Atimos (Aerosol) Instructions for Use

Marketing Authorization Holder

Chiesi Farmaceutici, S.p.A. (Italy)

ATC Code

R03AC13 (Formoterol)

Active Substance

Formoterol (Rec.INN registered by WHO)

Dosage Form

Atimos

Metered-dose inhalation aerosol 12 mcg/1 dose: canisters 100 doses or 120 doses with a metering valve and inhaler

Dosage Form, Packaging, and Composition

Metered-dose inhalation aerosol in the form of a colorless or light yellow, transparent solution.

Excipients: anhydrous ethanol – 8.854 mg, 1M hydrochloric acid – 0.028 mg, norflurane (1,1,1,2-tetrafluoroethane) – 64.906 mg.

100 doses – aluminum canisters (1) with a metering valve and inhaler – cardboard packs.
120 doses – aluminum canisters (1) with a metering valve and inhaler – cardboard packs.

Clinical-Pharmacological Group

Bronchodilator drug – beta₂-adrenergic agonist

Pharmacotherapeutic Group

Selective beta2-adrenomimetic

Pharmacological Action

Beta-adrenomimetic. Acts primarily on β₂-adrenergic receptors. Exerts a bronchodilatory effect, relieves and prevents bronchospasm. Inhibits the release of histamine, leukotrienes, and prostaglandin D₂ from mast cells, basophils, and sensitized cells of the bronchial tree.

Pharmacokinetics

With inhalation administration, about 90% of the active substance may be swallowed. When taken orally, it is rapidly absorbed from the gastrointestinal tract. Absorption is 65%. C_max is reached in 0.5-1 h. Plasma protein binding is 61-64%. It is metabolized mainly by glucuronidation. After oral administration of formoterol, T_1/2 is 2-3 h. After inhalation of formoterol, T_1/2 is 5 h. Formoterol and its metabolites are completely eliminated: when taken orally, 2/3 of the dose is excreted in the urine, 1/3 in the feces. After inhalation of formoterol, an average of 6-9% is excreted unchanged in the urine. The renal clearance of formoterol is 150 ml/min.

Indications

Prevention and treatment of bronchial obstruction disorders in patients with bronchial asthma as an add-on therapy to inhaled corticosteroids; prevention of bronchospasm caused by physical exertion, cold air, or allergen inhalation as an add-on therapy to inhaled corticosteroids; prevention and treatment of bronchial obstruction disorders in patients with COPD.

ICD codes

Dosage Regimen

Administer by inhalation only. The dosage regimen is set individually.

For bronchial asthma as add-on therapy: The usual adult and adolescent dose is one inhalation of 12 mcg, taken twice daily (morning and evening).

For prevention of exercise-induced bronchospasm: Use one inhalation of 12 mcg at least 15 minutes before physical exertion.

For COPD: The recommended dose is one inhalation of 12 mcg, taken twice daily.

Do not exceed the prescribed twice-daily maintenance dosing schedule.

This product is not indicated for the relief of acute asthma attacks; always have a short-acting bronchodilator available for rescue use.

If your bronchial asthma symptoms persist or worsen after initiating treatment, consult your doctor immediately for a re-evaluation of your therapy.

Once asthma control is achieved, your physician should consider gradually reducing the dose to the lowest effective level.

Adverse Reactions

From the hematopoietic system: very rarely – thrombocytopenia.

From the immune system: rarely – angioedema, bronchospasm, exanthema, urticaria, pruritus.

From metabolism: infrequently – hypokalemia, hyperglycemia.

From the psyche: infrequently – agitation, anxiety, increased excitability, sleep disorders; very rarely – behavioral disorders, hallucinations.

From the nervous system: often – tremor, headache; infrequently – dizziness, dysgeusia; very rarely – CNS stimulation (in the form of excessive excitability – mainly observed in children under 12 years of age).

From the cardiovascular system: infrequently – tachycardia, tachyarrhythmia; rarely – cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, extrasystole), angina pectoris, changes in blood pressure; very rarely – QTc interval prolongation.

From the respiratory system: often – cough; infrequently – oropharyngeal irritation; rarely – paradoxical bronchospasm; very rarely – dyspnea, exacerbation of bronchial asthma.

From the digestive system: infrequently – dry oral mucosa, nausea.

From the skin and subcutaneous tissues: infrequently – rash, hyperhidrosis.

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

From the urinary system: rarely – nephritis.

Other: very rarely – peripheral edema.

Treatment with beta₂-adrenomimetics can lead to an increase in the blood concentration of insulin, free fatty acids, glycerol, and ketone bodies.

Contraindications

Hypersensitivity to formoterol or other beta-adrenomimetics; pediatric age – depending on the dosage form; breastfeeding period.

With caution

In refractory diabetes mellitus; thyrotoxicosis; pheochromocytoma; hypertrophic obstructive cardiomyopathy; idiopathic subaortic stenosis; severe arterial hypertension; cardiac aneurysm or other severe cardiovascular diseases, such as coronary artery disease, including acute myocardial infarction, cardiac arrhythmias, including tachyarrhythmias; with AV block III degree; severe chronic heart failure; occlusive vascular diseases, aneurysm; congenital or drug-induced QT interval prolongation (QTc> 0.44 sec); prostatic hyperplasia; glaucoma; during pregnancy.

Use in Pregnancy and Lactation

During pregnancy, Formoterol is used with caution, only in cases where the expected therapeutic benefit for the mother outweighs the potential risk to the fetus. Formoterol, like other beta₂-adrenomimetics, may slow the process of labor due to its tocolytic effect.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Pediatric Use

It can be used in children according to indications, in age-recommended doses, regimens, and dosage forms. It is necessary to strictly follow the instructions in the formoterol drug labels regarding contraindications for the use of specific formoterol dosage forms in children of different ages.

Geriatric Use

It can be used in elderly patients according to indications, in recommended doses and regimens.

Special Precautions

Formoterol is not intended for the relief of acute attacks of bronchial asthma.

Patients with bronchial asthma who require treatment with long-acting beta₂-adrenomimetics should receive optimal maintenance anti-inflammatory therapy (inhaled or oral corticosteroids), including after the introduction of formoterol into the treatment regimen, even if they experience a reduction in symptoms. If symptoms persist or an increase in the dose of beta₂-adrenomimetics is required, this indicates a worsening of the underlying disease and the need to review maintenance therapy.

During treatment with formoterol, serious asthma-related adverse events and exacerbations of the underlying disease may occur. If asthma symptoms persist and are not controlled or worsen after starting treatment with formoterol, patients should be advised to continue treatment but consult a doctor. Once control of asthma symptoms is achieved, the issue of gradually reducing the doses of formoterol should be considered. The lowest effective doses of formoterol should be used.

A sudden and progressive increase in bronchial obstruction can be life-threatening and require immediate medical intervention.

Given the hyperglycemic effect inherent to beta₂-adrenomimetics, in patients with diabetes mellitus taking Formoterol, additional regular monitoring of blood glucose concentration is recommended.

If general anesthesia with halogenated anesthetics is planned, it should be ensured that Formoterol has not been used within 12 hours before the start of anesthesia.

During the use of formoterol, serum potassium levels should be regularly monitored, especially in patients with low baseline serum potassium levels or at increased risk of its decrease. Serum potassium levels should also be monitored if a decrease was observed during previous treatment with short-acting beta₂-adrenomimetics. If necessary, potassium losses should be replenished to correct hypokalemia.

Due to a decrease in serum potassium levels, the effects of digitalis drugs may be enhanced.

Effect on the ability to drive vehicles and mechanisms

During the use of formoterol, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use, class Ia antiarrhythmic drugs (quinidine, disopyramide, procainamide) and class III antiarrhythmic drugs (sotalol, amiodarone), phenothiazines, some antihistamines (such as terfenadine, astemizole, mizolastine), MAO inhibitors, tricyclic antidepressants, intravenous erythromycin, pentamidine, sultopride, vancomycin, halofantrine, bepridil may prolong the QTc interval and increase the risk of ventricular arrhythmias.

With simultaneous use of sympathomimetic agents, such as other beta₂-adrenomimetics or epinephrine (adrenaline), an increase in the undesirable effects of formoterol is possible.

Concomitant use of formoterol and theophylline may lead to mutual potentiation of bronchodilatory effects, but an increase in undesirable effects, such as cardiac arrhythmias, is possible.

Concomitant use with xanthine derivatives, corticosteroids, or diuretics, such as thiazide and loop diuretics, may enhance the hypokalemic effect of beta₂-adrenomimetics. Hypokalemia may increase the risk of arrhythmias in patients taking digitalis preparations.

L-dopa, L-thyroxine, oxytocin, ethanol potentiate sympathomimetic effects and may contribute to the development of dysregulation of the cardiovascular system when used concomitantly with formoterol.

There is an increased risk of arrhythmias in patients undergoing general anesthesia with halogenated anesthetics simultaneously.

The bronchodilatory effects of formoterol may be enhanced by the concomitant use of anticholinergic drugs.

With simultaneous use, beta-blockers (including in the form of eye drops) partially or completely block the action of formoterol.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.