Manufacturer:
AstraZeneca Canada Inc.

Generic Name:
formoterol fumarate

Route:
oral inhalation

Why is it prescribed?

Oxeze® turbuhaler contains formoterol fumarate.

Formoterol is used for the treatment and prevention of symptoms of reversible obstructive airways disease including asthma in patients 6 years of age and older who:

• require long-term twice daily maintenance treatment of asthma
• require occasional use of a bronchodilator (Oxeze® only NOT Foradil®)
• experience acute bronchoconstriction
• experience nocturnal asthma
• experience exercise-induced bronchoconstriction*

Side Effects

Oxeze® turbuhaler contains formoterol fumarate.

Along with its needed effects, formoterol may cause some unwanted or undesirable effects. Often, formoterol users who use their medication properly, never experience any unwanted effects. The severity and duration of these effects are dependant on many factors including duration of therapy, dose, route of administration and individual response. Common:

• headache
• tremor
• slight palpitations (awareness of heart beat)

• muscle cramps and pain
• feeling nervous or tired
• agitation
• difficulties in sleeping

• allergic reaction (rash, swelling of face and throat)
• cardiac arrythmias (e.g., atrial fibrillation, supraventricular tachycardia, estrasystoles)
• hypokalemia
• worsening of asthma symptoms

Precautions and Warnings for Oxeze® turbuhaler

Oxeze® turbuhaler contains formoterol fumarate

Long-acting beta(2)-adrenergic agonists (LABA), such as formoterol may increase the risk of asthma-related death. This increased risk was determined based on the evidence from a large study done in the United States with another LABA called salmeterol. Because of this risk, LABAs like formoterol must never be used alone to treat asthma. They should be used as add-on therapy for patients with asthma who continue to have poor asthma control despite an optimal dose of inhaled corticosteroids (ICS). In asthma, formoterol must be used together with an appropriate dose of inhaled corticosteroid .
Maximum benefit cannot be achieved unless the inhalation device is used correctly. Even if you have used this device before, you should have your technique reassessed by your pharmacist and read the patient instructions that are provided with each inhaler.
Formoterol should be used as an additional therapy to low-to-medium dose inhaled corticosteroids. Do not use Formoterol as monotherapy in asthma patients or as a substitute for oral or inhaled corticosteroids. Corticosteroids should not be stopped when Formoterol is initiated.
Formoterol can be used to treat acute symptoms (Oxeze® only; NOT Foradil®), however, medical attention should be sought if patients find that relief bronchodilator treatment becomes less effective or that they need more inhalations than usual.
Data from a large US study comparing the safety of the long-acting beta-2-agonist salmeterol to that of a placebo showed an increase in asthma-related deaths in patients receiving salmeterol. Although the trial results were specific to salmeterol, one of the conclusions derived from this study is that long- acting beta-2-agonists may increase the risk of asthma exacerbation and possibly asthma-related death.
Although available data for Formoterol do not suggest increased risk, it can not be excluded that the findings with salmeterol may apply to all long-acting beta-2-agonists including Formoterol.
When treating asthma patients, Formoterol should be used only as additional therapy for patients whose conditions are not adequately controlled using low-to-medium dose inhaled corticosteroids or whose disease severity clearly warrants the initiation of treatment with two maintenance therapies, i.e. formoterol in addition to an inhaled corticosteroid.

Patient Information

Before using Oxeze® for the first time, be sure you understand how to use the turbuhaler: (dry powder inhaler). Your doctor or pharmacist will demonstrate the proper method of loading and inhaling Oxeze® but you should also read and keep the package insert which comes with each inhaler. To ensure that you are getting maximum benefit from Oxeze® ask your pharmacist to assess your inhalation technique.
Do not shake Oxeze® before use.
When the inhaler is loaded, your dose will be lost if the inhaler is accidentally dropped, shaken, or if you breathe into the inhaler. If this happens, reload the inhaler before using.
Oxeze® turbuhaler does not contain an aerosol propellant. You draw the powder into your lungs with your breath. Therefore, it is important to inhale sharply and deeply through the mouthpiece when using the inhaler. Since only a very small amount of powder is inhaled with each dose, you may not taste or feel anything when you use the inhaler. As long as you are using the inhaler correctly, you will be receiving the prescribed amount of Oxeze®.
Oxeze® should not be used more often than recommended. If your forget a dose, take it as soon as possible. But, if it is almost time for your next dose, do not take the missed one, just resume your regular schedule. Doubling up on your regular dosage could increase the chance of serious unwanted effects.
Each turbuhaler contains 60 doses. When a red mark appears in the little window under the mouthpiece there are approximately 20 doses remaining. You should refill your prescription at this time.
When the red mark reaches the bottom of the window, all the doses of Oxeze® have been used. The drying agent in the inhaler will still make a rattling sound if the inhaler is shaken. This does not indicate that there is active ingredient remaining in the inhaler.
Oxeze® turbuhaler will not operate properly if it is exposed to moisture. Never use water or other fluids to clean the inhaler. Always replace the cap on the inhaler after using. Store at room temperature (15 to 30 degrees Centigrade) in a dry place.
Clean the turbuhaler once weekly using a clean, dry cloth.

Directions for Use

Oxeze® turbuhaler can be used for long-term twice daily maintenance therapy or it can be used for on-demand treatment.
A. Long-Term Twice Daily Maintenance Therapy:

• The usual maintenance dose of asthma in adults is 6 to 12 mcg twice daily, at 12 hour intervals. In adults, the maximum recommended daily dose is 48 mcg.
• The usual maintenance dose of asthma in children between the ages of 6 to 16 years is 6 to 12 mcg twice daily, at 12 hour intervals. In children, the maximum recommended daily dose is 24 mcg.

• 1. Relief of Acute Bronchoconstriction in Patients Who are on Maintenance Treatment with Oxeze® turbuhaler
  Adults and adolescent children (12-16 years); the usual dose is 6 or 12 mcg as needed.
• 2. For relief of acute bronchoconstrction and prevention of bronchospasm for patients who remain symptomatic on inhaled corticosteroids:
  Adults and adolescent children (12-16 years): The usual dose is 6 or 12 mcg as needed.
• 3. Prevention of exercise-induced bronchoconstriction
  Adults and children 6 years of age and older: 6 or 12 mcg before exercise.
  
  When Oxeze® turbuhaler is used on demand, the maximum dose during a 24 hour period should not normally exceed 72 mcg in adults and 48 mcg in adolescent children. Prolonged use (more than 3 consecutive days) of more than 48 mcg may be a sign of poor asthma control and treatment should be reassessed.
   
  

  Lung Diseases Treated with this Drug

  • asthma
  • bronchospasm associated with COPD
  • chronic bronchitis (COPD)
  • COPD
  • emphysema (COPD)
   
  

  Need More Information?

  For more information contact your physician, pharmacist, other health care professional or for general questions call your local lung association.