ipratropium bromide

FDA Drug Profile — Atrovent HFA, Ipratropium Bromide

ipratropium bromide is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including Atrovent HFA, Ipratropium Bromide. Available dosage forms: aerosol, metered, spray, metered, powder.

Drug Details

Generic Name
ipratropium bromide
Brand Names
Atrovent HFA, Ipratropium Bromide
Application Number
NDA021527
Sponsor
Boehringer Ingelheim Pharmaceuticals, Inc.
NDC Codes
5
Dosage Forms
AEROSOL, METERED, SPRAY, METERED, POWDER
Routes
RESPIRATORY (INHALATION), NASAL
Active Ingredients
IPRATROPIUM BROMIDE

Indications and Usage

INDICATIONS AND USAGE Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Warnings

WARNINGS The use of Ipratropium Bromide Inhalation Solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of Ipratropium Bromide Inhalation Solution and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation. Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.