Formoterol powder for inhalation 12 mcg – [60 capsules]

Formoterol is a selective beta2-adrenoreceptor agonist (beta2-adrenomimetic). It has a bronchodilator effect in patients with reversible airway obstruction. The action of the drug comes quickly (within 1-3 minutes) and lasts for 12 hours after inhalation. When using therapeutic doses, the effect on the cardiovascular system is minimal and is noted only in rare cases.

Formoterol inhibits the release of histamine and leukotrysin from mast cells. Some anti-inflammatory properties of formoterol have been shown in animal experiments, such as the ability to inhibit the development of edema and the accumulation of inflammatory cells.

In experimental animal studies in vitro, racemic formoterol and its (R.R) and (S.S) enantiomers have been shown to be highly selective beta2-receptor agonists. The (S.S) enantiomer was 800-1000 times less active than the (R,R) enantiomer and had no adverse effect on the activity of the (R.R) enantiomer with respect to effects on tracheal smooth muscle. There was no pharmacological evidence of an advantage of using one of these two enantiomers over the racemic mixture.

In studies in humans, formoterol has been shown to effectively prevent bronchospasm caused by inhaled allergens, exercise, cold air, histamine, or methacholine. As bronchodilator effect of formoterol remains expressed for 12 hours after inhalation, prescription of the drug 2 times a day for long-term maintenance therapy allows in most cases to provide the necessary control of bronchospasm in chronic lung disease, both during the day and at night.

In patients with chronic obstructive pulmonary disease (COPD) of stable course formoterol administered in the form of inhaled doses of 12 or 24 mcg 2 times a day is accompanied by improvement of quality of life parameters.

– Prophylaxis and treatment of bronchial obstruction in patients with bronchial asthma (BA) as an adjunct to inhaled glucocorticosteroid therapy.

– Prevention of bronchospasm caused by inhalation of allergens, cold air or physical activity as an adjunct to therapy with inhaled glucocorticosteroids.

– Prevention and treatment of bronchial obstruction in patients with

Chronic obstructive pulmonary disease (COPD), with both reversible and irreversible bronchial obstruction, chronic bronchitis and pulmonary emphysema.

– Hypersensitivity to the active substance and/or any excipient of the drug.

– Age under 18 years.

– Breast-feeding.

– Rare hereditary diseases, such as galactose intolerance, lactase deficiency.

• Formoterol is intended for inhaled use in patients over 18 years of age. The drug is not intended for oral administration.
• The dosage of Formoterol is adjusted individually according to the needs of the patient. The lowest dose that provides therapeutic effect should be used. When achieving control of bronchial asthma symptoms during therapy with Formoterol, it is necessary to consider gradual reduction of the drug dose. Dose reduction of Formoterol is carried out under regular medical supervision of the patient.
• The drug is a capsule with powder for inhalation, which should be used only with a special device – inhaler “Inhaler CDM ®” which is included in the package.
• Bronchial asthma
• The dose of Formoterol for regular maintenance therapy is 12-24 micrograms (1-2 capsule contents) two times a day.
• Formoterol should only be used as adjunctive therapy to inhaled glucocorticosteroids (GCS). Do not exceed the maximum recommended dose of 48 mcg (contents of 4 capsules) per day.
• Taking into account that the maximum daily dose of Formoterol is 48 mcg, if necessary, an additional 12-24 mcg per day may be used to relieve bronchial asthma symptoms.
• If the need for additional doses of Formoterol ceases to be episodic (e.g. more than 2 days a week), this may indicate a worsening of bronchial asthma, you should consult a doctor. Against the background of bronchial asthma exacerbation should not start treatment with Formoterol or change the dosage of the drug.
• Formoterol should not be used to relieve acute attacks of bronchial asthma.
• Prevention of bronchospasm caused by exercise or unavoidable exposure to a known allergen
• Formoterol should be used in a dose of 12 micrograms (the contents of 1 capsule) 15 minutes before the intended exposure to the allergen or before exercise. Additional inhalations of the drug should not be administered within the next 12 hours.
• Prevention of severe bronchospasm
• Patients with a history of severe bronchospasm may require a single inhalation dose of 24 mcg (contents of 2 capsules).
• COPD
• The dose of Formoterol for regular maintenance therapy of COPD is 12-24 mcg (contents of 1-2 capsules) 2 times daily.
• Elderly patients (over 65 years)
• There are no data on the necessity to correct the drug dose in patients older than 65 years old.
• Instructions for inhalations
• To ensure proper administration of the drug, the physician or other health care provider should:
• 1. Warn the patient that the capsules are for inhalation use only and are not intended to be swallowed;
• 2 Explain to the patient that the powder inhalation capsules should only be used with the Inhaler CDM®;
• 3. Show the patient how to use the inhaler.
• Take the capsule out of the cell pack immediately before use.
• Instructions for use of the CDM® Inhaler
• The CDM® Inhaler powder inhaler is a plastic device with a movable top and a retractable capsule compartment, about 6 cm high.
• “Inhaler CDM®” is a single-dose inhaler that allows you to dose and inhale the drug in very small doses. The Formoterol drug enters the patient’s airway with the air currents when actively inhaled through the mouthpiece of the device.
• “Inhaler CDM® is very easy to use.