Formoterol-Nativ, 12 mcg/dose 60 pcs

Beta-adrenomimetic. Acts mainly on β2-adrenoreceptors.

It has bronchodilator effect, stops and prevents bronchospasm.

Inhibits release of histamine, leukotrienes and prostaglandin D2 from mast cells, basophils and sensitized cells of bronchoalveolar tree.

Indications

Active ingredient

Composition

1 capsule contains Formoterol fumarate dihydrate 12 µg

Associated substances:

sodium benzoate – 0.02 mg,

lactose monohydrate – up to 12 mg.

Capsule shell composition:

Caramel dye (E150c) – 1.4388%, hypromellose – up to 100%.

How to take, the dosage

Formoterol-Nativ is intended for inhaled use in patients over 18 years of age. The drug is not intended for oral administration.

The dose of Formoterol-Nativ is adjusted individually according to the patient’s needs. The lowest dose that provides therapeutic effect should be used. When achieving control of bronchial asthma symptoms during therapy with Formoterol Nativ, gradual reduction of the drug dose should be considered. Dose reduction of Formoterol-nativ should be performed under regular medical supervision of the patient.

The drug is a capsule of powder for inhalation, which should only be used with a special device, the Inhaler CDM®, which is included in the package.

Bronchial asthma

The dose of Formoterol Nativ for regular maintenance therapy (12-24 mcg (contents 1-2 capsules) 2 times daily.

Formoterol-Nativ should only be used as adjunctive therapy to inhaled GCS. Do not exceed the maximum recommended dose of the drug of 48 mcg/day (contents of 4 capsules).

Because the maximum daily dose of Formoterol Nativ is 48 mcg, an additional 12-24 mcg/day may be used if needed to relieve bronchial asthma symptoms.

If the need for additional doses of Formoterol Nativ is no longer episodic (e.g. more than 2 days/week), this may indicate a worsening of asthma, consult a physician. Treatment with Formoterol Nativ or changing the dosage of Formoterol should not be started during an exacerbation of bronchial asthma.

Formoterol-Nativ should not be used to relieve acute attacks of bronchial asthma.

Prevention of bronchospasm caused by exercise or unavoidable exposure to a known allergen

The dose of Formoterol-Nativ 12 mcg (1 capsule contents) should be used 15 min before anticipated exposure to the allergen or before exercise. No additional inhalations of the drug should be given for the next 12 hours.

Prevention of severe bronchospasm

Patients with a history of severe bronchospasm may require a single inhaled dose of 24 mcg (contents of 2 capsules).

COPD

The dose of Formotrol-antive for regular maintenance therapy of COPD is 12-24 mcg (contents of 1-2 capsules) 2 times daily.

Interaction

Formoterol-Nativ, as well as other β2-adrenomimetics, should be prescribed with caution in patients receiving medications such as: quinidine, disopyramide, procainamide, phenothiazines, macrolides, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, antihistamines, and other drugs known to prolong the QT interval, as in these cases the cardiovascular effects of adrenostimulants may be enhanced and the risk of ventricular arrhythmias increases.

The concomitant use of other sympathomimetic agents may worsen the adverse reactions of Formoterol Nativ.

The concomitant use of xanthine derivatives, glucocorticosteroids, or diuretics may increase the potential hypokalemic effects of Formoterol-Nativ.

In patients receiving anesthesia with halogenated hydrocarbons, there is an increased risk of arrhythmias.

The drugs belonging to the β2-adrenoblockers may weaken the action of Formoterol-nativ and lead to severe bronchospasm in patients with bronchial asthma. In this regard Formoterol topical should not be used with β2-adrenoblockers (including eye drops), unless there are some extraordinary reasons to use such a combination of drugs.

Special Instructions

Inflammatory therapy

In patients with bronchial asthma Formoterol-nativ should be used only as adjunctive treatment when symptoms are not sufficiently controlled on monotherapy with inhaled GCS or in severe disease requiring a combination of inhaled GCS and a long-acting β2-adrenoreceptor agonist. Formoterol-nativ should not be used with other long-acting β2-adrenoreceptor agonists.

When prescribing Formoterol-Nativ, the patients’ condition should be evaluated with respect to the adequacy of the anti-inflammatory therapy they receive. After initiation of treatment with Formoterol-Nativ, patients should be advised to continue anti-inflammatory therapy without change, even if improvement is noted.

A β2-adrenoreceptor agonists should be used to control an acute attack of bronchial asthma. Patients should seek medical attention immediately if there is a sudden worsening of the condition.

Hypokalemia

A consequence of therapy with beta2-adrenomimetics, including Formoterol-nativ, may be the development of potentially serious hypokalemia. Hypokalemia may increase the risk of arrhythmias. Since this action of Formoterol-Nativ may be enhanced by hypoxia and concomitant treatment, special caution should be exercised in patients with severe bronchial asthma. In these cases, regular monitoring of serum potassium concentration is recommended.

Paradoxical bronchospasm

Like other inhaled drugs, Formoterol-nativ may cause paradoxical bronchospasm. In this case, the drug should be discontinued immediately and alternative treatment should be prescribed.

The use of formoterol in a dose greater than 54 mcg/day (over 4 inhalations) may lead to positive doping tests.

Influence on the ability to drive motor vehicles and other vehicles, to operate moving machinery

There are no data on the effect of Formoterol-Nativ on the ability to drive and operate machinery. In case of such adverse reactions as dizziness, tremor, convulsions or muscle spasm one should refrain from driving motor transport and operating machinery as well as from other potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

If you have any of the following conditions, please consult your doctor before taking this medicine.

Particular caution should be exercised with Formoterol Nativ (especially with regard to dose reduction) and patients should be closely monitored if they have the following comorbidities CHD; cardiac rhythm and conduction disorders, especially grade III AV blockade; severe heart failure; idiomatic hypertrophic subaortic stenosis; severe arterial hypertension; any localized aneurysm; pheochromocytoma; ketoacidosis; hypertrophic obstructive cardiomyopathy; thyrotoxicosis; known or suspected QTc interval prolongation (QT corrected >0.44 sec).

In view of the hyperglycemic effect inherent to beta2-adrenomimetics, additional regular monitoring of blood glucose concentrations is recommended in diabetic patients taking Formoterol-Nativ.

Side effects

The undesirable reactions are categorized according to the frequency of occurrence. The following criteria were used to evaluate the frequency: very common (>1/10), common (1/100 to 1/10), infrequent (1/1000 to 1/100), rare (1/10000 to 1/1000), very rare (

Infectious and parasitic diseases: common – pharyngitis, acute respiratory viral infection.

Immune system disorders: very rarely – anaphylactic reactions, urticaria, angioedema (Quincke’s edema), itching, rash.

Mechanism and nutrition disorders: very rare – metabolic acidosis.

Psychiatric disorders: very rarely – agitation, anxiety, increased excitability, insomnia; very rarely – increased fatigue.

Nervous system disorders: frequently – headache, tremor; infrequently – dizziness; very rarely – changes in sense of taste.

Chronic disorders: often – palpitations, chest pain; infrequent – tachycardia; very rare – peripheral edema; angina pectoris, cardiac pacing disorders (including atrial fibrillation, ventricular extrasistoles, tachyarrhythmia).

Vascular disorders: very rarely – decrease of blood pressure (hypotension), increase of blood pressure (hypertension).

Respiratory system disorders, thoracic and mediastinal organs: frequently – sinusitis, increased sputum production; infrequently – bronchospasm, including paradoxical, dysphonia; very rarely – cough.

Gastrointestinal disorders: infrequent – dry mouth; very rare – nausea.

Muscular and connective tissue disorders: often – back pain, leg cramps; infrequent – muscle spasm, myalgia.

General disorders and disorders at the site of administration: frequently – fever; infrequently – irritation of the mucous membrane of the throat and larynx.

Laboratory and instrumental data: infrequent – flattening or inversion of the T waveform, ST-segment depression, prolongation of the QT interval on electrocardiogram; very rarely – hypokalemia, hyperglycemia.

If any of the adverse reactions listed in the instructions worsen, or if you notice any other adverse reactions not listed in the instructions, tell your doctor.

Overdose

Symptoms: Overdose with formoterol is likely to cause phenomena characteristic of beta2-adsnomimetics overdose or increased side effects: chest pain, palpitations, tachycardia up to 200 bpm./min, ventricular arrhythmias, increased or decreased BP, dry mouth, nausea, vomiting, headache, dizziness, tremor, nervousness, weakness, anxiety, drowsiness, metabolic acidosis, hypokalemia, hyperglycemia, seizures. As with all inhaled beta2-adrenomimetics, formoterol overdose can lead to cardiac arrest and death.

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

The use of cardioselective beta2-adrenoblockers may be considered, but only under close medical supervision with extreme caution, as the use of such agents may cause bronchospasm. Monitoring of cardiac parameters is recommended.