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INSTRUCTIONS for medical use of the medicinal product ADASUVE
ADASUVE (ADASUVE)
Composition
active substance: loxapine; 1 dose contains 10.0 mg of loxapine base, which corresponds to a delivered dose of 9.1 mg of loxapine.
Pharmaceutical form
Powder for inhalation, dosed.
Main physical and chemical properties
white plastic body and activation insert without visible defects.
Pharmacotherapeutic group
Agents acting on the nervous system. Psychotropic agents. Antipsychotic agents. Diazepines, oxazepines, thiazepines, and oxepines. ATC code N05A H01.
Pharmacological properties
Pharmacodynamics
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.
Pharmacokinetics
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.
Clinical characteristics
Indications
For the rapid regulation of agitation from mild to moderate degree in adult patients with schizophrenia or bipolar disorders.
Contraindications
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).
Interaction with other medicinal products and other types of interactions
Concomitant use of benzodiazepines or other hypnotic-sedative agents, or respiratory depressants may be associated with increased sedation and respiratory depression or respiratory failure.
Special instructions
Proper use of the Adasuv inhaler
is important for the administration of the full dose of loxapine. Medical personnel should ensure that the patient uses the inhaler correctly.
Bronchospasm
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.
Overdose
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.
Adverse reactions
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.
Shelf life
4 years.
Storage conditions
No special storage conditions are required. Store in the original packaging. Store in a place inaccessible to children.
Packaging
One foil pack with one Staccato inhaler in a cardboard pack.
Release category
Prescription only.
Manufacturer
Ferrer Internacional, S.A., Spain.
Manufacturer's location and address
Joan Buscalla, 1-9, Sant Cugat del Valles, Barcelona, 08173, Spain.
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