Salbutamol-G

Salbutamol-G

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Full Prescribing Info
Contents
Salbutamol sulfate, guaiphenesin.
Description
Each 5 ml contains Salbutamol sulfate 1.2 mg (equivalent to Salbutamol 1 mg) and Guaiphenesin 50 mg.
It also contains Sodium benzoate 5 mg as preservative.
Action
Pharmacology: Pharmacodynamics: Salbutamol is a selective β2 adrenoceptor agonist. At therapeutic doses it acts on the β2 adrenoceptors of bronchial muscle, with little or no action on β1 adrenoceptors of cardiac muscle. It is suitable for the management and prevention of attack in asthma.
Guaiphenesin has an expectorant action which increase the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow or less viscid secretion promotes ciliary action and facilitate the removal of mucus. This changes a dry, unproductive cough to a cough that is more productive and less frequent.
Pharmacokinetics: Salbutamol: The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of 10%.
After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine. The bioavailability of orally administered salbutamol is about 50%.
Guaiphenesin: Guaiphenesin is absorbed from the gastrointestinal tract. It is metabolized and excreted in the urine.
Indications/Uses
To relief the viscosity of tenacious sputum. To reduce bronchospasm and airway resistance in asthmatic patients.
Dosage/Direction for Use
Adults: Oral, 10 to 20 ml two to three times a day.
Children: 2 to 6 years : Oral, 5 to 10 ml two times a day.
7 to 12 years: Oral, 10 ml two times a day.
>12 years: Oral, 10 to 20 ml two times a day.
Mode of Administration: To be taken orally on an empty stomach. Take 1 hour before or 2 hours after meals.
Overdosage
Overdosage symptoms are those of excessive β-stimulation, e.g. seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue and insomnia. Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Treatment consists of discontinuation of salbutamol together with appropriate symptomatic therapy. Administer a cardioselective β-adrenergic blocker (e.g. acebutalol, atenolol, metoprolol), if necessary for cardiac arrhythmias. However, β-adrenergic blocker should be used with caution because it could induce severe bronchospasm.
Contraindications
This product is contraindicated in patients who have shown hypersensitivity to any of the ingredients.
Special Precautions
The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function test.
Increasing use of short-acting inhaled β2 agonist to control symptoms indicates deterioration of asthma control. Under this condition, the patient’s therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroids therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Patients should be warned that is either the usual relief 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 should be administered cautiously to patients with thyrotoxicosis.
In common with other β-adrenoceptor agonists, salbutamol can induce reversible metabolic changes, for example increased blood sugar levels. Diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroid can exaggerate this effect.
Tocolysis: Serious adverse reactions including death have been reported of salbutamol to women in labor. In mothers, these include increased heart rate, transient hyperglyceamia, hypokalaemia, cardiac arrhythmias, pulmonary oedema and myocardial ischaemia. Increased fetal heart rate and neonatal hypoglycaemia may occur as a result of maternal administration.
As maternal pulmonary oedema and myocardial ischaemia have been reported during or following treatment of premature labour with β2 agonists, careful attention should be given to fluid balance and cardio-respiratory function, including ECG should be monitored. If signs of pulmonary oedema or myocardial ischaemia develop, discontinuation of treatment should be considered.
Bronchodilators should not be the only or main treatment in patient with severe or unstable asthma. Severe asthma requires regular medical assessment including lung function testing as patients are at risk of severe attacks and even death. Physicians should consider using oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in those patients.
Use In Pregnancy & Lactation
Administration of the drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. As with the majority of the drugs, there is little published evidence of salbutamol safety in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the foetus at very high dose levels.
As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
Side Effects
Fine tremors of skeletal muscle, palpitations, muscle cramps, slight tachycardia, tenseness, headaches, peripheral vasodilation, GI discomfort, nausea, vomiting.
Drug Interactions
Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Concomitant use of salbutamol and tricyclic antidepressants or monoamine oxidase inhibitors may cause a potentiation of the vascular effects of salbutamol. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Storage
Store at temperature below 30°C. Protect from light and moisture.
Shelf-Life: 2 years.
ATC Classification
R03CC02 - salbutamol ; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Expectorant (clear, colorless with blackcurrant flavor) 60 mL, 100 mL, 120 mL.
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