Foradil, 12 mcg 60 pcs

Beta-adrenergic stimulating agent, with selectivity towards the beta2-adrenoreceptors of bronchial smooth muscle, has a bronchodilator effect.

Foradil is effective for the prevention and relief of bronchospasm caused by allergens, physical activity, histamine, methacholine (diagnostic test).

Foradil has tocolytic properties. The onset of action is 1-3 minutes after inhalation, the duration of bronchodilator effect is 12 hours.

Indications

Relief and prevention of reversible airway obstruction – COPD, bronchial asthma.

Pharmacological effect

A beta-adrenergic stimulant, with selectivity towards beta2-adrenergic receptors of bronchial smooth muscle, has a bronchodilator effect.

Foradil is effective for the prevention and relief of bronchospasm caused by allergens, physical activity, histamine, methacholine (diagnostic test).

Foradil has tocolytic properties. The onset of action is 1-3 minutes after inhalation, the duration of the bronchodilator effect is 12 hours.

Special instructions

Particular caution when using Foradil (especially in terms of dose reduction) and careful monitoring of patients is required in the presence of the following concomitant diseases: IHD; disturbances of heart rhythm and conduction, especially AV blockade of the third degree; severe heart failure; idiopathic subvalvular aortic stenosis; hypertrophic obstructive cardiomyopathy; thyrotoxicosis; known or suspected prolongation of the QTc interval (QT corrected) >0.44 sec.

Due to the hyperglycemic effect characteristic of beta2-agonists, additional regular monitoring of blood glucose levels is recommended in patients with diabetes.

Typically, patients with bronchial asthma who require therapy with beta2-agonists should also regularly receive adequate doses of anti-inflammatory drugs (for example, corticosteroids for inhalation or oral administration, and/or in children, sodium cromoglycate). When prescribing the drug to patients who are not receiving anti-inflammatory therapy, it should be started simultaneously with the use of Foradil. When prescribing Foradil, it is necessary to assess the condition of patients regarding the adequacy of the anti-inflammatory therapy they receive. After starting treatment with Foradil, patients should be advised to continue anti-inflammatory therapy without changes, even if improvement is noted.

It is necessary to review the basic therapy of bronchial asthma by a doctor if asthma symptoms persist while using Foradil, or if the number of doses of Foradil required to control the symptoms of the disease increases, since this usually indicates a worsening of the disease.

Treatment with beta2-agonists may result in the development of potentially serious hypokalemia. Because this effect of the drug can be enhanced by hypoxia and concomitant treatment; special caution should be observed in patients with severe bronchial asthma. In these cases, regular monitoring of serum potassium levels is recommended.

As with other inhalation therapy, the possibility of developing paradoxical bronchospasm should be taken into account. If it occurs, the drug should be discontinued immediately and alternative treatment should be prescribed.

Active ingredient

Formoterol

Composition

1 capsule contains formoterol fumarate 12 mcg.

Pregnancy

Foradil is contraindicated during pregnancy and breastfeeding.

Contraindications

Hypersensitivity, children’s age (up to 5 years).

With caution.

Diabetes mellitus, severe CHF, coronary artery disease, heart rhythm disturbances, stage III AV block, prolongation of the Q-T interval (Q-T corrected > 0.44 s), HOCM, thyrotoxicosis, pregnancy, lactation.

Side Effects

headache, sleep disturbance, dizziness;
nausea, dry mouth;
nervousness, twitching, convulsions;
rapid heartbeat;
allergic reactions.

Adverse reactions are distributed according to frequency of occurrence. The following criteria were used to assess frequency: very often (≥10%); often (≥1%,

Allergic reactions: very rarely – hypersensitivity reactions, such as arterial hypotension, urticaria, angioedema, itching, exanthema.

From the side of the central nervous system: often – headache, tremor; sometimes – agitation, anxiety, nervousness, insomnia, dizziness.

From the cardiovascular system: often – palpitations; sometimes – tachycardia; very rarely – peripheral edema.

From the respiratory system: sometimes – bronchospasm.

From the digestive system: very rarely – nausea; distortion of taste sensations.

From the musculoskeletal system: sometimes – muscle cramps, myalgia.

Local reactions: sometimes – irritation of the mucous membrane of the pharynx and larynx.

Interaction

Foradil (as well as other beta2-agonists) should be prescribed with caution to patients receiving drugs such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAO inhibitors, tricyclic antidepressants, and other drugs known to prolong the QT interval, because in these cases, the effect of adrenergic stimulants on the cardiovascular system may be enhanced. When using drugs that can prolong the QT interval, the risk of ventricular arrhythmias increases.

The simultaneous use of other sympathomimetic drugs may lead to worsening of the side effects of Foradil.

The simultaneous use of xanthine derivatives, corticosteroids or diuretics may enhance the potential hypokalemic effect of beta2-agonists. Hypokalemia may increase the susceptibility to the development of cardiac arrhythmias in patients receiving digitalis preparations.

Beta blockers may weaken the effect of Foradil. In this regard, Foradil should not be used in conjunction with beta-blockers (including eye drops), unless the use of such a combination of drugs is forced by any emergency reasons.

Overdose

Symptoms: an overdose of Foradil can presumably lead to phenomena characteristic of the excessive action of other beta2-agonists, such as nausea, vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalemia, hyperglycemia.

Treatment: maintenance and symptomatic therapy is indicated. In serious cases, hospitalization is necessary.

The use of beta blockers may be considered, but only with extreme caution and under close medical supervision, as the use of such drugs may cause bronchospasm.

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

Novartis Pharma GmbH, Germany