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mometasone inhaled/formoterol (Rx)Brand and Other Names:Dulera

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

mometasone/formoterol

aerosol

  • (100mcg/5mcg)/actuation
  • (200mcg/5mcg)/actuation
more...

Asthma

200 mcg/10 mcg (2 actuations of 100 mcg/5 mcg) PO via metered-dose inhaler q12hr; for more severe asthma, 400 mcg/10 mcg (2 actuations of 200 mcg/5 mcg) PO q12hr; not to exceed 800 mcg/20 mcg daily

Dosing Considerations

Patients on inhaled medium-dose corticosteroids: 200 mcg/10 mcg (2 actuations of 100 mcg/5 mcg) PO q12hr; not to exceed 400 mcg/20 mcg daily

Patients on inhaled high-dose corticosteroids: 400 mcg/10 mcg (2 actuations of 200 mcg/5 mcg) PO q12hr; not to exceed 800 mcg/20 mcg daily

Administration

Prime before first use by releasing 4 test sprays into air, shaking well for 5 seconds before each spray; repeat priming if inhaler is unused for >5 days or has been dropped

After inhalation, rinse mouth with water without swallowing

Dosage Forms & Strengths

mometasone/formoterol

aerosol

  • (100mcg/5mcg)/actuation
  • (200mcg/5mcg)/actuation
more...

Asthma

<12 years: Safety and efficacy not established

≥12 years: 200 mcg/10 mcg (2 actuations of 100 mcg/5 mcg) PO via metered-dose inhaler q12hr; for more severe asthma, 400 mcg/10 mcg (2 actuations of 200 mcg/5 mcg) PO q12hr; not to exceed 800 mcg/20 mcg daily

Dosing Considerations

Patients on inhaled medium-dose corticosteroids: 200 mcg/10 mcg (2 actuations of 100 mcg/5 mcg) PO q12hr; not to exceed 400 mcg/20 mcg daily

Patients on inhaled high-dose corticosteroids: 400 mcg/10 mcg (2 actuations of 200 mcg/5 mcg) PO q12hr; not to exceed 800 mcg/20 mcg daily

≥12 years: If response is inadequate after 2 weeks, switching to higher-strength formulation may provide additional asthma control

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Interactions

Interaction Checker

mometasone inhaled/formoterol and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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)

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            Warnings

            Black Box Warnings

            Long-acting beta agonists (LABAs), such as formoterol, may increase risk of asthma-related deaths; therefore, they should be used only as additional therapy for patients whose disease is not adequately controlled on other asthma-control medications (eg, low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including formoterol

            Because of risk, use of formoterol without concomitant long-term asthma-control medication (eg, inhaled corticosteroid) is contraindicated

            Once asthma control is achieved or maintained, assess at regular intervals; step down therapy (eg, discontinue LABA) if possible without loss of asthma control, and maintain on long-term asthma-control medication (eg, inhaled corticosteroid)

            Do not use formoterol if asthma is adequately controlled on low- or medium-dose inhaled corticosteroids

            Controlled clinical trials suggest that LABAs increase risk of asthma-related hospitalization in pediatric and adolescent patients; if such patients require addition of LABA to inhaled corticosteroid, use fixed-dose combination product containing both inhaled corticosteroid and LABA to ensure adherence

            Contraindications

            Hypersensitivity

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

            Cautions

            Increased risk of asthma-related hospitalization and deaths (see Black Box Warnings)

            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

            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

            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

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

            Risk of transient hypokalemia; supplementation may not be necessary

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown whether drug is distributed in breast milk; caution is advised

            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.

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            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%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            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.
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