Introduction

Synthetic nonfluorinated glucocorticoid.

Uses for Mometasone

Asthma

Mometasone: Maintenance treatment of asthma as prophylactic therapy.

Mometasone in fixed combination with formoterol (mometasone/formoterol): Treatment of asthma in patients not responding adequately to long-term asthma controller therapy (e.g., inhaled corticosteroids) or whose disease severity warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β₂-adrenergic agonist.

Mometasone alone or in fixed combination with formoterol: Not indicated for treatment of acute bronchospasm (i.e., as rescue therapy for treatment of acute episodes of bronchospasm).

Mometasone Dosage and Administration

General

• Adjust dosage carefully according to individual requirements and response.

• After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response. Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Pediatric Use under Cautions.)

• Base initial and maximum dosages in adults and children ≥12 years of age on previous asthma therapy.

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• When switching from systemic corticosteroids to orally inhaled corticosteroids, including mometasone, asthma should be reasonably stable before initiating oral inhalation treatment.

• Initially, administer oral inhalation concurrently with the maintenance dosage of the systemic corticosteroid. After at least 1 week, gradually withdraw the systemic corticosteroid.

• Decrements of the systemic corticosteroid usually should not exceed 2.5 mg daily of prednisone (or its equivalent) each week in patients receiving an orally inhaled corticosteroid. Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, titrate dosage of the orally inhaled drug to the lowest effective level.

• Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly. (See Withdrawal of Systemic Corticosteroids under Cautions.)

Administration

Oral Inhalation

Mometasone (Asmanex Twisthaler): Administer by oral inhalation as an oral inhalation powder using the Twisthaler breath-actuated dry powder inhalation device.

Mometasone (Asmanex HFA): Administer by oral inhalation as an oral inhalation suspension using metered-dose aerosol inhaler with hydrofluoroalkane (HFA; non-chlorofluorocarbon) propellant.

Mometasone/formoterol fixed combination (Dulera): Administer by oral inhalation as an oral inhalation suspension using metered-dose aerosol inhaler with HFA propellant.

Following each mometasone or mometasone/formoterol dose, rinse the mouth thoroughly with water without swallowing.

Oral Inhalation Powder

Administer as a single oral inhalation once or twice daily. When administered once daily, use at the same time each day, preferably in the evening for optimal efficacy.

Removal of the cap from the Twisthaler device (by twisting in a counterclockwise direction) releases a single dose of drug from the drug storage unit into the inhalation channel, making the dose available for administration via oral inhalation through the mouthpiece. The dose counter will decrease by 1 each time the cap is removed. Remove the Twisthaler cap with the inhaler in an upright position. Before inhaling the dose, exhale as completely as possible, but not into the Twisthaler device. Place the mouthpiece of the inhaler between the lips and inhale quickly and deeply through the inhaler. Do not cover the ventilation holes on either side of the inhaler while inhaling the dose. Remove the inhaler from the mouth, hold breath for about 10 seconds, then exhale slowly.

Wipe mouthpiece dry with a dry cloth or tissue. Close and reload the Twisthaler device for the next dose by twisting the cap in a clockwise direction until a click is heard. Do not wash the inhaler; store in a dry place. Discard the inhaler when every inhalation is used (when the dose indicator reads “00”) or 45 days after removal from its foil overwrap pouch, whichever comes first.

Oral Inhalation Aerosol

Administer as 2 oral inhalations twice daily (morning and evening).

Use only with actuator supplied with the product.

Mometasone (Asmanex HFA): Test spray 4 times into the air (away from the face) before first use or if not used for >5 days; shake well before each test spray and each inhalation. Remove the cap from the mouthpiece of the actuator before use. Do not wash inhaler in water; clean the mouthpiece using a dry wipe every 7 days.

Mometasone/formoterol fixed combination (Dulera): Test spray 4 times into the air (away from the face) before first use or if not used for >5 days; shake well before each test spray and each inhalation. Clean inhaler every 7 days by wiping mouthpiece with a dry cloth; do not wash inhaler in water.

Dosage

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

Also available as fixed combination containing mometasone furoate and formoterol fumarate dihydrate (mometasone/formoterol); dosage of mometasone component expressed in terms of the salt and dosage of formoterol component expressed in terms of hydrated salt.

Strength and dosage of mometasone furoate administered as an oral inhalation powder (Asmanex Twisthaler) is expressed as the nominal (labeled) dose contained in the Twisthaler device. Amount of drug delivered to the lungs depends on several factors, such as the patient’s inspiratory flow. Each actuation of the Twisthaler device contains 110 or 220 mcg of mometasone furoate oral inhalation powder and delivers approximately 100 or 200 mcg of mometasone furoate from the mouthpiece, depending on preparation used.

Each actuation of the oral aerosol inhaler containing mometasone furoate (Asmanex HFA) delivers 115 or 225 mcg of mometasone furoate from the valve and 100 or 200 mcg of mometasone furoate from the actuator, depending on preparation used. Strength and dosage of the preparation expressed in terms of drug delivered from mouthpiece of the actuator. Actual amount of drug delivered to the lungs depends on several factors, such as coordination between actuation of the device and patient’s inspiratory flow. Asmanex HFA aerosol inhaler delivers 120 actuations per 13-g canister.

Each actuation of the oral aerosol inhaler containing the mometasone/formoterol fixed combination (Dulera) delivers 115 or 225 mcg of mometasone furoate and 5.5 mcg of formoterol fumarate dihydrate from the valve and delivers 100 or 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate from the actuator, depending on preparation used. Strength and dosage of the preparation expressed in terms of drug delivered from mouthpiece of the actuator. Actual amount of drug delivered to the lungs depends on several factors, such as coordination between actuation of the device and patient’s inspiratory flow. Dulera aerosol inhaler delivers 60 or 120 metered sprays per 8.8- or 13-g canister, respectively.

Pediatric Patients

Asthma

Mometasone

Children 4–11 years of age: Initial and maximum dosage is 110 mcg once daily in the evening, regardless of prior therapy.

Adolescents ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening. If control of asthma inadequate after 2 weeks of therapy at initial dosage, a higher dosage may provide additional asthma control. If required, dosage may be increased to a maximum 440 mcg daily (440 mcg once daily or 220 mcg twice daily).

Adolescents ≥12 years of age previously receiving oral corticosteroids: Initial and maximum dosage is 440 mcg twice daily.

Adolescents ≥12 years of age previously receiving inhaled medium-dose corticosteroids: 200 mcg (2 inhalations of preparation containing 100 mcg) twice daily.

Adolescents ≥12 years of age previously receiving inhaled high-dose corticosteroids or oral corticosteroids: 400 mcg (2 inhalations of preparation containing 200 mcg) twice daily.

If control of asthma inadequate after 2 weeks at lower dosage, consider switching to the higher strength preparation, initiating therapy with an oral corticosteroid, or initiating oral inhalation therapy with a fixed combination containing a corticosteroid and a long-acting β₂-agonist.

Mometasone/Formoterol Fixed Combination

Adolescents ≥12 years of age: 200 or 400 mcg of mometasone furoate and 10 mcg of formoterol fumarate dihydrate (2 inhalations of preparation containing 100 or 200 mcg of mometasone furoate/5 mcg of formoterol fumarate dihydrate) twice daily. Select initial dosage based on asthma severity, previous asthma therapy (including previous inhaled corticosteroid dosage), current control of asthma symptoms, and risk of future asthma exacerbations.

If control of asthma inadequate after 2 weeks at lower dosage, switching to higher strength preparation of the fixed combination (higher strengths contain higher dosages of mometasone only) may provide additional asthma control.

Adults

Asthma

Mometasone

Previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening. If control of asthma inadequate after 2 weeks of therapy at initial dosage, a higher dosage may provide additional asthma control. If required, dosage may be increased to a maximum of 440 mcg daily (440 mcg once daily or 220 mcg twice daily).

Previously receiving oral corticosteroids: Initial and maximum dosage is 440 mcg twice daily.

Previously receiving inhaled medium-dose corticosteroids: 200 mcg (2 inhalations of preparation containing 100 mcg) twice daily.

Previously receiving inhaled high-dose corticosteroids or oral corticosteroids: 400 mcg (2 inhalations of preparation containing 200 mcg) twice daily.

If control of asthma inadequate after 2 weeks of therapy at lower dosage, consider switching to the higher strength preparation, initiating therapy with an oral corticosteroid, or initiating oral inhalation therapy with a fixed combination containing a corticosteroid and a long-acting β₂-agonist.

Mometasone/Formoterol Fixed Combination

200 or 400 mcg of mometasone furoate and 10 mcg of formoterol fumarate dihydrate (2 inhalations of preparation containing 100 or 200 mcg of mometasone furoate/5 mcg of formoterol fumarate dihydrate) twice daily. Select initial dosage based on asthma severity, previous asthma therapy (including previous inhaled corticosteroid dosage), current control of asthma symptoms, and risk of future exacerbations.

If control of asthma inadequate after 2 weeks of therapy at lower dosage, switching to higher strength preparation of the fixed combination (higher strengths contain higher dosages of mometasone only) may provide additional asthma control.

Prescribing Limits

Pediatric Patients

Asthma

Mometasone

Children 4–11 years of age: Maximum 110 mcg daily.

Adolescents ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.

Adolescents ≥12 years of age previously receiving oral corticosteroids: Maximum 880 mcg daily.

Adolescents ≥12 years of age: Maximum 800 mcg daily.

Mometasone/Formoterol Fixed Combination

Adolescents ≥12 years of age: Maximum 800 mcg of mometasone furoate and 20 mcg of formoterol fumarate dihydrate daily.

Adults

Asthma

Mometasone

Previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.

Previously receiving oral corticosteroids: Maximum 880 mcg daily.

Maximum 800 mcg daily.

Mometasone/Formoterol Fixed Combination

Maximum 800 mcg of mometasone furoate and 20 mcg of formoterol fumarate dihydrate daily.

Special Populations

Hepatic Impairment

Monitor patients for signs of increased drug exposure.

Renal Impairment

No specific dosage recommendations at this time.

Contraindications

• Mometasone alone or in fixed combination with formoterol: Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids ) are required.

• Mometasone: Known hypersensitivity to the drug or any ingredient (e.g., milk proteins) in the formulation.

• Mometasone/formoterol fixed combination: Hypersensitivity to mometasone, formoterol, or any ingredient in the formulation.

Warnings/Precautions

Use of Fixed Combinations

When mometasone used in fixed combination with formoterol, consider cautions, precautions, contraindications, and interactions associated with formoterol. (See Risk of Serious Asthma-related Events under Cautions.)

Acute Exacerbations of Asthma

Do not use mometasone alone or in fixed combination with formoterol as a bronchodilator; not indicated for emergency use (e.g., status asthmaticus) or relief of acute bronchospasm. Treat acute asthma symptoms with a short-acting β₂-agonist bronchodilator. If inadequate control of symptoms persists with supplemental β₂-agonist bronchodilator therapy, promptly reevaluate asthma therapy. Such reevaluation may include dosage adjustment of inhaled corticosteroids or initiation of systemic corticosteroids.

Localized Candidal Infections

Candidal infections of the mouth and pharynx reported. If such infections occur, initiate appropriate local or systemic antifungal treatment while still continuing orally inhaled mometasone therapy. May require interruption of mometasone therapy in some patients. Rinse mouth with water (without swallowing) after oral inhalation to help reduce the risk of oropharyngeal candidiasis.

Immunosuppressed Patients.

Increased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals. Certain infections (e.g., chickenpox, measles) can have more serious or even fatal outcomes in such patients, particularly in children.

Take particular care to avoid exposure in susceptible patients. If exposure to chickenpox or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or, immune globulin IM (IGIM), respectively. Consider treatment with an antiviral agent if chickenpox develops.

Use with caution, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.

Withdrawal of Systemic Corticosteroids

Possible life-threatening adrenal insufficiency in patients being switched from systemic corticosteroids to orally inhaled corticosteroids, including mometasone.

Withdraw systemic corticosteroid therapy gradually and monitor for objective signs of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, hypotension) during withdrawal of systemic therapy. Carefully monitor lung function (FEV₁ or peak expiratory flow rate [PEFR]), adjunctive β₂-adrenergic agonist use, and asthma symptoms. In most patients, several months are required for total recovery of hypothalamic-pituitary adrenal (HPA) function following withdrawal of systemic corticosteroid therapy. Patients maintained on ≥20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during the later part of the transfer.

Monitor patients for corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression).

Monitor patients for acute adrenal insufficiency during exposure to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with acute electrolyte loss.

Possible unmasking of conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).

Systemic Corticosteroid Effects

Although only minimal systemic absorption occurs following oral inhalation, administration of higher than recommended dosages of orally inhaled mometasone over prolonged periods of time or in particularly sensitive individuals may result in manifestations of hypercorticism and suppression of HPA function. If such changes occur, reduce mometasone dosage slowly, consistent with accepted procedures for reducing systemic corticosteroid dosage and management of asthma symptoms.

Take particular care in monitoring patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

Musculoskeletal Effects

Long-term use may affect normal bone metabolism, resulting in a loss of bone mineral density (BMD).

Monitor patients with major risk factors for decreased BMD (e.g., family history of osteoporosis, prolonged immobilization, chronic use of drugs that can reduce bone mass [e.g., anticonvulsants, corticosteroids]) and treat with established standards of care.

Ophthalmic Effects

Long-term use may cause glaucoma, increased IOP, and cataracts. Consider referral to an ophthalmologist in patients who develop ophthalmic symptoms or in those receiving long-term therapy with mometasone.

Bronchospasm

Possible acute, life-threatening paradoxical bronchospasm may occur with an immediate increase in wheezing. If paradoxical bronchospasm occurs, immediately treat patient with an inhaled, short-acting bronchodilator and discontinue mometasone.

Sensitivity Reactions

Immediate hypersensitivity reactions (e.g., anaphylaxis, rash, pruritus, angioedema, urticaria, flushing, allergic dermatitis, bronchospasm) reported. Discontinue mometasone if such reactions occur.

Oral inhalation powder contains small amounts of lactose with trace amounts of milk proteins. Anaphylactic reactions in patients with milk protein allergy reported; do not use in patients with known milk protein allergy. (See Contraindications under Cautions.)

Risk of Serious Asthma-related Events

Monotherapy with long-acting β₂-adrenergic agonists, such as formoterol, a component of mometasone/formoterol, increases the risk of asthma-related death. Data from clinical trials suggest that monotherapy with long-acting β₂-adrenergic agonists also increases the risk of asthma-related hospitalization in children and adolescents.

Based on review of 4 clinical trials (3 in adults and adolescents and 1 in children), FDA concluded there is no clinically important increased risk of serious asthma-related events (i.e., asthma-related hospitalization, intubation, death) associated with use of fixed combinations containing long-acting β₂-adrenergic agonists and inhaled corticosteroids compared with inhaled corticosteroids alone for the treatment of asthma. These studies also showed that combination therapy with long-acting β₂-adrenergic agonists and inhaled corticosteroids reduced the incidence of asthma exacerbations compared with use of inhaled corticosteroids alone.

Use mometasone/formoterol fixed combination only in patients with asthma not responding adequately to long-term asthma controller therapy, (e.g., inhaled corticosteroids) or whose disease severity warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β₂-adrenergic agonist.

Specific Populations

Pregnancy

Category C.

No adequate and well-controlled studies in pregnant women. Use during pregnancy only if potential benefits justify potential risks to fetus.

Increased risk of adverse perinatal outcomes (e.g., preeclampsia, premature birth, low birth weight, small neonates for gestational age) in women with poorly or moderately controlled asthma. Closely monitor pregnant women with asthma and adjust medication as necessary to maintain optimal asthma control.

Effects of mometasone/formoterol fixed combination during labor and delivery not known. Because of potential for β-agonist interference with uterine contractility, restrict use of mometasone/formoterol during labor to those patients in whom the benefits clearly outweigh the risks.

Monitor infants born to women receiving substantial oral corticosteroid dosages during pregnancy for signs of hypoadrenalism.

Lactation

Not known whether mometasone is distributed into milk; however, other corticosteroids are distributed into milk. Data not available on effects of the drug on the breast-fed child or milk production. Consider the benefits of breast-feeding and importance of mometasone to the woman along with any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition. Caution advised if mometasone oral inhalation powder used in nursing women.

Manufacturer of mometasone/formoterol fixed combination states that a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Pediatric Use

Mometasone oral inhalation powder: Safety and efficacy not established in children <4 years of age.

Mometasone oral inhalation aerosol: Safety and efficacy not established in children <12 years of age.

Mometasone/formoterol oral inhalation aerosol: Safety and efficacy not established in children <12 years of age.

With prolonged use, may slow growth rate in children and adolescents. Monitor routinely (e.g., via stadiometry) the growth and development of pediatric patients receiving corticosteroid therapy. Weigh benefits of corticosteroid therapy versus possibility of growth suppression and the risks associated with alternative therapies. Use the lowest possible dosage that effectively controls asthma.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

Common Adverse Effects

Mometasone oral inhalation aerosol: Nasopharyngitis, headache, sinusitis, bronchitis, influenza.

Mometasone oral inhalation powder: Headache, allergic rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, dyspepsia.

Mometasone/formoterol oral inhalation aerosol: Nasopharyngitis, sinusitis, headache.

General

• Adjust dosage carefully according to individual requirements and response.

• After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response. Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Pediatric Use under Cautions.)

• Base initial and maximum dosages in adults and children ≥12 years of age on previous asthma therapy.

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• When switching from systemic corticosteroids to orally inhaled corticosteroids, including mometasone, asthma should be reasonably stable before initiating oral inhalation treatment.

• Initially, administer oral inhalation concurrently with the maintenance dosage of the systemic corticosteroid. After at least 1 week, gradually withdraw the systemic corticosteroid.

• Decrements of the systemic corticosteroid usually should not exceed 2.5 mg daily of prednisone (or its equivalent) each week in patients receiving an orally inhaled corticosteroid. Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, titrate dosage of the orally inhaled drug to the lowest effective level.

• Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly. (See Withdrawal of Systemic Corticosteroids under Cautions.)

Administration

Oral Inhalation

Mometasone (Asmanex Twisthaler): Administer by oral inhalation as an oral inhalation powder using the Twisthaler breath-actuated dry powder inhalation device.

Mometasone (Asmanex HFA): Administer by oral inhalation as an oral inhalation suspension using metered-dose aerosol inhaler with hydrofluoroalkane (HFA; non-chlorofluorocarbon) propellant.

Mometasone/formoterol fixed combination (Dulera): Administer by oral inhalation as an oral inhalation suspension using metered-dose aerosol inhaler with HFA propellant.

Following each mometasone or mometasone/formoterol dose, rinse the mouth thoroughly with water without swallowing.

Oral Inhalation Powder

Administer as a single oral inhalation once or twice daily. When administered once daily, use at the same time each day, preferably in the evening for optimal efficacy.

Removal of the cap from the Twisthaler device (by twisting in a counterclockwise direction) releases a single dose of drug from the drug storage unit into the inhalation channel, making the dose available for administration via oral inhalation through the mouthpiece. The dose counter will decrease by 1 each time the cap is removed. Remove the Twisthaler cap with the inhaler in an upright position. Before inhaling the dose, exhale as completely as possible, but not into the Twisthaler device. Place the mouthpiece of the inhaler between the lips and inhale quickly and deeply through the inhaler. Do not cover the ventilation holes on either side of the inhaler while inhaling the dose. Remove the inhaler from the mouth, hold breath for about 10 seconds, then exhale slowly.

Wipe mouthpiece dry with a dry cloth or tissue. Close and reload the Twisthaler device for the next dose by twisting the cap in a clockwise direction until a click is heard. Do not wash the inhaler; store in a dry place. Discard the inhaler when every inhalation is used (when the dose indicator reads “00”) or 45 days after removal from its foil overwrap pouch, whichever comes first.

Oral Inhalation Aerosol

Administer as 2 oral inhalations twice daily (morning and evening).

Use only with actuator supplied with the product.

Mometasone (Asmanex HFA): Test spray 4 times into the air (away from the face) before first use or if not used for >5 days; shake well before each test spray and each inhalation. Remove the cap from the mouthpiece of the actuator before use. Do not wash inhaler in water; clean the mouthpiece using a dry wipe every 7 days.

Mometasone/formoterol fixed combination (Dulera): Test spray 4 times into the air (away from the face) before first use or if not used for >5 days; shake well before each test spray and each inhalation. Clean inhaler every 7 days by wiping mouthpiece with a dry cloth; do not wash inhaler in water.

Dosage

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

Also available as fixed combination containing mometasone furoate and formoterol fumarate dihydrate (mometasone/formoterol); dosage of mometasone component expressed in terms of the salt and dosage of formoterol component expressed in terms of hydrated salt.

Strength and dosage of mometasone furoate administered as an oral inhalation powder (Asmanex Twisthaler) is expressed as the nominal (labeled) dose contained in the Twisthaler device. Amount of drug delivered to the lungs depends on several factors, such as the patient’s inspiratory flow. Each actuation of the Twisthaler device contains 110 or 220 mcg of mometasone furoate oral inhalation powder and delivers approximately 100 or 200 mcg of mometasone furoate from the mouthpiece, depending on preparation used.

Each actuation of the oral aerosol inhaler containing mometasone furoate (Asmanex HFA) delivers 115 or 225 mcg of mometasone furoate from the valve and 100 or 200 mcg of mometasone furoate from the actuator, depending on preparation used. Strength and dosage of the preparation expressed in terms of drug delivered from mouthpiece of the actuator. Actual amount of drug delivered to the lungs depends on several factors, such as coordination between actuation of the device and patient’s inspiratory flow. Asmanex HFA aerosol inhaler delivers 120 actuations per 13-g canister.

Each actuation of the oral aerosol inhaler containing the mometasone/formoterol fixed combination (Dulera) delivers 115 or 225 mcg of mometasone furoate and 5.5 mcg of formoterol fumarate dihydrate from the valve and delivers 100 or 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate from the actuator, depending on preparation used. Strength and dosage of the preparation expressed in terms of drug delivered from mouthpiece of the actuator. Actual amount of drug delivered to the lungs depends on several factors, such as coordination between actuation of the device and patient’s inspiratory flow. Dulera aerosol inhaler delivers 60 or 120 metered sprays per 8.8- or 13-g canister, respectively.

Pediatric Patients

Asthma

Mometasone

Children 4–11 years of age: Initial and maximum dosage is 110 mcg once daily in the evening, regardless of prior therapy.

Adolescents ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening. If control of asthma inadequate after 2 weeks of therapy at initial dosage, a higher dosage may provide additional asthma control. If required, dosage may be increased to a maximum 440 mcg daily (440 mcg once daily or 220 mcg twice daily).

Adolescents ≥12 years of age previously receiving oral corticosteroids: Initial and maximum dosage is 440 mcg twice daily.

Adolescents ≥12 years of age previously receiving inhaled medium-dose corticosteroids: 200 mcg (2 inhalations of preparation containing 100 mcg) twice daily.

Adolescents ≥12 years of age previously receiving inhaled high-dose corticosteroids or oral corticosteroids: 400 mcg (2 inhalations of preparation containing 200 mcg) twice daily.

If control of asthma inadequate after 2 weeks at lower dosage, consider switching to the higher strength preparation, initiating therapy with an oral corticosteroid, or initiating oral inhalation therapy with a fixed combination containing a corticosteroid and a long-acting β₂-agonist.

Mometasone/Formoterol Fixed Combination

Adolescents ≥12 years of age: 200 or 400 mcg of mometasone furoate and 10 mcg of formoterol fumarate dihydrate (2 inhalations of preparation containing 100 or 200 mcg of mometasone furoate/5 mcg of formoterol fumarate dihydrate) twice daily. Select initial dosage based on asthma severity, previous asthma therapy (including previous inhaled corticosteroid dosage), current control of asthma symptoms, and risk of future asthma exacerbations.

If control of asthma inadequate after 2 weeks at lower dosage, switching to higher strength preparation of the fixed combination (higher strengths contain higher dosages of mometasone only) may provide additional asthma control.

Adults

Asthma

Mometasone

Previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening. If control of asthma inadequate after 2 weeks of therapy at initial dosage, a higher dosage may provide additional asthma control. If required, dosage may be increased to a maximum of 440 mcg daily (440 mcg once daily or 220 mcg twice daily).

Previously receiving oral corticosteroids: Initial and maximum dosage is 440 mcg twice daily.

Previously receiving inhaled medium-dose corticosteroids: 200 mcg (2 inhalations of preparation containing 100 mcg) twice daily.

Previously receiving inhaled high-dose corticosteroids or oral corticosteroids: 400 mcg (2 inhalations of preparation containing 200 mcg) twice daily.

If control of asthma inadequate after 2 weeks of therapy at lower dosage, consider switching to the higher strength preparation, initiating therapy with an oral corticosteroid, or initiating oral inhalation therapy with a fixed combination containing a corticosteroid and a long-acting β₂-agonist.

Mometasone/Formoterol Fixed Combination

200 or 400 mcg of mometasone furoate and 10 mcg of formoterol fumarate dihydrate (2 inhalations of preparation containing 100 or 200 mcg of mometasone furoate/5 mcg of formoterol fumarate dihydrate) twice daily. Select initial dosage based on asthma severity, previous asthma therapy (including previous inhaled corticosteroid dosage), current control of asthma symptoms, and risk of future exacerbations.

If control of asthma inadequate after 2 weeks of therapy at lower dosage, switching to higher strength preparation of the fixed combination (higher strengths contain higher dosages of mometasone only) may provide additional asthma control.

Prescribing Limits

Pediatric Patients

Asthma

Mometasone

Children 4–11 years of age: Maximum 110 mcg daily.

Adolescents ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.

Adolescents ≥12 years of age previously receiving oral corticosteroids: Maximum 880 mcg daily.

Adolescents ≥12 years of age: Maximum 800 mcg daily.

Mometasone/Formoterol Fixed Combination

Adolescents ≥12 years of age: Maximum 800 mcg of mometasone furoate and 20 mcg of formoterol fumarate dihydrate daily.

Adults

Asthma

Mometasone

Previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.

Previously receiving oral corticosteroids: Maximum 880 mcg daily.

Maximum 800 mcg daily.

Mometasone/Formoterol Fixed Combination

Maximum 800 mcg of mometasone furoate and 20 mcg of formoterol fumarate dihydrate daily.

Special Populations

Hepatic Impairment

Monitor patients for signs of increased drug exposure.

Renal Impairment

No specific dosage recommendations at this time.

The following information addresses potential interactions with mometasone. No formal drug interactions studies performed to date using mometasone/formoterol. When the fixed combination used, also consider interactions associated with formoterol.

Mometasone metabolized by CYP3A4 isoenzyme.

Drugs Affecting Hepatic Microsomal Enzymes

Potent inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma mometasone concentrations).

Specific Drugs