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Tilade (Nedocromil Sodium Inhalation) - Indications and Dosage

 
 



Indications and Usage

Tilade Inhaler is indicated for maintenance therapy in the management of adult and pediatric patients 6 years and older with mild to moderate asthma.

Tilade is not indicated for the reversal of acute bronchospasm.

Dosage and Administration

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 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 Inhaler may be added to the patient’s existing treatment regimen (e.g., bronchodilators). When a clinical response to Tilade 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).

Patientsshould be advised that the optimal effect of Tilade therapy depends upon its administration at regular intervals, even during symptom-free periods.

HOW TO CHECK CONTENTS OF YOUR CANISTER

Shaking the Canister will NOT give you a good estimate of how much medication is left. We have included a convenient check-off chart to assist you in keeping track of medication inhalations used. This will help assure that you receive the labeled number of inhalations present. Please note that the Canister has been filled with extra suspension to accommodate the initial priming activity.

Each 16.2 gram inhaler delivers 104 metered inhalations. Tilade® Inhaler Check-Off Chart

  • Retain with medication or affix to convenient location.

  • Starting with inhalation #1, check off one circle for each inhalation used.

  • DISCARD MEDICATION AFTER THE LABELED NUMBER OF INHALATIONS HAVE BEEN USED.

  • NEVER IMMERSE THE METAL CANISTER IN WATER.

How Supplied

Tilade Inhaler is available in 16.2 g canisters providing at least 104 metered inhalations. Each Tilade 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 logo. The Tilade mouthpiece should not be used with other aerosol medications and the Tilade 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 60793-120-01........................ 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.

Rx only

Prescribing Information as of September 2005.

Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: Aventis Pharma LTD, Holmes Chapel CW48BE, United Kingdom

Made in United Kingdom

Storage

The contents of Tilade Inhaler are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures over 120°F may cause bursting. Never throw the Canister into a fire or incinerator.

Keep out of the reach of children. Store at room temperature. Avoid excessive humidity.

Note: The indented statement below is required by the Federal government’s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs).

This product contains CFC-12 and CFC-114, substances which harm the environment by destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.

Prescribing Information as of September 2005.

Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: Aventis Pharma LTD, Holmes Chapel CW48BE, United Kingdom

Made in United Kingdom

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