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PROTOMID

About the medicine

How to use PROTOMID

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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Need help understanding this medicine or your symptoms? Online doctors can answer your questions and offer guidance.

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Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

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Andrei Popov

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Dr. Andrei Popov is a licensed pain management specialist and general practitioner based in Spain. He provides expert online care for adults dealing with both chronic and acute pain, as well as a wide range of everyday health concerns.

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Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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