ADASUVE definition

ADASUVE means ADASUVE, the Company’s loxapine inhalation powder product, delivered via the Staccato System, for any indications for which it may be sold, approved or prescribed in any country.
ADASUVE means that certain drug-device combination product that is comprised of loxapine) delivered by the Staccato Device.

Examples of ADASUVE in a sentence

  • ElderlyThe safety and efficacy of ADASUVE in patients older than 65 years of age have not been established.

  • No data are available.Paediatric populationThe safety and efficacy of ADASUVE in children (less than 18 years of age) have not been established.

  • ADASUVE is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.3)].

  • ADASUVE is an inhalation powder supplied in a single-use, disposable inhaler containing 10 mg of loxapine base.

  • Nine of 26 (35%) patients in the ADASUVE group, compared to one of 26 (4%) in the placebo group, did not receive a second dose of study medication, because they had a ≥ 20% decrease in FEV1 or they developed respiratory symptoms after the first dose.

  • Respiratory adverse reactions occurred more frequently in the ADASUVE group (19%) than in the placebo group (11%).

  • The concomitant use of ADASUVE and other anticholinergic drugs can increase the risk of anticholinergic adverse reactions including exacerbation of glaucoma and urinary retention.

  • Seven of 25 (28%) patients in the ADASUVE group and 1of 27 (4%) in the placebo group did not receive a second dose of study medication because of a ≥ 20% decrease in FEV1 or the development of respiratory symptoms after the first dose.

  • Healthy Volunteers: In the healthy volunteer crossover trial, 30 subjects received 2 doses of either ADASUVE or placebo 8 hours apart, and 2 doses of the alternate treatment at least 4 days later.

  • The concurrent use of ADASUVE with other CNS depressants (e.g., alcohol, opioid analgesics, benzodiazepines, tricyclic antidepressants, general anesthetics, phenothiazines, sedative/hypnotics, muscle relaxants, and/or illicit CNS depressants) can increase the risk of respiratory depression, hypotension, profound sedation, and syncope.

Related to ADASUVE

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