ADASUVE Inhalation powder Ref.[9809] Active ingredients: Loxapine

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.

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 oxygen and intravenous fluids.

4 years.

Store in the original pouch until ready for use in order to protect from light and moisture.

This medicinal product does not require any special temperature storage conditions.

The white inhaler (housing) is molded from a medical-grade polycarbonate.

Each inhaler is provided in a sealed, multilaminate aluminum foil pouch. ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.

Not all pack-sized may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.