risperidone - injection, Risperdal Consta (cont.)
PRECAUTIONS: Before using risperidone, tell your doctor or pharmacist if you are allergic to it; or to paliperidone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, seizures, difficulty swallowing, low white blood cell count, Parkinson's disease, dementia.Also tell your doctor or pharmacist if either you or a family member has a history of the following: diabetes, heart disease, high blood cholesterol/triglyceride levels, high blood pressure, obesity.Risperidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using risperidone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using risperidone safely.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.Before having surgery (including cataract eye surgery), tell your doctor or dentist that you are using this medication or have used this medication in the past three months.This medication can make you more likely to get heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs).Older adults may be more sensitive to the side effects of this drug, especially dizziness, lightheadedness, and QT prolongation (see above).This medication should be used only when clearly needed during pregnancy or if planning pregnancy within 12 weeks after your last dose of this medication. Discuss the risks and benefits with your doctor. Do not stop using this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding (even if you have stopped this medication within the past 12 weeks).
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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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