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What is the most important information I should know about Dulera Aerosol?
Dulera Aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Hypersensitivity
Dulera Aerosol is contraindicated in patients with known hypersensitivity to Mometasone (Dulera Aerosol) furoate, Formoterol (Dulera Aerosol) fumarate, or any of the ingredients in Dulera Aerosol.
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What are the possible side effects of Dulera Aerosol?
Adverse Drug Reaction Overview: Dulera Aerosol contains both Mometasone (Dulera Aerosol) furoate and Formoterol (Dulera Aerosol); therefore, the type and severity of adverse reactions associated with each individual component of Dulera Aerosol may be expected. There is no evidence of additional adverse events following concurrent administration of the 2 components.
Long-acting β2-adrenergic agonists (LABA) eg, Formoterol (Dulera Aerosol), one of the active ingredients in Dulera Aerosol, may increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.
Tremor, palpitations, ECG QT prolongation, tachycardia, hypertension and headache have been reported and are associated with pharmacological side effects of β2-agonist treatment (including Dulera Aerosol). Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and ventricular extrasystoles) may occur in some patients.
Rarely, hypersensitivity reactions, including rash, urticaria, bronchospasm, arthralgia, angioedema and anaphylactic reaction may occur in some patients.
Due to the Mometasone (Dulera Aerosol) furoate component for oral inhalation, oral candidiasis can occur in some patients. Incidence of oral candidiasis may be reduced by rinsing the mouth with water after using Dulera Aerosol. Symptomatic candidiasis can be treated with topical antifungal therapy.
Systemic and local corticosteroid use may also result in the following: Immunosuppression, hypercorticism and adrenal suppression, growth retardation in children, glaucoma and cataracts, reduced bone density, osteoporosis and fracture.
As with other inhalation therapy, inhalation-induced bronchospasm may occur rarely.
Clinical Trial Adverse Drug Reactions: Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
Safety data is based on the 3 pivotal clinical trials (P04073, P04334 and P04431) and the long-term safety trial (P04139). The total number of patients (≥12 years with asthma) participating in these studies was 2659, of which 1131 were exposed to Dulera Aerosol. Eight hundred and sixty (860) patients were exposed to Dulera Aerosol in the 12-26 week studies and 271 patients were exposed to Dulera Aerosol in the 1-year study.
The following table demonstrates the incidence of treatment-related adverse reactions associated with Dulera Aerosol based upon the pooled data of the 3 pivotal clinical trials.
In a comparator safety study of 1-year treatment duration, patients ≥12 years were treated with medium-dose Dulera Aerosol 100/5 (n=141), high-dose Dulera Aerosol 200/5 (n=130) or an active comparator (n=133, 68 medium-dose and 65 high-dose inhaled corticosteroid/LABA combination).
Safety outcomes were similar to those observed in the 12-26 week trials and no treatment-related deaths or clinically judged asthma deteriorations or reduction in lung function were observed.
Dysphonia was observed at a higher frequency in the longer term treatment trial at a reported incidence of 7/141 (5%) patients receiving Dulera Aerosol 100/5 and 4/130 (3.1%) patients receiving Dulera Aerosol 200/5. Overall, through 52 weeks of observation, 15 patients demonstrated a ≥1 point change in lens opacities classification system, version III (LOCS III) score (measured at week 26 and week 52 time-points using the LOCS III) from baseline. At week 26, in the medium-dose group, 2 (1.4%) patients receiving Dulera Aerosol 100/5 and 4 (5.9%) patients receiving an active comparator demonstrated ocular changes. In the high-dose group, 3 (2.3%) patients receiving Dulera Aerosol 200/5 demonstrated ocular changes (no patients in the active comparator group). At week 52, in the medium-dose group, 4 (2.8%) patients receiving Dulera Aerosol 100/5 and 1 (1.5%) patient receiving an active comparator demonstrated ocular changes. In the high-dose group 3 (2.3%) patients receiving Dulera Aerosol 200/5 and 1 (1.5%) patient receiving an active comparator demonstrated ocular changes. No incidences of appearance of posterior subcapsular cataracts typically associated with chronic use of high dose inhaled corticosteroid were reported in this clinical study. No clinically significant changes in blood chemistry, hematology or ECG were observed.
Less Common Clinical Trial Adverse Drug Reactions (<1%): The following additional treatment-related adverse reactions occurred in these clinical trials (P04073, P04334, P04431, P04139) in patients using Dulera Aerosol with an incidence of <1% and occurred at a greater incidence than placebo: Cardiac Disorders: Tachycardia, palpitations.
Gastrointestinal Disorders: Dry mouth.
Immune System Disorders: Hypersensitivity reaction manifested by bronchospasm, dermatitis allergic, urticaria.
Infections and Infestations: Pharyngitis.
Musculoskeletal and Connective Tissue Disorders: Muscle spasms*.
Nervous System Disorders: Tremor, dizziness*.
Psychiatric Disorders: Insomnia, nervousness*.
Respiratory, Thoracic and Mediastinal Disorders: Throat irritation.
Vascular Disorders: Hypertension.
*Reported in the 52-week safety study (P04139).
Electrocardiogram QT prolongation occurred at the same incidence as placebo (<1%).
Post-Marketing Adverse Drug Reactions: The following additional adverse reactions have been reported in post-marketing use with Dulera Aerosol or post-marketing use with inhaled Mometasone (Dulera Aerosol) furoate or inhaled Formoterol (Dulera Aerosol) fumarate: Hypokalaemia; hyperglycaemia; atrial fibrillation; angina pectoris; ventricular extrasystoles; tachyarrhythmia; hypersensitivity reactions including rash, angioedema and anaphylactic reaction; asthma aggravation which may include cough, dyspnea, wheezing and bronchospasm.
Dulera Aerosol is indicated for the treatment of asthma in patients 12 years of age and older.
Long-acting beta2-adrenergic agonists, such as Formoterol (Dulera Aerosol), one of the active ingredients in Dulera Aerosol, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, Dulera Aerosol should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Dulera Aerosol) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Dulera Aerosol for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Important Limitation of Use
Formoterol (Dulera Aerosol) is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.
Mometasone (Dulera Aerosol) is a steroid. It prevents the release of substances in the body that cause inflammation.
Dulera Aerosol is a combination medicine used as a maintenance treatment for asthma in adults and children who are at least 12 years old. This medication is not for use in treating an asthma or bronchospasm attack.
Dulera Aerosol may also be used for purposes not listed in this medication guide.
Each actuation of Dulera Aerosol 50/5, 100/5 and 200/5 delivers Mometasone (Dulera Aerosol) furoate 50 mcg, 100 mcg and 200 mcg, respectively, and Formoterol (Dulera Aerosol) fumarate dihydrate 5 mcg.
Dulera Aerosol also contains the following excipients: Hydrofluoroalkane (HFA-227), anhydrous alcohol and oleic acid.
Mometasone (Dulera Aerosol) furoate is a synthetic, anti-inflammatory corticosteroid with a chemical name of 9,21-dichloro-11β, 17-dihydroxy-16α-methylpregna-1, 4-diene-3, 20-dione 17-(2)-furoate. It has a molecular weight of 521.44 and empirical formula of C27H30Cl2O6.
Formoterol (Dulera Aerosol) fumarate dihydrate, a racemate, is a selective β2-adrenergic bronchodilator with a chemical name of (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate. It has a molecular weight of 840.9 and empirical formula of (C19H24N2O4)2·C4H4O4·2H2O.
Use Dulera Aerosol aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Dulera Aerosol aerosol.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsAsthma: Treatment of asthma in patients ≥5 years of age
Limitations of use: Not indicated for the relief of acute bronchospasm.
Off Label UsesChronic obstructive pulmonary disease (stable)
Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines for the management of chronic obstructive pulmonary disease (COPD), inhaled corticosteroids (ICS) may be considered as part of dual or triple combination therapy (with a long-acting beta agonist [LABA] or with a LABA and long-acting muscarinic antagonist, respectively) in patients with moderate to very severe COPD. However, regular treatment with ICS has been shown to increase the risk of pneumonia, especially in those with severe disease. Combination therapy is recommended in patients with a history of hospitalization(s) for exacerbations of COPD, ≥2 moderate exacerbations of COPD per year, blood eosinophils >300 cells/microliter, and concomitant or history of asthma. Combination therapy may also be considered in patients with 1 moderate exacerbation of COPD per year and blood eosinophils of 100 to 300 cells/microliter.
Dulera Aerosol should be administered only by the orally inhaled route. After each dose, the patient should be advised to rinse his/her mouth with water without swallowing.
The cap from the mouthpiece of the actuator should be removed before using Dulera Aerosol.
Dulera Aerosol should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.
The Dulera Aerosol canister should only be used with the Dulera Aerosol actuator. The Dulera Aerosol actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the Dulera Aerosol canister.
Dosing
Dulera Aerosol 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 starting dosages for Dulera Aerosol treatment are based on prior asthma therapy.
The maximum daily recommended dose is two inhalations of Dulera Aerosol 200 mcg/5 mcg twice daily. Do not use more than two inhalations twice daily of the prescribed strength of Dulera Aerosol as some patients are more likely to experience adverse effects with higher doses of Formoterol (Dulera Aerosol). If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.
If a previously effective dosage regimen of Dulera Aerosol 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 Dulera Aerosol with a higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, should be considered.
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 ≥12 years of age who do not respond adequately after 2 weeks of therapy, higher strength may provide additional asthma control.
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What other drugs will affect Dulera Aerosol?
In clinical studies, concurrent administration of Dulera Aerosol and other drugs eg, short-acting β2-agonist and intranasal corticosteroids have not resulted in an increased frequency of adverse drug reactions. No formal drug interaction studies have been performed with Dulera Aerosol. The drug interactions of the combination are expected to reflect those of the individual components.
Ketoconazole: Co-administration of inhaled Mometasone (Dulera Aerosol) furoate with the potent CYP3A4 enzyme inhibitor ketoconazole causes an increase in plasma concentration of Mometasone (Dulera Aerosol) furoate.
Adrenergic Agents: Concomitant administration of other sympathomimetic agents may potentiate the undesirable effects of Formoterol (Dulera Aerosol).
Xanthine Derivatives and Diuretics: Concomitant treatment with xanthine derivatives, or non-potassium sparing diuretics may potentiate the possible hypokalaemic effect of β2-agonists.
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants and Drugs Known to Prolong the QTc Interval: Formoterol (Dulera Aerosol), as other β2-agonists, should be administered with caution to patients being treated with drugs eg, quinidine, disopyramide, procainamide, phenothiazines, terfenadine, astemizole, macrolides, monoamine oxidase inhibitors and tricyclic antidepressants or any drug known to prolong the QTc interval, because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc-interval have an increased risk of ventricular arrhythmia.
Beta-Adrenergic Receptor Antagonists: Beta-adrenergic blockers may weaken or antagonise the effect of Formoterol (Dulera Aerosol). Therefore, Formoterol (Dulera Aerosol) should not be given together with β-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Halogenated Hydrocarbons: There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
