July 26, 2016
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Tilade® Inhaler (nedocromil inhalation aerosol) (nedocromil sodium inhalation aerosol) is not a bronchodilator and, therefore, should not be used for the reversal of acute bronchospasm, particularly status asthmaticus. Tilade (nedocromil inhalation aerosol) 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 (nedocromil inhalation aerosol) should be discontinued and alternative therapy instituted.


General: The role of Tilade (nedocromil inhalation aerosol) 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 (nedocromil inhalation aerosol) , careful monitoring is necessary.

Information for Patients: Patients should be told that:

  • Tilade (nedocromil inhalation aerosol) must be taken regularly to achieve benefit, even during symptom-free periods.
  • Tilade (nedocromil inhalation aerosol) 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 (nedocromil inhalation aerosol) 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 (nedocromil inhalation aerosol) Inhaler pack.

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 (nedocromil inhalation aerosol) 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 (nedocromil inhalation aerosol) for 40 weeks and 24 received Tilade (nedocromil inhalation aerosol) for 52 weeks.

The safety and effectiveness of Tilade (nedocromil inhalation aerosol) in children ages 6 through 11 have been established in adequate and well-controlled clinical trials. (See Clinical Studies: Pediatric Studies.) Use of Tilade (nedocromil inhalation aerosol) in children ages 6 through 11 years is also supported by evidence from adequate and well-controlled studies of Tilade (nedocromil inhalation aerosol) in adults. The safety and effectiveness of Tilade (nedocromil inhalation aerosol) in patients below the age of 6 years have not been established.

Geriatric Use: Clinical studies of Tilade (nedocromil inhalation aerosol) 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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/29/2008


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