Paliperidone Extended-Release Tablets

Generic Name: Paliperidone (PAL-ee-PER-i-done)Brand Name: Invega

Paliperidone Extended-Release Tablets are an atypical antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Paliperidone Extended-Release Tablets are not approved to treat mental problems caused by dementia.

Paliperidone Extended-Release Tablets are used for:

Treating schizophrenia or schizoaffective disorder. It may also be used for other conditions as determined by your doctor.

Paliperidone Extended-Release Tablets are an atypical antipsychotic. Exactly how it works is not known. It is thought to work by affecting certain substances in the brain.

Do NOT use Paliperidone Extended-Release Tablets if:

  • you are allergic to any ingredient in Paliperidone Extended-Release Tablets or to risperidone
  • you cannot swallow the tablet whole
  • you have a history of certain heart problems (eg, irregular heartbeat, long QT syndrome)
  • you are taking certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol), a phenothiazine (eg, chlorpromazine, thioridazine), or certain quinolones (eg, gatifloxacin, moxifloxacin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Paliperidone Extended-Release Tablets:

Some medical conditions may interact with Paliperidone Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of seizures, heart problems (eg, heart failure; fast, slow, or irregular heartbeat), abnormal electrocardiogram (ECG), heart attack, stroke, blood vessel problems, low white blood cell levels, or high or low blood pressure
  • if you have a history of kidney problems, severe liver problems, stomach or bowel problems (eg, narrowing, inflammation, blockage), cystic fibrosis, neuroleptic malignant syndrome (NMS), suicidal thoughts or attempts, or alcohol abuse or dependence
  • if you have diabetes or are very overweight, or if a family member has had diabetes
  • if you have low blood potassium or magnesium levels, Alzheimer disease, dementia, Parkinson disease, diarrhea, or esophagus problems (eg, trouble swallowing)
  • if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk for breast cancer
  • if you are dehydrated, drink alcohol, or will be exposed to high temperatures

Some MEDICINES MAY INTERACT with Paliperidone Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Arsenic, certain antiarrhythmics, (eg, amiodarone, flecainide, procainamide, quinidine, sotalol), certain quinolones (eg, gatifloxacin, levofloxacin, moxifloxacin), cisapride, dofetilide, domperidone, H1 antagonists (eg, astemizole, terfenadine), macrolides (eg, erythromycin), methadone, phenothiazines, (eg, chlorpromazine,thioridazine), or streptogramins (eg, quinupristin/dalfopristin), or tyrosine kinase inhibitors (eg, nilotinib, sunitinib) because the risk of irregular heartbeat may be increased
  • Alpha-blockers (eg, doxazosin) or medicine for high blood pressure because the risk of low blood pressure and fainting may be increased
  • Anticholinergics (eg, scopolamine) because the risk of overheating may be increased
  • Carbamazepine because it may decrease Paliperidone Extended-Release Tablets's effectiveness
  • Dopamine receptor agonists (eg, pramipexole) or levodopa because their effectiveness may be decreased by Paliperidone Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Paliperidone Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Paliperidone Extended-Release Tablets:

Use Paliperidone Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Paliperidone Extended-Release Tablets by mouth with or without food. Take in the morning unless your doctor tells you otherwise.
  • Swallow Paliperidone Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
  • Take Paliperidone Extended-Release Tablets with a full glass of water (8 oz/240 mL).
  • Drinking extra fluids while you are taking Paliperidone Extended-Release Tablets are recommended. Check with your doctor for instructions.
  • Taking Paliperidone Extended-Release Tablets at the same time each day will help you remember to take it.
  • Continue to take Paliperidone Extended-Release Tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of Paliperidone Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Paliperidone Extended-Release Tablets.

Important safety information:

  • Paliperidone Extended-Release Tablets may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Paliperidone Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using Paliperidone Extended-Release Tablets.
  • Do not use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Paliperidone Extended-Release Tablets without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Paliperidone Extended-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • You may notice the tablet shell in your stool. This is normal and not a cause for concern.
  • Paliperidone Extended-Release Tablets may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • NMS is a possibly fatal syndrome that can be caused by Paliperidone Extended-Release Tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some patients who take Paliperidone Extended-Release Tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Paliperidone Extended-Release Tablets in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Paliperidone Extended-Release Tablets.
  • Paliperidone Extended-Release Tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Paliperidone Extended-Release Tablets may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
  • Paliperidone Extended-Release Tablets may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
  • Lab tests, including fasting blood sugar levels and complete blood cell counts, may be performed while you use Paliperidone Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Paliperidone Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscles movements.
  • Paliperidone Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Paliperidone Extended-Release Tablets while you are pregnant. Paliperidone Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Paliperidone Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Paliperidone Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; indigestion; lightheadedness; restlessness; sore throat; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; behavior changes; chest pain; confusion; decreased sexual ability; decreased urination; enlarged breasts; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; mental/mood changes; missed menstrual period; muscle pain, weakness, or stiffness; nipple discharge; prolonged, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual eye movements.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include fainting; fast or irregular heartbeat; loss of consciousness; seizures; severe drowsiness or dizziness; stiffness of the face, limbs, or neck; trouble walking; unusual muscle movement.

Proper storage of Paliperidone Extended-Release Tablets:

Store Paliperidone Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Paliperidone Extended-Release Tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Paliperidone Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Paliperidone Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Paliperidone Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Paliperidone Professional Patient Advice (Wolters Kluwer)
  • paliperidone Advanced Consumer (Micromedex) - Includes Dosage Information
  • Invega Prescribing Information (FDA)
  • Invega Consumer Overview
  • Invega Sustenna Prescribing Information (FDA)
  • Invega Sustenna Advanced Consumer (Micromedex) - Includes Dosage Information