paliperidone

Pronunciation

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

Slideshow: How to Manage Antidepressant Side Effects

Paliperidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Drinking alcohol can increase certain side effects of paliperidone.

Stop taking paliperidone and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, or feeling like you might pass out.

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).

To make sure you can safely take paliperidone, tell your doctor if you have any of these other conditions:

  • 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;

  • 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);

  • high cholesterol or triglycerides (a type of fat in the blood);

  • a stomach or intestinal disorder;

  • a history of suicidal thoughts;

  • Parkinson's disease; or

  • trouble swallowing.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking paliperidone, do not stop taking it without your doctor's advice.

Paliperidone can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking paliperidone.

Older adults may be more likely to have side effects from this medicine.

How should I take paliperidone?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. 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 it whole. Breaking the pill may cause too much of the drug to be released at one time.

Use paliperidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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 symptoms of hyperglycemia such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, or weight loss. If you are diabetic, check your blood sugar levels on a regular basis while you are taking paliperidone.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

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 may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain 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 a serious side effect such as:

  • 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.

See also: Side effects (in more detail)

Paliperidone dosing information

Usual Adult Dose for Schizophrenia:

Extended Release Tablets:
Recommended dose: 6 mg orally once daily in the morning
Initial dose titration is not required

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.

Note: Although dosing of the active ingredient in the US and Canada is the same, paliperidone extended-release injectable suspension is dosed as paliperidone palmitate in the US and as paliperidone in Canada:

US dosing: (Based on paliperidone palmitate):
-Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later (on day 8). 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 monthly maintenance dose is 117 mg IM. Some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on patient tolerability and efficacy.

Canada dosing: (Based on paliperidone):
-Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later (on day 8). 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 monthly maintenance dose is 75 mg IM. Some patients may benefit from lower or higher maintenance doses within the recommended range of 50 mg to 150 mg based on patient tolerability and efficacy.

Approved indication: For the acute and maintenance treatment of schizophrenia and for the acute treatment of schizoaffective disorder both as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

Usual Adult Dose for Schizoaffective Disorder:

Extended Release Tablets:
Recommended dose: 6 mg orally once daily in the morning
Initial dose titration is not required

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.

Note: Although dosing of the active ingredient in the US and Canada is the same, paliperidone extended-release injectable suspension is dosed as paliperidone palmitate in the US and as paliperidone in Canada:

US dosing: (Based on paliperidone palmitate):
-Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later (on day 8). 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 monthly maintenance dose is 117 mg IM. Some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on patient tolerability and efficacy.

Canada dosing: (Based on paliperidone):
-Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later (on day 8). 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 monthly maintenance dose is 75 mg IM. Some patients may benefit from lower or higher maintenance doses within the recommended range of 50 mg to 150 mg based on patient tolerability and efficacy.

Approved indication: For the acute and maintenance treatment of schizophrenia and for the acute treatment of schizoaffective disorder both as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

Usual Pediatric Dose for Schizophrenia:

12 years to 17 years:
Weight less than 51 kg:
Initial Dose: 3 mg orally once daily in the morning
Recommended Dose: 3 to 6 mg orally once daily in the morning
Maximum Dose: 6 mg daily
Weight 51 kg or more:
Initial Dose: 3 mg orally daily in the morning
Recommended Dose: 3 to 12 mg orally daily in the morning
Maximum Dose: 12 mg daily

Approved indication: For the acute and maintenance treatment of schizophrenia.

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, sedatives, 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, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);

  • an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), 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 (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, Treximet) or zolmitriptan (Zomig); or

  • narcotic medication such as methadone (Methadose, Diskets, Dolophine).

This list is not complete and other drugs may interact with paliperidone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start 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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 9.01. Revision Date: 2011-10-28, 3:48:09 PM.

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