ipratropium bromide

FDA Drug Profile — Ipratropium Bromide, Atrovent HFA

Drug Details

Generic Name
ipratropium bromide
Brand Names
Ipratropium Bromide, Atrovent HFA
Application Number
ANDA076155
Sponsor
NORTHSTAR RX LLC
NDC Codes
5
Dosage Forms
SPRAY, METERED, AEROSOL, METERED, POWDER
Routes
NASAL, RESPIRATORY (INHALATION)
Active Ingredients
IPRATROPIUM BROMIDE

Indications and Usage

INDICATIONS AND USAGE Ipratropium bromide nasal solution 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. Ipratropium bromide 0.03% 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 should be stopped at once and alternative treatment should be considered.