July 23, 2016
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"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.

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Invega Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking paliperidone (Invega)?

Paliperidone is not for use in psychotic conditions related to dementia. Paliperidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to paliperidone or a similar drug called risperidone (Risperdal).

To make sure you can safely take paliperidone, tell your doctor if you have any of these other conditions:

  • a history of low white blood cell (WBC) counts;
  • a personal or family history of Long QT syndrome;
  • heart disease, heart rhythm problems, or a history of heart attack or stroke;
  • high or low blood pressure;
  • an electrolyte imbalance, such as low potassium or magnesium levels in your blood;
  • a history of breast cancer;
  • seizures or epilepsy;
  • kidney or liver disease;
  • diabetes (paliperidone may raise your blood sugar);
  • high cholesterol or triglycerides (a type of fat in the blood);
  • a stomach or intestinal disorder;
  • a history of suicidal thoughts;
  • Parkinson's disease; or
  • trouble swallowing.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking paliperidone, do not stop taking it without your doctor's advice.

Paliperidone can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking paliperidone.

Older adults may be more likely to have side effects from this medicine.

How should I take paliperidone (Invega)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Paliperidone can be taken with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Use paliperidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Paliperidone may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have symptoms of hyperglycemia such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, or weight loss. If you are diabetic, check your blood sugar levels on a regular basis while you are taking paliperidone.

Store at room temperature away from moisture, heat, and light.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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