The highest recommended dose of Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) in a single administration is 2 inhalations. Four cumulative inhalations of the drug (total beclometasone dipropionate 400 micrograms, formoterol 24 micrograms given as a single dose) have been studied in asthmatic patients. The cumulative treatment did not cause abnormal, clinically relevant effect on vital signs and neither serious nor severe adverse reactions were observed (see also Adverse Reactions).
For the pressurised inhalation solution formulation, inhaled doses of up to twelve cumulative actuations (total beclometasone dipropionate 1200 micrograms, formoterol 72 micrograms) have been studied in asthmatic patients. The cumulative treatments did not cause abnormal effect on vital signs and neither serious nor severe adverse events were observed.
Excessive doses of formoterol may lead to effects that are typical of beta2-adrenergic agonists: nausea, vomiting, headache, tremor, somnolence, palpitations, tachycardia, ventricular arrhythmias, prolongation of QTc interval, metabolic acidosis, hypokalaemia, hyperglycaemia.
In case of overdose of formoterol, supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective beta-adrenergic blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm. Serum potassium should be monitored.
Acute inhalation of beclometasone dipropionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function recovers in a few days, as verified by plasma cortisol measurements. In these patients, treatment should be continued at a dose sufficient to control asthma.
Chronic overdose of inhaled beclometasone dipropionate: risk of adrenal suppression (see Precautions.). Monitoring of adrenal reserve may be necessary. Treatment should be continued at a dose sufficient to control asthma.
Single supra-therapeutic doses up to 800 micrograms of beclometasone dipropionate, 48 micrograms of formoterol, administered via Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) are generally safe and well-tolerated.