Salbutamol Inhalation Aerosol BP 100mcg/dose

NAME AND STRUCTURE

NAME： Salbutamol Inhalation Aerosol BP

MOLECULAR FORMULA： C13H21NO3

MOLECULAR WEIGHT ：239.31

CHARACTERISTICS

Salbutamol Inhalation Aerosol is a kind of white or slight yellow suspension mixed with just right quantity of propellant and kept in a pressurised canister with a metered valve system.

PHARMACOLOGICAL ACTION

Salbutamol is a beta-adrenergic stimulant which has a highly selective action on the beta2, receptors in bronchial muscle resulting in bronchodilatation.

INDICATIONS:
Salbutamol is indicated for the relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. Salbutamol is indicated for the prevention of exercise induced bronchospasm.
CONTRA-INDICATIONS:
Hypersensitivity to salbutamol. Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. Salbutamol and non-selective beta-blocking medicine such as propranolol should not be prescribed together.

Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
For oral inhalation only. Shake well before use. Do not exceed the recommended dose. For the relief of acute bronchospasm and for managing intermittent episodes of asthma, one or two inhalations may be administered as a single dose. The recommended dose for chronic maintenance or prophylactic therapy is two inhalations repeated four hourly if required. To prevent exercise induced bronchospasm, two inhalations four hourly daily prior to exercise.
An interval of at least one minute is recommended between successive inhalations.
Consult a doctor if the effect of a previously adequate dose lasts for less than three hours.
As there may be side-effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice
Increasing the use of Salbutamol inhaler maybe a sign of worsening asthma. Under these circumstances, a reassesment of the patient's therapy plan may be required and concomitant glucosteroid therapy should be considered.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Peripheral vasodilatation, slight tachycardia, tenseness and headache may occur. Salbutamol may cause fine tremor of skeletal muscle (particularly the hands), palpitations and muscle cramps.
Hypokalaemia may occur.
Overdosage may cause cardiac effects.
High dosages may increase the risk of serious side-effects, including cardiac dysrhythmias. The risk is further aggravated if administered concomitantly with other medicines that cause hypokalaemia and cardiac dysrthythmias or in the presence of hypoxia and acidosis.
The maximum dose should not be exceeded.
Fatalities have been reported in association with excessive use of inhaled sympathomimetic medicine.
This is sometimes attributed to the induction of ventricular arrhythmias. It is important to avoid excessive dosing.
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported.

SPECIAL PRECAUTIONS
Salbutamol should be used with caution in patients with cardiovascular disorders especially ischaemic heart disease, angina, cardiac tachycardias and arrhythmias, hypertension and thyrotoxicosis. Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation of salbutamol or a different fast acting bronchodilator.
In this instance Salbutamol inhaler should be discontinued immediately, and the patient assessed and if necessary alternative therapy be instituted.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Cardiovascular and skeletal muscle effects may be noted with gross overdosage. Treatment is symptomatic and supportive.

 
STORAGE INSTRUCTIONS:
Store below 30°C and protect from direct sunlight. Do not freeze.
KEEP OUT OF REACH OF CHILDREN.