Salbutamol, bromhexine hydrochloride.
Each 5 ml contains: Salbutamol 2 mg (as Salbulamol Sulphate), Bromhexine Hydrochloride 4 mg, Palatable base q.s.
Excipients/Inactive Ingredients: Preservative: Sodium Benzoate 10 mg.
Permitted Colour: Carmoisine.
ATC Code: R03AC02 SALBUTAMOL.
Pharmacology: Pharmacodynamics: Salbutamol is a synthetic sympathomimetic amine. Salbutamol stimulates beta-adrenergic receptors and has little or no effect on alpha adrenergic receptors. Beta-adrenergic agonists stimulate the production of cyclic adenosine-3',5'- monophosphate (AMP) by activation of the enzyme adenyl cyclase. Cyclic AMP appears to have greater stimulating effect on beta receptors of the bronchial, uterine, and vascular smooth muscles (beta-1 receptors).
Bromhexine is a mucolytic agent used in the treatment of respiratory disorders associated with viscid or excessive mucus.
Pharmacokinetics: Salbutamol sulfate is rapidly and well absorbed following oral administration. Peak plasma salbutamol concentrations occur within 2.5 and 2 hours following administration of the conventional tablets and oral solution, respectively. Following oral administration of 2 mg of salbulamol every 6 hours as conventional tablets in healthy individuals, steady-state peak plasma salbutamol concentrations average 5.3-6.8 and steady-state trough plasma concentrations average 3.8-4.3 ng/mL. Bronchodilation begins within 30 minutes after oral administration of conventional tablets, with peak effect in 2-3 hours, and may persist up to 4-6 hours.
Results of animal studies indicate that salbutamol does not cross the blood-brain barrier, but the drug apparently crosses the placenta. After oral administration, the plasma half-life is reportedly 2.7-5 hours.
Following oral administration of salbulamol sulfate to healthy individuals, about 75% of a single dose is excreted in urine within 72 hours, mainly as the major metabolite; about 4% of the dose is excreted in feces.
Bromhexine hydrochloride is rapidly absorbed from the gastro-intestinal tract and about 85 to 90% of a dose is excreted in the urine mainly as metabolites of bromhexine. Bromhexine is highly bound to plasma proteins.
A bronchodilator with mucolytic expectorant for clearance of viscid purulent sputum in acute and chronic brochiectasis and whooping cough.
Children below 6 years: 1.25 to 2.5 ml 3 to 4 times a day.
Older children: 2.5 to5 ml 3 to 4 times a day.
Or as directed by the physician.
MODE OF ADMINISTRATION: For oral use only.
Salbutamol: The preferred antidote for overdosage with salbutamol is a cardioselective beta-blocking agent, but beta-blocking drugs should be used with caution in patients with a history of bronchospasm. Hypokalaemia may occur following overdosage with salbutamol. Serum potassium levels should be monitored.
Bromhexine: Data not available.
Thyrotoxicosis, angina pectoris, severe cardiovascular diseases and peptic ulcers.
Patients should be warned that if either the usual relief with salbutamol tablets is diminished, or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice.
Salbutamol oral preparations and non-selective beta-blocking drugs such as propranolol, should not usually be prescribed together.
Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.
Potentially serious hypokalaemia may result from beta-2 agonist therapy.
Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia.
Since mucolytics may disrupt the gastric mucosal barrier, bromhexine should be used with care in patients with history of peptic ulceration.
Administration of salbutamol during pregnancy should only be considered if the expected benefit to mother is greater than any possible risk to fetus.
As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk.
Tachycardia, palpitation, precordial pain, nervousness, tremors in a few patients. Upper gastrointestinal complaints like nausea, vomiting may be observed in a few cases.
Store in a dry place below 30°C.
Shelf-Life: 24 months from the date of manufacturing of finished product.
R05CB10 - combinations ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
100 mL x 1's;60 mL x 1's