Salbutamol Tablets 4 MG Bronchodilators Medicines 10 * 10BP / USP

 Salbutamol Tablets 4 MG Bronchodilators Medicines 10 * 10BP / USP

Salbutamol Tablets 4 MG

COMPOSITION:

Salbutamol Tablet-4 TABLETS contain 4,8 mg Salbutamol sulphate equivalent to 4 mg Salbutamol.


PHARMACOLOGICAL CLASSIFICATION:
A 10.2 Bronchodilators.

PHARMACOLOGICAL ACTION:
Salbutamol is a beta-adrenergic stimulant which has a selective action on bronchial beta-adreno-receptors.

INDICATIONS:
Salbutamol Tablet is indicated as a bronchodilator in the treatment of bronchospasm associated with bronchial asthma, emphysema and chronic bronchitis.

CONTRA-INDICATIONS:
Salbutamol Tablet should not be taken together with beta-blocking agents.
Hyperthyroidism and cardiac disease.
Safety in pregnant and lactating women has not been established.
Salbutamol Tablet is not indicated for the prevention of premature labour associated with toxaemia of pregnancy or ante partum haemorrhage, nor should it be used for threatened abortion during the first and second trimesters of pregnancy.
Salbutamol Tablet may interact with mono-amine oxidase inhibitors, and should not be given to patients receiving such treatment or within 14 days after stopping treatment.

WARNING:
Tolerance may develop in asthmatic patients givenSalbutamol Tablet. If tolerance develops and the patient's condition worsens, alternative or additional therapy should be instituted. The dosage of Salbutamol Tabletshould not be increased in these cases.
Salbutamol Tablet should be avoided or used with care in patients undergoing anaesthesia with any halogenated anaesthetics.

DOSAGE AND DIRECTIONS FOR USE:
Adults: The usual dose is 2 to 4 mg three or four times daily.
Elderly patients should be given the lower dose initially.
Children: 2-6 years: 1 to 2 mg three or four times daily.
        6-12 years: 2 mg three or four times daily.
Over 12 years: Adult dose.
Syrup
Children: 2-6 years: 2,5 to 5 mL (½ to 1 medicine measure) three to four times daily.
Over 6 years: 5 mL (1 medicine measure) three to four times daily.
Adults: 5 - 10 mL (1 - 2 medicine measures) three to four times daily.
Some patients may require dosages of up to 20 mL.
Elderly patients should be given the lower dose initially.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Salbutamol Tablet may cause fine tremor of skeletal muscle (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilation have been reported after large doses. Anxiety, fever, restlessness, insomnia confusion, irritability, weakness, psychotic states, decreased appetite, nausea and vomiting may occur due to the central effects of Salbutamol Tablet.
Difficulty in micturition and urinary retention, dyspnoea, altered metabolism, sweating and hypersalivation may occur.

SPECIAL PRECAUTIONS:
Salbutamol Tablet should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension or aneurysms.
Hypokalaemia associated with high doses of salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmias.
Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed-angle glaucoma, and in those receiving antihypertensive therapy.
It is important to avoid excessive doses as this is thought to be linked to sudden death probably due to the induction of ventricular arrhythmias.

INTER-ACTIONS:
The adverse effects of high doses of Salbutamol Tablet may be exacerbated by concomitant administration of high doses of corticosteroids.
The effects of Salbutamol Tablet are antagonised by propranolol and other ß-adrenoceptor blocking agents and enhanced by aminophylline or other xanthines.
An increased risk of arrhythmias may occur if patients are receiving cardiac glycosides, quinidine or tricyclic antidepressants. Interaction with alpha-and beta-blocking agents may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Fine tremor of skeletal muscles, tachycardia, palpitations and peripheral vasodilation. Treatment is symptomatic and supportive.

IDENTIFICATION:
Flat bisected lilac tablets with bevelled edges, engraved with mortar and pestle on one side.
The 2 mg tablet has a diameter of 6,5 mm.
The 4 mg tablet has a diameter of 8,8 mm.


PRESENTATION:

Salbutamol Tablet: Packs of 100 and 500 tablets.


STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.