paliperidone (injection)

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Pronunciation: PAL ee PER i DONE

Brand: Invega Sustenna, Invega Trinza

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

Paliperidone is not approved for use in psychotic conditions related to dementia. Paliperidone may increase the risk of death in older adults with dementia-related conditions.

What is paliperidone?

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

Paliperidone is used to treat schizophrenia in adults. Paliperidone is also used alone or with other medicines to treat schizoaffective disorder in adults.

Paliperidone may also be used for purposes not listed in this medication guide.

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

You should not use this medicine if you are allergic to paliperidone injection or to risperidone (Risperdal).

Paliperidone is not approved for use in psychotic conditions related to dementia. Paliperidone may increase the risk of death in older adults with dementia-related conditions.

Paliperidone can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you use paliperidone, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

To make sure paliperidone is safe for you, tell your doctor if you have:

  • a history of heart disease or heart rhythm disorder;
  • a personal or family history of Long QT syndrome;
  • a history of low white blood cell (WBC) counts;
  • high or low blood pressure, or a history of fainting spells;
  • liver or kidney disease;
  • seizures or epilepsy;
  • a history of breast cancer;
  • high cholesterol or triglycerides (a type of fat in the blood);
  • a history of uncontrolled muscle movements in your face;
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
  • diabetes (paliperidone may raise your blood sugar); or
  • if you have ever had a serious neurologic disorder caused by taking an antipsychotic medicine.

Before you receive your first injection, tell your doctor if you have never taken oral (by mouth) paliperidone or risperidone.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Using 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 using your medicine during pregnancy. If you become pregnant while using paliperidone, do not stop using it without your doctor's advice.

Paliperidone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Paliperidone is not approved for use by anyone younger than 18 years old.

How is paliperidone given?

Paliperidone is injected into a muscle. A healthcare provider will give you this injection.

Paliperidone injection is usually given only once a month, but the first two doses are given 1 week apart. Follow your doctor's dosing instructions very carefully.

Your doctor will need to check your progress while you are using paliperidone.

Get your paliperidone injections regularly to get the most benefit.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your paliperidone injection.

What happens if I overdose?

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

What should I avoid while using paliperidone?

While you are using 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 using paliperidone.

Avoid drinking alcohol. Dangerous side effects could occur.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What are the possible side effects of paliperidone?

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

Call your doctor at once if you have:

  • headache with chest pain, pounding heartbeats or fluttering in your chest;
  • a light-headed feeling, like you might pass out;
  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • trouble swallowing;
  • a seizure (convulsions);
  • breast swelling (in women or men), nipple discharge;
  • changes in menstrual periods;
  • penis erection that is painful or lasts 4 hours or longer;
  • sudden weakness or ill feeling, fever, chills, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
  • weight gain;
  • low white blood cell counts --sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, swollen gums, pain when swallowing, skin sores, cough, trouble breathing;
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
  • severe nervous system reaction --very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting.

Common side effects may include:

  • dizziness, drowsiness;
  • agitation, restless feeling;
  • tremors or shaking;
  • uncontrolled muscle movements, trouble with walking or balance;
  • weight gain; or
  • pain or tenderness where the medicine was injected.

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.

What other drugs will affect paliperidone?

Using paliperidone with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • carbamazepine;
  • citalopram;
  • lumefantrine;
  • rifampin;
  • St. John's wort;
  • cancer medicine --arsenic trioxide, toremifene, vandetanib;
  • heart rhythm medicine --amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol; or
  • medicine to treat a psychiatric disorder --iloperidone, pimozide, ziprasidone, others.

This list is not complete. Other drugs may interact with paliperidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about paliperidone injection.


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.

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