Cromolyn Sodium

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 ).

Cromolyn sodium inhalation solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.

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

Drug Interaction During Pregnancy Cromolyn sodium and isoproterenol were studied following subcutaneous injections in pregnant mice. Cromolyn sodium alone in doses up to 540 mg/kg (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) increased both resorptions and malformations.

The addition of cromolyn sodium (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) to isoproterenol (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) appears to have increased the incidence of both resorptions and malformations.

Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg and 164 mg/kg, respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg produced no evidence of fetal malformations. These doses represent approximately 27, 17, and 98 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m 2 basis.