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Mometasone Furoate topical

Pronunciation

Class: Anti-inflammatory Agents
ATC Class: D07AC13
VA Class: DE200
Chemical Name: 9α,21 - Dichloro - 11β,17 - dihydroxy - 16α - methyl - 17(2 - furanylcarbonyl)pregna - 1,4 - diene - 3,20 - dione
Molecular Formula: C27H30Cl2O6
CAS Number: 83919-23-7
Brands: Elocon

Warning(s)

REMS:

FDA approved a REMS for mometasone furoate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of mometasone furoate and consists of the following: communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Synthetic nonfluorinated corticosteroid.1 2 3 6 10

Uses for Mometasone Furoate

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

Slideshow: Psoriasis: Treatment Options to Manage Your Symptoms

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

Mometasone Furoate Dosage and Administration

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

Administration with Occlusive Dressing

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.)

Corticosteroid-responsive Dermatoses
Topical

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

Corticosteroid-responsive Dermatoses
Topical

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

Corticosteroid-responsive Dermatoses
Topical

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

Cautions for Mometasone Furoate

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

Hypothalamic-Pituitary-Adrenal Axis Suppression.

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 Effects

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.)

Local Effects

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

Skin Infection

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

Occlusive Dressings

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

Pregnancy

Category C.1 2 10 a

Lactation

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

Pediatric Use

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

Geriatric Use

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

Interactions for Mometasone Furoate

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Corticosteroids

Potential pharmacologic interaction with other corticosteroid-containing preparationsd

Nitroblue-tetrazolium test for bacterial infection

Concurrent use of corticosteroids reportedly may result in false-negative resultsd

Mometasone Furoate Pharmacokinetics

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

Stability

Storage

Topical

Cream

2–25°C.a

Ointment

25°C (may be exposed to 15–30°C).b

Lotion

2–30°C.10

Actions

  • Medium-range corticosteroid activity.a b c d

  • Produces anti-inflammatory, antipruritic, and vasoconstrictive actions,a b c possibly resulting in part from steroid receptor binding.d

  • Anti-inflammatory effects may occur through induction of phospholipase A2 inhibitory proteins (lipocortins), which are thought to inhibit release of arachidonic acid from membrane phospholipids, thereby downregulating biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).a b c

Advice to Patients

  • Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed.a b c (See Topical Administration under Dosage and Administration.)

  • Importance of discontinuing therapy when control is achieved.a b c Consult clinician if no improvement is noted after 2 weeks.a b c

  • Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.1 2 9 10 a

  • Importance of not applying to the face, underarms, or groin areas unless directed by the clinician.a b c

  • Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to clinician.a b c

  • Importance of informing parents of children receiving the drug that if mometasone is applied in the diaper area,a b c tight-fitting diapers or plastic pantsd should not be used since they may act as an occlusive dressing.a b c d

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs; other corticosteroid-containing preparations should not be used without first consulting with clinician.a b c

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.a b c

  • Importance of informing patients of other important precautionary information.a b c (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Mometasone Furoate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

0.1%*

Elocon

Schering-Plough

Mometasone Furoate Cream

Clay-Park, Fougera, Warrick

Lotion

0.1%

Elocon (with isopropyl alcohol 40% and propylene glycol)

Schering-Plough

Ointment

0.1%*

Elocon

Schering-Plough

Mometasone Furoate Ointment

Clay-Park, Fougera, Sandoz, Taro, Warrick

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Elocon 0.1% Cream (SCHERING): 15/$50.49 or 45/$131.96

Elocon 0.1% Cream (SCHERING): 45/$81.99 or 135/$224.95

Elocon 0.1% Lotion (SCHERING): 30/$52.95 or 90/$138.72

Elocon 0.1% Lotion (SCHERING): 60/$91.83 or 180/$252.84

Elocon 0.1% Ointment (SCHERING): 15/$49.99 or 45/$125.97

Elocon 0.1% Ointment (SCHERING): 45/$81.53 or 135/$223.41

Mometasone Furoate 0.1% Cream (PERRIGO PHARMACEUTICALS): 15/$29.99 or 30/$49.98

Mometasone Furoate 0.1% Cream (PERRIGO PHARMACEUTICALS): 45/$48.99 or 135/$129.96

Mometasone Furoate 0.1% Ointment (PERRIGO PHARMACEUTICALS): 15/$20.99 or 45/$54.97

Mometasone Furoate 0.1% Ointment (PERRIGO PHARMACEUTICALS): 45/$39.99 or 135/$101.97

Mometasone Furoate 0.1% Solution (GLENMARK PHARMACEUTICALS): 60/$55.99 or 180/$145.97

Mometasone Furoate 0.1% Solution (PERRIGO PHARMACEUTICALS): 30/$35.99 or 90/$85.99

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Schering Corporation. Elocon prescribing information. Kenilworth, NJ; 1987 April.

2. Schering Corporation. Elocon basic data book. Kenilworth, NJ; (undated).

3. Medansky RS, Brody NI, Kanof NB et al. Clinical investigations of mometasone furoate—a novel, nonfluorinated topical corticosteroid. Semin Derm. 1987; 6:94-100.

4. Cornell RC, Stoughton RB. The use of topical steroids in psoriasis. Dermatol Clin. 1984; 2:397-409.

5. Food and Drug Administration. Topical corticosteroids class labeling guideline. Available from: Professional Labeling Branch, Division of Drug Advertising and Labeling, Food and Drug Administration, Rockville, MD; (undated).

6. Shapiro EL, Gentles MJ, Tiberi RL et al. 17-Heteroaroyl esters of corticosteroids. 2: 11β-Hydroxy series. J Med Chem. 1987; 30:1581-8. [IDIS 233359] [PubMed 3625707]

7. Anon. Mometasone—a new topical steroid. Med Lett Drugs Ther. 1987; 29:96-8. [PubMed 3670213]

8. Reviewers’ comments (personal observations); 1987 Nov.

9. Winter-Sperry RL (Schering Corporation, Kenilworth, NJ): Personal communication; 1987 Nov 25.

10. Schering Corporation. Elocon lotion prescribing information. Kenilworth, NJ; 1989 Mar.

a. Schering Corporation. Elocon (mometasone furoate 0.1%) cream prescribing information. Kenilworth, NJ; 2002 Dec.

b. Schering Corporation. Elocon (mometasone furoate 0.1%) ointment prescribing information. Kenilworth, NJ; 2002 Nov.

c. Schering Corporation. Elocon (mometasone furoate 0.1%) lotion prescribing information. Kenilworth, NJ; 2002 Dec.

d. AHFS drug information 2003. McEvoy GK, ed. Topical Corticosteroids General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2003:3403-6.

e. AHFS drug information 2006. McEvoy GK, ed. Neomycin Sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2006: 2739-40.

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