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Atrovent Nasal Spray .06

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Atrovent Nasal Spray .06

Indications
Dosage
How Supplied

INDICATIONS

ATROVENT Nasal Spray 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ATROVENT Nasal Spray 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis.

The safety and effectiveness of the use of Atrovent® (ipratropium bromide) Nasal Spray 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.

DOSAGE AND ADMINISTRATION

For Symptomatic Relief of Rhinorrhea Associated with the Common Cold

The recommended dose of ATROVENT Nasal Spray 0.06% is two sprays (84 mcg) per nostril three or four times daily (total dose 504 to 672 mcg/day) in adults and children age 12 years and older. Optimum dosage varies with response of the individual patient. The recommended dose of ATROVENT Nasal Spray 0.06% for children age 5-11 years is two sprays (84 mcg) per nostril three times daily (total dose of 504 mcg/day).

The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond four days in patients with the common cold have not been established.

For Symptomatic Relief of Rhinorrhea Associated with Seasonal Allergic Rhinitis

The recommended dose of ATROVENT Nasal Spray 0.06% is two sprays (84 mcg) per nostril four times daily (total dose 672 mcg/day) in adults and children age 5 years and older.

The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond three weeks in patients with seasonal allergic rhinitis have not been established.

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. Avoid spraying into eyes.

HOW SUPPLIED

ATROVENT Nasal Spray 0.06% is supplied in a white high density polyethylene (HDPE) bottle fitted with a metered nasal spray pump, a green safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 16.6 g of product formulation, 165 sprays, each delivering 42 mcg of ipratropium bromide per spray (70 μL), or 10 days of therapy at the maximum recommended dose (two sprays per nostril four times a day) (NDC 0597-0086-76).

Store tightly closed at 25°C (77°F); excursions permitted to 15°- 30°C (59°-86°F) [see USP Controlled Room Temperature]. Avoid freezing. Keep out of reach of children. Do not spray in the eyes.

Address medical inquiries to: http://us.boehringer-ingelheim.com, (800) 542-6257 or (800) 459-9906 TTY.

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

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Rev: April 2008. FDA rev date: 10/14/2008

Last reviewed on RxList: 12/5/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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