Medication Information
Paliperidone (generic) ~ Invega (brand)

Classification: Paliperidone belongs to the chemical class of benzisoxazole derivatives. Paliperidone is the major active metabolite of risperidone.

Common Usage: Paliperidone is indicated for the treatment of schizophrenia. Safety and efficacy of paliperidone in patients under 18 years of age have not been established.

Important Safety Information: Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Invega (paliperidone) is not approved for the treatment of dementia-related psychosis. In some studies among elderly patients with dementia-related psychosis, paliperidone was associated with deaths that were cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

Major Side Effects: In patients with schizophrenia, the most commonly reported side effects with paliperidone are restlessness and extrapyramidal disorder (e.g., tremors, muscle stiffness, and involuntary movements). Paliperidone may also change your heart rhythm. You should discuss any current or past heart problems with your doctor before taking paliperidone. Other potential side effects include elevated blood sugar levels which may sometimes be potentially fatal. If you have diabetes mellitus your doctor should test your blood glucose level on a regular basis. Patients with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should inform their physician before taking paliperidone. A rare side effect has been reported with paliperidone, neuroleptic malignant syndrome, which can cause muscle rigidity, fever and can be serious. Some patients taking paliperidone may feel faint or lightheaded when they stand up or sit up too quickly. By taking care to stand or sit up slowly and following your doctor's dosing instructions, this side effect may be reduced or go away over time. Paliperidone may also make you more sensitive to heat. You may be more likely to become dehydrated or have trouble cooling off when taking paliperidone, so take care when exercising or doing things that make you warm. If you see something that looks like a tablet in your stool, do not be worried. This is the shell of the tablet and all that is left after the medicine has been released in your body.

Pregnancy: There are no adequately controlled studies investigating paliperidone in pregnant women. The drug should only be used during pregnancy if the benefit justifies the potential risk to the fetus.

Nursing mothers: Studies have shown that paliperiidone is excreted in mother's mild. Breast-feeding women should not use paliperidone.

Geriatric use: No overall differences in safety and effectiveness have been observed in clinical studies of paliperidone between patients 75 years of age or older and younger subjects. However, greater sensitivity to paliperidone may be possible in some older individuals. Elderly patients with decreased renal function may need to be given reduced doses of paliperidone, and be monitored for renal function on a regular basis.

This is not a complete list of known or potential adverse effects. Notify your prescriber or pharmacist of any symptoms that have started since you began taking this medication, changing its dose, or adding or changing other medication or diet. Take care when performing any task (such as driving a car or operating machinery) that requires your attention until you have experience with this drug and are confident you can perform this task safely.

Intearctions with Other Medications: Some medications may interact with paliperidone. Drugs that should be avoided when taking paliperidone include antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxilfloxacin) or any other drugs that may cause changes in heart rhythm. Paliperidone may also interact with levodopa and other dopamine agonists. Alcohol or drugs that act on the central nervous system should also be avoided when taking paliperidone.

This is not a complete list of all known or potential drug interactions. To help prevent problems, always make sure that your pharmacist and prescribers know about all medications you are taking, including over-the-counter drugs, dietary herbal supplements, folk or home remedies, or unusual foods, drinks or dietary habits.

Common Dosages: The recommended dose of Invega Extended-Release Tablets is 6 mg once daily in the morning. In some patients, a lower dose of 3 mg may be sufficient. Invega can be taken with or without food and must be swallowed whole with liquids. Tablets should not be chewed, divided or crushed. For patients with mild renal impairment, the normal dose is 6 mg once daily. For patients with moderate to severe renal impairment, the maximum recommended daily dose is 3 mg.

Identification: Invega Extended-Release Tablets are available in 3-mg, 6-mg and 9-mg doses. All tablets are capsule-shaped. 3-mg tablets are white and imprinted with "Pali 3". 6-mg tablets are beige and imprinted with "Pali 6". 9-mg tablets are pink and imprinted with "Pali 9". All Invega Extended-Release Tablets are available in bottles of 30 tablets, bottles of 350 tablets, and hospital-unit dose packs of 100.

Storage: Invega should be stored at controlled room temperature (59° to 86°) in a tightly closed, child, light, and moisture-resistant container. If you have difficulty opening child-resistant containers, your pharmacist can provide you with a container that is easier to open. Keep the medication out of direct sunlight and avoid storing it in a warm and humid area, such as the bathroom or kitchen, to avoid deterioration. To prevent accidental poisoning, keep all medications out of the reach of children or adults with dementia. Do not take expired medication. Do not transfer medication from one container to another. Carefully discard discontinued medication where children or adults with dementia cannot find it.