Product Description.:
Aerosol , clear , clear
DULERA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for:
* Treatment of asthma in patients 12 years of age and older. (1.1)
* Important limitations:
* Not indicated for the relief of acute bronchospasm. (1.1)
-------------------------DOSAGE AND ADMINISTRATION---------------------
For oral inhalation only.
Treatment of asthma in patients �� years: 2 inhalations twice daily of DULERA 100 mcg/5 mcg or 200 mcg/5 mcg. Starting dosage is based on prior asthma therapy. (2.2)
-----------------------DOSAGE FORMS AND STRENGTHS--------------------
Inhalation aerosol containing a combination of mometasone furoate (100 or 200 mcg) and formoterol fumarate dihydrate (5 mcg) per actuation. (3)
-----------------------------CONTRAINDICATIONS--------------------------------
* Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. (4.1)
* Hypersensitivity to any of the ingredients of DULERA. (4.2)
-----------------------WARNINGS AND PRECAUTIONS------------------------
* Asthma-related death: Long-acting beta2-adrenergic agonists increase the risk. Prescribe only for recommended patient populations. (5.1)
* Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or to treat acute symptoms. (5.2)
* Use with additional long-acting beta2-agonist: Do not use in combination because of risk of overdose. (5.3)
* Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation. (5.4)
* Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection or ocular herpes simplex infections. 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 the potential for worsening of these infections. (5.5)
* Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to DULERA. (5.6)
* Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue DULERA slowly. (5.7)
* Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects. Exercise caution when used with DULERA. (5.8)
* Paradoxical bronchospasm: Discontinue DULERA and institute alternative therapy if paradoxical bronchospasm occurs. (5.9)
* Patients with cardiovascular disorders: Use with caution because of beta-adrenergic stimulation. (5.11)
* Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. (5.12)
* Effects on growth: Monitor growth of pediatric patients. (5.13)
* Glaucoma and cataracts: Monitor patients with change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely. (5.14)
* Coexisting conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.15)
* Hypokalemia and hyperglycemia: Be alert to hypokalemia and hyperglycemia. (5.16)
-------------------------------ADVERSE REACTIONS------------------------------
Most common adverse reactions (reported in ��% of patients) included:
* Nasopharyngitis, sinusitis and headache. (6.1)
