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Intal

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Intal Inhaler

Intal Inhaler

WARNINGS

Intal Inhaler (cromolyn sodium inhalation aerosol) has no role in the treatment of an acute attack of asthma, especially status asthmaticus. Severe anaphylactic reactions can occur after cromolyn sodium administration. The recommended dosage should be decreased in patients with decreased renal or hepatic function. Intal Inhaler (cromolyn sodium inhalation aerosol) should be discontinued if the patient develops eosinophilic pneumonia (or pulmonary infiltrates with eosinophilia). Because of the propellants in this preparation, it should be used with caution in patients with coronary artery disease or a history of cardiac arrhythmias.

PRECAUTIONS

General: In view of the biliary and renal routes of excretion for cromolyn sodium, consideration should be given to decreasing the dosage or discontinuing the administration of the drug in patients with impaired renal or hepatic function.

Occasionally, patients may experience cough and/or bronchospasm following cromolyn sodium inhalation. At times, patients who develop bronchospasm may not be able to continue administration despite prior bronchodilator administration. Rarely, very severe bronchospasm has been encountered.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg/day three days per week), hamsters (intraperitoneal administration at doses up to 53 mg/kg/day three days per week for 15 weeks followed by 17.5 mg/kg/day three days per week for 37 weeks), and rats (18 months subcutaneous treatment at doses up to 75 mg/kg/day six days per week) showed no neoplastic effects. These doses in mice, hamsters, and rats correspond to approximately 40, 10, and 80 times, respectively, the maximum recommended daily inhalation dose in adults on a mg/m2 basis, or, approximately 20, 5, and 40 times, respectively, the maximum recommended daily inhalation dose in children on a mg/m2 basis.

Cromolyn sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae, and in an in vitro cytogenetic study in human peripheral lymphocytes.

No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day in males and 100 mg/kg/day in females. These doses are approximately 220 and 130 times, respectively, the maximum recommended daily inhalation dose in adults on a mg/m2 basis.

Pregnancy: Pregnancy Category B: Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg/day and 160 mg/kg/day, respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg/day produced no evidence of fetal malformations. These doses represent approximately 340, 210, and 1,200 times, respectively, the maximum recommended daily inhalation dose in adults on a mg/m2 basis. Adverse fetal effects (increased resorption and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, Intal Inhaler should be used during pregnancy only if clearly needed.

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/day (approximately 340 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg/day (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis) increased both resorptions and malformations. The addition of 540 mg/kg/day of cromolyn sodium (approximately 340 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis) to 2.7 mg/kg/day of isoproterenol (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis) appears to have increased the incidence of both resorptions and malformations.

Nursing Mothers: It is not known whether this drug is excreted in human milk, therefore, caution should be exercised when Intal Inhaler is administered to a nursing woman and the attending physician must make a benefit/risk assessment in regard to its use in this situation. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 5 years have not been established. For young pediatric patients unable to utilize the Inhaler, Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) is recommended. Because of the possibility that adverse effects of this drug could become apparent only after many years, a benefit/risk consideration of the long-term use of Intal Inhaler is particularly important in pediatric patients.

Geriatric Use: Clinical studies of Intal Inhaler did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Last reviewed on RxList: 4/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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