Manufacturer:
Novartis Pharmaceuticals

Generic Name:
formoterol fumarate

Route:
oral inhalation

Why is it prescribed?

Foradil® capsules for inhalation 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*

Foradil® is indicated as long-term, twice-daily administration in the maintenance treatment of asthma in patients 6 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma, who are using optimal corticosteroid treatment and experiencing regular or frequent breakthrough symptoms requiring use of a short-acting bronchodilator. Foradil® should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled β2-agonists.
Foradil® is indicated as long-term, twice-daily administration in the treatment of adults with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Side Effects

Foradil® capsules for inhalation 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 Foradil® capsules for inhalation

Foradil® capsules for inhalation 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

The contents of Foradil® capsules should be inhaled using the inhaler provided with each prescription. Do not take the capsules by mouth.
It is important that you understand how to operate the inhaler before using Foradil® for the first time. Your doctor or pharmacist will demonstrate how to load and use the inhaler but you should also read and keep the package insert which comes with the inhaler device. To be sure that you are getting the maximum effect from the medication, ask your pharmacist to assess your technique.
Foradil® should not be used more often than twice a day. 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.
Keep Foradil® capsules at room temperature in a dry place. The capsules should be removed from the blister pack just before use.
Clean and care for the inhaler device according to the manufacturer's instructions.
Foradil® capsules should not be used to treat acute symptoms.

Directions for Use

The usual adult dose for asthma in adults and children over 6 years of age is 1 capsule (12 mcg) inhaled using the Aerolizer inhaler twice daily, in the morning and evening. In severe cases, 2 capsules twice daily, in the morning and evening may be recommended. The usual adult dose for COPD is 1 (12 mcg) or 2 (24 mcg) capsules inhaled using the Aerolizer inhaler twice daily, in the morning and evening.
A daily dose of 48 µg should not be exceeded.

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.