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Tilade® Inhaler
(nedocromil sodium) Inhalation Aerosol
Tilade (nedocromil sodium) is an inhaled anti-inflammatory agent for the preventive management of asthma. Nedocromil sodium is a pyranoquinoline with the chemical name 4H-Pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt, and it has a molecular weight of 415.3. The empirical formula is C19H15NNa2O7. Nedocromil sodium, a yellow powder, is soluble in water.
The molecular structure of nedocromil sodium is:
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Chemical Class: Pyranoquinoline
Tilade Inhaler (nedocromil sodium inhalation aerosol) is a pressurized metered-dose aerosol suspension for oral inhalation containing micronized nedocromil sodium and sorbitan trioleate, as well as dichlorotetrafluoroethane and dichlorodifluoromethane as propellants. Each Tilade canister contains 210 mg nedocromil sodium. Each actuation meters 2.00 mg nedocromil sodium from the valve and delivers 1.75 mg nedocromil sodium from the mouthpiece. Each 16.2 g canister provides at least 104 metered actuations. After 104 metered actuations, the amount delivered per actuation may not be consistent and the unit should be discarded.
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 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.
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) therapy depends upon its administration at regular intervals, even during symptom-free periods.
Tilade (nedocromil inhalation aerosol) Inhaler is available in 16.2 g canisters providing at least 104 metered inhalations. Each Tilade (nedocromil inhalation aerosol) canister contains 210 mg nedocromil sodium. Each pack is supplied with patient instructions, a tan-colored rubber valve cover, and white plastic mouthpiece and cover, bearing the Tilade (nedocromil inhalation aerosol) logo. The Tilade (nedocromil inhalation aerosol) mouthpiece should not be used with other aerosol medications and the Tilade (nedocromil inhalation aerosol) canister should not be used with other mouthpieces. Each actuation meters 2.00 mg nedocromil sodium from the valve and delivers 1.75 mg nedocromil sodium from the mouthpiece.
NDC 0585-0685-02 One 16.2 g Canister (104 Metered Inhalations)
The canister should be discarded after the labeled number of actuations have been used. The amount of medication in each actuation cannot be assured after this point.
Store between 2 to 30°C (36 to 86°F). Do not freeze. Avoid spraying in eyes. Contents under pressure. Do not puncture, incinerate, place near sources of heat, or use with other mouthpieces. Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or incinerator. Keep out of the reach of children. For best results, the canister should be at room temperature before use.
Shake well before using.
Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs).
WARNING: Contains CFC-12 and CFC-114, substances which harm public health and the environment by destroying ozone in the upper atmosphere.
A notice similar to the above WARNING has been placed in the "Patient Instructions for Use" portion of this package insert under the Environmental Protection Agency's (EPA's) regulations. The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.
Distributed by: King Pharmaceuticals™, Inc. Bristol, TN 37620. Manufactured by: Aventis Pharma LTD, Holmes Chape,l Cheshire CW48B3, United Kingdom. FDA rev date:
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.
| % Experiencing AE | % Withdrawing | |||
| ADVERSE EVENT (AE) | Tilade (N=2632) |
Placebo (N=2402) |
Tilade | Placebo |
| Special Senses | ||||
| Unpleasant Taste* | 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** | 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 Disorders | ||||
| Conjunctivitis | 1.1% | 0.7% | 0.0% | 0.1% |
| Skin and Appendages Disorders | ||||
| Rash** | 0.5% | 1.2% | 0.1% | 0.0% |
| * Statistically significant higher frequency on Tilade (nedocromil inhalation aerosol) , p | ||||
