Foradil capsules with powder for inhalation 12mcg/dose, 60pcs

Composition

1 capsule contains formoterol fumarate 12 mcg.

Pharmacological action

Beta-adrenostimulating agent, with selectivity towards beta-2-adrenergic receptors of the smooth muscles of the bronchi, has a bronchodilator effect.

Foradil is effective for the prevention and relief of bronchospasm caused by allergens, exercise, histamine, and 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.

Indications

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

Use during pregnancy and lactation

Foradil is contraindicated during pregnancy and lactation.

Contraindications

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

With caution.

Diabetes mellitus, severe CHF, CHD, cardiac arrhythmias, grade III AV block, prolongation of the Q-T interval (Q-T corrected > 0.44 s), HOCMP, 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 the frequency of occurrence. The following criteria were used to estimate the frequency: very often (≥10%); often (≥1%,

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

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

From the cardiovascular system:  often-palpitation of the heart; sometimes-tachycardia; very rarely-peripheral edema.

Respiratory system disorders:  sometimes-bronchospasm.

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

Musculoskeletal disorders:  sometimes-muscle cramps, myalgia.

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

Interaction

Foradil Patients receiving medications such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAO inhibitors, tricyclic antidepressants, and other medications known to prolong the QT interval should be treated with caution, because in these cases, the effect of adrenostimulants on the cardiovascular system may increase. When using drugs that can prolong the QT interval, the risk of ventricular arrhythmias increases.

Concomitant use of other sympathomimetic agents may increase the side effects of Foradil.

Concomitant use of xanthine derivatives, corticosteroids, or diuretics may increase the potential hypokalemic effects of beta-2-adrenomimetics. Hypokalemia may increase the predisposition to developing cardiac arrhythmias in patients receiving digitalis preparations.

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

How to take, course of use and dosage

Foradil is used by inhalation.

Adults with bronchospastic syndrome — 12-24 mcg 2 times a day, children from 5 years and older-12 mcg (no more) 2 times a day; if necessary, an additional 1-2 capsules can be used; to prevent bronchospasm caused by physical exertion or exposure to a known allergen, inhale 1 dose (12 mcg) approximately 15 minutes before work or contact with the specified factor; in severe cases of bronchial asthma, inhaling 2 doses (24 mcg) may be required.

Overdose

Symptoms:  overdose of Foradil is suspected to cause symptoms that are characteristic of the excessive action of other beta-2-adrenomimetics, 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 agents may cause bronchospasm.

Special instructions

Special care should be taken when applying the product Foradila (especially from the point of view of dose reduction) and careful monitoring of patients are required in the presence of the following concomitant diseases: CHD; cardiac arrhythmia and conduction disorders, especially grade III AV block; severe heart failure; idiopathic subvalvular aortic stenosis; hypertrophic obstructive cardiomyopathy; thyrotoxicosis; known or suspected prolongation of the QTc interval (corrected QT) >0.44 seconds.

Due to the hyperglycemic effect of beta-2-adrenomimetics, additional regular monitoring of blood glucose levels is recommended in diabetic patients.

Usually, patients with asthma who require beta-2-adrenomimetic therapy should also receive regular adequate doses of anti-inflammatory drugs (for example, corticosteroids for inhalation or oral use, 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 making an appointment Foradil is necessary to assess the condition of patients with regard to the adequacy of the anti-inflammatory therapy that they receive. After starting treatment Foradil patients should be advised to continue anti-inflammatory therapy unchanged, even if there is an improvement.

It is necessary to review the basic therapy of bronchial asthma by the doctor if, against the background of the use of Foradil if asthma symptoms persist, or if the amount of dosforadil required to control the symptoms of the disease increases, as this usually indicates a worsening of the course of the disease.

Treatment with beta-2-adrenomimetics may result in the development of potentially serious hypokalemia. Since this effect of the drug can be enhanced by hypoxia and concomitant treatment, special care should be taken 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, you should immediately discontinue the drug and prescribe an alternative treatment.

Form of production

Capsules with powder for inhalation.

Storage conditions

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

Shelf life

2 years

Active ingredient

Formoterol

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor, Children over 5 years of age

Indications

Chronic obstructive pulmonary disease, Bronchospasm, Bronchitis, Bronchial asthma