Broncholytin® [Glaucine, Ephedrine]

Pharmacological properties

Broncholytin is a combined drug with a pronounced antitussive, bronchodilating effect. the complex effect of the drug is due to the properties of its main components: Glaucine hydrobromide and ephedrine hydrochloride. the alkaloid Glaucine inhibits the cough center, without affecting the respiratory center. It has a mild bronchospasmolytic and adrenolytic effect and is not addictive and addictive, subject to the method of application and dose.

Ephedrine is an adrenomimetic of direct (stimulates alpha and beta receptors) and indirect (inhibits the activity of amino oxidase) effects. Causes the release of norepinephrine and epinephrine from their depot. Ephedrine has an antispasmodic effect on the smooth muscles of the bronchi. For a long time relaxes the bronchial muscles, which is due to the pronounced stimulating effect on β₂adrenergic receptors. Under the influence of ephedrine, swelling of the mucous membrane of the bronchi decreases and their lumen expands. Pharmacological studies of the syrup Broncholytin show that it reduces the spastic effect of histamine on the bronchi.

Facilitation of sputum removal and reduction of bronchial obstruction are due to the bronchodilating effect of ephedrine.

Pharmacokinetics Suction. After oral administration, Glaucine and ephedrine are rapidly and completely absorbed in the digestive tract.

Distribution. C_max plasma Glaucine is reached 1.5 hours after its administration.

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

Metabolism. Glaucine and ephedrine (a small part) are metabolized in the liver.

Glaucine is excreted in the urine as metabolites and unchanged.

T_½ ephedrine is about 3-6 hours. Eliminated with urine mainly in unchanged form.

Indications

Broncholytin is recommended to be used as part of the complex therapy of diseases of the respiratory system, accompanied by dry unproductive cough: acute and chronic bronchitis, tracheobronchitis, BA, pneumonia, bronchiectasis.

Application

Apply orally after a meal.

Adults and children over the age of 10 years: 10 ml 3-4 times a day.

Children aged 3 to 5 years: 5 ml of the drug, diluted immediately before use in 10 ml of chilled boiled water, 3 times a day; from 5 to 10 years - 5 ml 3 times a day.

The duration of treatment is 5-7 days.

Contraindications

Hypersensitivity to the active substance or any auxiliary component of the drug.

Ischemic heart disease; severe and / or uncontrolled hypertension; acute myocardial infarction; severe organic heart disease with manifestations of decompensation; thyrotoxicosis; pheochromocytoma; angle-closure glaucoma; prostate hypertrophy with urinary retention; insomnia.

Side effects

When using the drug broncholithin, the following adverse reactions may occur:

on the part of the immune system: hypersensitivity reactions (rashes on the skin, urticaria, itching, angioedema, bronchospasm);

from the respiratory system, chest organs: dyspnea;

on the part of the cardiovascular system: impaired heart rhythm and conduction, tachycardia, extrasystole, arrhythmia, palpitation, increased blood pressure, myocardial ischemia, chest pain, circulatory disturbance in the limbs;

from the nervous system: headache, tremor, agitation, anxiety, anxiety, insomnia, sedation, dizziness;

from the digestive system: dry mouth, anorexia, nausea, vomiting, constipation;

from the urinary system: difficulty urinating, in patients with prostatic hypertrophy urinary retention is possible;

on the part of the skin and mucous membranes: increased sweating;

from the sensory organs: impaired vision;

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

In patients taking ephedrine or pseudoephedrine, myocardial infarction is very rare.

Ephedrine can act as a stimulant in children with nocturnal enuresis and cause insomnia, and also have a sedative effect in some children.

special instructions

Due to the stimulating effect on the central nervous system and possible sleep disturbances, it is not recommended to take the drug Broncholytin syrup after 16 hours.

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

Use with caution in patients prone to drug dependence.

If after 5-7 days from the start of therapy, the symptoms of the disease persist or the condition worsens, you must consult a doctor to assess the feasibility of further treatment.

In the treatment of sympathomimetics, including the drug Broncholytin, effects from the cardiovascular system may occur. Post-marketing research data, as well as literature data, contain well-known evidence of rare cases of myocardial ischemia associated with the use of beta-agonists (ephedrine hydrochloride). Patients with heart diseases (coronary heart disease, arrhythmia, or heart failure) who are using this medication should be warned about the need to seek medical help for chest pain or other symptoms of worsening heart disease. Particular attention should be paid to evaluating symptoms such as dyspnea and chest pain, as they can be of either respiratory or cardiac origin.

Glaucine hydrobromide should not be used for a productive cough, which is accompanied by sputum production, since there is a risk of obstruction of the bronchi as a result of a delay in bronchial secretion. In the case of labile blood pressure, a doctors consultation is necessary. The drug should be used with extreme caution in patients with hypertension and prostatic hyperplasia. Use with caution because of the risk of collapse as a result of the sympatholytic effect of Glaucine hydrobromide.

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

After prolonged use of ephedrine, tolerance is observed with the development of dependence.

Broncholytin contains 43.75 g of sucrose. When used in recommended doses, each dose (5 ml) contains up to 2 g of sucrose. Persons with an intolerance to certain sugars should consult a physician before taking this medicine. The drug may be harmful to the teeth.

Broncholytin contains up to 1.7 vol.% Ethanol. Each dose (5 ml) contains up to 0.069 g of alcohol. It is dangerous for patients with liver diseases, patients with alcoholism, epilepsy, brain diseases. The alcohol content should be considered when used by pregnant women.

The syrup contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) as excipients, which can cause allergic reactions (possibly delayed).

The content of ephedrine in the composition of the drug can give a positive result with a doping test in athletes.

During pregnancy and breastfeeding. Do not use in the first trimester of pregnancy and during lactation. There is no data on the safety of use in the second trimester, therefore it is recommended to use only in cases where the benefit to the mother outweighs the potential risk to the fetus.

The use of ephedrine in the third trimester can lead to an acceleration of heart rate in the fetus.

Children. Recommended for children over 3 years.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. The drug should be used with caution when driving vehicles and working with automated mechanisms due to the action of ephedrine. Ephedrine can cause mydriasis and affect the reaction rate when driving vehicles and working with machinery.

Interactions

Broncholytin can be used simultaneously with antibiotics, antipyretic drugs and vitamins. due to the presence of ephedrine in the composition, the effects of narcotic and sleeping pills are weakened. with simultaneous use with cardiac glycosides, some sympathomimetics, quinidine, tricyclic antidepressants, the risk of developing arrhythmias increases. similar effects can be observed with simultaneous use with ergot alkaloids or oxytocin. with simultaneous use with reserpine, a sharp increase in hell is possible.

Since ephedrine has the properties of both alpha and beta agonists, it should be used with caution in patients undergoing anesthesia with cyclopropane, halothane, or other volatile anesthetics.

Ergoalkaloids, MAO inhibitors, and oxytocin potentiate the pressor effect of ephedrine (risk of hypertensive crisis with simultaneous use). If treatment with Broncholytin is necessary, you should adhere to the two-week interval after stopping the use of MAO inhibitors.

When combined with non-selective β-adrenoreceptor blockers, the bronchodilator effect of the drug decreases.

Sympathomimetics have an antagonistic effect on the antihypertensive effect of β-adrenergic receptor blockers.

Ephedrine can counteract the neuron blocking effect of guanethidine, which leads to a loss of its hypotensive effect.

Ephedrine accelerates the metabolism of dexamethasone.

With simultaneous treatment with Broncholytin and oral antidiabetic drugs, a decrease in their hypoglycemic effect is possible.

The drug should not be used simultaneously with drugs that inhibit the cough, both central (codeine, codterpin) and peripheral mechanism of action (exangitis, prenoxdiazine).

The combination with drugs that cause a decrease in bronchial secretion (for example, atropine derivatives) is not justified.

The simultaneous use of ephedrine with theophylline can lead to increased nausea, nervousness and insomnia. Other CNS-stimulating drugs or herbal tonic drinks (coffee, tea, Coca-Cola) can enhance the stimulating effects of the drug Broncholytin on the central nervous system with simultaneous use.

In patients with hypertension who receive concomitant therapy with ephedrine and adrenergic drugs that block neurons, a loss of blood pressure control was detected, which can also occur if other antihypertensive drugs are used.

There is an increase in vasoconstriction and pressor effects of ergotamine or metisergide; concomitant use of ergotamine is not recommended (risk of gangrene).

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

Overdose

In case of an overdose, nausea, vomiting, fever, loss of appetite, nervous excitement, tremor of the extremities, dizziness, increased sweating, difficulty urinating, increased hell, decreased hell, headache, drowsiness, weakness, fatigue, increased manifestations of adverse reactions, paranoid, paranoid delirium, hallucinations.

Treatment: gastric lavage, the use of activated charcoal and symptomatic treatment.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° C. do not freeze! Shelf life after opening the bottle - 1 month.