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warnings
Warnings 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.
Adverse Reactions Tilade is generally well tolerated. Adverse event information was derived from 6,469 patients receiving Tilade in controlled and open-label clinical trials of 1–52 weeks in duration. A total of 4,400 patients received two inhalations four times a day. An additional 2,069 patients received two inhalations twice daily or another dose regimen. Seventy-seven percent of patients were treated with Tilade for eight weeks or longer. Of the 4,400 patients who received two inhalations of Tilade four times a day, 2,632 were in placebo-controlled, parallel trials and of these 6.0% withdrew from the trials due to adverse events, compared to 5.7% of the 2,446 patients who received placebo. The reasons for withdrawal were generally similar in the Tilade and placebo-treated groups, except that patients withdrew due to bad taste statistically more frequently on Tilade than on placebo. Headache reported as severe or very severe, some with nausea and ill feeling, was experienced by 1.0% of Tilade patients and 0.7% of placebo patients. The events reported with a frequency of 1% or greater across all placebo-controlled studies are displayed for all patients ages 6 years and older who received Tilade or placebo at two inhalations four times daily. The adverse event profile observed in children ages 6 through 11 was similar to that observed in adults. % Experiencing AE % Withdrawing ADVERSE EVENT (AE) Tilade (N=2632) Placebo (N=2402) Tilade Placebo Special Senses Unpleasant Taste Statistically significant higher frequency on Tilade , p<0.05 11.6% 3.1% 1.6% 0.0% Respiratory System Disorders Coughing 8.9% 10.2% 1.1% 1.2% Pharyngitis 7.6% 7.5% 0.5% 0.4% Rhinitis 7.3% 6.0% 0.1% 0.1% Upper Respiratory Infection 6.7% 6.3% 0.1% 0.2% Sputum Increased 1.5% 1.4% 0.1% 0.2% Bronchitis 1.1% 1.5% 0.1% 0.1% Dyspnea 2.5% 3.3% 0.8% 1.0% Bronchospasm Statistically significant higher frequency on Placebo, p<0.05 8.4% 11.8% 1.4% 2.0% Sinusitis 3.3% 4.1% 1.1% 0.0% Respiratory Disorder 0.8% 1.1% 0.0% 0.0% Gastrointestinal Tract Nausea 3.9% 2.3% 1.1% 0.5% Vomiting 2.5% 1.6% 0.2% 0.3% Dyspepsia 1.5% 1.1% 0.1% 0.1% Diarrhea 1.3% 1.2% 0.1% 0.0% Abdominal Pain 1.9% 1.3% 0.2% 0.1% Central and Peripheral Nervous System Dizziness 0.8% 1.3% 0.1% 0.2% Body as a Whole Headache 8.1% 7.5% 0.4% 0.2% Chest Pain 3.6% 3.8% 0.7% 0.5% Fatigue 1.0% 0.8% 0.2% 0.0% Fever 3.1% 3.7% 0.1% 0.1% Resistance Mechanism Disorders Infection Viral 2.4% 3.2% 0.1% 0.1% Vision Disorder Conjunctivitis 1.1% 0.7% 0.0% 0.1% Skin and Appendages Disorders Rash 0.5% 1.2% 0.1% 0.0% Other adverse events present at less than the 1% level of occurrence, but that might be related to Tilade administration, include arthritis, tremor, and a sensation of warmth. In clinical trials with 2,632 patients receiving Tilade , 2 patients (0.08%) developed neutropenia and 3 patients (0.11%) developed leukopenia. Although it is unclear if these reactions were caused by Tilade , in several cases these abnormal laboratory tests returned to normal when Tilade was discontinued. There have been reports of clinically significant elevation of hepatic transaminases (ALT and AST greater than 10 times the upper limit of the normal reference range in one patient) associated with the administration of Tilade . It is unclear if these abnormal laboratory tests in asymptomatic patients were caused by Tilade . Cases of bronchospasm immediately following dosing with Tilade have been reported from postmarketing experience. (See WARNINGS .) Isolated cases of pneumonitis with eosinophilia (PIE syndrome) and anaphylaxis have also been reported in which a relationship to drug is undetermined.