As Fludalt DUO contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the 2 compounds.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast- and short- acting inhaled bronchodilator. Salmeterol/fluticasone propionate should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Adverse events which have been associated with salmeterol or fluticasone propionate are as follows: Salmeterol:
The pharmacological adverse effects of β2-agonist treatment eg, tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) may occur, usually in susceptible patients.
There have been very rare reports of anthralgia.
Hypersensitivity reactions, including anaphylactic reactions eg, oedema and angioedema, bronchospasm and anaphylactic shock have been reported rarely. There have been reports of rash.
There have been common reports of muscle cramps.
There have been very rare reports of hyperglycaemia.
Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients.
There have been uncommon reports of cutaneous hypersensitivity reactions. There have also been rare reports of hypersensitivity reactions manifesting as angioedema (mainly facial and oropharyngeal oedema), respiratory symptoms (dyspnoea and/or bronchospasm) and very rarely, anaphylactic reactions.
Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of salmeterol/fluticasone propionate. Symptomatic candiasis can be treated with topical antifungal therapy while still continuing with salmeterol/fluticasone propionate.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma (see Precautions). There have been very rare reports of hyperglycaemia.
There have been very rare reports of anxiety, sleep disorders and behavioural changes including hyperactivity and irritability (predominantly in children).