This product is inhaled into the lungs using the Turbuhaler®.
Why is it prescribed?
Formoterol is to be used regularly to relieve airways-related problems in people who have asthma or chronic obstructive pulmonary disease (COPD).
- Before using Oxeze® for the first time, be sure you understand how to use the Turbuhaler®. Your doctor or pharmacist will demonstrate the proper method of loading and inhaling Oxeze® Turbuhaler® 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® Turbuhaler® ask your pharmacist to assess your inhalation technique.
- Do not shake Oxeze® Turbuhaler® before use.
- When the Turbuhaler® is loaded, your dose will be lost if the Turbuhaler® is accidentally dropped, shaken, or if you breathe into the Turbuhaler®. If this happens, reload the Turbuhaler® 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 Turbuhaler®. Since only a very small amount of powder is inhaled with each dose, you may not taste or feel anything when you use the Turbuhaler®. As long as you are using the Turbuhaler® correctly, you will be receiving the prescribed amount of Oxeze® Turbuhaler®.
- Oxeze® Turbuhaler® 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® Turbuhaler® have been used. The drying agent in the Turbuhaler® will still make a rattling sound if the inhaler is shaken. This does not indicate that there is active ingredient remaining in the Turbuhaler®.
- Oxeze® Turbuhaler® will not operate properly if it is exposed to moisture. Never use water or other fluids to clean the Turbuhaler®. Always replace the cap on the Turbuhaler® 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.
- Do not bite or chew the mouthpiece.
- Do not use the Turbuhaler® if it has been damaged or if the mouthpiece has become detached.
Oxeze® Turbuhaler® is supplied in two strengths: 6 µg/metered dose (60 doses) and 12 µg/metered dose (60 doses).
Adults: The usual dose is 6 or 12 µg, twice daily, at 12 hour intervals. Some adults may need 24 µg, twice daily. In adults, the maximum recommended daily dose is 48 µg.
Children (6-16 years): The usual dose is 6 or 12 µg, twice daily, at 12 hour intervals. In children, the maximum recommended daily dose is 24 µg.
For the prevention of exercise-induced asthma:
Adults and Children 6 years of age and older: 6 or 12 µg before exercise.
Formoterol is a long-acting bronchodilator that acts at specific receptors called beta2-adrenergic receptors. Stimulating these receptors makes breathing easier by opening the small air passages in the lungs. Formoterol starts to improve breathing within 1 to 3 minutes. This fast onset of action is similar to that seen with short-acting bronchodilators. The bronchodilating effect of formoterol typically lasts for 12 hours. This duration is similar to that seen with other long-acting beta2-agonists.
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:
- dry mouth
- slight palpitations (awareness of heart beat)
- muscle cramps and pain
- feeling nervous or tired
- difficulties in sleeping
- allergic reaction (rash, swelling of face and throat)
- cardiac arrythmias (e.g., atrial fibrillation, supraventricular tachycardia, estrasystoles)
- worsening of asthma symptoms
Check with your pharmacist or doctor if mild effects persist and become bothersome or if more severe effects occur.
Long-acting beta2-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.
Do not use formoterol:
- If you are allergic to it or to other bronchodilators such as salbutamol
Caution is advised in:
- heart disease
- high blood pressure
- overactive thyroid
- history of seizures
- low blood levels of potassium or magnesium
Drug interactions: Make sure your doctor and pharmacist know that you are on the following:
- diuretics or water pills
- any medications that affect heart rhythm such as: amiodarone, quinidine, sotalol
- some antibiotics, such as: erythromycin, clarithromycin
Use in pregnancy: Human data is limited. If you suspect that you might be pregnant, consult your doctor.
Use in breastfeeding: Human data is limited. It is unlikely that the amount in breast milk would present problems to the infant, but always check with doctor or pharmacist before use.