Dulera Information
Dulera (Mometasone)
Dulera (Mometasone) Dosage And Administration
Dulera (Mometasone) should be administered only by the orally inhaled route (see in the Medication Guide). After each dose, the patient should be advised to rinse his/her mouth with water without swallowing.
Dulera (Mometasone) 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 (Mometasone) canister should only be used with the Dulera (Mometasone) actuator. The Dulera (Mometasone) actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the Dulera (Mometasone) canister.
Dulera (Mometasone) 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 (Mometasone) treatment are based on prior asthma therapy.
The maximum daily recommended dose is two inhalations of Dulera (Mometasone) 200 mcg/5 mcg twice daily. Do not use more than two inhalations twice daily of the prescribed strength of Dulera (Mometasone) as some patients are more likely to experience adverse effects with higher doses of formoterol. If symptoms arise between doses, an inhaled short-acting beta-agonist should be taken for immediate relief.
If a previously effective dosage regimen of Dulera (Mometasone) fails to provide adequate control of asthma, the therapeutic regimen should be reevaluated and additional therapeutic options, e.g., replacing the current strength of Dulera (Mometasone) 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.
Dulera (Mometasone) Dosage Forms And Strengths
Dulera (Mometasone) is a pressurized metered dose inhaler that is available in 2 strengths.
Dulera (Mometasone) 100 mcg/5 mcg delivers 100 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.
Dulera (Mometasone) 200 mcg/5 mcg delivers 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.
Dulera (Mometasone) Warnings And Precautions
Long-acting beta-adrenergic agonists, such as formoterol, one of the active ingredients in Dulera (Mometasone) , increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs 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. Therefore, when treating patients with asthma, physicians should only prescribe Dulera (Mometasone) for patients with asthma 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 (Mometasone) ) 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 (Mometasone) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
A 28-week, placebo-controlled US study comparing the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34). This finding with salmeterol is considered a class effect of the LABAs, including formoterol, one of the active ingredients in Dulera (Mometasone) . No study adequate to determine whether the rate of asthma-related death is increased with Dulera (Mometasone) has been conducted.
Clinical studies with formoterol suggested a higher incidence of serious asthma exacerbations in patients who received formoterol fumarate than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.
Dulera (Mometasone) should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. Dulera (Mometasone) has not been studied in patients with acutely deteriorating asthma. The initiation of Dulera (Mometasone) in this setting is not appropriate.
Increasing use of inhaled, short-acting beta-agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of Dulera (Mometasone) with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids. Patients should not use more than 2 inhalations twice daily (morning and evening) of Dulera (Mometasone) .
Dulera (Mometasone) is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta-agonist, not Dulera (Mometasone) , should be used to relieve acute symptoms such as shortness of breath. When prescribing Dulera (Mometasone) , the physician must also provide the patient with an inhaled, short-acting beta-agonist (e.g., albuterol) for treatment of acute symptoms, despite regular twice-daily (morning and evening) use of Dulera (Mometasone) .
When beginning treatment with Dulera (Mometasone) , patients who have been taking oral or inhaled, short-acting beta-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.
Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals.
Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Dulera (Mometasone) should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Particular care is needed for patients who are transferred from systemically active corticosteroids to Dulera (Mometasone) because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.
Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although Dulera (Mometasone) may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity necessary for coping with these emergencies.
During periods of stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or severe asthma attack.
Patients requiring systemic corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Dulera (Mometasone) . Lung function (FEV1 or PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.
Transfer of patients from systemic corticosteroid therapy to Dulera (Mometasone) may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.
During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.
Mometasone furoate, a component of Dulera (Mometasone) , will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since mometasone furoate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of Dulera (Mometasone) in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.
Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with Dulera (Mometasone) 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.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when mometasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of Dulera (Mometasone) should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.
Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Therefore, Dulera (Mometasone) should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Formoterol fumarate, a component of Dulera (Mometasone) , can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Dulera (Mometasone) at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate, one of the components of Dulera (Mometasone) . The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care.
In a 2-year double-blind study in 103 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (Baseline FEV 85%–88% predicted), treatment with mometasone furoate dry powder inhaler 200 mcg twice daily resulted in significant reductions in lumbar spine (LS) BMD at the end of the treatment period compared to placebo. The mean change from Baseline to Endpoint in the lumbar spine BMD was -0.015 (-1.43%) for the mometasone furoate group compared to 0.002 (0.25%) for the placebo group. In another 2-year double-blind study in 87 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (Baseline FEV 82%–83% predicted), treatment with mometasone furoate 400 mcg twice daily demonstrated no statistically significant changes in lumbar spine BMD at the end of the treatment period compared to placebo. The mean change from Baseline to Endpoint in the lumbar spine BMD was -0.018 (-1.57%) for the mometasone furoate group compared to -0.006 (-0.43%) for the placebo group.
Dulera (Mometasone) Adverse Reactions
Long-acting beta-adrenergic agonists, such as formoterol, one of the active ingredients in Dulera (Mometasone) , increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs 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. Data from a large placebo-controlled US trial that compared the safety of another long-acting beta-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol .
Systemic and local corticosteroid use may result in the following:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Dulera (Mometasone) Drug Interactions
In clinical trials, concurrent administration of Dulera (Mometasone) and other drugs, such as short-acting beta-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 (Mometasone) . The drug interactions of the combination are expected to reflect those of the individual components.
Dulera (Mometasone) Use In Specific Populations
There are no adequate and well-controlled human studies that have studied the effects of Dulera (Mometasone) during labor and delivery.
Because beta-agonists may potentially interfere with uterine contractility, Dulera (Mometasone) should be used during labor only if the potential benefit justifies the potential risk .
The safety and effectiveness of Dulera (Mometasone) have been established in patients 12 years of age and older in 3 clinical trials up to 52 weeks in duration. In the 3 clinical trials, 101 patients 12 to 17 years of age were treated with Dulera (Mometasone) . Patients in this age-group demonstrated efficacy results similar to those observed in patients 18 years of age and older. There were no obvious differences in the type or frequency of adverse drug reactions reported in this age group compared to patients 18 years of age and older. Similar efficacy and safety results were observed in an additional 22 patients 12 to 17 years of age who were treated with Dulera (Mometasone) in another clinical trial. The safety and efficacy of Dulera (Mometasone) have not been established in children less than 12 years of age.
Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. In these studies, the mean reduction in growth velocity was approximately 1 cm per year (range 0.3 to 1.8 per year) and appears to depend upon dose and duration of exposure. This effect was observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied.
The growth of children and adolescents receiving orally inhaled corticosteroids, including Dulera (Mometasone) , should be monitored routinely (e.g., via stadiometry). If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect should be considered. The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including Dulera (Mometasone) , each patient should be titrated to his/her lowest effective dose .
Dulera (Mometasone) Description
Dulera (Mometasone) 100 mcg/5 mcg and Dulera (Mometasone) 200 mcg/5 mcg, are combinations of mometasone furoate and formoterol fumarate dihydrate for oral inhalation only.
One active component of Dulera (Mometasone) is mometasone furoate, a corticosteroid having the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16 (alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) with the following chemical structure:
Mometasone furoate is a white powder with an empirical formula of CHClO, and molecular weight 521.44. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone.
One active component of Dulera (Mometasone) is formoterol fumarate dihydrate, a racemate. Formoterol fumarate dihydrate is a selective beta-adrenergic bronchodilator having the chemical name of (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate with the following chemical structure:
Formoterol fumarate dihydrate has a molecular weight of 840.9, and its empirical formula is (CHNO)•CHO•2HO. Formoterol fumarate dihydrate is a white to yellowish powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether.
Each Dulera (Mometasone) 100 mcg/5 mcg and 200 mcg/5 mcg is a hydrofluoroalkane (HFA-227) propelled pressurized metered dose inhaler containing sufficient amount of drug for 60 or 120 inhalations . After priming, each actuation of the inhaler delivers 115 or 225 mcg of mometasone furoate and 5.5 mcg of formoterol fumarate dihydrate in 69.6 mg of suspension from the valve and delivers 100 or 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. Dulera (Mometasone) also contains anhydrous alcohol as a cosolvent and oleic acid as a surfactant.
Dulera (Mometasone) 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.
Dulera (Mometasone) How Supplied/storage And Handling
Dulera (Mometasone) is available in two strengths and supplied in the following package sizes (Table 7):
Each strength is supplied as a pressurized aluminum canister that has a blue plastic actuator integrated with a dose counter and a blue dust cap. Each 120-inhalation canister has a net fill weight of 13 grams and each 60-inhalation canister has a net fill weight of 8.8 grams. Each canister is placed into a carton. Each carton contains 1 canister and a Medication Guide.
Initially the dose counter will display "64" or "124" actuations. After the initial priming with 4 actuations, the dose counter will read "60" or "120" and the inhaler is now ready for use.
The Dulera (Mometasone) canister should only be used with the Dulera (Mometasone) actuator. The Dulera (Mometasone) actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the Dulera (Mometasone) canister.
The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read "0").
Store at controlled room temperature 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
The 120-inhalation inhaler does not require specific storage orientation. For the 60-inhalation inhaler, after priming store the inhaler with the mouthpiece down or in a horizontal position.
For best results, the canister should be at room temperature before use. Shake well before using. Keep out of reach of children. Avoid spraying in eyes.
Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.
Dulera (Mometasone) Patient Counseling Information
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Patients should be informed that formoterol, one of the active ingredients in Dulera (Mometasone) , increases the risk of asthma-related death. In pediatric and adolescent patients, formoterol may increase the risk of asthma-related hospitalization. They should also be informed that data are not adequate to determine whether the concurrent use of inhaled corticosteroids, the other component of Dulera (Mometasone) , or other long-term asthma-control therapy mitigates or eliminates this risk
Dulera (Mometasone) is not indicated to relieve acute asthma symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting, beta-agonist (the health care provider should prescribe the patient with such medication and instruct the patient in how it should be used).
Patients should be instructed to seek medical attention immediately if they experience any of the following:
Patients should be advised not to increase the dose or frequency of Dulera (Mometasone) . The daily dosage of Dulera (Mometasone) should not exceed two inhalations twice daily. If they miss a dose, they should be instructed to take their next dose at the same time they normally do. Dulera (Mometasone) provides bronchodilation for up to 12 hours.
Patients should not stop or reduce Dulera (Mometasone) therapy without physician/provider guidance since symptoms may recur after discontinuation .
Dulera (Mometasone)
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