ADASUVE (ADASUVE)
active substance: loxapine; 1 dose contains 10.0 mg of loxapine base, which corresponds to a delivered dose of 9.1 mg of loxapine.
Powder for inhalation, dosed.
white plastic body and activation insert without visible defects.
Agents acting on the nervous system. Psychotropic agents. Antipsychotic agents. Diazepines, oxazepines, thiazepines, and oxepines. ATC code N05A H01.
The efficacy of loxapine is believed to be mediated by its high-affinity antagonism of dopamine D2 receptors and serotonin 5-HT2A receptors. Loxapine binds to noradrenergic, histaminergic, and cholinergic receptors, and this interaction may influence the spectrum of its pharmacological effects.
Absorption. After administration of the Adasuv preparation, rapid absorption of loxapine was noted; the median time to reach its maximum concentration in plasma (Tmax) is 2 minutes.
For the rapid regulation of agitation from mild to moderate degree in adult patients with schizophrenia or bipolar disorders.
Increased sensitivity to the active substance or amoxapine. Presence of acute respiratory symptoms, such as stridor, or respiratory diseases, including bronchial asthma or chronic obstructive pulmonary disease (COPD).
Concomitant use of benzodiazepines or other hypnotic-sedative agents, or respiratory depressants may be associated with increased sedation and respiratory depression or respiratory failure.
is important for the administration of the full dose of loxapine. Medical personnel should ensure that the patient uses the inhaler correctly.
During placebo-controlled clinical trials involving patients with bronchial asthma or COPD, bronchospasm was very frequently observed, which usually developed within 25 minutes after administration of the preparation.
During clinical trials, no overdose with Adasuv was reported. In case of accidental overdose, symptoms will depend on the amount of the preparation taken and the individual patient's tolerance.
The assessment of adverse reactions is based on data from short-term (24-hour) placebo-controlled clinical trials (two phase 3 studies and one phase 2A study) involving 524 adult patients with agitation associated with schizophrenia (including 27 patients with schizoaffective disorders) or bipolar disorders, using the Adasuv preparation.
4 years.
No special storage conditions are required. Store in the original packaging. Store in a place inaccessible to children.
One foil pack with one Staccato inhaler in a cardboard pack.
Prescription only.
Ferrer Internacional, S.A., Spain.
Joan Buscalla, 1-9, Sant Cugat del Valles, Barcelona, 08173, Spain.
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