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Generic Name: paliperidone (pal ee PER i done)
Brand Names: Invega

What is paliperidone?

Paliperidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Paliperidone is used to treat schizophrenia.

Paliperidone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about paliperidone?

Paliperidone is not for use in psychotic conditions that are related to dementia. Paliperidone has caused fatal heart attack and stroke in older adults with dementia-related conditions. While you are taking paliperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking paliperidone. Paliperidone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by paliperidone.

Avoid drinking alcohol. It can increase some of the side effects of paliperidone. Stop using paliperidone and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

There may be other drugs that can affect paliperidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking paliperidone?

Paliperidone is not for use in psychotic conditions that are related to dementia. Paliperidone has caused fatal heart attack and stroke in older adults with dementia-related conditions. Do not use this medication if you are allergic to paliperidone or a similar drug called risperidone (Risperdal).

Before taking paliperidone, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;

• a personal or family history of Long QT syndrome;

• heart disease, high blood pressure, heart rhythm problems;

• a history of heart attack or stroke;

• an electrolyte imbalance, such as low potassium or magnesium levels in your blood;

• a history of breast cancer;

• seizures or epilepsy;

• diabetes (paliperidone may raise your blood sugar);

• a stomach or intestinal disorder;

• a history of suicidal thoughts;

• Parkinson's disease; or

• trouble swallowing.

If you have any of these conditions, you may not be able to use paliperidone, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Paliperidone passes into breast milk and could cause harm to a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

How should I take paliperidone?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Paliperidone can be taken with or without food.

Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

It is important to take paliperidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Paliperidone may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking paliperidone.

Store paliperidone at room temperature away from moisture, light, and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical treatment if you think you have used too much of this medicine.

Symptoms of a paliperidone overdose may include drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck.

What should I avoid while taking paliperidone?

While you are taking paliperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking paliperidone. Paliperidone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by paliperidone. Tell your doctor if you need to use any of these other medicines while you are taking paliperidone. Avoid drinking alcohol. It can increase some of the side effects of paliperidone.

Paliperidone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using paliperidone and call your doctor at once if you have any of these serious side effects:

• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

• urinating less than usual or not at all;

• restless muscle movements in your eyes, tongue, jaw, or neck;

• tremor (uncontrolled shaking);

• trouble swallowing; or

• feeling light-headed, fainting.

Continue taking paliperidone and talk to your doctor if you have any of these less serious side effects:

• breast swelling or discharge;

• changes in menstrual periods;

• mild restlessness, drowsiness, or tremor;

• blurred vision;

• dizziness or headache;

• weight gain;

• nausea, dry mouth, upset stomach; or

• decreased sex drive, impotence, or difficulty having an orgasm.

This list is not complete and other side effects may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect paliperidone?

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• arsenic trioxide (Trisenox);

• bepridil (Vascor),

• chloroquine (Arelan);

• clozapine (Clozaril);

• droperidol (Inapsine);

• fluoxetine (Prozac) or paroxetine (Paxil);

• halofantrine (Halfan);

• rifampin (Rifadin, Rimactane, Rifater);

• antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), pentamidine (NebuPent, Pentam), or sparfloxacin (Zagam);

• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), quinidine (Cardioquin, Quinaglute), sotalol (Betapace), and others;

• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril);

• narcotic medication such as levomethadyl (Orlaam) or methadone (Dolophine, Methadose);

• seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton); or

• medicines to treat Parkinson's Disease such as levodopa (Dopar, Larodopa, Sinemet, Atamet, others), bromocriptine (Parlodel, others), pergolide (Permax), pramipexole (Mirapex), or ropinirole (Requip).

This list is not complete and there may be other drugs that can affect paliperidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about paliperidone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 08/15/2007 2:17:17 PM.