Adasuve is an antipsychotic medication that affects the actions of chemicals in your brain.

Adasuve inhalation powder is used to treat agitation related to schizophrenia or bipolar disorder.

Adasuve inhalation is given only in a hospital or clinic setting where any breathing problems can be quickly treated.

You should not use Adasuve inhalation if you have breathing problems that can cause bronchospasm (such as asthma or COPD), or if you are currently having trouble breathing with cough and wheezing. You should not use this medicine if you have ever had breathing problems after using it in the past.

Adasuve inhalation can cause bronchospasm (wheezing, chest tightness, shortness of breath) that can lead to serious lung problems or make your breathing stop. This medicine must be given in a hospital or clinic setting where your doctor can quickly treat any serious side effects that occur.

This medicine is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

You should not be treated with Adasuve if you are allergic to loxapine or amoxapine, or if you have:

• trouble breathing with cough and wheezing;

• a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung problems;

• a breathing disorder you are currently treating with medication; or

• a history of having bronchospasm after using Adasuve inhalation.

Loxapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Adasuve is safe for you, tell your doctor if you have ever had:

• epilepsy or other seizure disorder;

• high or low blood pressure;

• glaucoma;

• urination problems;

• Parkinson's disease;

• heart disease;

• a heart attack or stroke; or

• if you drink alcohol or use street drugs.

Tell your doctor if you are pregnant or you get pregnant. Using antipsychotic medication during the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn.

You should not breastfeed while using Adasuve.

Adasuve inhalation is usually given once every 24 hours as needed.

A healthcare provider will give you this medicine in a hospital or clinic setting where you can be quickly treated if any serious side effects occur.

A healthcare provider can teach you how to properly use the Adasuve inhaler device.

The inhaler device has a green indicator light on one side and a pull tab at one end. When the pull tab is released the green light will turn on, showing that the device is ready for use.

Once the green light turns on, you must use the inhaler within 15 minutes or the device will deactivate. Do not try to use the inhaler if the green light is off.

While using the Adasuve inhaler device, you may hear a clicking sound and the device may feel warm. These are normal functions. After you have inhaled your dose, the green light will turn off to show that the entire dose has been used.

You will be watched closely for at least 1 hour after using Adasuve, to make sure you do not have any breathing problems.

Use: For the treatment of schizophrenia. Usual Adult Dose for Agitated State:

10 mg by oral inhalation once within a 24-hour period

Comments:
-To mitigate the risk of bronchospasm, all patients must undergo screening and examination prior to administration.
-This drug must be administered by a healthcare professional only in an enrolled healthcare facility.

Use: For the acute treatment of agitation associated with schizophrenia or bipolar I disorder

You should not be treated with Adasuve if you are allergic to loxapine or amoxapine, or if you have:

• trouble breathing with cough and wheezing;

• a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung problems;

• a breathing disorder you are currently treating with medication; or

• a history of having bronchospasm after using Adasuve inhalation.

Loxapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Adasuve is safe for you, tell your doctor if you have ever had:

• epilepsy or other seizure disorder;

• high or low blood pressure;

• glaucoma;

• urination problems;

• Parkinson's disease;

• heart disease;

• a heart attack or stroke; or

• if you drink alcohol or use street drugs.

Tell your doctor if you are pregnant or you get pregnant. Using antipsychotic medication during the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn.

You should not breastfeed while using Adasuve.

Since Adasuve inhalation is used when needed, you may need only one dose. Adasuve is usually not given more than once in a 24-hour period.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Do not drink alcohol. Dangerous side effects could occur.

Get emergency medical help if you have signs of an allergic reaction to Adasuve: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• a light-headed feeling, like you might pass out;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• bronchospasm (wheezing, cough, chest tightness, trouble breathing);

• little or no urination;

• a seizure (convulsions); or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Adasuve side effects may include:

• drowsiness;

• sore throat; or

• an unusual or unpleasant taste in the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Adasuve with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• bronchodilator asthma medication.

This list is not complete. other drugs may interact with loxapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.