Medicinal Products

ADASUVE 9.1 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
Active ingredients: Loxapine
laboratory: Alexza UK Ltd

Inhalation powder
Box of 5 single-dose containers
All forms

Indication

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 controlling the symptoms of acute agitation.

Dosage ADASUVE 9.1 mg Inhalation powder Box of 5 Single-dose containers

ADASUVE should only be administered in a hospital setting under the supervision of a health professional.

Treatment with a fast-acting beta-agonist bronchodilator should be available to treat possible severe respiratory side effects (bronchospasm).

Dosage

The recommended starting dose of ADASUVE is 9.1 mg. A second dose may be given after 2 hours, if necessary. Do not administer more than two doses.

A lower dose of 4.5 mg may be given if the 9.1 mg dose has not previously been tolerated by the patient or if the physician decides that a lower dose is more appropriate.

The patient should be observed for the first hour after each dose to detect any signs or symptoms of bronchospasm.

The elderly

The safety and efficacy of ADASUVE have not been established in patients over 65 years of age. No data available.

Renal and / or hepatic insufficiency

ADASUVE has not been studied in patients with renal or hepatic impairment. No data available.

Pediatric population

The safety and effectiveness of ADASUVE have not been established in children (under 18 years of age). No data available.

Administration mode

Inhalation use. The product is packaged in a sealed pouch. Important: the product must remain in the pocket until it is used.

Before use, the product will be removed from the pouch. Once the pull tab is removed, a green light will come on, indicating that the product is ready for use (NOTE: the product must be used within 15 minutes after the tab has been removed). The drug is delivered by inhalation through the mouthpiece, the patient taking a regular and deep breath. At the end of the inhalation, the patient removes the mouthpiece from the mouth and holds his breath for a short moment. The drug was delivered when the green light goes out. The outside of the device may become hot during use. This is normal.

For complete instructions on how to use ADASUVE, see the information in the health professional section of the package leaflet.

Against indications

Hypersensitivity to the active substance or to amoxapine.

Patients with acute respiratory signs or symptoms (eg, wheezing) or active airway disease (such as patients with asthma or chronic obstructive pulmonary disease [COPD] (see Warnings and Precautions section). employment ).

Adasuve side effects

Summary of the security profile

The evaluation of adverse reactions from clinical trial data is based on two Phase 3 clinical trials and one short-term (24-hour), placebo-controlled, Phase 2A trial involving 524 adult patients in a clinical trial. agitation associated with schizophrenia (including 27 patients with schizoaffective disorder) or bipolar disorder, treated with ADASUVE 4.5 mg (265 patients) or ADASUVE 9.1 mg (259 patients).

In studies with agitated patients, bronchospasm has been reported as an infrequent but serious adverse reaction, whereas in individuals with active airway disease, bronchospasm has been reported frequently and has often required treatment with fast-acting beta-agonist bronchodilator. The most common adverse reactions reported during ADASUVE treatment were dysgeusia, sedation / drowsiness, and dizziness (the latter was more common after placebo treatment than after treatment with loxapine).

Tabulated list of adverse effects

The adverse reactions listed below are classified by frequency according to the following convention: very common (≥ 1/10); frequent (≥ 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

Classes of MedDRA Organ Systems

Nervous system disorders

Very common: sedation / drowsiness

Frequent: dizzying sensation

Uncommon: dystonia, dyskinesia, oculogyration, tremors, akathisia / agitation

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

Frequency: tiredness

Description of some adverse reactions

bronchospasm

In short-term (24-hour) placebo-controlled trials in patients with agitation associated with schizophrenia or bipolar disorder, without active airway disease, bronchospasm (including wheezing, shortness of breath, or coughing) were uncommon in patients treated with ADASUVE. However, in placebo-controlled clinical trials, including subjects with mild to moderate persistent asthma or moderate to severe COPD, adverse events of bronchospasm have been reported very frequently. The majority of these events occurred within 25 minutes after dosing, were of mild to moderate severity and could be relieved by bronchodilator inhalation.

Adverse Reactions Observed During Chronic Use of Loxapine Orally

In the chronic oral administration of loxapine, the reported adverse reactions were: sedation and somnolence; extrapyramidal symptoms (eg, tremor, akathisia, rigidity and dystonia); cardiovascular effects (such as tachycardia, hypotension, hypertension, orthostatic hypotension, dizziness and syncope); anticholinergic effects (eg, dry eye, blurred vision and urinary retention).

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