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Adasuve is a brand name for Loxapine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.
Verbatim from this product's EMA label. Tap a section to expand.
ADASUVE should be administered in a medical setting under the direct supervision of a healthcare professional. Patients should be observed during the first hour after each dose for signs and symptoms of bronchospasm. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).
1 mg. 1 mg should be used initially. A second dose can be given after 2 hours, if necessary. No more than two doses should be administered. 1 mg dose was not previously tolerated by the patient or if the physician decides a lower dose is more appropriate.
Elderly The safety and efficacy of ADASUVE in patients older than 65 years of age have not been established. No data are available. Renal and/or hepatic impairment ADASUVE has not been studied in patients with renal or hepatic impairment.
No data are available. 3 Paediatric population The safety and efficacy of ADASUVE in children (less than 18 years of age) have not been established. No data are available. Method of administration Inhalation use. The product is packaged in a sealed pouch.
When needed, the product is removed from the pouch. Once the pull-tab is removed, a green light turns on, indicating the product is ready for use (Note: the product must be used within 15 minutes of pulling the tab). To deliver the medicinal product, the patient inhales through the mouthpiece with a steady deep breath.
Upon completion of the inhalation, the patient removes the mouthpiece from mouth and holds breath briefly. The medicinal product has been delivered when the green light turns off. The device exterior may become warm during use. This is normal.
For complete instructions on how to use ADASUVE see information for the healthcare professional section of the package leaflet.
Summary of the safety profile Assessment of adverse reactions from clinical study data is based on two Phase 3 and one Phase 2A short-term (24-hour) placebo-controlled clinical trials enrolling 524 adult patients with agitation associated with schizophrenia or bipolar disorder.
In those studies, bronchospasm was uncommonly found. However, in specific Phase 1 clinical safety trials in subjects with asthma or COPD, bronchospasm was commonly reported and often required treatment with a short-acting beta-agonist bronchodilator.
3). The most commonly reported adverse reactions during treatment with ADASUVE were dysgeusia, sedation/somnolence and dizziness (dizziness was more common after placebo treatment than loxapine treatment). 8 Tabulated list of adverse reactions The adverse reactions listed below are categorized using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 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 and possible symptoms of bronchospasm (which includes reports of wheezing, shortness of breath or cough) wereuncommon in patients treated with ADASUVE.
Correct use of ADASUVE inhaler is important for administration of the full dose of loxapine. Healthcare professionals should ensure the patient will use the inhaler properly. ADASUVE may have limited effectiveness when patients are on concomitant medicinal products, predominantly other antipsychotics.
8). 3). ADASUVE has not been investigated in patients with other forms of lung disease. It is recommended to observe patients during the first hour for signs and symptoms of bronchospasm following administration of ADASUVE. 8). 3). , anxiolytics, most antipsychotics, hypnotics, opiates, etc.
5). 4 Elderly patients with dementia-related psychosis ADASUVE has not been studied in elderly patients, including those with dementia-related psychosis. Clinical studies with both atypical and conventional antipsychotic medicinal products have demonstrated that elderly patients with dementia-related psychosis are at an increased risk of death compared to placebo.
ADASUVE is not indicated for the treatment of patients with dementia-related psychosis. Extrapyramidal symptoms Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics. ADASUVE should be used with caution in patients with a known history of extrapyramidal symptoms.
Tardive dyskinesia If signs and symptoms of tardive dyskinesia appear in a patient being treated with loxapine, discontinuation should be considered. These symptoms can temporally worsen or can even arise after discontinuation of treatment.
Neuroleptic malignant syndrome (NMS) Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, ADASUVE must be discontinued.
Hypersensitivity to the active substance, or to amoxapine. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
, 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 the national reporting system listed in Appendix V.
Hypotension Mild hypotension was reported in short-term (24-hour), placebo-controlled trials in agitated patients administered ADASUVE. If vasopressor therapy is required, noradrenaline or phenylephrine is preferred. 5). Cardiovascular No data are available on the use of ADASUVE in patients with underlying cardiovascular diseases.
ADASUVE is not recommended in patient populations with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (dehydration, hypovolaemia, and treatment with antihypertensive medicinal products).
QT interval Clinically relevant QT prolongation does not appear to be associated with single and repeat doses of ADASUVE. Caution should be exercised when ADASUVE is administered in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products known to prolong the QT interval.
The potential risk of QTc prolongation due to interaction with medicinal products known to prolong QTc interval is unknown. Seizures / convulsions Loxapine should be used with caution in patients with a history of convulsive disorders since it lowers the convulsive threshold.
5). Anticholinergic activity Because of anticholinergic action, ADASUVE should be used cautiously in patients with glaucoma or a tendency to urinary retention, particularly with concomitant administration of anticholinergic-type antiparkinson medicinal products.
Intoxication or physical disease (delirium) The safety and efficacy of ADASUVE has not been evaluated in patients with agitation due to intoxication or physical disease (delirium). 5). Severe cutaneous adverse reactions (SCARs) Drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, has been reported in relation to loxapine containing products.
Patients should be advised of the signs and symptoms of DRESS and monitored closely for skin reactions. If the patient has developed DRESS with the use of loxapine, treatment with loxapine containing products should not be restarted.