INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ASTHAVENT Metered Dose Inhaler

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ASTHAVENT Metered Dose Inhaler

COMPOSITION:
Each actuation delivers salbutamol 100 µg.

PHARMACOLOGICAL CLASSIFICATION:
A 10.2.1 Inhalants

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:
ASTHAVENT is indicated for the relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. ASTHAVENT is indicated for the prevention of exercise induced bronchospasm.

CONTRA-INDICATIONS:
Hypersensitivity to salbutamol. ASTHAVENT should be administered cautiously to patients suffering from thyrotoxicosis. ASTHAVENT 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 ASTHAVENT 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 ASTHAVENT 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.

IDENTIFICATION:
Aluminium pressurised metered dose container, containing a milky white homogenous suspension of micronised powder in a mixture of propellants.

PRESENTATION:
Metered dose inhaler of 200 single doses of 100 µg each.

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

Caution: The metal canister is pressurised. Do not puncture or burn even when apparently empty.

REGISTRATION NUMBER:
30/10.2.1/0119

NAME AND BUSINESS ADDRESS OF APPLICANT:
Medpro Pharmaceutica (Pty) Ltd
Rosen Park, South Africa 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
SEPTEMBER 1995

3323A
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