Mometasone (inhalation)

Mometasone (inhalation)
Black Box Warning
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];

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Treatment of Asthma

• ASMANEX® HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
• Important Limitations of Use

• ASMANEX HFA is NOT indicated for the relief of acute bronchospasm.

Dosing

• ASMANEX HFA should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route.
• Shake well prior to each inhalation.
• The recommended doses for ASMANEX HFA treatment based on prior asthma therapy are provided in Table 1.

• If a dosage regimen of ASMANEX HFA fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of ASMANEX HFA with a higher strength, initiating an inhaled corticosteroid and long-acting beta2-agonist combination product, or initiating oral corticosteroids, should be considered.
• The maximum daily recommended dose is two inhalations of ASMANEX HFA 200 mcg twice daily (maximum of 800 mcg a day). If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.
• The maximum benefit may not be achieved for 1 week or longer after beginning treatment. Individual patients may experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately after 2 weeks of therapy, higher strength may provide additional asthma control.
• After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.

DOSAGE FORMS AND STRENGTHS

• ASMANEX HFA is a pressurized metered dose inhaler that is available in 2 strengths.
• ASMANEX HFA 100 mcg delivers 100 mcg of mometasone furoate per actuation.
• ASMANEX HFA 200 mcg delivers 200 mcg of mometasone furoate per actuation

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Mometasone (inhalation) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mometasone (inhalation) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Mometasone (inhalation) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

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 practice. The safety of ASMANEX HFA was evaluated in 2 randomized placebo and active-controlled trials of 12 and 26 weeks' duration, conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program, which enrolled 1509 patients with persistent asthma. Patient ages ranged from 12 to 84 years of age, 41% were male and 59% female, 73% were Caucasian and 27% non-Caucasian. Of the total population enrolled in the 2 trials, 432 patients received two inhalations twice daily of either ASMANEX HFA, 100 mcg or 200 mcg/actuation. In the 26-week trial (Trial 1) 192 patients received two inhalations twice daily of ASMANEX HFA 100 mcg/actuation and 196 patients received placebo. In the 12 week trial (Trial 2) 240 patients received two inhalations twice daily of ASMANEX HFA 200 mcg/actuation and 233 and 255 patients received mometasone furoate and formoterol fumarate 100 mcg/5 mcg and 200 mcg/5 mcg/actuation combination products, respectively, as comparators.
• In these trials, the proportion of patients who discontinued study treatment early due to adverse reactions was 3% and 2% for ASMANEX HFA 100 and 200 mcg treated patients, respectively, and 4% for placebo-treated patients. Serious adverse reactions, whether considered drug-related or not by the investigators, which occurred more frequently in ASMANEX HFA-treated patients included colitis ulcerative, colonic polyp, chest pain, gastroenteritis, endometriosis, asthma, and hemoptysis; all events occurred at rates less than 1%.
• The incidence of treatment emergent adverse reactions associated with ASMANEX HFA are shown in Tables 2 and 3. These are based upon data from each of the 2 clinical trials of 12 or 26 weeks in duration in patients 12 years and older treated with two inhalations twice daily of ASMANEX HFA (100 mcg or 200 mcg), mometasone furoate/formoterol fumarate (100 mcg/5 mcg or 200 mcg/5 mcg), or placebo.

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 (inhalation) 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 (inhalation) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mometasone (inhalation) during labor and delivery.

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Mometasone (inhalation) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Mometasone (inhalation) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Mometasone (inhalation) in the drug label.

Pharmacology

There is limited information regarding Mometasone (inhalation) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Mometasone (inhalation)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Mometasone (inhalation) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Mometasone (inhalation) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Mometasone (inhalation) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Mometasone (inhalation) in the drug label.

How Supplied

Storage

There is limited information regarding Mometasone (inhalation) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

This image is provided by the National Library of Medicine.

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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