Paliperidone

Paliperidone is a prescription medication used for the treatment of schizophrenia and schizoaffective disorder. Paliperidone belongs to a group of drugs called atypical antipsychotics. It may work by changing the activity of certain natural substances in the brain.

This medication comes in an extended-release (long-acting) tablet form and is taken once a day in the morning with or without food. Swallow the tablets whole with plenty of water or other liquid. Do not split, chew, or crush the tablets. 

This medication is also available in an injectable form to be given directly into a muscle (IM) by a healthcare professional. It is given once, then one week later, than every month thereafter.

Paliperidone is a prescription medication used in the treatment of schizophrenia and schizoaffective disorder.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Paliperidone may be found in some form under the following brand names:

• Invega

Oral/Injectable:

Paliperidone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• extreme tiredness
• weakness
• headache
• dry mouth
• increased saliva
• weight gain
• stomach pain

Some side effects can be serious. If you experience any of these, call your doctor immediately:

• fever
• muscle pain or stiffness
• confusion
• fast, pounding, or irregular heartbeat
• sweating
• unusual movements of your face or body that you cannot control
• slow or stiff movements
• restlessness
• painful erection of the penis that lasts for hours

Paliperidone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Some medicines may interact with paliperidone which may increase side effects, and increase or decrease the action of either drug. Your doctor may need to change the doses of your medicines or carefully monitor for side effects if you are taking medicines that interact with paliperidone.

Tell your doctor about the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal supplements. Especially tell your doctor if you take:

• antidepressants
• certain antibiotics such as erythromycin (E.E.S., E-Mycin, Erythrocin), and moxifloxacin (Avelox)
• certain antipsychotics such as chlorpromazine (Thorazine), pimozide (Orap), risperidone (Risperdal) and thioridazine
• levodopa (in Sinemet, in Stalevo)
• medications for anxiety
• high blood pressure medicines 
• medications for seizures
• medications for irregular heartbeat such as amiodarone (Cordarone), disopyramide (Norpace), dofetilide (Tikosyn), procainamide (Procanbid, Pronestyl), quinidine (Quinidex), and sotalol (Betapace, Betapace AF)
• sedatives
• sleeping pills
• tranquilizers

• Paliperidone has caused some rare, but serious side effects including Neuroleptic Malignant Syndrome (NMS), Tardive Dyskinesia (TD) and changes in heart rhythm. It has also been associated with high blood sugar and diabetes, changes in cholesterol and triglycerides, and weight gain. Paliperidone and similar medicines have been associated with decreases in white blood cell counts.
• Paliperidone should be used with caution in people with a seizure disorder or those at increased risk for seizures.
• Tell your doctor if you are allergic to paliperidone, risperidone (Risperdal) or any other medications.
• Tell your doctor if you have heart problems. If you have or have ever had a rare heart problem that may cause fainting or irregular heartbeat (prolonged QT interval) or a heart attack, you should tell your doctor before taking Paliperidone.
• Tell  your doctor if you have or have ever had any condition that causes blockage or narrowing of the esophagus, stomach, or intestines. Also tell your doctor if you have inflammatory bowel disease (IBD), and kidney or liver disease.
• Tell your doctor if you are pregnant, planning to become pregnant or breastfeeding. Paliperidone may harm your unborn baby or your nursing baby.
• Paliperidone may cause drowsiness. You should not drive a car or operate machinery until you know how it will affect you. You should not drink alcohol while on paliperidone. Alcohol may add to the drowsiness caused by paliperidone.
• While taking paliperidone, you may experience increases in your blood sugar (hyperglycemia) even if you don't already have diabetes. You may be at an increased risk of developing diabetes if you take paliperidone or similar medicines.
• Paliperidone may make it harder for your body to cool down during exercise or in hot weather. 
• Get out of bed slowly, resting your feet on the floor before standing, to avoid dizziness, lightheadedness, and fainting while taking paliperidone.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of paliperidone there are no specific foods that you must exclude from your diet when receiving paliperidone.

Tell your doctor and pharmacist if you:

• are allergic to paliperidone, risperidone (Risperdal), or any other medications
• have inflammatory bowel disease (IBD)
• have kidney or liver disease
• have or have ever had a prolonged QT interval (a rare heart problem that may cause fainting or irregular heartbeat)
• have a slow or irregular heartbeat
• have had a heart attack
• have low levels of potassium or magnesium in your blood
• have had a seizure
• have had a stroke
• have had a head injury
• have a brain tumor
• have Parkinson's disease (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance)
• have diabetes
• have breast cancer
• have had surgery involving the intestines
• have any condition that causes blockage or narrowing of the esophagus (tube that connects the mouth and stomach), stomach, or intestines such as cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction), and inflammatory bowel disease (a group of conditions that cause swelling of the lining of the intestines)

Tell your doctor if you are pregnant, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking paliperidone, call your doctor. 

If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking paliperidone.

Tell your doctor if you plan to exercise or be exposed to extreme heat.

Tell your doctor about the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Paliperidone falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if palidperidone is excreted in human breast milk or if it will harm your nursing baby.

Palidperidone is an extended-release (long-acting) tablet to take by mouth.

• It is usually taken once a day in the morning with or without food.
• Take it at around the same time every day.  
• Do not take more or less of it or take it more often than prescribed by your doctor.
• Swallow the tablets whole with plenty of water or other liquid. Do not split, chew, or crush the tablets. 

Continue to take palidperidone even if you feel well. Do not stop taking palidperidone without talking to your doctor.

This medication is also available in an injectable form to be given directly into a muscle (IM) by a healthcare professional. It is given once, then one week later, than every month thereafter.

Take paliperidone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Do not take more or less of it or take it more often than prescribed by your doctor. Continue to take paliperidone even if you feel well. Do not stop taking paliperidone without talking to your doctor.

Oral:

• Schizophrenia
  • The recommended dose with paliperidone extended-release tablets for the treatment of schizophrenia in adults is 6 mg taken once daily. The maximum recommended dose is 12 mg a day.
  • The recommended starting dose with paliperidone extended-release tablets for the treatment of schizophrenia in adolescents 12–17 years of age is 3 mg administered once daily. Dose increases may be required, and should occur at increments of 3 mg/day at intervals of more than 5 days.
• Schizoaffective Disorder
  • The recommended dose with paliperidone extended-release tablets for the treatment of schizoaffective disorder in adults is 6 mg administered once daily. The maximum recommended dose is 12 mg a day.

Injection:

This medication is available in an injectable form to be dosed by a healthcare professional. It is given once, then one week later, than every month thereafter.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at room temperature.
• Protect tablets from moisture.
• Keep this and all medicines out of the reach of children.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Paliperidone is not approved for the treatment of patients with dementia-related psychosis.