Salmol Syrup

Salbutamol sulfate.

Each 5 ml contains Salbutamol sulfate equivalent to Salbutamol 2 mg.

Pharmacology: Pharmacodynamics: Salbutamol is sympathomimetic agent that stimulate beta₂-adrenergic receptors. Salbutamol relaxes the bronchial smooth muscle by action on with little effect on heart rate.
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.

SALMOL is used for long-term treatment of asthma and symptomatic management of bronchospasm in patients with reversible, obstructive airway disease such as asthma, chronic obstructive pulmonary disease (COPD) and chronic bronchitis-associated bronchospasm.

Adults and children over 14 years of age: Take 2 - 4 mg (1 - 2 teaspoons), orally 3 - 4 times/day.
Children: over 6 to 14 years of age: Take 2 mg (1 teaspoon), orally 3 - 4 times/day.
2 - 6 years of age: Initiate at 0.4 mg/kg of body weight 3 times/day. Children weigh 10 - 20 kg may take 1 - 2 mg (½ - 1 teaspoon), orally 3 times/day.
Elderly patients and those sensitive to beta-adrenergic stimulators: Take 2 mg (1 teaspoon), orally 3 - 4 times/day.

Symptoms: Overdosage of oral salbutamol produces symptoms that are mainly extensions of common adverse effects of salbutamol (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 effects, angina, tachycardia and hypokalemia have occurred following overdosage.
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 salbutamol.

Hypersensitivity to salbutamol, adrenergic amines, 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.

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

Incidence of adverse effects is dependent upon age of patients, dose, and route of administration.
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.
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.

Store at temperature not exceeding 30°C.

Antiasthmatic & COPD Preparations

R03CC02 - salbutamol ; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

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