Paliperidone

Pronunciation

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

Paliperidone is 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 is not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.


Paliperidone is used for:

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

Paliperidone is an atypical antipsychotic. Exactly how it works is not known. It is thought to affect certain substances in the brain.

Do NOT use paliperidone if:

  • you are allergic to any ingredient in paliperidone or to risperidone
  • you have moderate to severe kidney problems or a history of irregular heartbeat (eg, long QT syndrome, prolonged QT interval)
  • you are taking certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol), certain antipsychotic medicines (eg, chlorpromazine, thioridazine), asenapine, citalopram, metoclopramide, nilotinib, certain quinolone antibiotics (eg, gatifloxacin, moxifloxacin), tetrabenazine, or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using paliperidone:

Some medical conditions may interact with paliperidone. 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), an abnormal electrocardiogram (ECG), a heart attack, a stroke, transient ischemic attack (TIA) or "mini-stroke," blood vessel problems, low white blood cell levels, high blood cholesterol or triglyceride levels, or high or low blood pressure
  • if you have a history of kidney problems; liver problems; stomach or bowel problems (eg, narrowing, inflammation, blockage); cystic fibrosis; aspiration (inhaling foreign matter into the airway or lungs), including aspiration pneumonia; neuroleptic malignant syndrome (NMS); tardive dyskinesia (TD) (abnormal movements of the tongue or face); suicidal thoughts or attempts; Reye syndrome; alcohol abuse or dependence; or a condition that can cause dizziness or fainting
  • if you have diabetes or high blood sugar, 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, 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 of breast cancer
  • if you are dehydrated or have low blood volume, if you drink alcohol, or will be exposed to high temperatures or you exercise strenuously
  • if you are taking oral paliperidone or risperidone, or any other antipsychotic medicine
  • if you have never taken paliperidone or risperidone

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

  • Many prescription and nonprescription medicines (eg, used for allergies, cancer, depression or other mental or mood problems, heartburn, high blood pressure, immune system suppression, irregular heartbeat or other heart problems, malaria or other infections, narcotic or other substance abuse or dependence, nausea or vomiting, pain, Parkinson disease, seizures, sleep problems, Tourette syndrome), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with paliperidone. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with paliperidone

This may not be a complete list of all interactions that may occur. Ask your health care provider if paliperidone 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:

Use paliperidone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with paliperidone. Talk to your pharmacist if you have questions about this information.
  • Paliperidone is given as an injection into the muscle at your doctor's office, hospital, or clinic. Be sure to keep all doctor appointments while using paliperidone.
  • Drinking extra fluids while you are taking paliperidone is recommended. Check with your doctor for instructions.
  • Do not use paliperidone if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • Continue to use paliperidone even if you feel well. Do not miss any doses.
  • If you miss a dose of paliperidone, contact your doctor right away. If you think you are going to miss a dose of paliperidone, call your health care provider as soon as you can.

Ask your health care provider any questions you may have about how to use paliperidone.

Important safety information:

  • Paliperidone may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use paliperidone 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.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using paliperidone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • It may take some time before your symptoms improve. Do not change your dose or stop taking paliperidone without checking with your doctor.
  • Paliperidone may cause dizziness, light-headedness, 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.
  • Paliperidone may raise your blood sugar. High blood sugar may make you feel confused, drowsy, thirsty, or unusually weak. It can also make you flush, breathe faster, have to urinate more often than usual, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • NMS is a possibly fatal syndrome that can be caused by paliperidone. 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 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 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.
  • Tell your doctor or dentist that you take paliperidone before you receive any medical or dental care, emergency care, or surgery.
  • Paliperidone 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 may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts in men, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
  • Paliperidone 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, complete blood cell counts, and blood cholesterol or lipid levels, may be performed while you use paliperidone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Paliperidone may cause weight gain. Your weight may need to be monitored while you use paliperidone.
  • Use paliperidone with caution in the ELDERLY; they may be more sensitive to its effects.
  • Paliperidone 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 while you are pregnant. Using paliperidone during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Paliperidone is found in breast milk. Do not breast-feed while you are using paliperidone.

Possible side effects of paliperidone:

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; diarrhea; dizziness; drowsiness; dry mouth; headache; light-headedness; mild pain, swelling, or redness at the injection site; mild stomach pain or discomfort; nausea; restlessness; trouble sleeping; vomiting; weakness; 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 urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; muscle cramps, pain, weakness, or stiffness; new or worsening mental or mood changes (eg, agitation, anxiety); one-sided weakness; prolonged, painful erection; seizures; severe or persistent constipation or stomach pain; severe or persistent dizziness, drowsiness, or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; tremor; trouble concentrating, speaking, or swallowing; trouble urinating or inability to control urination; trouble sitting still; trouble walking or standing; uncontrolled or involuntary muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bleeding or bruising; unusual eye movements; vision problems (eg, blurred vision).

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or irregular heartbeat; severe drowsiness or dizziness; trouble walking, speaking, or swallowing; unusual or uncontrolled muscle movement.

Proper storage of paliperidone:

Paliperidone is usually handled and stored by a health care provider. If you are using paliperidone at home, store paliperidone as directed by your pharmacist or health care provider. Keep paliperidone out of the reach of children and away from pets.

General information:

  • If you have any questions about paliperidone, please talk with your doctor, pharmacist, or other health care provider.
  • Paliperidone is 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take paliperidone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about paliperidone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to paliperidone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using paliperidone.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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