INDICATIONS AND USAGE

ATROVENT HFA is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema (1)

DOSAGE AND ADMINISTRATION

For oral inhalation ONLY

• Two inhalations four times a day, not to exceed 12 inhalations in 24 hours (2)

DOSAGE FORMS AND STRENGTHS

• Inhalation Aerosol: Each actuation of ATROVENT HFA Inhalation Aerosol delivers 17 mcg of ipratropium bromide from mouthpiece. Supplied in a 12.9 g canister containing 200 actuations (3)

CONTRAINDICATIONS

• Hypersensitivity to ipratropium bromide or other ATROVENT HFA components (4)
• Hypersensitivity to atropine or any of its derivatives (4)

WARNINGS AND PRECAUTIONS

• Not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response (5.1)
• Hypersensitivity reactions: Discontinue ATROVENT HFA at once and consider alternative treatments (5.2)
• Paradoxical bronchospasm: Discontinue ATROVENT HFA and consider other treatments if paradoxical bronchospasm occurs (5.3)
• Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if signs or symptoms of narrow-angle glaucoma develop (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 signs or symptoms of urinary retention develop (5.5)

ADVERSE REACTIONS

Most common adverse reactions (> 5% incidence in the 12-week placebo-controlled trials) were bronchitis, COPD exacerbation, dyspnea, and headache (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY, 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 Atrovent HFA with other anticholinergic-containing drugs (7.1)

1  INDICATIONS AND USAGE

2  DOSAGE AND ADMINISTRATION

3  DOSAGE FORMS AND STRENGTHS

4  CONTRAINDICATIONS

5  WARNINGS AND PRECAUTIONS

5.1  Use for Maintenance Treatment Only

5.2  Hypersensitivity Reactions, Including Anaphylaxis

5.3  Paradoxical Bronchospasm

5.4  Ocular Effects

5.5  Urinary Retention

6  ADVERSE REACTIONS

6.1  Clinical Trials Experience

6.2  Post-Marketing Experience