Generic
Aclidinium Bromide + Formoterol Fumarate
Pharmacology
For oral inhalation only. Should be taken by revolizer. 400 mcg/12 meg, twice daily (One inhalation capsule in the morning and one in the evening ). Do not take more than one inhalation twice daily.
Dosage Administration
For oral inhalation only. Should be taken by revolizer. 400 mcg/12 meg, twice daily (One inhalation capsule in the morning and one in the evening ). Do not take more than one inhalation twice daily.
Contraindications
Use of a long-acting beta 2-adrenergic agonist (LABA), including formoterol fumarate, one of the active ingredients in this combination, without an inhaled corticosteroid is contraindicated in patients with asthma. Hypersensitivity to aclidinium bromide or formoterol fumarate or to any component of this product.
Side Effects
Most common adverse reactions (incidence 3% and more common than with placebo) include: upper respiratory tract infection and headache.
Pregnancy And Lactation
There are no adequate and well-controlled studies of Aclitol or its individual components, formoterol fumarate or aclidinium bromide, in pregnant women to inform drug-associated risks. There are no available data on the effects of aclidinium bromide, or formoterol fumarate on the breastfed child or on milk production or presence in human milk.
Therapeutic
Asthma-related death: Long-acting beta2-adrenergic agonists as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of serious asthma-related events. Do not initiate in acutely deteriorating COPD or to treat acute symptoms. Do not use in combination with additional medicine containing a LABA because of risk of overdose. If paradoxical bronchospasm occurs, discontinue this combination and institute alternative therapy. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus and ketoacidosis. Be alert to hypokalemia and hyperglycemia. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur. Worsening urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if symptoms occur.
Storage Conditions
Combined bronchodilators
Over The Counter Products
