ADASUVE 9.1mg inhalation powder, pre-dispensed
1. Name of the medicinal product
ADASUVE 9.1 mg inhalation powder, pre-dispensed
2. Qualitative and quantitative composition
Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg loxapine.
3. Pharmaceutical form
Inhalation powder, pre-dispensed (inhalation powder).
White device with a mouthpiece on one end and a pull-tab protruding from the other end.
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
ADASUVE should only be administered in a hospital-setting under the supervision of a healthcare professional.
Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).
Posology
The recommended initial dose of ADASUVE is 9.1 mg. A second dose can be given after 2 hours, if necessary. No more than two doses should be administered.
A lower dose of 4.5 mg may be given if the 9.1 mg dose was not previously tolerated by the patient or if the physician decides a lower dose is more appropriate.
Patient should be observed during the first hour after each dose for signs and symptoms of bronchospasm.
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.
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.
4.3 Contraindications
Hypersensitivity to the active substance, or to amoxapine.
Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease [COPD] (see section 4.4).
4.4 Special warnings and precautions for use
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.
Bronchospasm
In placebo-controlled clinical trials in subjects with asthma or COPD, bronchospasm was very commonly observed. When it occurred, it was typically reporte