Rx Item-SEEBRI NEOHALER 15.6 MCG CAP 60 BY SUNOVION

For: Chronic Obstructive Pulmonary Disease

Seebri Neohaler (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). These highlights do not include all the information needed to use SEEBRI NEOHALER safely and effectively. See full prescribing information for SEEBRI NEOHALER.
SEEBRI� NEOHALER� (glycopyrrolate) inhalation powder, for oral inhalation use
Initial U.S. Approval: 1961
INDICATIONS AND USAGE

SEEBRI NEOHALER is an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). (1)
DOSAGE AND ADMINISTRATION

For oral inhalation only. Do not swallow SEEBRI capsules. Only use SEEBRI capsules with the NEOHALER device. (2)
Maintenance treatment of COPD: The inhalation of the powder contents of one SEEBRI capsule (15.6 mcg) twice-daily (2)

DOSAGE FORMS AND STRENGTHS

Inhalation powder: SEEBRI capsules contain 15.6 mcg of glycopyrrolate inhalation powder for use with the NEOHALER device. (3)

CONTRAINDICATIONS

History of known hypersensitivity to glycopyrrolate or to any of the ingredients. (4, 5.3)

WARNINGS AND PRECAUTIONS

Do not initiate in acutely deteriorating COPD or to treat acute symptoms. (5.1)
If paradoxical bronchospasm occurs, discontinue SEEBRI NEOHALER immediately and institute alternative therapy. (5.2)
Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur. (5.4)
Worsening of 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. (5.5)

ADVERSE REACTIONS

Most common adverse reactions (incidence greater than or equal to 2% and higher than placebo) are upper respiratory tract infection and nasopharyngitis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of SEEBRI NEOHALER with other anticholinergic-containing drugs. (7.2)

USE IN SPECIFIC POPULATIONS

Use in patients with severe renal impairment should be considered if the potential benefit of the treatment outweighs the risk. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 1/2018

Rx Item-SEEBRI NEOHALER 15.6 MCG CAP 60
RX768218

Rx Item-SEEBRI NEOHALER 15.6 MCG CAP 60
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