Mometasone furoate: Difference between revisions

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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of Mometasone furoate in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Mometasone furoate in pediatric patients.
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Mometasone furoate in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=*None
 
|warnings======Effects on Endocrine System=====
<!--Warnings-->
*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.
|warnings=* Description
*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.
====Precautions====
*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.
* Description
=====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.
<!--Adverse Reactions-->
=====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.


<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.



Revision as of 14:52, 12 January 2015

Mometasone furoate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Mometasone furoate is a corticosteroid that is FDA approved for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥ 2 years of age.. Common adverse reactions include burning, pruritus, and skin atrophy..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Mometasone Furoate Cream USP, 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.

Dosage

  • Apply a thin film of Mometasone Furoate Cream to the affected skin areas once daily. Mometasone Furoate Cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate Cream 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. Safety and efficacy of Mometasone Furoate Cream in pediatric patients for more than 3 weeks of use have not been established.
  • Mometasone Furoate Cream should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Cream should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
  • Mometasone Furoate Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
  • Avoid use on the face, groin, or axillae.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mometasone furoate cream in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mometasone furoate cream in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Mometasone furoate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mometasone furoate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mometasone furoate in pediatric patients.

Contraindications

  • None

Warnings

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.
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

There is limited information regarding Clinical Trial Experience of Mometasone furoate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Mometasone furoate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mometasone furoate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mometasone furoate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Mometasone furoate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Mometasone furoate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Mometasone furoate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Mometasone furoate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mometasone furoate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mometasone furoate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mometasone furoate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mometasone furoate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mometasone furoate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Mometasone furoate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Mometasone furoate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Mometasone furoate in the drug label.

Pharmacology

There is limited information regarding Mometasone furoate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Mometasone furoate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Mometasone furoate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Mometasone furoate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Mometasone furoate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Mometasone furoate in the drug label.

How Supplied

Storage

There is limited information regarding Mometasone furoate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Mometasone furoate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Mometasone furoate in the drug label.

Precautions with Alcohol

  • Alcohol-Mometasone furoate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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