Adult Dosing

Agitation associated with schizophrenia or bipolar I disorder

• 10 mg inhaled PO using an inhaler
• Administer as a single dose within any 24-hour period
• Must be administered only by a healthcare professional

Note:

• Before administering, screen all patients for a history of pulmonary disease, and examine patients for any respiratory abnormalities such as wheezing
• Monitor patients for signs and symptoms of bronchospasm at least every 15 minutes for at least one hour

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults

• Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm
• Current use of medications to treat airways disease, such as asthma or COPD
• Acute respiratory symptoms or signs (eg, wheezing)
• History of bronchospasm following treatment
• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to amoxapine

• Therapy can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Prior to administering, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment
• Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS)
• Administer only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation)
• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.Therapy is not approved for the treatment of patients with dementia-related psychosis

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

• Therapy can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Prior to administering, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment [US black box warnings]
• Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) [US black box warnings]
• Administer only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation) [US black box warnings]
• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.Therapy is not approved for the treatment of patients with dementia-related psychosis [US black box warnings]
• Before initiating therapy screen patients for a current diagnosis or history of asthma, COPD, and other lung disease associated with bronchospasm, acute respiratory symptoms or signs, current use of medications to treat airways disease, such as asthma or COPD; and examine patients (including chest auscultation) for respiratory abnormalities such as wheezing
• Therapy is not approved for the treatment of elderly patients with dementia-related psychosis
• Atypical antipsychotics in elderly patients with dementia related psychosis have been associated with higher incidence of cerebrovascular adverse reactions including stroke and transient ischemic attacks
• Antipsychotics may cause potentially fatal Neuroleptic Malignant Syndrome (NMS) which may be characterised by hyperpyrexia, muscle rigidity, altered mental status, autonomic instability, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia. Associated features can include elevated serum creatine phosphokinase (CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration, and renal failure
• NMS should be managed by immediate discontinuation of antipsychotic drugs and other drugs that may contribute to the underlying disorder, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems
• Therapy may cause hypotension, orthostatic hypotension, and syncope. Use with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, or treatment with antihypertensive medications or other drugs that affect blood pressure or reduced heart rate)
• Therapy may lower the seizure threshold
• Therapy may cause cognitive and motor impairment, sedation and somnolence and may impair judgment, thinking, and motor skills; use with caution when coadministered with other drugs known to cause CNS depression
• May cause anticholinergic adverse reactions, including exacerbation of glaucoma and urinary retention; use cautiously when coadministered with other drugs that elicit anticholinergic effects

Pregnancy Category:C

Breastfeeding: It is not known whether loxapine is present in human milk. Loxapine and its metabolites are present in the milk of lactating dogs. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from a decision should be made whether to discontinue nursing or discontinue therapy, taking in to account the importance of the drug to the mother.

• CNS: Sedation, syncope, seizure
• GI: Dysgeusia
• CV: Hypotension, stroke
• EENT: Throat irritation, exacerbation of glaucoma
• GU: Urinary retention
• RESP: Bronchospasm, wheezing, shortness of breath, cough chest tightness, pharyngitis
• NEURO: Dystonia, prolonged abnormal contractions of muscle groups, neuroleptic malignant syndrome, sedated
• MISC: Hypersensitivity

• Antipsychotics; exact mode of action is unknown; it is a dopamine antagonist and also a serotonin 5-HT2 blocker
• Metabolism: Liver; undergoes hydroxylation, n-oxidation and de-methylation to form metabolites
• Excretion: Urine (conjugated metabolites), feces (unconjugated metabolites)
• Half-life: 6-8 hrs following oral administration

US Trade Name(s)

• Adasuve

US Availability

Adasuve

• PWDR: 10 mg/vial

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Psychiatric

Antipsychotics

Miscellaneous Agents