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Paliperidone (Injection)

Paliperidone Palmitate (pal-ee-PER-i-done PAL-mi-tate)

Treats schizophrenia (a mental disorder).

Brand Name(s):

Invega Sustenna

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not receive this medicine if you have had an allergic reaction to paliperidone or risperidone (Risperdal®).

How to Use This Medicine:

Injectable

  • Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
  • A nurse or other health provider will give you this medicine.

If a dose is missed:

  • You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using carbamazepine (Tegretol®), levodopa (Dopar®, Larodopa®), paroxetine (Paxil®), medicine for heart rhythm problems (such as amiodarone, quinidine, procainamide, sotalol, Betapace®, Cordarone®, or Procanbid®), medicine for mental illness (such as chlorpromazine, thioridazine, Mellaril®, or Thorazine®), or certain antibiotic medicines (such as gatifloxacin, moxifloxacin, Avelox®, or Tequin®).
  • Do not drink alcohol while you are using this medicine.
  • Tell your doctor if you drink alcohol or if you are using any medicine that makes you sleepy, such as allergy medicine or narcotic pain medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, diabetes, stomach or bowel blockage, Parkinson's disease, trouble with swallowing, or a history of seizures or neuroleptic malignant syndrome (NMS). Tell your doctor if you have any kind of blood vessel or heart problems, including low blood pressure, heart failure, a low amount of blood, heart rhythm problems (such as QT prolongation), or a history of a heart attack or stroke. Also tell your doctor if you have ever been depressed or had thoughts of hurting yourself or others.
  • This medicine should not be used to treat mental disorders in elderly patients who have dementia. Using this medicine to treat this condition could increase the risk for serious side effects, including death. Some side effects are more likely to happen in elderly people who have memory problems or reduced mental skills. Make sure the doctor knows if the person who will be using this medicine has forgetfulness or confusion related to aging (such as Alzheimer's disease or dementia).
  • Stop using this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
  • Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
  • This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
  • This medicine may cause an increase in your blood sugar. If you have diabetes, you may need to check your urine or blood sugar more often. Check with your doctor right away if you have increased thirst or increased urination, or if you have any questions.
  • Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
  • This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert, well-coordinated, or able to think well.
  • This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Avoid people who are ill, and wash your hands often. Brush and floss your teeth gently, do not play rough sports, and be careful with sharp objects.
  • This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
  • This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and cannot cool down.
  • This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Blood tests may be needed to check for any unwanted effects.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Change in how much or how often you urinate.
  • Chills, cough, runny or stuffy nose, sore throat, and body aches.
  • Dry mouth, increased thirst, muscle cramps, nausea, or vomiting.
  • Fast, slow, pounding, or uneven heartbeat.
  • Fever, confusion, sweating, or muscle stiffness.
  • Lightheadedness, dizziness, or fainting.
  • Mood or behavioral changes, or thoughts of hurting yourself or others.
  • Neck muscle spasm, throat tightness, difficulty with swallowing or breathing, or sticking out of the tongue.
  • Painful, prolonged erection of your penis (in males).
  • Problems with balance or walking.
  • Seizures or tremors.
  • Swelling of the breasts or unusual milk production.
  • Trouble with speaking or swallowing.
  • Twitching or muscle movements you cannot control (often in your face, tongue, or jaw).
  • Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

  • Anxiety or restlessness.
  • Diarrhea, stomach pain, or upset stomach.
  • Headache.
  • Pain, itching, burning, swelling, or a lump under your skin where the shot was given.
  • Sleepiness or unusual drowsiness.
  • Trouble with sleeping.
  • Unusual tiredness or weakness.
  • Weight gain.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 8/4/2014


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