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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.

Precautions

Instructions

Side Effects

Interactions

Precautions

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:

• 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.

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.

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.

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Instructions

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.

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.

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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 like you might pass out.

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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

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);
• 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.

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