mometasone inhaled/formoterol (Rx)

Brand and Other Names:Dulera
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

mometasone/formoterol

aerosol

  • (50mcg/5mcg)/actuation
  • (100mcg/5mcg)/actuation
  • (200mcg/5mcg)/actuation

Asthma

Indicated for asthma in patients who are not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA)

Initial: 200 mcg/10 mcg (2 actuations of 100 mcg/5 mcg) inhaled PO q12hr; may increase to higher dose after 2 wk if inadequate response; maximum benefit may not be achieved for 1 week or longer after beginning treatment

Severe asthma (initial) or inadequate response to lower dose (after 2 wk): 400 mcg/10 mcg (2 actuations of 200 mcg/5 mcg) inhaled PO q12hr

Not to exceed more than 2 inhalations twice daily of prescribed strength

Maximum daily dose: 800 mcg/20 mcg daily (ie, 2 actuations of 200 mcg/5 mcg q12hr)If therapy fails to provide adequate control of asthma, re-evaluate therapeutic regimen; consider replacing with higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids

If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief

Dosing Considerations

Limitation of use

  • Not indicated for the relief of acute bronchospasm

Dosage Forms & Strengths

mometasone/formoterol

aerosol

  • (50mcg/5mcg)/actuation
  • (100mcg/5mcg)/actuation
  • (200mcg/5mcg)/actuation

Asthma

Indicated for asthma in patients who are not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA)

<5 years: Safety and efficacy not established

5 to <12 years

  • 100 mcg/10 mcg (2 actuations of 50 mcg/5 mcg) inhaled PO q12hr; maximum daily dosage is 200 mcg/20 mcg

≥12 years

  • Initial: 200 mcg/10 mcg (2 actuations of 100 mcg/5 mcg) inhaled PO q12hr; may increase to higher dose after 2 wk if inadequate response; maximum benefit may not be achieved for 1 week or longer after beginning treatment
  • Severe asthma (initial) or inadequate response to lower dose (after 2 wk): 400 mcg/10 mcg (2 actuations of 200 mcg/5 mcg) inhaled PO q12hr
  • Not to exceed more than 2 inhalations twice daily of prescribed strength
  • Maximum daily dose: 800 mcg/20 mcg daily (ie, 2 actuations of 200 mcg/5 mcg q12hr)
  • If therapy fails to provide adequate control of asthma, re-evaluate therapeutic regimen; consider replacing with higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids
  • If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief

Dosing Considerations

Limitations of use

  • Not indicated for the relief of acute bronchospasm
Next:

Interactions

Interaction Checker

and mometasone inhaled/formoterol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            1-10%

            Nasopharyngitis (4.7%)

            Headache (2-4.5%)

            Sinusitis (2-3.3%)

            <1%

            Oral candidiasis

            Postmarketing Reports

            Cardiac: Angina pectoris, cardiac arrhythmias (eg, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), QT prolongation, elevated blood pressure (including hypertension)

            Metabolic, nutritional: Hypokalemia, hyperglycemia

            Respiratory, thoracic, mediastinal: Asthma aggravation (potentially including cough, dyspnea, wheezing, bronchospasm)

            Vision blurred

            Previous
            Next:

            Warnings

            Contraindications

            Hypersensitivity

            Primary treatment for acute bronchospasm, status asthmaticus, or exercise-induced bronchospasm

            Cautions

            Risk of LABAs used as monotherapy

            • Use of LABAs as monotherapy (without inhaled corticosteroids) for asthma is associated with an increased risk of asthma-related death
            • Data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patient
            • These findings are considered a class effect of LABA monotherapy
            • When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

            Fungal infections

            • Localized infections of the mouth and pharynx with Candida albicans reported; if oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment; at times therapy may need to be interrupted
            • To reduce risk of oropharyngeal candidiasis, after dosing, advise patients to rinse their mouth with water and spit out the contents without swallowing

            Do not use to treat acutely deteriorating asthma or acute symptoms; additionally, increased inhaled short-acting beta agonist (SABA) use is marker of deteriorating asthma

            Do not use in combination with additional LABA, because of risk of overdose

            Localized Candida albicans infections develop in mouth and pharynx in some patients; to reduce risk, mouth must be rinsed after inhalation

            Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals; risk of more serious or fatal course of chickenpox or measles exists in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure

            Because of possibility of systemic absorption of inhaled corticosteroids, patients should be observed carefully for any evidence of systemic corticosteroid effects; particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response

            Particular care is needed in switching patients from systemic to inhaled corticosteroids; potentially fatal adrenal insufficiency may occur before or afterward; taper withdrawal gradually

            During stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should resume PO corticosteroids immediately

            Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress

            Risk of paradoxical bronchospasm, which may be life-threatening; discontinue, and treat immediately with inhaled SABA

            Cardiovascular and central nervous system (CNS) effects may occur as consequences of excess beta-adrenergic stimulation; may result in asthma-related death; caution must be exercised in patients with cardiovascular (eg, aneurysm, pheochromocytoma) or convulsive disorders or thyrotoxicosis

            Long-term administration of corticosteroids may decrease in bone mineral density; monitor patients at risk

            May decrease growth velocity in children

            Risk of cataracts, glaucoma, and increased intraocular pressure; consider referral to an ophthalmologist in patients who develop ocular symptoms or use therapy long term

            Risk of systemic eosinophilic conditions, some consistent with Churg-Strauss syndrome

            Risk of transient hypokalemia; supplementation may not be necessary

            Exercise caution when considering coadministration with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, telithromycin); consider benefit of coadministration versus potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects

            Prolonged treatment with corticosteroids associated with development of Kaposi sarcoma; consider discontinuing therapy if it occurs

            Psychiatric disturbances reported with corticoid use; therapy may exacerbate preexisting psychiatric conditions

            Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections may occur; 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 potential for worsening of these infections

            Risk of impaired adrenal function when transferring from oral steroids; taper patients slowly from systemic corticosteroids if transferring to inhaler

            Hypercorticism and adrenal suppression; may occur with very high dosages or at regular dosage in susceptible individuals

            Decreases in bone mineral density; monitor patients with major risk factors for decreased bone mineral content

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy: There are no randomized clinical studies in pregnant women; there are clinical considerations with use in pregnant women In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control

            Lactation: There are no available data on the presence of mometasone furoate, or formoterol fumarate in human milk; the effects on the breastfed child, or the effects on milk production; The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Mometasone: Glucocorticoid; elicits local anti-inflammatory effects on respiratory tract with minimal systemic absorption

            Formoterol: Long-acting selective beta2-adrenergic agonist with rapid onset of action; acts locally as bronchodilator; stimulates intracellular adenyl cyclase, which results in increased cyclic adenosine monophosphate levels, causing relaxation of bronchial smooth muscle and inhibition of release of mast cell mediators

            Absorption

            Peak plasma time: Mometasone, 1-2 hr; formoterol, 0.5-2 hr

            Peak plasma concentration: Mometasone, 20-60 pg/mL; formoterol, 22-125 pg/mL

            Distribution

            Protein bound: Mometasone, 98-99%; formoterol, 31-38%

            Vd: Mometasone, 152 L

            Metabolism

            Metabolized in liver by CYP3A4 (mometasone); glucuronidation and O-demethylation followed by conjugation (CYP2D6, CYP2C19, CYP2C9, and CYP2A6 involved in O-demethylation)

            Elimination

            Half-life: Mometasone, 25 hr; formoterol, 9-11 hr

            Total body clearance: Mometasone, 12.5 mL/min/kg; formoterol, 217 mL/min/kg

            Excretion (mometasone): Urine (8%), feces (74%)

            Excretion (formoterol): Urine (59-62%), feces (32-34%)

            Previous
            Next:

            Administration

            Oral Inhalation Preparation

            Priming

            • Prime inhaler before first use or when inhaler is unused for >5 days
            • Release 4 test puffs into air, away from face
            • Remove cap; shake well for 5 sec before each test puff

            Instructions

            • Check mouthpiece for objects before use
            • Make sure canister is fully inserted
            • Shake well before each use

            Oral Inhalation Administration

            For oral inhalation only

            Remove cap; place middle or index finger on canister top while placing thumb underneath mouthpiece

            Breathe out fully through your mouth, expelling as much air from lungs as possible; hold inhaler upright, placing the mouthpiece fully into the mouth, closing your lips around it

            While pushing firmly on canister top, continue breathing in slowly until lungs are full; avoid breathing out

            Hold breath as comfortably possible, up to 10 sec

            Remove inhaler from mouth; breathe through nose while keeping lips closed

            Repeating dose

            • Wait at least 30 seconds prior preceding second puff
            • Shake well prior to use; repeat steps (see under Oral Inhalation Administration)
            • Replace the cap after use
            • When finished administering 2 puffs, rinse mouth out with water (do not swallow water)

            Cleaning

            Wash and dry mouthpiece at least weekly

            When mouthpiece becomes blocked, wash mouthpiece thoroughly

            Storage

            Store at room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.