Loxapine

ADASUVE is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. ADASUVE is an atypical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Limitations of Use: ADASUVE must be administered only in a certified healthcare setting. Limitations of Use: As part of the ADASUVE REMS Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in a certified healthcare setting.

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.

Must be administered only by a healthcare professional 10 mg by oral inhalation using an inhaler. Administer only a single dose within any 24-hour period. Prior to administering, screen all patients for a history of pulmonary disease, and assess patients (including chest auscultation) for respiratory abnormalities (e.g. wheezing). Refer to Full Prescribing Information for important instructions on use of the ADASUVE inhaler. After administration, monitor patients for signs and symptoms of bronchospasm for at least one hour

ADASUVE is contraindicated in patients with the following: Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm Acute respiratory symptoms or signs (e.g., wheezing) Current use of medications to treat airways disease, such as asthma or COPD History of bronchospasm following ADASUVE treatment Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred with oral loxapine and amoxapine. Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung disease associated with bronchospasm. Acute respiratory signs/symptoms (e.g., wheezing).

Boxed warning: can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest, particularly in patients with lung diseases. ADASUVE is available only through a restricted program called the ADASUVE REMS. Neuroleptic Malignant Syndrome: May develop in patients treated with antipsychotic drugs. Discontinue treatment. Hypotension and Syncope: Use with caution in patients with known cardiovascular or cerebrovascular disease. Seizure: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Potential for Cognitive and Motor Impairment: Use caution when driving or operating machinery. Cerebrovascular Adverse Reactions: Increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis treated with antipsychotic drugs

The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity (serious skin reactions) Bronchospasm Increased Mortality in Elderly Patients with Dementia-Related Psychosis Neuroleptic Malignant Syndrome Hypotension and syncope Falls Seizure Potential for Cognitive and Motor Impairment Cerebrovascular Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis Anticholinergic Reactions Including Exacerbation of Glaucoma and Urinary Retention Most common adverse reactions (incidence ≥ 2% and greater than placebo) were dysgeusia, sedation, and throat irritation

CNS Depressants ADASUVE is a central nervous system (CNS) depressant. 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. Therefore, consider reducing the dose of CNS depressants if used concomitantly with ADASUVE.

Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F).