Nuplazid is an antipsychotic medicine that works by changing the actions of chemicals in the brain.

Nuplazid is used to treat hallucinations and delusions caused by psychosis that is related to Parkinson's disease.

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

Before taking this medicine

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

You should not use Nuplazid if you are allergic to pimavanserin.

Tell your doctor if you have ever had:

• a heart rhythm disorder;

• long QT syndrome (in you or a family member);

• kidney disease; or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I take Nuplazid?

Nuplazid is usually taken once daily. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Nuplazid with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of pudding, applesauce, yogurt, or a nutrition drink. Swallow the mixture right away without chewing. Do not save it for later use.

When you start or stop taking other medicines, your doctor may need to adjust your Nuplazid dose.

Store at room temperature away from moisture and heat.

Nuplazid is usually taken once daily. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Nuplazid with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of pudding, applesauce, yogurt, or a nutrition drink. Swallow the mixture right away without chewing. Do not save it for later use.

When you start or stop taking other medicines, your doctor may need to adjust your Nuplazid dose.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Psychosis:

34 mg (as two 17 mg tablets) orally once a day

Comment: This drug does not require titration.

Use: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

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

You should not use Nuplazid if you are allergic to pimavanserin.

Tell your doctor if you have ever had:

• a heart rhythm disorder;

• long QT syndrome (in you or a family member);

• kidney disease; or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause nausea and vomiting.

Avoid drinking alcohol. Dangerous side effects could occur.

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

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest;

• shortness of breath; or

• sudden dizziness (like you might pass out).

Common Nuplazid side effects may include:

• confusion; or

• swelling in your hands or feet.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Your pimavanserin dose may need to be adjusted if you use certain other medications. It is very important to tell your doctor if you start or stop using any other medications.

Nuplazid can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can interact with pimavanserin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.