Mood disorders:
Indications for: ADASUVE
Acute treatment of agitation associated with bipolar I disorder in adults. Limitations of use: must be administered only in an enrolled healthcare facility.
Adult Dosage:
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 Dosage:
Not established.
ADASUVE 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.
Boxed Warning:
Bronchospasm. Increased mortality in elderly patients with dementia-related psychosis.
ADASUVE 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.
ADASUVE Classification:
Dibenzoxazepine.
ADASUVE 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.
Adverse Reactions:
Dysgeusia, sedation, throat irritation; hypotension, syncope, lowered seizure threshold, anticholinergics effects (eg, glaucoma, urinary retention).
Note:
Available only through a restricted program under Adasuve REMS. Call (888) 970-7367 or visit www.adasuverems.com to enroll.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-use, disposable inhaler—5
Psychosis:
Indications for: ADASUVE
Acute treatment of agitation associated with schizophrenia in adults. Limitations of use: must be administered only in an enrolled healthcare facility.
Adult Dosage:
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 Dosage:
Not established.
ADASUVE 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.
Boxed Warning:
Bronchospasm. Increased mortality in elderly patients with dementia-related psychosis.
ADASUVE 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.
ADASUVE Classification:
Dibenzoxazepine.
ADASUVE 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.
Adverse Reactions:
Dysgeusia, sedation, throat irritation; hypotension, syncope, lowered seizure threshold, anticholinergics effects (eg, glaucoma, urinary retention).
Note:
Available only through a restricted program under Adasuve REMS. Call (888) 970-7367 or visit www.adasuverems.com to enroll.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-use, disposable inhaler—5
