Atrovent Nasal (Ipratropium Bromide Nasal) - Indications and Dosage

INDICATIONS AND USAGE

ATROVENT^® (ipratropium bromide) Nasal Spray 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ATROVENT (ipratropium bromide) Nasal Spray 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.

DOSAGE AND ADMINISTRATION

The recommended dose of ATROVENT^® (ipratropium bromide) Nasal Spray 0.03% is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Optimum dosage varies with the response of the individual patient. Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime.

HOW SUPPLIED

ATROVENT^® (ipratropium bromide) Nasal Spray 0.03% is supplied in a white high density polyethylene (HDPE) bottle fitted with a white and clear metered nasal spray pump, a green safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 31.1g of product formulation, 345 sprays, each delivering 21 mcg (70µL) of ipratropium per spray, or 28 days of therapy at the maximum recommended dose (two sprays per nostril three times a day).

Store tightly closed between 59°F (15°C) and 86°F (30°C). Avoid freezing. Keep out of reach of children. Do not spray in the eyes.

Patients should be reminded to read and follow the accompanying Patient's Instructions for Use, which should be dispensed with the product.

Rx only

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT 06877

Licensed from: Boehringer Ingelheim International GmbH

U.S. Patent No. 4,385,048

Rev. May 29, 2003

10001900/US/2                                         10001900/02