SALBUTAMOL DEMOGEN NEBULES

What it is

ASMOL Inhaler is a pressurised metered dose inhaler which delivers 100 micrograms of salbutamol (as sulfate) per actuation. The suspension is contained in an aluminium alloy can, sealed with a metering valve, fitted with a plastic actuator incorporating an atomising nozzle and fitted with a mouthpiece cover.

Approved indications

— Relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease — Acute prophylaxis against exercise-induced asthma and other stimuli known to induce bronchospasm

Dosing overview

Adults and children: if required, one or two inhalations, repeated four-hourly. The bronchodilator effect of each administration of ASMOL Inhaler lasts for at least four hours and more frequent use should be unnecessary. Initial doses of salbutamol in the elderly should be lower than the recommended adult dosage, with the dose then gradually increased if sufficient bronchodilatation is not achieved.

Key safety warnings

Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control, and under these conditions, the patient's therapy plan should be reassessed as soon as possible by a physician. Overuse of short-acting beta agonists may mask the progression of the underlying disease which could contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and possibly mortality. Potentially serious hypokalaemia may result from beta-2 agonist therapy, particularly in acute severe asthma where this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and hypoxia, and it is recommended that serum potassium levels are monitored in such situations. As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing, which should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator if immediately available, and if necessary a different fast-acting bronchodilator should be instituted for ongoing use.

Contraindications

Hypersensitivity to any of the ingredients. Non-intravenous formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

Regulatory history

ASMOL CFC-Free Inhaler was first approved on 26 November 1998.