Paliperidone

Generic Name: paliperidone (pal ee PER i done)Brand names: Invega, Invega Sustenna

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 other purposes not listed in this medication guide.

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

Paliperidone is not for use in psychotic conditions related to dementia. Paliperidone may cause heart failure, sudden death, or pneumonia 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.

Before using paliperidone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, 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.

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

Paliperidone is not for use in psychotic conditions related to dementia. Paliperidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to paliperidone or a similar drug called risperidone (Risperdal).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take paliperidone, tell your doctor if you have:

  • a history of low white blood cell (WBC) counts;

  • a personal or family history of Long QT syndrome;

  • heart disease, heart rhythm problems, or a history of heart attack or stroke;

  • a history of low white blood cell (WBC) counts;

  • high or low blood pressure;

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

  • a history of breast cancer;

  • seizures or epilepsy;

  • kidney or liver disease;

  • diabetes (paliperidone may raise your blood sugar);

  • a stomach or intestinal disorder;

  • a history of suicidal thoughts;

  • Parkinson's disease; or

  • trouble swallowing.

FDA pregnancy category C. It is not known whether paliperidone is 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, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking 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.

See also: Paliperidone dosage in more detail

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.

Overdose symptoms 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. 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:
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;

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

  • tremor (uncontrolled shaking);

  • trouble swallowing;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden and severe headache, or problems with vision, speech, or balance;

  • fever, chills, body aches, flu symptoms; or

  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • 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 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.

Paliperidone Dosing Information

Usual Adult Dose for Schizophrenia:

Extended-Release Tablets:Recommended dose: 6 mg once daily, administered in the morning.Initial dose titration is not required.Paliperidone can be taken with or without food.Extended-Release Injectable Suspension:For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension.Initial dose: 234 mg on treatment day 1 followed by 156 mg one week later. Both of these doses should be administered by intramuscular injection in the deltoid muscle. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.The recommended monthly maintenance dose is 117 mg. Some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on individual patient tolerability and/or efficacy.

Usual Adult Dose for Schizoaffective Disorder:

Extended-Release Tablets:Recommended dose: 6 mg once daily, administered in the morning.Initial dose titration is not required.Paliperidone can be taken with or without food.Extended-Release Injectable Suspension:For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension.Initial dose: 234 mg on treatment day 1 followed by 156 mg one week later. Both of these doses should be administered by intramuscular injection in the deltoid muscle. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.The recommended monthly maintenance dose is 117 mg. Some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on individual patient tolerability and/or efficacy.

What other drugs will affect paliperidone?

Before using paliperidone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by paliperidone.

The following drugs can interact with paliperidone. Tell your doctor if you are using any of these:

  • arsenic trioxide (Trisenox);

  • blood pressure medications;

  • carbamazepine (Carbatrol, Tegretol);

  • droperidol (Inapsine);

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);

  • an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), or desipramine (Norpramin);

  • anti-malaria medications such as chloroquine (Arelan) or mefloquine (Lariam);

  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace);

  • medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);

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

  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);

  • migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or

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

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: 4.01. Revision Date: 09/03/2009 11:39:43 AM.
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