Salmol Expectorant

Salbutamol sulfate, guaifenesin.

Each 5 mL contains: Salbutamol sulfate equivalent to Salbutamol 1 mg, Guaifenesin 50 mg.

Pharmacology: Pharmacodynamics: Salbutamol is sympathomimetic agent that stimulate beta₂ - adrenergic receptors. Salbutamol relaxes the bronchial smooth muscle with little effect on heart rate.
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.
Pharmacokinetics: Salbutamol sulfate is rapidly and well-absorbed following oral administration. Peak plasma concentrations occur within about 2 hours following administration of oral solution. Salbutamol crosses the blood-brain barrier, reaching the brain at concentrations that are approximately 5% of plasma concentrations. Salbutamol apparently crosses the placenta, but it is not known whether salbutamol is distributed into milk. After oral administration, the half-life of salbutamol is 5 - 6 hours. Salbutamol is extensively metabolized in the liver, mainly to salbutamol 4'-O-sulfate which has little effect or no β-adrenergic blocking effect. Salbutamol and its metabolites are rapidly excreted in urine and feces. About 75% of single dose oral administration is excreted in urine within 72 hours, mainly as the major metabolite; about 4% of the dose is excreted in feces.
Guaifenesin is readily absorbed from the gastrointestinal tract and rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of 1 hour, the major urinary metabolite is β-(2-methoxyphenoxy) lactic acid.

SALMOL EXPECTORANT is used for symptomatic management of cough associated with bronchitis or asthma.

Adults and children over 12 years of age : Take 2 - 3 teaspoonfuls, orally 2-3 times/day.
Children: 6 - 12 years of age : Take 1- 2 teaspoonfuls, orally 2-3 times/day; 2 - 6 years of age : Take 1 teaspoonfuls, orally 2-3 times/day.

Symptoms: Overdosage of oral salbutamol produces symptoms that are mainly extensions of common adverse effect of sulbutamol (e.g., seizures, hypotension or hypertension, arrhythmias, palpitation, nervousness, dizziness, fatigue, malaise, insomnia/sleeplessness, headache, tremor, dry mouth, nausea). In addition to exaggeration of common adverse effect, angina, tachycardia and hypokalemia have occurred following overdosage.
Overdosage of guaifenesin is unlikely to produce toxic effects since its toxicity is low.
Treatment: The drug should be discontinued and appropriate symptomatic therapy initiated. A relatively selective β₁-adrenergic blocking agent (e.g., metoprolol tartrate) may be used, if necessary, but only with extreme caution in asthmatic patients because an asthmatic attack may be induced. Evidence is insufficient to determine if dialysis is beneficial for the management of overdosage with sulbutamol.

Hypersensitivity to salbutamol, adrenergic amines, guaifenesin or any components of the formulation.

Use caution in patients with cardiovascular disease (arrhythmia or hypertension or heart failure), convulsive disorders, diabetes, glaucoma, hyperthyroidism, or hypokalemia.
Beta-agonists may cause elevation in blood pressure, heart rate, and result in CNS stimulation/excitation. Beta₂-agonists may increase risk of arrhythmia, increase serum glucose, or decrease serum potassium.
Consumption of large quantities of guaifenesin-containing medications may be associated with an increased risk of drug-induced kidney stone formation.
Doses of guaifenesin larger than those required for expectorant action may produce emesis.
Unless directed by a physician, guaifenesin should not be used for persistent or chronic cough. A persistent cough may be indicative of a serious conditions.
Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified.

Pregnancy category : C.
SALMOL EXPECTORANT should be used during pregnancy only if the possible benefits outweigh the potential risks.
Lactation: It is not known whether salbutamol and guaifenesin are distributed into human milk. A decision should be made whether to discontinue nursing or this medication, taking into account the importance of drugs to the woman.

Cardiovascular : Angina, atrial fibrillation, arrhythmias, chest discomfort, chest pain, extrasystoles, flushing, hyper-hypotension, palpitation, supraventricular tachycardia, tachycardia.
Central nervous system : CNS stimulation, dizziness, drowsiness, headache, insomnia, irritability, lightheadedness, migraine, nervousness, nightmares, restlessness, seizure.
Dermatologic : Angioedema, rash, urticaria.
Endocrine & metabolic : Hyperglycemia, hypokalemia, lactic acidosis.
Gastrointestinal : Diarrhea, dry mouth, dyspepsia, gastroenteritis, nausea, unusual taste, vomiting, GI discomfort.
Genitourinary : Micturition difficulty.
Neuromuscular & skeletal : Muscle cramps, musculoskeletal pain, tremor, weakness.
Otic : Otitis media, vertigo.
Respiratory : Asthma exacerbation, bronchospasm, cough, epistaxis, laryngitis, oropharyngeal drying/irritation, oropharyngeal edema, pharyngitis, rhinitis, upper respiratory inflammation, viral respiratory infection.
Miscellaneous : Allergic reaction, anaphylaxis, diaphoresis, lymphadenopathy.

Beta-blockers : Concomitant use may inhibit bronchodilating effects. Severe bronchospasms may be produced in asthmatic patients taking salbutamol.
Methyldopa : Concurrent administration may result in an increased pressor response.
MAO inhibitors : Coadministration may result in severe headache, hypertension, and hyperpyrexia, resulting in hypertensive crisis. MAO inhibitors also potentiate the actions of beta-adrenergic agonists on the vascular system. Avoid coadministration with sympathomimetics or within 2 weeks.
Tricyclic antidepressants (TCAs) : TCAs potentiate the pressor response of direct-acting sympathomimetics; dysrhythmias have occurred.
Theophylline : Enhanced toxicity, particularly cardiotoxicity, has been noted. Decreased theophylline levels may occur.
Diuretics : ECG changes and hypokalemia associated with these diuretics may worsen with coadministration.
Digoxin : Patients receiving such concomitant therapy may decrease in serum digoxin concentration. Carefully evaluated their serum digoxin concentration.
DRUG/LAB 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 temperature not exceeding 30°C and protect from light. The shelf life period is 2.5 years.

Antiasthmatic & COPD Preparations / Cough & Cold Preparations

R05CA10 - combinations ; Belongs to the class of expectorants. Used in the treatment of wet cough.

C