PHARMACOLOGICAL ACTION: Salbutamol is a beta-adrenergic stimulant which has a highly selective action on the receptors in bronchial muscle and, in therapeutic dosage, little or no action on the cardiac receptors. The inhaler drug delivery system, using Salbutamol in microgram dosage avoids the skeletal muscle tremor sometimes associated with oral therapy.
Published clinical evidence indicates that the action of Salbutamol by inhalation is rapid, near maximal bronchodilation occurring within five minutes. Venteze Inhaler in therapeutic dosages has minimal effect on the cardiovascular system. It has been found that Venteze has no significant effect on the heart rate and circulation time and it does not lead to a significant fall in lowered arterial oxygen tension.
INDICATIONS: Venteze inhaler is indicated for relief of bronchospasm in:
Bronchial asthma of all types
Venteze Inhaler has been found to be suitable for the relief of bronchospasm in patients with co-existing heart disease, but caution is advised.
CONTRA-INDICATIONS: There are no known contra-indications but Venteze should be administered cautiously to patients suffering from thyrotoxicosis. Venteze and beta-blocking drugs such as propranolol should not usually be prescribed together.
DOSAGE AND DIRECTIONS FOR USE: Shake before use. Do not exceed the recommended dose. One or two inhalations repeated four hourly if required. The bronchodilator effect of each administration of Venteze Inhaler lasts for at least four hours and more frequent use should be unnecessary. This long duration of action provides a margin of safety. The patient can readily recognise any reduction in the length of action and should be instructed to consult a doctor if the effect of a previously adequate dose lasts for less than three hours. Venteze Inhaler acts rapidly and may be used when necessary to relieve attacks of acute dyspnoea. Doses may be taken prophylactically before exertion or to prevent exercise-induced asthma. Because Venteze Inhaler is also long-acting, it is ideally suited for routine maintenance therapy in chronic asthma and chronic bronchitis when a degree of reversible airways obstruction exists.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Care should be taken with patients suffering from hypertension, myocardial insufficiency or thyrotoxicosis. Notice should be taken of recent suggestions that the administration of any drug during the first trimester of pregnancy is undesirable. No side-effects have been reported from Venteze given by inhalation in therapeutic doses. Doses greatly in excess of those needed for full bronchodilatation could cause short-lived secondary effects such as peripheral vasodilatation, minor increase in pulse rate and skeletal muscle tremor. In the event of a previously effective dose failing to give relief for at least three hours the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
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.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: With gross overdosage cardiovascular and skeletal muscle effects may be noted. The specific antidote for overdosage with Venteze is a selective beta-blocking agent given by intravenous injection. In general beta-blocking drugs should be used with caution in patients with a history of bronchospasm or in patients who are pregnant.
IDENTIFICATION: Metered dose aerosol inhaler.
PRESENTATION: Venteze Inhaler is a metered aerosol delivering 100 µg of Salbutamol per inhalation with a specially designed actuator. Each canister provides 200 inhalations. It is available as Venteze Inhaler (complete unit) and Venteze Inhaler (refill).
STORAGE INSTRUCTIONS: Store below 25°C. Protect from frost and direct sunlight. The canister should not be broken, punctured or burnt even when empty. Shake before use. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: R/10.2.1/292.
NAME AND BUSINESS ADDRESS OF APPLICANT: Lennon Limited, 7 Fairclough Road, PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT: November 1983
G133 KOHLER C&P P.E.