Tilade

Name: Tilade

Before using a nedocromil inhaler

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you (or your child) start using the inhaler, it is important that your doctor knows:

  • If you are pregnant, trying for a baby or breast-feeding.
  • If you have ever had an allergic reaction to a medicine.
  • If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

Tilade Overview

Tilade is a brand name medication included in a group of medications called Other antiallergics. For more information about Tilade see its generic Nedocromil

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.

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* 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 Disorder
  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 , p<0.05
**Statistically significant higher frequency on Placebo, p<0.05

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.

Instructions for Use

Tilade® Inhaler (NEDOCROMIL SODIUM INHALATION AEROSOL)

Metered-Dose Inhaler

Rx Only

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, 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.

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.

For the Consumer

Applies to nedocromil: inhalation aerosol powder

Along with its needed effects, nedocromil (the active ingredient contained in Tilade) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nedocromil:

Less common
  • Abdominal pain
  • body aches or pain
  • chills
  • congestion
  • cough
  • dryness or soreness of throat
  • ear congestion
  • fever
  • hoarseness
  • increased wheezing, tightness in chest, or difficulty in breathing
  • loss of voice
  • nasal congestion
  • noisy breathing
  • runny nose
  • shortness of breath
  • sneezing
  • stuffy nose
  • tender, swollen glands in neck
  • trouble in swallowing
  • unusual tiredness or weakness
  • voice changes
Rare
  • Pain, stiffness, or swelling of joints

Some side effects of nedocromil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Headache
  • nausea or vomiting
  • sensation of warmth
  • throat irritation
  • tremor
  • unpleasant taste

For Healthcare Professionals

Applies to nedocromil: inhalation aerosol with adapter

Gastrointestinal

Gastrointestinal side effects have included unpleasant taste which was reported in approximately 13% of patients receiving nedocromil (the active ingredient contained in Tilade) and resulted in drug withdrawal in up to 3%. Less commonly, nedocromil has caused nausea and vomiting (2% to 4%).[Ref]

Respiratory

Throat irritation may be relieved by drinking water before and after inhalation of nedocromil (the active ingredient contained in Tilade) Use of a beta-2 agonist prior to nedocromil inhalation may relieve cough and bronchospasm.[Ref]

Respiratory side effects have included cough and throat irritation in 6% to 7% of patients treated with nedocromil. Bronchospasm has been induced in 5% of patients.[Ref]

Nervous system

Nervous system side effects have included headache in up to 6% of patients treated. Less commonly dizziness has been reported.[Ref]

Hepatic

Hepatic side effects have included elevations of liver function tests (SGPT) in approximately 3% of patients treated with nedocromil (the active ingredient contained in Tilade) [Ref]

Some side effects of Tilade may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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