Cromolyn Sodium Inhalation

FDA Drug Profile — Cromolyn Sodium Inhalation Solution

Drug Details

Generic Name
Cromolyn Sodium Inhalation
Brand Names
Cromolyn Sodium Inhalation Solution
Application Number
ANDA075437
Sponsor
Bryant Ranch Prepack
NDC Codes
1
Dosage Forms
SOLUTION
Routes
INTRABRONCHIAL
Active Ingredients
CROMOLYN SODIUM

Indications and Usage

INDICATIONS AND USAGE Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma. In patients whose symptoms are sufficiently frequent to require a continuous program of medication, Cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION ). The effect of cromolyn sodium is usually evident after several weeks of treatment, although some patients show an almost immediate response. In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ).

Warnings

WARNINGS Cromolyn sodium inhalation solution has no role in the treatment of status asthmaticus. Anaphylactic reactions with cromolyn sodium administration have been reported rarely.