Bronchosirop

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BRONCHOSYRUP (BRONCHOSYRUP)

Composition:

5 ml of syrup contain:

Active substances: ephedrine hydrochloride 4.6 mg, glaucine hydrobromide 5.75 mg;

Excipients: basil oil; citric acid monohydrate; sucrose; methylparaben (E 218); propylparaben (E 216); polysorbate 80; ethanol 96%, purified water.

Medicinal form. Syrup.

Main physicochemical properties: colorless or slightly brownish or brownish-yellow viscous liquid with a specific odor of basil oil; opalescence may be present.

Pharmacotherapeutic group.

Agents acting on the respiratory system. Other antitussive agents.

ATC code R05D B.

Pharmacological Properties.

Pharmacodynamics.

Bronchosyrup is a combined preparation with pronounced antitussive and bronchodilating effects. The complex action of the drug is due to the properties of its main components: glaucine hydrobromide and ephedrine hydrochloride. The alkaloid glaucine suppresses the cough center without affecting the respiratory center. It has a weak bronchospasmolytic and adrenolytic effect and does not cause habituation or dependence when used according to the section "Administration and Dosage". Ephedrine is an adrenomimetic agent with both direct (stimulates α- and β-receptors) and indirect (inhibits amine oxidase activity) actions. It causes the release of norepinephrine and epinephrine from their depots. Ephedrine exerts a spasmolytic effect on the smooth bronchial musculature. It provides prolonged relaxation of bronchial muscles due to pronounced stimulation of β2-adrenergic receptors. Under the influence of ephedrine, edema of the bronchial mucosa decreases and the bronchial lumen expands. Pharmacological studies of Bronchosyrup show that it reduces the spastic effect of histamine on the bronchi.

Facilitation of sputum expectoration and bronchial dilation are due to the bronchodilating action of ephedrine.

Pharmacokinetics.

Absorption: after oral administration, glaucine and ephedrine are rapidly and completely absorbed from the gastrointestinal tract.

Distribution: maximum plasma concentration of glaucine is reached within 1.5 hours after administration.

Ephedrine is distributed throughout the body with predominant accumulation in the liver, lungs, kidneys, spleen, and brain.

Metabolism: glaucine and a small portion of ephedrine are metabolized in the liver.

Excretion: glaucine is excreted in urine in both unchanged form and as metabolites.

The elimination half-life of ephedrine is approximately 3–6 hours. It is mainly excreted in urine in unchanged form.

Clinical characteristics.

Indications.

Bronchosyrup is used as part of complex therapy for respiratory diseases accompanied by dry, non-productive cough: acute and chronic bronchitis, tracheobronchitis, bronchial asthma, pneumonia, bronchiectasis.

Contraindications.

• Hypersensitivity to the active substance or to any excipients of the medicinal product;
• Ischemic heart disease;
• Severe and/or uncontrolled arterial hypertension;
• Acute myocardial infarction;
• Severe organic heart diseases with signs of decompensation;
• Thyrotoxicosis;
• Pheochromocytoma;
• Closed-angle glaucoma;
• Prostatic hyperplasia with urinary retention;
• Insomnia.

Interaction with other medicinal products and other forms of interaction.

Bronchosyrup can be used concomitantly with antibiotics, antipyretics, and vitamins. It reduces the effects of narcotic and sedative agents due to the presence of ephedrine in the formulation.

When used concomitantly with cardiac glycosides, certain sympathomimetics, quinidine, tricyclic antidepressants, halogenated anesthetics (halothane), the risk of cardiac arrhythmia increases. Similar effects may also be observed when used concomitantly with ergot alkaloids or oxytocin. When used simultaneously with reserpine, a sharp increase in blood pressure is possible.

Since ephedrine has properties of both α-agonists and β-agonists, it should be used with caution in patients who have undergone anesthesia with cyclopropane, halothane, or other volatile anesthetics.

Ergot alkaloids, monoamine oxidase inhibitors (MAO inhibitors), and oxytocin potentiate the pressor effect of ephedrine (risk of hypertensive crisis with concomitant use). If treatment with the drug is necessary, a two-week interval should be observed after discontinuation of MAO inhibitors.

When used concomitantly with non-selective β-blockers, the bronchodilating effect of the medicinal product is reduced.

Sympathomimetics have antagonistic action on the antihypertensive effect of β-blockers.

Ephedrine may counteract the neuron-blocking effect of guanethidine, leading to loss of its hypotensive efficacy.

Ephedrine accelerates the metabolism of dexamethasone.

Concomitant treatment with Bronchosyrup and oral antidiabetic medicinal products may result in reduced hypoglycemic effect.

The drug should not be used simultaneously with medicinal products that suppress cough, both of central (codeine, codterpin) and peripheral (exalgit, libexin) mechanisms of action. Combination with agents that reduce bronchial secretion (e.g., atropine derivatives) is not justified.

Concomitant use of ephedrine with theophylline may lead to increased nausea, nervousness, and insomnia.

Other medicinal products that stimulate the central nervous system (CNS), or tonic plant-derived beverages (coffee, tea, Coca-Cola), may enhance the CNS-stimulating effects of Bronchosyrup when used concomitantly.

In patients with arterial hypertension undergoing concomitant therapy with ephedrine and adrenergic agents that block neurons, loss of blood pressure control has been observed, which may also occur with the use of other antihypertensive agents.

An increased vasoconstriction and pressor effects of ergotamine or methysergide are observed; concomitant use of ergotamine is not recommended (risk of gangrene).

The effects of ephedrine may be reduced by acidification and increased by alkalinization of urine.

Special precautions.

Due to the central nervous system stimulation and possible sleep disturbances, administration of Bronchosyrup after 4 p.m. is not recommended.

Use with caution in patients with diabetes mellitus and renal insufficiency.

Use with caution in patients prone to drug dependence.

If symptoms do not resolve or condition worsens within 5–7 days of starting treatment, consult a physician to evaluate the appropriateness of continuing therapy.

Cardiovascular effects may occur during treatment with sympathomimetics, including Bronchosyrup. Post-marketing surveillance data and scientific literature confirm an association between rare cases of myocardial ischemia and the use of β-agonists (hydrochloride ephedrine). Patients with cardiac disorders (ischemic heart disease, arrhythmia, or heart failure) who are taking this medication should be advised to seek medical help in case of chest pain or development of other cardiac symptoms. Particular attention should be paid to symptoms such as dyspnea and chest pain, as they may be of either respiratory or cardiac origin.

Glaucine hydrobromide should not be used in productive cough associated with sputum production, as there is a risk of bronchial obstruction due to retention of bronchial secretions. Medical consultation is required in case of labile arterial pressure. The medicinal product should be used with particular caution in patients with arterial hypertension and benign prostatic hyperplasia. Use with caution due to the risk of collapse resulting from the sympatholytic effect of glaucine hydrobromide.

Children and elderly patients are more sensitive to the effects of ephedrine.

Tolerance and dependence may develop after prolonged use of ephedrine.

Patients with known intolerance to certain sugars should consult a physician before taking this medicinal product. The product may be harmful to teeth.

This medicinal product contains a small amount of 96% ethanol: less than 100 mg per 5 ml dose.

This medicinal product contains 1.7% v/v ethanol, i.e., 138 mg per 10 ml dose. It is harmful for patients with alcoholism. Caution is advised when used during pregnancy and breastfeeding, in children, and in patients with liver disease or epilepsy.

The syrup contains excipients methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).

The presence of ephedrine in the product may lead to a positive doping test in athletes.

Use during pregnancy or breastfeeding.

Contraindicated during the first trimester of pregnancy and during breastfeeding.

There are no safety data available for use during the second trimester; therefore, use is recommended only when the benefit to the mother outweighs the potential risk to the fetus.

If ephedrine is used during the third trimester, it may lead to fetal tachycardia.

Ability to influence reaction speed when driving or operating machinery.

The medicinal product should be used with caution when driving vehicles or operating machinery due to the action of ephedrine. Ephedrine may cause mydriasis and affect reaction speed when operating vehicles or handling machinery.

Dosage and Administration.

Take orally after meals.

Adults and children aged 10 years and older: 10 mL 3–4 times daily.

Children:

• Aged 3 to 5 years ― 5 mL of syrup, diluted immediately before use in 10 mL of cooled boiled water, 3 times daily;
• Aged 5 to 10 years ― 5 mL 3 times daily.

The duration of treatment is 5–7 days.

Children.

Recommended for children aged 3 years and older.

Overdose.

Symptoms of overdose may include nausea, vomiting, fever, loss of appetite, nervous excitement, limb tremor, dizziness, excessive sweating, difficulty in urination, increased or decreased arterial pressure, headache, drowsiness, weakness, rapid fatigue, intensification of adverse reactions, paranoid psychosis, delirium, hallucinations.

Treatment: gastric lavage, administration of activated charcoal, and symptomatic therapy.

Adverse Reactions

The following adverse reactions may occur during the use of the medicinal product Broncho Syrup:

Immune system disorders: hypersensitivity reactions (skin rashes, urticaria, itching sensation, angioedema, bronchospasm);

Respiratory system and thoracic disorders: dyspnea;

Cardiovascular system disorders: cardiac rhythm and conduction disturbances, tachycardia, extrasystoles, arrhythmia, palpitations, increased blood pressure, myocardial ischemia, chest pain, impaired circulation in limbs;

Nervous system disorders: headache, tremor, excitement, anxiety, restlessness, insomnia, sedative effect, dizziness;

Gastrointestinal disorders: dry mouth, anorexia, nausea, vomiting, constipation;

Renal and urinary disorders: difficulty in urination; urine retention may occur in patients with prostate hyperplasia;

Skin and mucous membrane disorders: increased sweating;

Sensory organ disorders: visual disturbances;

Other: shortness of breath, weakness, increased libido, dysmenorrhea, tachyphylaxis, tolerance with development of dependence (with prolonged use).

Myocardial infarction has been reported very rarely in patients taking ephedrine or pseudoephedrine.

Ephedrine may act as a stimulant in children with nocturnal enuresis and may cause insomnia; it may also produce a sedative effect in some children.

Reporting of Adverse Reactions

Reporting of adverse reactions following medicinal product registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf Life. 2 years.

Shelf life after opening the bottle ― 1 month.

Storage Conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Do not freeze!

Packaging

Syrup, 100 ml or 200 ml in a bottle. One bottle with a dosing device in a cardboard box.

Prescription Status

Over-the-counter.

Manufacturer

LLC "Kharkiv Pharmaceutical Enterprise "Zdorovya Narodu".

Manufacturer's Address and Place of Business

41, Kulikovska Street, Kharkiv, Kharkiv Oblast, 61002, Ukraine.