Salmodil/Salmodil-SF

Salmodil/Salmodil-SF

Manufacturer:

FDC

Distributor:

Unimed
Full Prescribing Info
Contents
Salbutamol, bromhexine hydrochloride.
Description
Salmodil Syrup: Each 5 ml contains: Salbutamol 2 mg (as Salbulamol Sulphate), Bromhexine Hydrochloride 4 mg, Palatable base q.s.
Salmodil-SF syrup: Each 5ml contains: 2.41 mg Salbutamol Sulphate equivalent to Salbutamol 2mg and 4.0 mg Bromhexine Hydrochloride.
Excipients/Inactive Ingredients: Salmodil syrup: Preservative: Sodium Benzoate 10 mg.
Permitted Colour: Carmoisine.
Action
ATC Code: Salmodil syrup: 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.
Indications/Uses
A bronchodilator with mucolytic expectorant for clearance of viscid purulent sputum in acute and chronic brochiectasis and whooping cough.
Dosage/Direction for Use
Salmodil syrup: 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.
Salmodil-SF syrup: Adults: 5ml 3 to 4 times a day.
Children below 6 years: 1.25 to 2.5 ml 3 to 4 times a day.
Older children: 2.5 to 5ml 3 to 4 times a day.
Or as directed by the physician.
MODE OF ADMINISTRATION: For oral use only.
Overdosage
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.
Salmodil syrup: Bromhexine: Data not available.
Contraindications
Thyrotoxicosis, angina pectoris, severe cardiovascular diseases and peptic ulcers.
Warnings
WARNING FOR ASPARTAME: Salmodil-SF syrup: Unsuitable for phenylKetonurics.
Special Precautions
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.
Salmodil-SF syrup: Tocolysis: Serious adverse reactions including death have been reported after administration of terbutaline/salbutamol to women in labor. In the mother, these include increased heart rate, transient hyperglycaemia, hypokalaemia, cardiac arrhythmias, pulmonary oedema and myocardial ischaemia. Increased fetal heart rate and neonatal hypoglycaemia may occur as a result of maternal administration.
Use In Pregnancy & Lactation
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.
Side Effects
Tachycardia, palpitation, precordial pain, nervousness, tremors in a few patients. Upper gastrointestinal complaints like nausea, vomiting may be observed in a few cases.
Drug Interactions
Salmodil syrup: Not shown.
Salmodil-SF syrup: Beta-blockers inhibit the bronchodilator effect of sympathomimetic bronchodilators. Diuretics and xanthines may augment hypokalemia. Hypokalemia associated with high doses of salbutamol may result in increased susceptibility to digitalis induced cardiac arrhythmiac.
Storage
Salmodil syrup: Store in a dry place below 30°C.
Salmodil-SF syrup: Store in a cool, dark place below 25°C.
Shelf-Life: 24 months from the date of manufacturing of finished product.
ATC Classification
R05CB10 - combinations ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Salmodil syr (clear, pink coloured having a sweet and slightly bitter taste, with cooling effect) 60 mL, 100 mL. Salmodil-SF syr 100 mL (clear, pink colored solution having sweet and slightly bitter taste with cooling effect. 100ml filled in amber colored labeled PET bottle packed in a carton).
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