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ADASUVE
Mood disorders
Psychosis
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Drug Name:

ADASUVE Rx

Generic Name and Formulations:
Loxapine 10mg; powder for oral inhalation.

Company:
Alexza Pharmaceuticals

Therapeutic Use:

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:

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.

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.

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.

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.

Pharmacological Class:

Dibenzoxazepine.

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:

YES

Generic Availability:

NO

How Supplied:

Single-use, disposable inhaler—5

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:

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.

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.

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.

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.

Pharmacological Class:

Dibenzoxazepine.

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:

YES

Generic Availability:

NO

How Supplied:

Single-use, disposable inhaler—5

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