Precautions and Warnings With Paliperidone (Cont.)

• The U.S. Food and Drug Administration (FDA) has issued a special warning (a "black box warning") about the use of paliperidone in elderly people with dementia (a condition involving confusion; disorientation; and a loss of memory, intellect, and judgment) or psychosis.

Elderly people with dementia (Alzheimer's disease is the most common form of dementia) who are treated with antipsychotics -- including paliperidone -- are more likely to die (of various causes) than those who are not treated with those medications. Paliperidone is not approved to treat dementia or dementia-related psychosis, and caution should be used before using paliperidone in elderly people with dementia.

• Paliperidone can cause a life-threatening irregular heart rhythm (arrhythmia) called QT prolongation. People with long QT syndrome should not take paliperidone, and paliperidone should not be combined with other medications that can prolong the QT interval (see Drug Interactions With Paliperidone).
   
• Paliperidone can cause a life-threatening condition called neuroleptic malignant syndrome (NMS). Some symptoms of NMS include:

• A high fever
• Stiff muscles
• Confusion
• Irregular pulse or blood pressure
• A fast heart rate (tachycardia)
• Sweating
• Irregular heart rhythms (arrhythmias). 

Tell your healthcare provider right away if think you might have NMS.

• Paliperidone can cause tardive dyskinesia. Tardive dyskinesia is a condition involving unusual, uncontrollable body or face movements. The condition can become permanent (even if paliperidone is stopped). The best way to prevent it from becoming permanent is to tell your healthcare provider right away if you notice any abnormal movements (including abnormal movements of the tongue) while taking paliperidone.
   
• There is an increased risk of stroke in elderly people who take paliperidone for dementia. Paliperidone is not approved for the treatment of dementia in the elderly -- though it may sometimes be prescribed "off-label" for the treatment of behavior problems in elderly people with dementia.
   
• Paliperidone can cause an increase in blood sugar levels and may increase the risk of developing diabetes. Tell your healthcare provider if you develop signs of diabetes while taking paliperidone. Signs of diabetes can include increased thirst, increased urination, or hunger. If you have diabetes, your blood sugar should be monitored carefully and regularly during treatment with paliperidone to make sure your diabetes is not becoming more severe (see Invega and Diabetes).
   
• The specially designed paliperidone tablets do not dissolve. Because they do not dissolve, they can get stuck in a narrowing of the gastrointestinal tract. Do not take paliperidone if you have a narrowing of the gastrointestinal tract. It is normal to see the undissolved tablets in your stool.
   
• Paliperidone can increase the level of the hormone prolactin. Tell your healthcare provider if you have signs of high prolactin levels, such as breast enlargement, breast pain, or breast discharge.
   
• Because the kidneys help clear paliperidone from the blood, people with kidney disease often need to take a lower paliperidone dosage.
   
• Paliperidone can cause a drop in blood pressure when going from a sitting or lying position to standing (known medically as orthostatic hypotension). This can cause a person to have lightheadedness or dizziness, or to faint. Tell your healthcare provider if you have any of these symptoms when standing. Orthostatic hypotension can be especially dangerous in people with heart disease or congestive heart failure (CHF).
   
• Paliperidone may increase the risk of seizures. Before starting paliperidone, tell your healthcare provider if you have epilepsy or a history of seizures.
   
• Paliperidone can cause difficulty swallowing, which can lead to inhalation of food (causing pneumonia). Tell your healthcare provider if you notice any problems swallowing during treatment with paliperidone.
   
• Paliperidone is considered a pregnancy Category C medication. This means that it may not be safe to take during pregnancy. Be sure to talk with your healthcare provider about the risks and benefits of using paliperidone during pregnancy (see Invega and Pregnancy).
   
• Paliperidone passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about using paliperidone (see Invega and Breastfeeding for more information).
   
• Generally, alcohol should be avoided while taking paliperidone (see Alcohol and Invega).