Generic Name and Formulations:
Aclidinium bromide 400mcg, formoterol fumarate 12mcg; per actuation; dry powder for oral inhalation.
Circassia Pharmaceuticals Inc.
Maintenance treatment of COPD.
Not indicated for relief of acute bronchospasm or for treatment of asthma.
1 inhalation twice daily (in the AM + PM). Max 1 inhalation twice daily.
Use of LABA without inhaled corticosteroid (ICS) in asthma. Milk protein sensitivity.
LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in acute deteriorating COPD. Not for relief of acute symptoms. Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Discontinue immediately and treat if paradoxical bronchospasm or immediate hypersensitivity reactions occur; use alternative therapy. Cardiovascular disorders (eg, coronary insufficiency, cardiac arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Pregnancy. Labor & delivery. Nursing mothers.
Anticholinergic + long-acting beta-2 agonist (LABA).
Caution with concomitant other adrenergic drugs; may potentiate sympathetic effects. Concomitant xanthine derivatives, steroids, or diuretics may potentiate hypokalemia. Caution with non-K+-sparing diuretics. Extreme caution with MAOIs, tricyclics, or others that prolong QTc interval. Antagonized by β-blockers; if needed, use cardioselective agents if no acceptable alternatives. Additive effects with concomitant other anticholinergic-containing drugs; avoid.
Upper respiratory tract infection, headache, back pain; paradoxical bronchospasm, hypersensitivity reactions, cardiovascular effects.
Dry powder inhaler—30, 60 doses
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