Ipratroprium Bromide

FDA Drug Profile — Ipratroprium Bromide

Drug Details

Generic Name
Ipratroprium Bromide
Brand Names
Ipratroprium Bromide
Application Number
ANDA076025
Sponsor
Oceanside Pharmaceuticals
NDC Codes
1
Dosage Forms
SPRAY, METERED
Routes
NASAL
Active Ingredients
IPRATROPIUM BROMIDE

Indications and Usage

INDICATIONS AND USAGE: Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.

Warnings

WARNINGS: Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. If such a reaction occurs, therapy with Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) should be stopped at once and alternative treatment should be considered.