Generic name: mometasone furoate and formoterol fumarate dihydrate
Dosage form: aerosol
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DULERA should be administered only by the orally inhaled route (see Patient Instructions for Use in the Medication Guide). 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.
DULERA 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 canister should only be used with the DULERA actuator. The DULERA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the DULERA canister.
DULERA 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 treatment are based on prior asthma therapy.
|Previous Therapy||Recommended Dose||Maximum Recommended Daily Dose|
|Inhaled medium dose corticosteroids||DULERA 100 mcg/5 mcg, 2 inhalations twice daily||400 mcg/20 mcg|
|Inhaled high dose corticosteroids||DULERA 200 mcg/5 mcg, 2 inhalations twice daily||800 mcg/20 mcg|
The maximum daily recommended dose is two inhalations of DULERA 200 mcg/5 mcg twice daily. Do not use more than two inhalations twice daily of the prescribed strength of DULERA as some patients are more likely to experience adverse effects with higher doses of formoterol. 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 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 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.