Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

• 2 inhalations orally once a day, at the same time

Renal Dose Adjustments

Mild renal dysfunction: No adjustment recommended.
Moderate to Severe renal dysfunction (CrCl less than 60 mL/min): Use with caution; monitor closely for anticholinergic side effects

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: A study was not performed.

Precautions

CONTRAINDICATIONS:

• Use of a long-acting beta-2 (LABA) agonist without an inhaled corticosteroid (ICS) in asthma patients; this drug is not indicated for asthma treatment
• Hypersensitivity to any of the ingredients or ipratropium

Dialysis

Data not available

Other Comments

Administration advice:

• Administer this drug at the same time of the day.
• The recommended daily dose should not be exceeded.
• This drug is for oral inhalation only.
• To ensure proper use of the inhalation device, see Instructions for its use.

• This drug is not indicated to treat acute deteriorations of COPD and asthma.
• The safety and effectiveness of this drug in asthma patients have not been established.

• Patients should read the medication guide and instructions for the use of this drug.
• Notify the physician immediately if experiencing any of the following: Worsening of symptoms; decreasing effectiveness of inhaled, short-acting beta2-agonists; need for more inhalations than usual of the inhaled, short-acting beta2-agonists; significant decrease in lung function as outlined by the physician.
• Therapy with this drug should not be stopped without physician/provider guidance since symptoms may recur after discontinuation.
• Discontinue previous regular use of short acting beta2-agonist and use them only for the symptomatic relief of acute symptoms.
• Consult a provider immediately if symptoms of eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema develop. The use of miotic eye drops alone is not considered to be effective treatment.
• Caution must be taken not to allow the aerosol cloud to enter into the eyes as this may cause blurring of vision and pupil dilation.
• This drug can cause dizziness and blurred vision, caution is recommended when driving or operating or machinery.