Salbutamol sulfate, guaifenesin.
Clear, colorless with menthol-flavoured solution.
Each 5 mL contains: Salbutamol sulfate equivalent to Salbutamol 1.0 mg, Guaifenesin 50.0 mg.
Pharmacology: Pharmacodynamics: Salbutamol is used as a bronchodilator by direct-action sympathomimetic agent with predominantly β-adrenergic activity and selective action on β2-receptors.
Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions. By reducing the viscosity of secretions and increasing sputum volume, guaifenesin increases the efficiency of the cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi.
As a result, bronchial drainage is improved and less frequent.
Pharmacological actions: Salbutamol is a β-adrenergic stimulant which has a selective action on the receptors in bronchial muscle.
Guaifenesin, given orally, makes the viscous mucus of the respiratory pathways more fluid facilitating expectoration.
Pharmacokinetics: Relevant Pharmacokinetic data: Salbutamol: Absorption: Oral: Well absorbed from the gastrointestinal tract.
Metabolism: Liver, primarily to salbutamol 4'-O-sulfate which has little or no β-adrenergic stimulating effect and no β-adrenergic blocking effect.
Elimination: Plasma Half-life: Oral: 2.7 to 5 hours.
Onset of action: Improvement in pulmonary function.
Oral: Within 30 minutes.
Time to peak plasma concentration: Oral: Within 2.5 hours following administration of conventional tablets.
Time to peak effect: Improvement in pulmonary function.
Oral: 2 to 3 hours.
Duration of action: Improvement in pulmonary function.
Oral: 6 hours or longer.
Excretion: Renal: Oral: Approximately 75% of single dose is excreted within 3 days in the urine.
Fecal: Oral: About 4% of an oral dose is excreted in the feces. It is not known if salbutamol is excreted in breast milk.
Guaifenesin: Guaifenesin is readily absorbed from the gastrointestinal tract.
It is rapidly metabolized and excreted in the urine.
It is used for prophylactic treatment and relief of asthma, chronic bronchitis, emphysema, and other bronchopulmonary disorders involving bronchospasm in adults and children 2 years of age and older.
It may be useful for the symptomatic relief of respiratory conditions characterized and in the presence of mucus in the respiratory tract because of guaifenesin.
Adults and children over 12 years: 2-3 teaspoonfuls 2-3 times a day.
Children 6-12 years: 1-2 teaspoonfuls 2-3 times a day.
Children 2-6 years: 1 teaspoonful 2-3 times a day.
Mode of administration: Oral.
Symptoms: Overdosage of oral salbutamol produces symptoms that are mainly extensions of common adverse effects. In addition to exaggeration of common adverse effects, angina, hypertension, and hypokalemia have occurred following overdosage.
Overdosage with guaiphenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 g/kg, produced no signs of toxicity.
Treatment: In the management of salbutamol overdosage, a relatively selective beta 1-adrenergic blocking agent (e.g., metoprolol tartrate) may be used, if necessary, but only with extreme caution on asthmatic attack may be induced. Dialysis is not appropriate therapy for the management of salbutamol overdosage.
In severe cases of overdosage with guaiphenesin, treatment should be aimed at reducing further absorption of the drug. Gastric emptying (emesis or gastric lavage) is recommended as soon as possible after ingestion. Treatment is symptomatic and supportive.
Should not be used in patients with co-existing hypertension, heart disease and patients suffering from thyrotoxicosis.
Unnecessary administration of drugs during the first trimester of pregnancy is undesirable.
Hypersensitivity to guaifenesin or any of the constituents.
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 hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hyperglycemia may occur as a result of maternal administration.
Patients should be advised to contact their physician if they do not respond to the usual dose of this medication, since this may be a sign of seriously worsening asthma which requires reassurance of therapy.
Salmol should be used during pregnancy only if the potential benefit justifies the potential risk. Salbutamol has the potential to delay preterm labor. There are no well-controlled studies that demonstrate that they stop preterm labor or prevent labor at term. Therefore, use cautiously in pregnant patients when given for relief of bronchospasm to avoid interference with uterine contractility. Salbutamol is probably secreted in breast milk, caution should be exercised when Salmol is administered to a nursing woman.
A fine tremor of skeletal muscle which occurs in some patients; usually the hands are most obviously affected.
Small increase in heart rate may occur.
Adverse effects of salbutamol are CNS stimulation, malaise, emotional lability, fatigue, nightmares, aggressive behavior, lightheadedness, disturbed sleep, irritability, bronchitis, nasal congestion, sputum increase, epistaxis, hoarseness, increased appetite, stomachache, muscle cramps, pallor, conjunctivitis, anorexia, teeth discoloration, dyspepsia, dilated pupils, epigastric pain, micturition difficulty, muscle spasm, voice changes, urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, erythema multiforme, and Stevens-Johnson syndrome have been associated with the administration of salbutamol sulfate syrup in children.
Guaifenesin is well tolerated and has a wide margin of safety. Products containing guaiphenesin have been associated with nausea, vomiting, GI discomfort, dizziness, headache, skin rash, and urticaria.
Beta blockers: Concomitant use with salbutamol may inhibit cardiac, bronchodilating and vasodilating effects.
Severe bronchospasm may be produced in asthmatic patients taking salbutamol. Consider cardioselective beta blockers, and use with caution if there are no alternatives to beta blocker therapy.
Diuretics: ECG changes and hypokalemia associated with these diuretics may worsen with coadministration.
Digoxin: Digoxin serum levels may be decreased.
Drug/Lab test interactions: Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic (5-HIAA) acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the vanillylmandelic acid (VMA) test for catechols. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.
Store at a temperature below 30°C. Protect from light.
Shelf life: 2.5 years.
R05CA10 - combinations ; Belongs to the class of expectorants. Used in the treatment of wet cough.
Salmol Expectorant syr
(menthol flavour) 60 mL x 1's
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