Elocon topical

Synthetic nonfluorinated corticosteroid.1 2 3 6 10

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.1 2 3 7 10 a

Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).d

Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.d

Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.d

Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy.d (See Administration with Occlusive Dressing under Dosage and Administration.)

Response may vary from one topical corticosteroid preparation to another.d

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.d

Should not be used in the treatment of acne, rosacea, or perioral dermatitis.8

General

• Consider location of the lesion and the condition being treated when choosing a dosage form.d

• Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.d

• Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin).d Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.d

• Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercial preparations with another vehicle may decrease effectiveness.d

• Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).d (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

Administration

Topical Administration

Apply topically as a 0.1% cream, ointment, or lotion.a b c

For dermatologic use only; avoid contact with the eyes.a b c d

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.d

Apply cream or ointment sparingly in a thin film and rub into affected area.1 2 a

Apply a few drops of lotion to the affected area by holding the nozzle of the bottle close to the affected area and squeezing gently; massage lightly until absorbed.10

After a favorable response is achieved, frequency of application may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.d

Occlusive dressings may be used for severe or resistant dermatoses.d (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film.d Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.d

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow escape of excess moisture.d For added moisture in dry lesions, cover cream, ointment, or lotion with a dampened cloth before applying the plastic film or briefly soak the affected area in water before applying mometasone and plastic film.d

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.d

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of mometasone are essential at each dressing change.d

Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed.d Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.d

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.d

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.d (See Occlusive Dressings under Cautions.)

Dosage

Available as mometasone furoate; dosage expressed in terms of the salt.a b c

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy.d (See Pediatric Use under Cautions.)

Children ≥2 years of age: Apply 0.1% cream or ointment sparingly to affected area, usually once daily; safety and efficacy for >3 weeks not established.a b Cream and ointment also have been applied twice daily.2 3 7

Children ≥12 years of age: Apply a few drops of 0.1% lotion to affected area once daily.c

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.a b c

Adults

Apply 0.1% cream or ointment sparingly to affected area, usually once daily.1 2 10 Cream and ointment also have been applied twice daily.2 3 7

Apply a few drops of 0.1% lotion to affected area once daily.1 2 10

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.a b c

Prescribing Limits

Pediatric Patients

Children ≥2 years of age: Safety and efficacy of therapy with 0.1% cream or ointment for >3 weeks have not been established.a b

Contraindications

• Known hypersensitivity to mometasone furoate, other corticosteroids, or any ingredient in the formulation.1 2 10 a

Warnings/Precautions

Sensitivity Reactions

Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.a b c

General Precautions

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.2 8 9 10 a b c d

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.a b c d

If HPA axis suppression occurs, withdraw the drug, reduce the frequency of application, discontinue occlusive therapy, and/or substitute a less potent corticosteroid.a

HPA-axis function recovery generally is prompt and complete following drug discontinuance.a

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.a b

Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.d

Adverse systemic effects may occur when corticosteroids are used on large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.a b c d

Infants and children may be more susceptible to adverse systemic effects.a (See Pediatric Use under Cautions.)

Possible adverse local reactions (e.g., irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.a b c d

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue;d these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.d

If irritation occurs, discontinue drug and initiate appropriate therapy.a b c d

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.a b c d If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.a b c d

When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.d e In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.d e

Do not use occlusive dressings in patients with primary skin infection.d

Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin);d however, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.d

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly.a b c d (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.a b c d (See Local Effects under Cautions.)

Do not use occlusive dressings on weeping or exudative lesions.d

Do not use occlusive dressings in patients with primary skin infection.d

Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.d

Use plastic occlusive material with care to avoid the risk of suffocation.d

Specific Populations

Category C.1 2 10 a

Not known whether topical mometasone is distributed into milk.a b c d Caution advised if topical mometasone is used.a b c

Safety and efficacy of cream or ointment not established in children <2 years of age; use not recommended in this age group.a b In children ≥2 years of age, safety and efficacy of ointment or cream for >3 weeks not established.a b

Safety and efficacy of lotion not established in children <12 years of age; use not recommended in this age group.c

Not recommended for treatment of diaper dermatitis if tight-fitting diapers or plastic pants are required, since such garments may constitute occlusive dressings.a b c d

Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio,a b c d especially when topical corticosteroids are applied to >20% of body surface area.a b c The risk of adrenal suppression appears to increase with decreasing age.d (See Systemic Effects under Cautions.)

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.a b c d

Children also are at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment.e

Children may be more susceptible than adults to skin atrophy, including striae.a b c

Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.a b c d

Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.d

No substantial differences in safety and efficacy of mometasone furoate cream or ointment in geriatric patients relative to younger adults, but increased sensitivity cannot be ruled out.a b

Insufficient experience with mometasone furoate lotion in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.c

Common Adverse Effects

Acneiform reaction, burning, tingling, stinging, folliculitis, furunculosis, pruritus, rosacea, skin atrophy (including shininess, telangiectasia, loss of elasticity, loss of normal skin markings, thinness, bruising).a b c

Absorption

Bioavailability

Only minimal amounts of topical corticosteroid reach the dermis and subsequently the systemic circulation after application to most normal skin areas; more absorption occurs from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole.d

Following a single topical application of mometasone furoate 0.1% cream or ointment to normal skin, only about 0.4–0.7% of the drug reaches systemic circulation.1 2 9 a

Percutaneous penetration varies among individuals;1 4 5 10 d may be altered by using different vehicles;1 4 5 10 may be increased by occlusive dressings and by the presence of inflammation and/or other diseases of the epidermal barrier (e.g., psoriasis, eczema).1 5 10

Extent of systemic absorption appears to be similar following topical application of the cream, ointment, or lotion.1 10 a

Distribution

Extent

Not known whether topical mometasone is distributed into milk.a b c d

Elimination

Metabolism

Systemic metabolism of mometasone has not been fully characterized.8 9

Elimination Route

Systemically absorbed mometasone and its metabolites may be excreted in urine and, to some extent, in bile.1 2 10

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Different brands of this medication have differentstorage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Applies to mometasone topical: topical application cream, topical application lotion, topical application ointment, topical application solution

Along with its needed effects, mometasone topical (the active ingredient contained in Elocon) 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 while taking mometasone topical:

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

• Dryness
• irritation
• redness and scaling around the mouth

Some side effects of mometasone topical 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:

• 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

• 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