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Tilade

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Tilade

PATIENT INFORMATION

Tilade®
INHALER

(NEDOCROMIL SODIUM INHALATION AEROSOL)

Metered-Dose Inhaler

This leaflet does not contain the complete information about your medication. If you have any further questions, or are not sure about something, you should ask your doctor or pharmacist. You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished this canister.

TELL YOUR DOCTOR BEFORE STARTING TO TAKE THIS MEDICINE:

  • if you are pregnant (or intending to become pregnant),
  • if you are breast-feeding a baby,
  • if you are allergic to Tilade (nedocromil inhalation aerosol) , or any other components of the drug product.

In some circumstances, this medication may not be suitable and your doctor may wish to give you a different medicine. Make sure that your doctor knows what other medicines you are taking.

DO NOT use after the date shown as "EXP" on the label or box.

INSTRUCTIONS FOR USE

The following is one of several acceptable inhalation techniques. If your physician has suggested another method, you should use that method.

1. To use the Tilade (nedocromil inhalation aerosol) Inhaler, remove the Mouthpiece Cover and make sure the metal Canister is fully and firmly inserted into the plastic Mouthpiece. Do not remove the Valve Cover from the metal Canister (Figures 1a & 1b).

Inhaler Components and Assembly - Illustration

2. To prepare your Tilade (nedocromil inhalation aerosol) Inhaler for use, the Inhaler must be primed prior to the first use. To prime, hold the Inhaler upright, with the Mouthpiece facing away from you. Shake the Inhaler, then press firmly downward on the Canister. Repeat this procedure again until a total of three (3) sprays are released. Your Tilade (nedocromil inhalation aerosol) Inhaler is now ready for use. Repriming is only necessary when your Inhaler remains unused for more than 7 days. To reprime, shake the Inhaler and release one spray. Repeat this procedure until a total of three (3) sprays are released.

3. Hold the Inhaler (as illustrated in Figure 2) and shake well before each use. The Mouthpiece should be inspected for the presence of foreign objects before use. For optimal results, the Canister should be at room temperature before use.

4. Avoid spraying in eyes.

5. Hold the Inhaler away from your mouth, as shown, and exhale slowly. Do not breathe into the Inhaler as moisture could cause it to clog (Figure 3).

Holding the Inhaler and Exhaling - Illustration

6. Place the Mouthpiece in your mouth and close your lips around it. Tilt your head back, keeping your tongue below the opening of the Inhaler (Figure 4).

7. Press the top of the Canister down firmly at exactly the same time as you begin to inhale. Keep the Canister depressed as you continue to inhale slowly through your mouth until you have taken a full breath (Figure 5). After you have finished your full breath, release the pressure of your finger from the top of the Canister.

Placing the mouth piece and inhaling - Illustration

8. Remove the Inhaler from your mouth, and hold your breath as long as comfortably possible before breathing out slowly. This step is very important because it allows the medication to spread throughout your lungs.

9. Repeat Steps 3-8; then replace the Mouthpiece Cover.

10. Keeping the plastic Mouthpiece clean is extremely important to prevent medication buildup and blockage. To clean, simply remove the Canister and Mouthpiece Cover, and wash the Mouthpiece through the top and bottom in HOT water (Figures 6 & 7). Never immerse the metal Canister in water. The Mouthpiece can be washed every day, and should be washed at least twice a week. To dry, shake off excess water and let the Mouthpiece air dry in a warm place overnight. When the Mouthpiece is completely dry, replace the Canister and Mouthpiece Cover.

Cleaning the mouth piece - Illustration

FOR BEST RESULTS

  1. Use the Inhaler every day, as directed by your physician. Do not stop the treatment, or even reduce the dosage during symptom-free periods, without your physician's permission.
  2. Remember, your Tilade (nedocromil inhalation aerosol) Inhaler must be primed prior to the first use. Repriming is only necessary when the Inhaler remains unused for more than 7 days. Do not reprime between more frequent usage. (See Step 2 under INSTRUCTIONS FOR USE.) Note: The Valve Cover should not be removed from the Canister (see Step 1 under INSTRUCTIONS FOR USE).
  3. It is essential that the Canister be pressed at exactly the same time as you inhale. It is well worth your time to review this technique with your physician.
  4. The dose delivered from the Inhaler can be seen as a fine mist. If you notice this mist escaping from your mouth or nose, you may not be breathing in at the exact moment the Canister is being pressed (see Steps 6 & 7 under INSTRUCTIONS FOR USE).
  5. Keep the Mouthpiece Cover on the Inhaler when not in use so that dirt can't get into it.
  6. Keep a record of the number of sprays used and discard the Canister after 104 sprays. The amount of medication in each spray cannot be assured after 104 sprays. Please note that the Canister has been filled with extra suspension to accommodate the initial priming activity.
  7. The Tilade (nedocromil inhalation aerosol) Canister is to be used only with the Tilade (nedocromil inhalation aerosol) Inhaler Mouthpiece and should not be used with other mouthpieces. In addition, the Tilade (nedocromil inhalation aerosol) Mouthpiece should not be used with canisters of other inhaled medications.
  8. While taking Tilade (nedocromil inhalation aerosol) Inhaler, other inhaled drugs should be taken only as directed by your physician.

PRODUCT UTILIZATION

For the treatment of mild to moderate asthma in patients 6 years of age and older, the recommended dosage is two (2) inhalations four times a day at regular intervals. For maintenance therapy, daily dosing frequency will depend upon your physician's assessment of your asthma and may be four times a day or less at regular intervals.

With regular use, Tilade (nedocromil inhalation aerosol) will decrease asthma symptoms. However, Tilade (nedocromil inhalation aerosol) will not relieve the symptoms of an asthma attack once the attack has started.

It is important that you follow your physician's daily dosing instructions - even during symptom-free periods - to achieve optimal benefit from this medication. Please note that Tilade (nedocromil inhalation aerosol) is not a steroid medication.

Benefits which may be achieved from regular use of Tilade (nedocromil inhalation aerosol) include:

  • Prevention or reduction of asthma symptoms such as wheezing, chest tightness, cough, and shortness of breath.
  • Treatment of the bronchial inflammation that causes asthma.

Tilade (nedocromil inhalation aerosol) Canisters should only be used with the Tilade (nedocromil inhalation aerosol) Inhaler Mouthpiece. The Tilade (nedocromil inhalation aerosol) Mouthpiece should not be used with canisters of other inhaled medications.

Tilade (nedocromil inhalation aerosol) Inhaler will provide at least 104 metered sprays. However, after 104 sprays, the amount of drug delivered per spray may not be consistent. You should keep track of the number of sprays used from each Canister of Tilade (nedocromil inhalation aerosol) Inhaler and discard the Canister after 104 sprays.

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.

 - 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.

STORAGE

The contents of Tilade (nedocromil inhalation aerosol) 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.

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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