet determined.

    Because of its unknown etiology, the treatment of vitiligo is still unsatisfactory for some patients, in spite of the advances achieved in recent decades. Several types of treatment, such as UVB phototherapy, UVA associated with oral or topical psoralens and local steroids are commonly used in unstable vitiligo and result in incomplete repigmentation. 4

    Abnormalities of both humoral and cell-mediated immunity have been documented in vitiligo patients and they present a basis for using immunomodulating agents, such as corticosteroids and macrolide immunomodulators such as tacrolimus and pimecrolimus, in the treatment of vitiligo.5,6

    Topical corticosteroids have been widely used in the treatment of vitiligo, but their use is impractical in generalized vitiligo because of associated adverse effects, such as skin atrophy, telangiectasia, and striae distensae.7

    In actively spreading vitiligo, systemic corticosteroids can be used to suppress immunity and may arrest the progression of vitiligo and lead to repigmentation.8 Complementary therapies have also been used, like oral Zinc, oral L-phenylalanine and others vitamins.

    Corticosteroids are a well established treatment of vitiligo and they have been used for a long time.9 They are effective in stimulating the repopulation of melanocytes and have anti-inflammatory and immunosuppressive action.10

    In 1959, Tsukada used corticosteroids intradermally and Bleehen reported that this treatment was effective in repigmentation when used topically. Later, several clinical trials demonstrated the satisfactory effect of corticosteroids, with success rates of 80%.11

    In a meta-analysis involving randomized controlled trials on the non-surgical treatment of localized and generalized vitiligo, Njoo et al. suggested that class 3 corticosteroids such as betamethasone, mometasone, fluticasone, fluocinolone, and methylprednisolone should be recommended as first-line therapy for patients with localized disease.12

    From all class 3 corticosteroids, mometasone is a non fluorinated topical one with safety profile and effective in all areas of the human body, mainly in the head, because of its higher melanocyte density. 13

    Many vitiligo patients respond to standard therapeutic options. However, some patients remain recalcitrant, or only improve partially. There are many treatment possibilities for vitiligo, resulting in varying degrees of success. Some attempts are unsuccessful and sometimes frustrating, indicating the absence of melanocyte reserve in the achromic areas.14 Treatments are most commonly focused on stopping progression or achieving repigmentation through clinical or surgical methods.15

    The first reports about the use of surgery in leukoderma date back to the 19th century when Baronio demonstrated good results with experimental skin grafts in sheep. In 1941, Lewin and Peck performed grafts in pigs with good results. In 1972, Norman Orentriech was the first to report repigmentation with autografts in humans.16 In 1983, Falabella innovated with the use of 1.5 mm punches for repigmentation of three cases of segmental vitiligo. Later, this same author reported several cases of successful repigmentation of chemical leukoderma or post-dermabrasion and focal and segmental vitiligo.17

    The surgical treatments have greatly evolved in the past four decades and brought hope to patients with clinically stable vitiligo.18 All of them are based on the same basic principle: autologous transplantation of melanocytes from a pigmented donor area to a receiving achromic area.19 Currently, there are several surgical techniques for graft collection: using suction bubble, thin skin fragments, punches, simple curettage, expanded epidermal grafts, in vitro culture, among others.20 Among all of these methods, punch grafting is the one most often used as it is easy and quick to perform. Additionally, it is less aggressive and less expensive.21

    Surgery candidates must have clinically stable vitiligo for at least 1 year, be resistant to other treatments, do not have koebnerization, do not use immunosuppressants, do not have a history of unsightly scars, and not be pregnant.22

    The objective of the present study was to assess whether mometasone enhances repigmentation of grafts performed in patients with clinically stable vitiligo.

    PATIENTS AND METHODS

    We conducted an open non randomized paired controlled clinical trial with an intentional sample, which was obtained from a group of patients treated at the outpatient clinic of vitiligo, Skin Institute, Faculdade de Medicina do ABC. The patients included in the study must have had clinically stable vitiligo for at least 1 year (a less frequent condition in this disease). The inclusion criteria were: have been previously treated clinically and showing no satisfactory improvement and being over 12 years (Chart 1). The exclusion criteria were: use of immunosuppressants, unsightly scars or achromic patches in the sacral region (donor area chosen not to be exposed). The study was
    Approved by the Research Ethics Committee of the Faculdade de Medicina do ABC on September 2, 2009.

    The stability of the disease was clinically established and defined as either absence of new lesions or lesions with progressive depigmentation, as well as absence of koebnerization, characterized by the appearance of vitiligo lesions induced by physical trauma to the healthy skin. The patients underwent the minigrafting test to confirm this stability. The test consists of collecting two 3-mm fragments of healthy skin using punch from the donor area (sacral region). These fragments were placed in saline solution. Next, a 2-mm skin fragment was collected using punch from each of the two achromic patches (recipient areas), which were selected in advance to receive the graft. After placing these fragments, such recipient areas were occluded with medical tape. Seven days later, the patients returned for a follow-up visit to have the tape removed and to receive counseling. After two months, the patients were reassessed to confirm the absence of koebnerization in the donor and recipient areas, as well as to check for the presence of repigmentation in the recipient area (pigmented halo approximately 1 to 2 mm around the graft). If both these data were confirmed, the patients were selected and invited to participate in the protocol. They were also asked to sign a written consent form.

    Only eleven patients agreed to participate in the study and continued until the end of the protocol. They were photographed and underwent a new surgical session with the implantation of new grafts in each patch (the number of grafts depended on the size of the lesion area). Thereafter, the patients were asked to avoid using medications that stimulate pigmentation, like oral corticosteroids, psoralens or others complementary treatments.

    The procedure consisted on the following phases: asepsis, antisepsis, and local anesthesia (with xylocaine 2%) in the donor area; collection of 3-mm skin fragments using punch from the donor area, which were placed in saline solution at 0.9%. The donor area was sutured for better healing. Next, we conducted asepsis, antisepsis, and local anesthesia of two recipient achromic patches of similar size, from which 2-mm fragments were removed using punch to accommodate the grafts. The fragments of the donor area were degreased and implanted into these holes on the donor patches. The patients received a number of grafts required to partially cover these patches, allowing 1-cm spaces between them. Next, the grafted areas were covered using a semi-permeable dressing (Bioclusive® Johnson and Johnson), which was removed seven days later during a follow-up visit.

    During this first visit after the procedure, the dressing was removed and the grafts were examined. The recipient patches were photographed using a digital camera attached to the software fotofinder, which was used to file the images. All patients were instructed to use mometasone furoate cream 0.1% (pharmaceutical industry Glenmark, São Paulo, Brazil) twice daily for 30 days, only on the lesion located on the right side of the body for those who had generalized vitiligo or on a chosen area of the lesion for those who had segmental or focal vitiligo.

    In the second follow-up visit (1 month after the procedure), images of the pigmented halos were recorded using fotofinder and the patients were instructed to use mometasone cream once a day on the selected areas.

    The third follow-up visit took place in the 3rd month of treatment. The lesions were photographed once more and the use of the cream once a day was recommended.

    The fourth follow-up visit was conducted six months after the grafting. The pigmented halos were photographed for the last time during this visit.

    Later, we measured each halo using an application of fotofinder that allowed drawing the outer edge of each halo and calculating the internal area in mm2. Based on such data, we were able to compare the increase of the pigmented halos in each patch with and without the use of mometasone, for each patient.

    Six months after the procedure, the patients continued to be followed up and treated at the outpatient clinic of dermatology.

    The choice of measures of central tendency and dispersion of the values pertinent to the sample and statistical tests for comparison between them were based on the types of distribution. The distributions were defined as non-parametric by the Kolmogorov-Smirnov test according to the statistical program SPSS® version 17.0 (SSPS® Inc; Illinois, USA). The values of each continuous variable were organized and described by median and interquartile ranges. Absolute and relative frequencies were used for categorical variables. To compare the median areas of the halos with and without mometasone of each patient (nonparametric dependent samples) the Wilcoxon test was used.

    RESULTS

    Of the 11 patients enrolled, 8 were female and 3 were male. Their ages ranged from 14 to 78 years (median: 29, interquartile range: 37. The disease duration varied from 3 to 30 years (median: 7, interquartile range: 15). As for the clinical type of vitiligo, 7 had generalized vitiligo, 2 had focal vitiligo, and 2 had segmental vitiligo. Of the 11 patients studied, 5 had satellite repigmentation (Table 1).

    Figures 1 and 2 show the photographic analysis of the areas of pigmented halos after 6 months of minigrafting to patient 10’s cheeks.

    The median size of the areas of pigmented halos treated with mometasone was 25,96 mm2 (interquartile range: 51,59), which was larger than the median area of the halos that did not receive mometasone (13,86 mm2 , interquartile range: 44,94), with statistical significance between them (p=0,026) (Table 2).

    DISCUSSION

    In cases of clinically stable vitiligo, grafting provides good results because it allows repopulation of achromic areas using functional cells derived from normally pigmented areas.23

    In some cases, there is a phenomenon called satellite repigmentation. This event has been poorly studied so far and it occurs after punch grafting. It consists on the appearance of melanin pigmentation in peripheral areas that did not receive grafting. This could be caused by the action of donor keratinocytes that might act as a source of growth factors, which stimulate melanocyte donors to proliferate and migrate to the vitiligo patches or, alternatively, by the action of growth factors spread in the achromic patches and responsible for stimulating “dormant” melanocytes.24

    Conversely, topical corticosteroids are one of the oldest and most widely used methods to treat vitiligo. Studies have reported that corticosteroids enhance the protective and anti-destructive mechanism of melanocytes, inhibit immune changes, blocking T-cells and allowing melanocytes to reactivate.25 Class 3 corticosteroids are the most effective and, among them, mometasone was shown to be effective in all parts of the body. Its ability to enhance the protective and anti-destructive mechanism of melanocytes and locally suppress immune changes, enabling melanocytes to repigment, has been demonstrated. Therefore, mometasone is a good therapeutic option to treat vitiligo either alone or in combination.26

    It is well documented that it is possible to associate surgical methods with other therapeutic modalities, such as laser, heliotherapy, NB-UVB and PUVA therapy, to stimulate melanocyte migration from the follicle and thus promote the occurrence of pigmented halo around the implanted graft.27,28

    In the present study, which combined autologous punch grafting and use of topical mometasone for 6 months, the statistical analysis using the Wilcoxon test demonstrated that the median areas of the pigmented halos treated with mometasone were larger than those in the areas that were not treated with the corticosteroid, showing a statistically significant difference (p = 0,026).

    We found that the largest halos occurred in the patients 9 and 10, who had sun exposure more often, which confirms the importance of light stimulation for repigmentation.

    In five out of the 11 patients there was satellite repigmentation. In one patient (number 2), the mean areas of the treated and untreated halos were similar, which may have been caused by the proximity of the grafts. Both findings may be due to the hypothesis of stimulation of donor melanocytes and keratinocytes or action of growth factors on inactive melanocytes.

    It is important to highlight that the measure of round halos was more difficult to calculate using fotofinder, as the line drawn on the outer edge of the halos was manually done with the computer mouse, which often makes it difficult to perform short and round movements. Therefore, there might have been a measurement bias, which is inherent to all cases, since there was only one observer.

    We could not find studies in the literature using the combination of autologous punch grafting and subsequent use of mometasone to evaluate the real impact of this topical corticoid on repigmentation after grafting.

    A randomized study was conducted in 2004 by Barman et al evaluating 42 patients divided into two groups. The first group underwent punch grafting and PUVA, and the second group received punch grafting and topical fluocinolone. However, there was no statistically significant difference between the groups.29

    Conversely, in the present study, we were able to analyze the positive association between mometasone and punch grafting in patients with clinically stable vitiligo, showing a statistical significance, which might serve as a basis for further studies with larger samples.

    CONCLUSION

    In spite of the small size of our sample which, from a statistical point of view, is not sufficient to draw definite conclusions, our results suggest a positive impact of mometasone on the progression of pigmented halos.

    Further studies with larger samples are needed to reach an accurate conclusion about the true effect of topical mometasone on repigmentation after grafting, which may become a new treatment option for patients with clinically stable vitiligo.

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    2. Nunes DH, Esser LMH. Epidemiological profile of patients with vitiligo and its association with thyroid disease. An Bras Dermatol. 2011;86:241-8.

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    11. Geraldez CB, Gutierrez GT. A clinical trial of clobetasol propionate in Filipino vitiligo patients. Clin Ther. 1987;9:474-82.

    13. Masuria BL, Batra A, Kothiwala RK, Khuller R, Singhi MK. Topical mometasone fuorate for the treatment of childhood vitiligo. Indian J Dermatol Venerol Leprol. 1999;65:219-21.

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    15. Czajkowski R. Comparision of melanocytes transplantation methods for treatment of vitiligo. Dermatol Surg. 2004;30:1400-5.

    16. Lahiri K, Sengupta SR. Treatment of stable and recalcitrant depigment skin conditions by autologous punch grafting. Indian J Dermatol Venereol Leprol. 1997;63:11-4.

    17. Lahiri K. Evolution and evaluation of autologous mini punch grafting in vitiligo. Indian J Dermatol. 2009;54:159-67.

    18. Rusfianti M, Wirohadidjodjo YW. Dermatosurgical techniques for repigmentation of vitiligo. Int J Dermatol. 2006;45:411-7.

    20. Holla AP, Parsad D. Vitiligo surgery: its evolution as a definite treatment in the stable vitiligo. G Ital Dermatol Venereol. 2010;145:79-88.

    22. Steiner D, Bedin V, Moraes MB, Villas RT, Steiner T. Vitiligo. An Bras Dermatol. 2004;79:335-51.

    23. Pianigiani E, Andreassi A, Andreassi L. Autografts and cultured epidermis in the treatment of vitiligo. Clin Dermatol. 2005;23:424-9.

    24. Agarwal US. Satellite repigmentation after punch grafting. Int J Dermatol. 2004;43:273-4.

    25. Le Poole C, Boissy R.E. Vitiligo. Semin Cutan Med Surg. 1997;16:3-14.

    28. Lahiri K, Malakar S, Sarma N, Banerjee U. Inducing repigmentation by regrafting and phototherapy (311 nm) in punch grafting failure cases of lip vitiligo: a pilot study. Indian J Dermatol Venerol Leprol. 2004;70:156-8.

    29. Barman KD, Khaitan BK, Verma KK. A comparative study of punch grafting followed by topical corticosteroid versus punch grafting followed by PUVA therapy in stable vitiligo. Dermatol Surg. 2004;30:49-53.

    Received on 28.07.2011
    Approved by the Advisory Board and accepted for publication on 23.01.2012.
    Conflict of interest: I deny any conflict of interest. The objective was the use of mometasone. This laboratory just made the samples available in a bigger quantity, therefore enough for the study.
    Financial Support: Mometasone creams (Dermotil) supplied by Glenmark pharmaceutical industry to myself (main author) who would distribute them to all study patients.

    Work performed at the Faculdade de Medicina do ABC (FMABC) – Santo André (SP), Brazil.

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