Glycopyrrolate / Indacaterol Dosage

Applies to the following strengths: 15.6 mcg-27.5 mcg

Usual Adult Dose for:

Chronic Obstructive Pulmonary Disease - Maintenance

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

UTIBRON NEOHALER (R):

1 inhalation (glycopyrrolate 15.6 mcg-indacaterol 27.5 mcg) orally TWICE a day (in the morning and in the evening)

Comments:

For each inhalation, administer the content of 1 capsule using the NEOHALER device.
More frequent administration or a greater number of inhalations (more than 1 capsule twice a day) is not recommended. Do not use 2 capsules at one time.

ULTIBRO BREEZHALER (R):

1 inhalation (glycopyrrolate 50 mcg-indacaterol 110 mcg) orally ONCE a day

Comment:

Inhale orally the content of one capsule using the BREEZHALER inhaler.

Use: Long term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Benefit should outweigh the potential risk.
End-stage renal disease: Benefit should outweigh the potential risk.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: No studies have been 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

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: Benefit should outweigh the potential risk.
Peritoneal 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.

Storage requirements:

Capsules should be stored in the blister, and only removed immediately before use with the inhaler device.

Limitations of use:

This drug is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Patient advice:

Patients should read the medication guide and instructions for the use of this drug.
A rescue inhaler should be provided to patients to treat acute symptoms. Patients should be instructed on how to use the rescue inhaler.
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.