International generic name
Drug form and composition
Syrup. 5 ml syrup contains: 5.75 mg Glaucine hydrobromide; 4.60 mg Ephedrine
Combined treatment of the diseases affecting respiratory system and causing cough
and catarrhal changes of different intensity: acute catarral inflamations of the
upper respiratory tract, acute and chronic bronchitis and tracheitits; bronchial
asthma; pneumonia; bronchiectases.
Dosage and administration
In adult patients is administered 10 ml syrup, 3-4 times daily. In children older
than 10 years the dosage is 10 ml, 3 times daily, and in children from 3 to 10 years
- 5 ml, 3 times daily.
As the preparation contains ephedrine, it is contraindicated in angina pectoris;
severe heart diseases; thyrotoxicosis; hypertension; pheochromocytoma; glaucoma;
prostatic gland adenoma with urine retention. Broncholytin is contraindicated in
patients with hypersensitivity to any of its components.
Special warnings and precautions
Administration of the medecine during the first trimester of pregnancy; during
nursing, and in children younger than 3 years to be avoid.
As the medicine contains ephedrine, following drug interactions should be taken
in account: with guanetidine - displaces its bounding to α-adrenergic neurons and
enhances the direct α-adrenergic effect of the drug; with reserpine - reduces the
effect of ephedrine, exhausting the norepinephrine stores; with tricycled antidepressants
- intensifies the pressor effect of the direct and indirect adrenergic agents, due
to blocking of the catecholamine uptake in the adrenergic neural terminations. Broncholytin
may be used together with antibiotics, chemotherapeutics, antipyretics, and vitamins.
Usually Broncholytin is well tolerated by the patients. Rarely 15-30 minutes
after administration transient adverse reactions may appear, including tremor, palpitations,
mild agitation, and sweating, all due to ephedrine. In children ephedrine may provoke
somnolence. In case of overdosage nausea, vomiting, distaste, agitation, circulation
disorders, limb tremor, dizziness, sweating, and dysuria may appear.
A combined preparation possessing antitussive, bronchodilating, and antiseptic
effects. The alkaloid glaucine, like codeine, depresses the cough center, with no
side effect (depressing of the breathing, drug tolerance, drug dependency, and constipation).
The medicine possesses also analgesic, bronchial spasmolytic, and antiseptic effects.
Ephedrine is an adrenergic agent with mixed action. It reduces the bronchial swelling,
causes arteriolar constriction, and elevates the blood pressure; improves atrioventricular
conduction; reinforces and accelerates heart activity. Exerts stimulating effect
on the CNS and increases excitation of the center of breath. The action of the preparation
is of short duration. The additive basil oil depresses the cough reflex and possesses
some bronchial spasmolytic and antiseptic activity. Experimental pharmacology investigations
of Broncholytin - syrup showed, that the preparation reduces the spastic effect
of histamine on the bronchi. Ephedrine and glaucine exert contrary action on the
cardiovascular system. Ephedrine accelerates the heart rate and elevates the blood
pressure, whereas glaucine reduces the same variables. Improvement of the secretion
elimination and desobstruction are due to the bronchodilating effect of ephedrine.
Antiseptic activity of the preparation is a result of action of the basil oil, as
well as the mild anti-inflammatory action of glaucine, which determines its place
in the complex treatment of the respiratory tract diseases.
Vials containing 125 ml syrup.