Index of drugs

As an add-on in the maintenance treatment of inhaled corticosteroids, in the treatment of bronchial obstruction symptoms and in the prevention of exercise-induced symptoms in patients with asthma, if treatment with corticosteroids is insufficient. Formoterol is also indicated for the treatment of symptoms of bronchial obstruction in patients with chronic obstructive pulmonary disease (COPD). It is recommended that the treatment should be initiated by a pulmonologist or a pediatrician.

1 hard capsules contain 12 μg of formoterol fumarate dihydrate (metered dose). The delivered dose contains 9 μg of formoterol fumarate dihydrate. The preparation contains lactose.

A selective β-receptor agonist₂-renergic in smooth muscle. It exerts a powerful bronchodilator effect, which begins within 1-3 min and persists for 12 hours after inhalation. Formoterol blocks the release of histamine and leukotrienes from passively sensitized pulmonary mast cells. In animal studies, some anti-inflammatory properties of formoterol have been observed, such as inhibition of edema and accumulation of cells involved in inflammatory processes. In humans, the preparation inhibits bronchoconstriction caused by allergens, exercise, cold air, histamine or methacholine. Approx. 90% of the inhaled dose is swallowed and absorbed from the gastrointestinal tract. The maximum concentration in the plasma occurs in the 0.5-1 h strings. The drug is bound in 61-64% with plasma proteins. It is eliminated from the body mainly in the process of glucuronization. Formoterol and its metabolites are completely removed from the body, 2/3 of the oral dose is excreted in the urine and 1/3 in the faeces.

Hypersensitivity to formoterol or to lactose (which contains small amounts of milk proteins).

Formoterol should not be used (and is not enough) to start treatment for asthma. Patients with asthma requiring treatment with long-acting β-receptor agonists₂- adrenergic should also receive adequate, supportive anti-inflammatory corticosteroids. Anti-inflammatory therapy should be continued after the start of formoterol, even if the symptoms have been reduced. Do not start using the medicine during severe asthma exacerbation or when there is a significant or acute worsening of your asthma. Patients with hyperthyroidism, phaeochromocytoma, hypertrophic cardiomyopathy with narrowing of the outflow tract, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular diseases such as ischemic heart disease, tachyarrhythmia or severe heart failure should be closely monitored as well as patients with prolonged QT interval_C (> 0.44 s) and treated with drugs that affect the QT interval. Due to the risk of severe hypokalemia, extreme caution is recommended in patients with severe asthma when the risk of hypoxia is increased. Symptoms of hypokalemia may be exacerbated by simultaneous treatment with xanthine derivatives, steroids and diuretics. In these cases, it is recommended to monitor the concentration of potassium in the blood serum. Due to the hyperglycemic effect of β₂- patients, special control of blood Glucose is recommended in patients with diabetes. In the case of a paradoxical bronchoconstriction, administration should be stopped immediately and other treatment should be applied. The maximum daily dose should not be exceeded. No safe long-term, regular treatment with doses higher than 36 μg / day in adults with asthma, 18 μg / day in children with asthma and 18 μg / day in patients with COPD has been established. Use in children is not recommended. The preparation contains lactose (less than 500 mg at the stated dose); this amount usually does not cause problems for people with lactose intolerance. Patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or glucose-galactose malabsorption should not use this medicinal product.

Treatment with formoterol can be considered at any stage of pregnancy if it is necessary to achieve asthma control and the expected benefit to the mother is greater than any possible risk to the fetus. Clinical experience in pregnant women is limited. In animal models, formoterol caused a lack of implantation as well as reduced survival in early postnatal period and birth weight (such effects were observed at significantly higher systemic exposure than that achieved during the clinical use of formoterol). It is not known if formoterol is excreted in human milk. Administration of formoterol to breastfeeding women may only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Common: tremor, palpitations, headache. Uncommon: tachycardia, muscle spasms, muscle aches, agitation, restlessness, sleep disturbances, anxiety, nervousness, irritation of the mouth, throat irritation. Rare: atrial fibrillation, supraventricular tachycardia, additional spasms, nausea, hypokalaemia, hypersensitivity reactions (bronchospasm, urticaria, angioneurotic edema, pruritus, rash, peripheral edema). Very rare: angina pectoris, QT prolongation_c, changes in blood pressure, hyperglycemia, taste disorders, dizziness. During β treatment₂-marginics may increase the concentration of insulin, free fatty acids, glycerol and ketone bodies in the blood. In very rare cases, paradoxical bronchospasm may occur.

Inhalation. Adults and adolescents.Bronchial asthma. Dosage usually used: 1 inhalation 1-2 times a day; some patients may require 2 inhalations 1-2 times a day. Prevention of airflow obstruction caused by exercise: 1 inhalation before exercise. The regular daily dose should not exceed 4 inhalations; however, in exceptional circumstances, a maximum of 6 inhalations are permitted within 24 hours. No more than 3 inhalations should be used at the same time. After monitoring the symptoms of asthma, a gradual dose reduction may be considered. When decreasing a dose, it is important to regularly monitor the patient's condition.COPD. Dosage usually used: 1 inhalation 1-2 times a day. The regular daily dose should not exceed 2 inhalations. If necessary, additional inhalations, in addition to the regular ones, up to a maximum daily dose of 4 inhalations (including regularly used doses) may be used to relieve symptoms. Do not use more than 2 inhalations at a time. No dose adjustment is necessary in elderly patients, patients with renal or hepatic impairment. If you are switching from another inhaled formoterol preparation to Forastmin, it should be taken into account that the dose of the active substance that you are receiving may change - you may need to adjust your dose.