Foradile

Foradile - How to apply | Side Effects

Foradile contains active substance called formoterol (also known as eformoterol) and belongs to the family of beta-2 agonists used in asthma therapy due to its bronchodilatory effects. After it binds to the beta-2 receptors in the lungs and bronchi, it exhibits an agonistic effect that causes opening of breathing passages. In this way, Foradile helps you breathe more easily.

It is used to treat asthma (usually as an add-on therapy to inhaled corticosteroids) and to relieve bronchospasm that occurs in chronic obstructive pulmonary disease.

Formoterol is a long-acting bronchodilator and its effect lasts about 12 hours.

Precautions

The FDA warns that the use of Foradile alone, without concomitant use with long-term asthma control medications (such as inhaled corticosteroids) is strictly contraindicated as it increases the risk of asthma-related death!

The use of this medicine is contraindicated in the treatment of status asthmaticus, acute asthma attacks or acute bronchospasm episodes in patients with chronic obstructive pulmonary disease.

Foradile must be very cautiously applied in the following conditions:

  • Hypertension and other heart problems. Although Foradile selectively binds to beta receptors in the lungs and exhibits significantly lower affinity for beta receptors in the heart, there is still a risk of cardiac adverse effects and therefore it should be applied cautiously in patients with hypertension, angina pectoris, coronary insufficiency, aneurysm or arrhythmia.
  • Diabetes. Studies have shown that Foradile can diminish hypoglycaemia in diabetics who receive insulin, and therefore blood sugar levels should be closely monitored during therapy.
  • Hyperthyroidism (increased secretion of thyroid hormone) or thyrotoxicosis.
  • Tumor of the adrenal glands (pheohromocytoma).
  • Convulsions. Foradile can cause CNS stimulation, which can trigger convulsions. Patients with positive history of convulsions must avoid use this medicine.
  • Prior surgery.
  • Pregnancy.
  • Hypokalaemia. This medicine can cause a significant decrease in blood potassium levels which can cause cardiac side effects.

Foradile, Pregnancy and Breastfeeding

FDA pregnancy category: C.

Studies in rats and rabbits revealed evidence of teratogenic effects, but there is insufficient data on its use during pregnancy. For this reason, Foradile should be used during pregnancy only if the benefit outweighs the potential risk to the fetus.

Animal studies showed that this drug is excreted into milk, but there is no data on whether this medicine is excreted into breast milk or not. Because of possible adverse effects on infants, this medicine should not be used during breastfeeding.

How to apply

Foradile is administered only with the Aerolizer inhalation device included in the drug pack. This device is intended only for the use of Foradile. Carefully read the instructions how to use the device, and if you are not sure how to use the device, consult your doctor and pharmacist.

Capsules are intended for inhalation use only and will not work if you take them orally.

The recommended dosage is given in the table below:

Condition Age Recommended dose
Asthma

> 18 years

5 - 18 years

1-2 capsules, twice daily

1 capsule twice daily

Chronic obstructive pulmonary disease

> 18 years

< 18 years

1 capsule twice daily

Not recommended.

The maximum daily dose for adult patients is 4 capsules, while in children 5-18 years of age the maximum daily dose is 2 capsules.

It is recommended to use this medicine once in the morning and once in the evening (with time space of 12 hours), as this will relieve symptoms during whole day and night.

Always consult your doctor about the dose you need to use.

Interactions

Foradile should not be administered concurrently with the following medicines:

  • Medicines used to treat coronary insufficiency (e.g. digoxin and digitoxin).
  • Beta blockers used to treat hypertension and other cardiac diseases, such as: Neither timolol nor levobunolol, which exists in the form of eye drops (because they are used to treat glaucoma), should be used concomitant with Foradile. Simultaneous administration with these medicines reduces the effectiveness of both, beta-blockers and Foradile.
  • Nasal decongestants, such as: naphazoline and ephedrine.
  • Xanthine derivatives, such as: theophylline and aminophylline (also used to treat asthma).
  • Non-potassium-sparing diuretics, such as: hydrochlorothiazide, furosemide (Lasix), bumetanide, and others. Simultaneous administration with these medicines increases the risk of hypokalaemia and severe cardiac arrhythmias.
  • Systemic corticosteroids that are administered orally, such as: prednisolone. Simultaneous administration increases the risk of hypokalaemia.

Concomitant use with the following drugs increases the risk of QT prolongation and severe ventricular arrhythmias:

  • Monoamino oxidase inhibitors (MAOs), such as: tranylcypromine, isocarboxazide, moclobemide, phenelzine and linezolid.
  • Tricyclic antidepressants, such as: imipramine, amitriptyline, amoxapine, desipramine, clomipramine, doxepin, and nortriptyline.
  • Macrolide antibiotics, such as: erythromycin, clarithromycin, and azithromycin.
  • Antihistamines used to treat allergies, such as: terfenadine and astemizole.

Side effects

Foradile can cause the following side effects:

  • Palpitations.
  • Tremor.
  • Headache.
  • Tachycardia.
  • Hypokalaemia.
  • Hyperglycaemia.
  • Nausea.
  • Insomnia.
  • Arrhythmias.
  • Taste disturbances.
  • Viral infections.
  • Inflammation of tonsils.
  • Difficulty breathing (dyspnoea).
  • Bronchial inflammation.
  • Muscle cramps.
  • Dry mouth.
  • Fever.
  • Anxiety and restlessness.
  • Allergy.

References

  1. PIL
  2. NCBI
  3. FDA

Information on this website are provided for educational purposes only and are not intended for medical advice, diagnosis or treatment.

If you have any concerns or questions about your health, you should always consult with a physician or other health-care professional.