Adasuve

— THERAPEUTIC CATEGORIES —
  • Mood disorders
  • Psychosis
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Adasuve Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Loxapine 10mg; powder for oral inhalation.

    Pharmacological Class

    Dibenzoxazepine.

    How Supplied

    Single-use, disposable inhaler—5

    Manufacturer

    Galen US Inc.

    Generic Availability

    NO

    Mechanism of Action

    The mechanism of action of loxapine in the treatment of agitation associated with schizophrenia and bipolar I disorder is unclear. However, its efficacy could be mediated through a combination of antagonism of central serotonin and dopamine receptors.

    Adasuve Indications

    Indications

    Acute treatment of agitation associated with bipolar I disorder in adults. Limitations of use: must be administered only in an enrolled healthcare facility.

    Adasuve Dosage and Administration

    Adult

    10mg by oral inhalation using a single-use inhaler. Administer only a single dose within a 24 hour period. Prior to administration, screen for current diagnosis or history of asthma, COPD, other lung diseases, and examine for respiratory signs. Monitor for signs/symptoms of bronchospasm and perform a physical exam at least every 15 mins for at least one hour after administration.

    Children

    Not established.

    Adasuve Contraindications

    Contraindications

    Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm. Acute respiratory signs/symptoms (eg, wheezing). Concomitant drugs to treat airways disease (eg, asthma, COPD). History of bronchospasm after Adasuve treatment. Amoxapine sensitivity.

    Adasuve Boxed Warnings

    Boxed Warning

    Bronchospasm. Increased mortality in elderly patients with dementia-related psychosis.

    Adasuve Warnings/Precautions

    Warnings/Precautions

    Risk of bronchospasm. Administer only by a healthcare personnel in facility that has immediate access to manage acute bronchospasm. Increased mortality in elderly patients with dementia-related psychosis (not approved use). Monitor for neuroleptic malignant syndrome. Cardio- or cerebrovascular disease. Conditions that predispose to hypotension (eg, dehydration, hypovolemia, or concomitant antihypertensive drugs). Perform fall risk assessments when initiating and recurrently on long-term therapy. History of seizures. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd trimester of pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.

    REMS

    YES

    Adasuve Pharmacokinetics

    Metabolism

    Hepatic. 96.6% serum protein bound.

    Elimination

    Renal. Half-life: 6–8 hours.

    Adasuve Interactions

    Interactions

    Additive effects with concomitant other anticholinergics (eg, antiparkinson drugs) or other CNS depressants (eg, alcohol, opioids, benzodiazepines, tricyclic antidepressants, general anesthetics, phenothiazines, sedative/hypnotics, muscle relaxants); consider reducing dose of these drugs.

    Adasuve Adverse Reactions

    Adverse Reactions

    Dysgeusia, sedation, throat irritation; hypotension, syncope, lowered seizure threshold, anticholinergics effects (eg, glaucoma, urinary retention).

    Adasuve Clinical Trials

    See Literature

    Adasuve Note

    Notes

    Available only through a restricted program under Adasuve REMS. Call (888) 970-7367 or visit www.adasuverems.com to enroll.

    Adasuve Patient Counseling

    See Literature

    Adasuve Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Loxapine 10mg; powder for oral inhalation.

    Pharmacological Class

    Dibenzoxazepine.

    How Supplied

    Single-use, disposable inhaler—5

    Manufacturer

    Galen US Inc.

    Generic Availability

    NO

    Mechanism of Action

    The mechanism of action of loxapine in the treatment of agitation associated with schizophrenia and bipolar I disorder is unclear. However, its efficacy could be mediated through a combination of antagonism of central serotonin and dopamine receptors.

    Adasuve Indications

    Indications

    Acute treatment of agitation associated with schizophrenia in adults. Limitations of use: must be administered only in an enrolled healthcare facility.

    Adasuve Dosage and Administration

    Adult

    10mg by oral inhalation using a single-use inhaler. Administer only a single dose within a 24 hour period. Prior to administration, screen for current diagnosis or history of asthma, COPD, other lung diseases, and examine for respiratory signs. Monitor for signs/symptoms of bronchospasm and perform a physical exam at least every 15 mins for at least one hour after administration.

    Children

    Not established.

    Adasuve Contraindications

    Contraindications

    Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm. Acute respiratory signs/symptoms (eg, wheezing). Concomitant drugs to treat airways disease (eg, asthma, COPD). History of bronchospasm after Adasuve treatment. Amoxapine sensitivity.

    Adasuve Boxed Warnings

    Boxed Warning

    Bronchospasm. Increased mortality in elderly patients with dementia-related psychosis.

    Adasuve Warnings/Precautions

    Warnings/Precautions

    Risk of bronchospasm. Administer only by a healthcare personnel in facility that has immediate access to manage acute bronchospasm. Increased mortality in elderly patients with dementia-related psychosis (not approved use). Monitor for neuroleptic malignant syndrome. Cardio- or cerebrovascular disease. Conditions that predispose to hypotension (eg, dehydration, hypovolemia, or concomitant antihypertensive drugs). Perform fall risk assessments when initiating and recurrently on long-term therapy. History of seizures. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd trimester of pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.

    REMS

    YES

    Adasuve Pharmacokinetics

    Metabolism

    Hepatic. 96.6% serum protein bound.

    Elimination

    Renal. Half-life: 6–8 hours.

    Adasuve Interactions

    Interactions

    Additive effects with concomitant other anticholinergics (eg, antiparkinson drugs) or other CNS depressants (eg, alcohol, opioids, benzodiazepines, tricyclic antidepressants, general anesthetics, phenothiazines, sedative/hypnotics, muscle relaxants); consider reducing dose of these drugs.

    Adasuve Adverse Reactions

    Adverse Reactions

    Dysgeusia, sedation, throat irritation; hypotension, syncope, lowered seizure threshold, anticholinergics effects (eg, glaucoma, urinary retention).

    Adasuve Clinical Trials

    See Literature

    Adasuve Note

    Notes

    Available only through a restricted program under Adasuve REMS. Call (888) 970-7367 or visit www.adasuverems.com to enroll.

    Adasuve Patient Counseling

    See Literature

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