(and dosage form):
Each 5 mL contains Salbutamol sulphate equivalent to salbutamol 2.0 mg.
Methyl paraben 0.2% m/v
Propyl paraben .02% m/v
A 10.2.2 Medicines acting on respiratory system. Bronchodilators. Other.
Salbutamol acts by stimulating beta-2-adrenergic receptors in the lungs to relax bronchial smooth muscle, thereby relieving bronchospasm associated with bronchial asthma, emphysema and chronic bronchitis. Because of this action, salbutamol increases vital capacity, decreases residual volume and reduces airway resistance.
ASTHAVENT is indicated for the treatment of reversible bronchospasm as in bronchial asthma, bronchitis and pulmonary emphysema.
Beta-blocking drugs such as propranolol should not be taken concomitantly with ASTHAVENT.
Hypersensitivity to any of the ingredients or sympathomimetic thyrotoxicosis.
The safety of this medication during pregnancy has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Do not exceed the recommended dose.
Adults: 5 mL - 10 mL three to four times a day. The dosage can be increased as needed and tolerated up to a maximum of four medicine measures four times a day.
Patients sensitive to BETA-ADRENERGIC stimulants and geriatric patients are recommended lower starting doses.
One 5 mL medicine measure three to four times a day initially, the dosage being increased as needed and is tolerated.
Children up to 2 years: Dosage has not been established.
Children 2 to 6 years: ½ to 1 medicine measure (2.5 to 5 mL) three to four times daily.
Children 6 to 12 years: 1 medicine measure (5 mL) three to four times a day.
Children 12 years and over: Adult dose.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Caution should be exercised in patients suffering from cardiovascular disease; especially, arrhythmias, coronary insufficiency, and ischemic heart disease, hypertension, diabetes mellitus, hyperthyroidism, ketoacidosis, and pheochromocytoma. Tolerance may develop with prolonged use.
Hypokalaemia may occur. Overdosage may cause cardiac effects. High dosages may increase the risk of serious side-effects, including cardiac dysrhythmias. This risk is further aggravated if administered concomitantly with other medicines that cause hypokalaemia and cardiac dysrhythmias or in the presence of hypoxia and acidosis. The maximum dose should not be exceeded.
Central effects of sympathomimetic agents include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, and psychotic states. Appetite may be reduced, and nausea and vomiting may occur.
Cardiovascular System: Vascular constriction which can give rise to hypertension, cerebral haemorrhage and pulmonary oedema, tachycardia, cardiac arrhythmias, anginal pain, palpitations and cardiac arrest, hypotension with dizziness, fainting and flushing may occur.
Other effects that may occur with sympathomimetic agents include difficulty in micturition and urinary retention, dyspnoea, weakness, altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also common.
Medical advice should be sought if relief from symptoms is not obtained within three hours of taking a previously effective dose, in order that alternative or additional measures may be taken if necessary.
Precautions for Sympathomimetics: Use with caution in patients who may be particularly susceptible to their effects, particularly those with hyperthyroidism.
Care is also needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms.
Anginal pain may be precipitated in patients with angina pectoris.
Caution is required in patients with diabetes mellitus, closed angle glaucoma, patients receiving antihypertensive therapy. Sympathomimetics should be avoided in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics.
Possible drug interactions include: Salbutamol with: monoamine oxidase inhibitors, and other sympathomimetic agents.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms expected on overdosage with salbutamol are tachycardia, CNS stimulation, tremor, hypokalaemia, and hyperglycaemia. Treatment is symptomatic and supportive.
A pink coloured clear solution, with a characteristic fruity flavour.
Packed in amber bottles, of sizes 100 mL, 150 mL and 500 mL.
Store at room temperature (below 25°C).
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
CIPLA MEDPRO (PTY) LTD.
Rosen Heights, Pasita Street
Rosen Park, Bellville 7530. RSA
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Updated on this site: January 2017
Source: Pharmaceutical Industry
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