Tilade® Inhaler (nedocromil sodium inhalation aerosol) is not a bronchodilator and, therefore, should not be used for the reversal of acute bronchospasm, particularly status asthmaticus. Tilade should ordinarily be continued during acute exacerbations, unless the patient becomes intolerant to the use of inhaled dosage forms.
As with other inhaled asthma medications, bronchospasm, which can be life-threatening, may occur immediately after administration. If this occurs, Tilade should be discontinued and alternative therapy instituted.
General: The role of Tilade as a corticosteroid-sparing agent in patients receiving oral or inhaled corticosteroids remains to be defined. If systemic or inhaled corticosteroid therapy is reduced in patients receiving Tilade, careful monitoring is necessary.
Information for Patients: Patients should be told that:
Tilade must be taken regularly to achieve benefit, even during symptom-free periods.
Tilade is not meant to relieve acute asthma symptoms. If symptoms do not improve or the patient’s condition worsens, the patient should not increase the dosage but should notify the physician immediately.
They should not decrease the dose without the physician’s knowledge. The recommended dose should not be exceeded.
The full therapeutic effect of Tilade may not be obtained for 1 week or longer after initiating treatment.
Because the therapeutic effect depends upon local delivery to the lungs, it is essential that patients be properly instructed in the correct method of use (see Patient Instructions for Use).
An illustrated leaflet for the patient is included in each Tilade Inhaler pack.
Drug Interactions: In clinical studies, Tilade has been co-administered with other anti-asthma medications, including inhaled and oral bronchodilators, and inhaled corticosteroids, with no evidence of increased frequency of adverse events or laboratory abnormalities. No formal drug-drug interaction studies, however, have been conducted.
Carcinogenesis, Mutagenesis, Impairment of Fertility: A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 8 times the maximum recommended human daily inhalation dose on a mg/m2 basis) in Wistar rats showed no carcinogenic potential. A 21-month oral dietary carcinogenicity study of nedocromil sodium performed in B6C3F1 mice with doses up to 180 mg/kg/day (approximately 30 times the maximum recommended human daily inhalation dose on a mg/m2 basis) showed no carcinogenic potential.
Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in Saccharomyces cerevisiae, mouse lymphoma forward mutation, and mouse micronucleus assays.
Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (approximately 30 times and 60 times, respectively, the maximum recommended human daily inhalation dose on a mg/m2 basis).
Pregnancy: Pregnancy Category B: Reproduction studies performed in mice, rats, and rabbits using a subcutaneous dose of 100 mg/kg/day (approximately 30 times, 60 times, and 116 times, respectively, the maximum recommended human daily inhalation dose on a mg/m2 basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tilade is administered to a nursing woman.
Pediatric Use: Safety data in normal volunteers and asthmatic patients between the ages of 6 and 11 years are available on a total of 311 children from U.S. clinical trials and 192 children from foreign clinical trials (total = 503) of 4–12 weeks duration. An additional 225 children received Tilade for 40 weeks and 24 received Tilade for 52 weeks.
The safety and effectiveness of Tilade in children ages 6 through 11 have been established in adequate and well-controlled clinical trials. (See CLINICAL STUDIES: Pediatric Studies.) Use of Tilade in children ages 6 through 11 years is also supported by evidence from adequate and well-controlled studies of Tilade in adults. The safety and effectiveness of Tilade in patients below the age of 6 years have not been established.
Geriatric Use: Clinical studies of Tilade 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.