Salamol ECO Easi breathe (Aerosol) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Norton Waterford Trading As Ivax Pharmaceuticals Ireland (Ireland)

ATC Code

R03AC02 (Salbutamol)

Active Substance

Salbutamol (Rec.INN registered by WHO)

Dosage Form

Salamol ECO Easi breathe

Breath-activated metered inhalation aerosol 100 mcg/1 dose: 200 dose canister

Dosage Form, Packaging, and Composition

Breath-activated metered inhalation aerosol, in the form of a suspension, which when sprayed onto glass forms a white spot.

Excipients : hydrofluoroalkane (HFA-134a) – 26.46 mg, ethanol 96% – 3.42 mg.

200 doses – aluminum canisters (1) – breath-activated aerosol inhalers (Easi Breathe) (1) – cardboard packs.

Clinical-Pharmacological Group

Bronchodilator drug – beta₂-adrenergic agonist

Pharmacotherapeutic Group

Selective beta2-adrenomimetic

Pharmacological Action

A bronchodilator drug, a selective agonist of β₂-adrenergic receptors. In therapeutic doses, the drug acts on β₂-adrenergic receptors of bronchial smooth muscle, providing a pronounced bronchodilator effect, prevents and relieves bronchospasm, and increases lung capacity.

It prevents the release of histamine, slow-reacting substance from mast cells, and neutrophil chemotaxis factors.

It causes a slight positive chronotropic and inotropic effect on the myocardium, dilates the coronary arteries, and practically does not reduce blood pressure.

It has a tocolytic effect: reduces the tone and contractile activity of the myometrium. The effect of the drug begins 5 minutes after inhalation and lasts for 4-6 hours.

It has a number of metabolic effects: reduces plasma potassium ion concentration, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, and increases the risk of acidosis.

Pharmacokinetics

Absorption, Distribution, Metabolism

After inhalation, up to 21% of the dose reaches the airways. The remainder stays in the device or is deposited in the oropharynx and then swallowed.

The part of the dose that reaches the airways is absorbed by the lung tissues without undergoing metabolism in the lungs and enters the bloodstream. Upon entering the systemic circulation, Salbutamol is partially metabolized in the liver and excreted mainly by the kidneys unchanged or as a phenolic sulfate.

The part of the dose that enters the gastrointestinal tract is absorbed and undergoes intensive metabolism during the first pass through the liver, turning into phenolic sulfate.

The binding of salbutamol to plasma proteins is 10 %. C_max in blood plasma is 30 ng/ml. T_1/2 is 3.7-5 hours.

Excretion

It is excreted mainly by the kidneys unchanged and as a conjugate. Most of the salbutamol dose administered intravenously, orally, or by inhalation is excreted within 72 hours.

Indications

Prevention and relief of bronchospasm

• In bronchial asthma;
• In chronic obstructive pulmonary disease;
• In chronic bronchitis;
• In pulmonary emphysema.

ICD codes

Dosage Regimen

For adults and children over 12 years old for relief of bronchospasm attacks, Salamol ECO Easi Breathe is prescribed at 100-200 mcg (1-2 inhalation doses). For control of mild asthma – 1-2 doses 1-4 times/day; for moderate disease severity – in the same dose in combination with other anti-asthmatic drugs. For prevention of exercise-induced asthma, the drug is used 20-30 minutes before exercise at 100-200 mcg (1-2 inhalation doses) per administration.

For children aged 2 to 12 years during the development of a bronchial asthma attack, as well as for preventing bronchial asthma attacks associated with allergen exposure or caused by physical exertion, the recommended dose is 100-200 mcg (1 or 2 inhalations).

The daily dose of Salamol ECO Easi Breathe should not exceed 800 mcg (8 inhalations).

Instructions for using the inhaler

Before use, shake the inhaler several times. Then, holding the inhaler upright, open the cap. Take a deep exhalation. Firmly grasp the mouthpiece with your lips. Make sure your hand does not block the ventilation holes on the top of the inhaler and that the inhaler is in an upright position. Take a slow, maximum inhalation through the mouthpiece, hold your breath for 10 seconds or as long as comfortable. Then remove the inhaler from your mouth and exhale slowly. After use, while continuing to hold the inhaler upright, close the cap. If more than one inhalation is needed, close the cap and, after waiting at least one minute, repeat the inhalation process.

Cleaning the inhaler

Unscrew the top part of the inhaler and remove the metal canister. Then rinse the lower part of the inhaler in warm water and dry it. Then insert the canister back into place. Close the cap and screw the top part of the inhaler back onto its body. Do not wash the top part of the inhaler. If the inhaler is not working properly, unscrew its top part and manually press the canister.

Adverse Reactions

From the nervous system hand tremor (a typical side effect for all beta₂-adrenergic agonists), headache, dizziness, increased excitability, anxiety, sleep disturbance, insomnia. The drug can cause agitation and increased motor activity in children.

From the cardiovascular system peripheral vasodilation (facial skin flushing), slight compensatory increase in heart rate, increased blood pressure. The occurrence of arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystole) is possible.

Allergic reactions angioedema, urticaria, erythema, nasal congestion, bronchospasm, arterial hypotension, collapse.

From the digestive system nausea, vomiting, dyspepsia.

Local reactions : irritation of the oral and pharyngeal mucosa (pharyngitis), cough.

From the respiratory system : paradoxical bronchospasm.

From metabolism hypokalemia (may pose a serious risk to the patient), reversible hyperglycemia are possible.

Other muscle cramps.

Contraindications

• Cardiac rhythm disorders (paroxysmal tachycardia, multifocal ventricular extrasystole, tachyarrhythmia);
• Myocarditis;
• Heart defects, aortic stenosis;
• Coronary artery disease;
• Thyrotoxicosis;
• Decompensated diabetes mellitus;
• Glaucoma;
• Epilepsy;
• Pyloroduodenal stenosis;
• Hepatic insufficiency;
• Renal insufficiency;
• Pregnancy;
• Concomitant use of non-selective beta-blockers;
• Children under 2 years of age;
• Hypersensitivity to the drug components.

Use with caution in chronic heart failure, hyperthyroidism, arterial hypertension, pheochromocytoma.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy. During lactation (breastfeeding), it is prescribed only in cases where the expected benefit to the mother outweighs any potential risk to the child.

Use in Hepatic Impairment

The drug is contraindicated in hepatic insufficiency.

Use in Renal Impairment

The drug is contraindicated in renal insufficiency.

Pediatric Use

Contraindication: children under 2 years of age.

Special Precautions

In patients with severe or unstable bronchial asthma, the use of bronchodilators should not be the main or only method of therapy. The patient should be warned to consult a doctor if the use of Salamol ECO Easi Breathe at the standard dose becomes less effective or of shorter duration (the drug’s effect should last at least 3 hours).

Frequent use of salbutamol can lead to increased bronchospasm and various complications (up to sudden death), therefore, breaks of several hours should be taken between successive inhalations.

An increased need for the use of short-acting inhaled beta₂-adrenergic agonists to control the symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, the patient’s treatment plan should be reviewed and the issue of prescribing or increasing the dose of inhaled or systemic corticosteroids should be considered.

Therapy with beta₂-adrenergic agonists can lead to hypokalemia. . Particular caution is recommended when treating severe attacks of bronchial asthma, since in these cases hypokalemia may be enhanced by the concomitant use of xanthine derivatives, corticosteroids, diuretics, as well as due to hypoxia. In such situations, it is necessary to monitor serum potassium levels.

The Salamol ECO Easi Breathe canister must not be punctured, disassembled, or thrown into fire, even if it is empty.

Like most other inhalation agents in aerosol packaging, Salamol ECO Easi Breathe may be less effective at low temperatures. If the canister is cold, it is recommended to remove it from the plastic casing and warm it with your hands for a few minutes.

Overdose

Symptoms nausea, vomiting, increased excitability, hallucinations, tachycardia, ventricular flutter, peripheral vasodilation, decreased blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremor, headache.

Treatment drug withdrawal, administration of cardioselective beta-blockers; if necessary, symptomatic therapy is carried out. If an overdose is suspected, serum potassium levels should be monitored.

Drug Interactions

Theophylline and other xanthines, when used concomitantly with salbutamol, increase the likelihood of tachyarrhythmias; and inhalation anesthetics, levodopa – severe ventricular arrhythmias.

Concomitant use of Salamol ECO Easi Breathe and non-selective beta-blockers (such as propranolol) is not recommended.

MAO inhibitors and tricyclic antidepressants enhance the effect of salbutamol and can lead to a sharp decrease in blood pressure.

When used concomitantly, Salbutamol enhances the effect of drugs with a stimulating effect on the central nervous system, the side effects of thyroid hormones, and cardiac glycosides.

When used concomitantly, Salbutamol reduces the effectiveness of antihypertensive drugs and nitrates.

Concomitant use with xanthine derivatives, corticosteroids, and diuretics may enhance hypokalemia.

Concomitant administration with anticholinergic agents (including inhaled ones) may contribute to increased intraocular pressure.

Storage Conditions

The drug should be stored out of the reach of children, protected from direct sunlight, at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.