Clinical Information
Gen. Code and Des.
73198 mometasone furoate INHALATION HFA AER AD 100 MCG
GCN and Des.
37566 mometasone furoate INHALATION HFA AER AD 100 MCG
Strength
100MCG
Dose Form
HFA AEROSOL WITH ADAPTER (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
48100808 ORALLY INHALED PREPARATIONS (STEROIDS)
68040000 ADRENALS
Active Ingredients
2205 mometasone furoate 83919237
Inactive Ingredients
2464 alcohol 64175
2530 oleic acid 112801
FDA NDA Approved
These highlights do not include all the information needed to use ASMANEX HFA safely and effectively. See full prescribing information for ASMANEX HFA.
ASMANEX® HFA (mometasone furoate) inhalation aerosol, for
oral inhalation use
Initial U.S. Approval: 1987
INDICATIONS AND USAGE
ASMANEX HFA is a corticosteroid indicated for:
Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. (1.1)
Important limitations:
Not indicated for the relief of acute bronchospasm. (1.1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
Treatment of asthma in patients 12 years of age and older: 2 inhalations twice daily of ASMANEX HFA 100 mcg or 200 mcg. Starting dosage is based on prior asthma therapy. (2.2)
Treatment of asthma in patients aged 5 to less than 12 years: 2 inhalations twice daily of ASMANEX HFA 50 mcg. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation aerosol containing 50 mcg, 100 mcg, or 200 mcg of mometasone furoate per actuation. (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. (4.1)
Hypersensitivity to any of the ingredients of ASMANEX HFA. (4.2)
WARNINGS AND PRECAUTIONS
Deterioration of asthma and acute episodes: ASMANEX HFA should not be used for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. (5.1)
Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. After dosing, advise patients to rinse their mouth with water and spit out contents without swallowing. (5.2)
Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections. (5.3)
Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Wean patients slowly from systemic corticosteroids if transferring to ASMANEX HFA. (5.4)
Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ASMANEX HFA slowly. (5.5)
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects. Exercise caution when used with ASMANEX HFA. (5.6)
Paradoxical bronchospasm: Discontinue ASMANEX HFA and institute alternative therapy if paradoxical bronchospasm occurs. (5.7)
Hypersensitivity reactions including anaphylaxis: Hypersensitivity reactions, such as urticaria, flushing, allergic dermatitis, bronchospasm, rash, pruritus, angioedema, and anaphylactic reaction may occur. Discontinue ASMANEX HFA if such reactions occur. (5.8)
Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. (5.9)
Effects on growth: Monitor growth of pediatric patients. (5.10)
Glaucoma and cataracts: Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX HFA long term. (5.11)
ADVERSE REACTIONS
Most common adverse reactions (reported in greater than or equal to 3% of patients) included:
nasopharyngitis, headache, sinusitis, bronchitis, and influenza. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. (7.1)
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Monitor patients for signs of increased drug exposure. (8.6)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 6/2021
