Tilade CFC-Free Inhaler (Nedocromil Sodium)

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Tilade CFC-Free Inhaler

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Tilade CFC-Free Inhaler (Nedocromil Sodium)

Tilade (nedocromil inhalation aerosol) Inhaler is indicated for maintenance therapy in the management of adult and pediatric patients 6 years and older with mild to moderate asthma. Tilade (nedocromil inhalation aerosol) is not indicated for the reversal of acute bronchospasm.

Proper Use of this medication

The recommended dosage for adult and pediatric patients 6 years of age and older is two inhalations four times a day at regular intervals, which provides a dose of 14 mg per day. In patients whose asthma is well controlled on this dosage (e.g., patients who only need occasional inhaled or oral beta2-agonists and who are not experiencing serious exacerbations), less frequent administration may be effective.

Each Tilade (nedocromil inhalation aerosol) Inhaler canister must be primed with 3 actuations prior to the first use. If a canister remains unused for more than 7 days, then it should be reprimed with 3 actuations. Tilade (nedocromil inhalation aerosol) Inhaler may be added to the patient's existing treatment regimen (e.g., bronchodilators). When a clinical response to Tilade (nedocromil inhalation aerosol) Inhaler is evident and if the patient's asthma is under good control, an attempt may be made to decrease concomitant medication usage gradually. Proper inhalational technique is essential (see Patient Instructions for Use). Patients should be advised that the optimal effect of Tilade (nedocromil inhalation aerosol) therapydepends upon its administration at regular intervals, even during symptom-free periods.

Warnings and Precautions

WARNINGS

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.

PRECAUTIONS

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.

Side Effects

Tilade (nedocromil inhalation aerosol) is generally well tolerated. Adverse event information was derived from 6,469 patients receiving Tilade (nedocromil inhalation aerosol) 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 (nedocromil inhalation aerosol) for eight weeks or longer.

Of the 4,400 patients who received two inhalations of Tilade (nedocromil inhalation aerosol) 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 (nedocromil inhalation aerosol) and placebo-treated groups, except that patients withdrew due to bad taste statistically more frequently on Tilade (nedocromil inhalation aerosol) than on placebo. Headache reported as severe or very severe, some with nausea and ill feeling, was experienced by 1.0% of Tilade (nedocromil inhalation aerosol) 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 (nedocromil inhalation aerosol) 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.

Interactions with this medication

In clinical studies, Tilade (nedocromil inhalation aerosol) 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.

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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