t; 1/1,000); very rare (< 1/10,000).
Table 1: Adverse reactions
MedDRA system organ classification
Nervous system disorders
Very common: sedation/somnolence
Common: dizziness
Uncommon: dystonia, dyskinesia, oculogyration, tremor, akathisia/restlessness
Vascular disorders
Uncommon: hypotension
Respiratory, thoracic and mediastinal disorders
Common: throat irritation
Uncommon: bronchospasm (including shortness of breath)
Gastrointestinal disorders
Very common: dysgeusia
Common: dry mouth
General disorders and administration site conditions
Common: fatigue
Description of selected adverse reactions
Bronchospasm
In short-term (24-hour), placebo-controlled trials in patients with agitation associated with schizophrenia or bipolar disorder without active airways disease, bronchospasm (which includes reports of wheezing, shortness of breath or cough) was uncommon in patients treated with ADASUVE. However, in placebo-controlled clinical trials in subjects with mild-to-moderate persistent asthma or moderate-to-severe COPD, adverse reactions of bronchospasm were reported very commonly. Most of these events occurred within 25 minutes of dosing, were mild to moderate in severity, and could be relieved with an inhaled bronchodilator.
Adverse reactions seen with chronic oral loxapine use
With chronic oral administration of loxapine, the reported adverse reactions include sedation and drowsiness; extrapyramidal symptoms (e.g., tremor, akathisia, rigidity, and dystonia); cardiovascular effects (e.g., tachycardia, hypotension, hypertension, orthostatic hypotension, light-headedness, and syncope); and anticholinergic effects (e.g., dry eyes, blurred vision, and urinary retention).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
No cases of overdosage of ADASUVE were reported in clinical studies.
Symptoms
In the event of accidental overdosage, signs and symptoms will depend on the number of units taken and individual patient tolerance. As would be expected from the pharmacologic actions of loxapine, the clinical findings may range from mild depression of the CNS and cardiovascular systems to profound hypotension, respiratory depression, and unconsciousness (see section 4.4). The possibility of occurrence of extrapyramidal symptoms and/or convulsive seizures should be kept in mind. Renal failure following oral loxapine overdosage has also been reported.
Management
The treatment of overdosage is essentially symptomatic and supportive. Severe hypotension might be expected to respond to the administration of noradrenaline or phenylephrine. Adrenaline should not be used since its use in a patient with partial adrenergic blockage may further lower the blood pressure (see sections 4.4 and 4.5). Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson medicinal products or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated. Additional measures include ox |
