Salbutamol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SALMOTEK

Composition:

Active substances: 5 ml of syrup contains salbutamol (as salbutamol sulfate) 2 mg, bromhexine hydrochloride 4 mg;

Excipients: sodium citrate; citric acid, monohydrate; aspartame (E 951); sodium benzoate (E 211); propylene glycol; cherry flavoring; carmoisine (E 122); menthol; hypromellose; purified water.

Pharmaceutical form. Syrup.

Main physico-chemical properties: clear pink-colored syrup with a pleasant odor.

Pharmacotherapeutic group. Medicinal products for obstructive airway diseases. Adrenergic agents for systemic use. Selective beta2-adrenoreceptor agonists. ATC code R03C C.

Pharmacological properties.

Pharmacodynamics. Salmetek is a combination containing an expectorant component (bromhexine) and a bronchodilator component (salbutamol).

Salbutamol is a selective beta-2 adrenergic receptor agonist. At therapeutic doses, it acts on beta2-adrenergic receptors in the bronchial smooth muscle, resulting in bronchodilation in patients with reversible airway obstruction.

Bromhexine is a mucolytic agent used in the treatment of respiratory disorders associated with increased mucus viscosity or excessive mucus production.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. Prevention and relief of bronchospasm in bronchial asthma. Reversible airway obstruction in chronic bronchitis.

Contraindications. Hypersensitivity to any component of the drug; hyperthyroidism, severe cardiovascular disorders, peptic ulcer, phenylketonuria.

Interaction with other medicinal products and other forms of interaction.

Salbutamol should not be administered concomitantly with non-selective beta-adrenoblockers such as propranolol. Salbutamol is not contraindicated in patients receiving MAO inhibitors.

Bromhexine. Concomitant use of bromhexine with antitussive agents may lead to dangerous mucus retention due to suppression of the cough reflex; therefore, such combination should be used with particular caution. When bromhexine is used concomitantly with drugs that irritate the gastrointestinal tract, mutual enhancement of mucosal irritation is possible. Hypokalemia may be potentiated when Salmotel is used concomitantly with xanthine derivatives, glucocorticoids, or diuretics.

Do not administer to patients prior to anesthesia.

Special precautions for use

Use with caution in patients with diabetes mellitus and glaucoma.

Bromhexine. Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome may occur during bromhexine treatment. If skin or mucous membrane changes appear, medical advice must be sought immediately and bromhexine should be discontinued. Bromhexine should be used with particular caution in patients with impaired bronchial motility associated with excessive bronchial secretion (e.g. primary ciliary dyskinesia syndrome) due to the risk of secretion retention. Bromhexine should also be used with special caution (by reducing the dose or increasing the interval between doses) in patients with renal impairment (including severe renal insufficiency) or severe hepatic disorders.

Salbutamol. Treatment of bronchial asthma should follow a stepwise management plan, with regular clinical and pulmonary function assessments. An increased frequency of use of short-acting inhaled beta2-agonists indicates worsening asthma control. In such cases, the patient's therapy should be reviewed urgently, as worsening asthma control may be life-threatening and may require initiation or dose escalation of corticosteroids. Patients at risk should perform daily peak expiratory flow monitoring. Sympathomimetic medicinal products, including salbutamol, may affect the cardiovascular system. Post-marketing experience and published scientific data provide evidence of isolated cases of myocardial ischemia associated with salbutamol use. Patients with pre-existing cardiac conditions (e.g. ischemic heart disease, arrhythmias) treated with salbutamol should seek immediate medical attention if chest pain or other symptoms suggestive of cardiac deterioration occur. Symptoms such as dyspnea and chest pain should be carefully evaluated, as they may result from either cardiac or respiratory disorders. Beta2-agonist therapy may lead to severe hypokalemia. This is mainly observed with parenteral administration or nebulizer use. Particular attention should be paid to patients with acute severe asthma, as hypokalemia may be potentiated by concomitant use of xanthine derivatives, corticosteroids, diuretics, and hypoxia. In such cases, serum potassium levels should be monitored. Like other beta-adrenergic agonists, salbutamol may cause reversible metabolic changes, such as increased blood glucose levels.

Compensation for these changes in diabetic patients is not always possible, and there have been isolated reports of ketoacidosis in such patients. Concomitant use of corticosteroids may exacerbate this condition. Do not administer to patients prior to anesthesia.

Use during pregnancy or breastfeeding. Not recommended.

Ability to affect reaction speed when driving or operating machinery. No studies on the effect on reaction speed have been conducted. However, potential adverse effects that may impair the ability to drive or operate precision machinery should be taken into account.

Dosage and Administration.

For children from 7 years of age: 2.5–5 mL taken 3–4 times daily. Adults should take 5 mL 3–4 times daily. Dosing should be performed using the provided graduated measuring cap. 1 marking corresponds to 2.5 mL of syrup.

The duration of treatment should be determined by a physician.

Children. Do not use in children under 7 years of age.

Overdose.

Bromhexine. Dangerous cases of overdose are currently unknown. There has been a report in which, in 4 out of 25 cases of high-dose bromhexine administration, vomiting was observed, and in 3 young children, disturbances of consciousness, ataxia, diplopia, mild metabolic acidosis, and rapid breathing occurred. No symptoms were observed after administering up to 40 mg of bromhexine in young children.

Treatment. In cases of significant overdose, monitoring of the cardiovascular system is recommended, and symptomatic therapy should be administered if necessary. Due to the low toxicity of bromhexine, invasive procedures aimed at reducing absorption or accelerating elimination are generally not required. Furthermore, due to the high degree of plasma protein binding, large volume of distribution, and slow redistribution of bromhexine from tissues into blood, enhanced elimination via hemodialysis or forced diuresis is not expected to be effective.

Salbutamol. The most common signs and symptoms of salbutamol overdose are transient, pharmacologically induced beta-agonist effects (e.g., tachycardia, tremor, headache).

Overdose of salbutamol may lead to hypokalemia; therefore, serum potassium levels should be monitored. Treatment consists of discontinuing salbutamol and administering appropriate symptomatic therapy, such as cardioselective beta-blockers for patients experiencing cardiac disturbances (e.g., tachycardia, palpitations). Beta-blockers should be administered with caution in patients with a history of bronchospasm.

Adverse reactions.

The drug is well tolerated when used at the indicated doses.

Salbutamol: hypersensitivity reactions, including angioneurotic edema, urticaria, bronchospasm, hypotension, collapse, hypokalemia, tremor, headache, hyperactivity, tachycardia, palpitations, cardiac arrhythmia, including atrial fibrillation, supraventricular tachycardia, extrasystoles, myocardial ischemia, peripheral vasodilation, muscle cramps, sensation of muscle pressure.

Bromhexine: dyspepsia, chills, nausea, stomach pain, vomiting, diarrhea, exacerbation of pre-existing gastric or intestinal ulcers, severe skin reactions such as Stevens–Johnson syndrome and Lyell’s syndrome, dizziness, headache, transient increase in serum aspartate aminotransferase levels, hypersensitivity reactions including pruritus; skin rashes, urticaria, angioneurotic edema, respiratory disorders, anaphylactic reactions, including anaphylactic shock. Adverse effects resolve rapidly after discontinuation of the drug. If any unusual reactions occur, the patient must consult a physician regarding further use of the drug.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 100 ml in bottles; 1 bottle with a measuring cap in a cardboard box.

Prescription category. Prescription only.

Manufacturer. JSC "Chemical and Pharmaceutical Plant "Chervona Zirka".

Address.

1 Gordienkovskaya Street, Kharkiv, Kharkiv region, 61010, Ukraine.