You should not use this medication if you are allergic to risperidone. To make sure you can safely take risperidone, tell your doctor if you have any of these other conditions: Risperidone may cause you to have high blood sugar hyperglycemia. Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness.
If you are diabetic, check your blood sugar levels on a regular basis while you are taking risperidone. The risperidone orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of risperidone if you have phenylketonuria PKU. 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 risperidone, do not stop taking it without your doctor's advice.
Risperidone can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking risperidone. Do not give this medicine to a child without a doctor's advice. If you drink alcohol, talk to your doctor. Warnings for people with certain health conditions For people with diabetes: This drug may increase your blood sugar levels. This may make your diabetes worse. Very high blood sugar may lead to coma being unconscious for a long time or death.
If you have diabetes or risk factors of diabetes such as being overweight or a family history of diabetes , your doctor should check your blood sugar before starting and during treatment with this drug. For people with high cholesterol: This drug may increase your cholesterol and triglyceride levels.
This may raise your risk for heart attack and stroke. High cholesterol may not cause any symptoms. Your doctor may check your cholesterol and triglyceride levels during treatment with this drug.
For people with low blood pressure: This drug may further lower your blood pressure. This may make your condition worse. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. This medication may make you sweat less, making you more likely to get heat stroke.
Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness , and QT prolongation see above. Drowsiness, dizziness, and lightheadedness can increase the risk of falling.
During pregnancy , this medication should be used only when clearly needed. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away. If you are planning pregnancy, become pregnant , or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast -feeding. What should I know regarding pregnancy, nursing and administering Risperidone to children or the elderly? Interactions Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.
Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers such as codeine, hydrocodone , alcohol, marijuana , drugs for sleep or anxiety such as alprazolam , lorazepam , zolpidem , muscle relaxants such as carisoprodol , cyclobenzaprine , or antihistamines such as cetirizine , diphenhydramine.
Check the labels on all your medicines such as allergy or cough -and-cold products because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Always tell your doctor if you have allergies to any medications and discuss the risks and benefits of risperidone. Tell your doctor if you use or have ever used illegal or "street" drugs, or if you are a heavy drinker. Also let your doctor know if you have ever abused prescription drugs.
Because it may be more difficult for your body to warm up or cool down while taking risperidone, let your doctor know if you plan to engage in vigorous exercise or if you will be in a place where temperatures are very hot or very cold. Your doctor should also know if you ever developed severe side effects from a medication to treat mental illness. Tell your doctor if you are pregnant, particularly if you are in your third trimester.
Risperidone may be harmful for newborns right after delivery. As was seen in the autistic disorder trials, these events were most often of early onset and transient in duration.
Hyperprolactinemia, Growth, and Sexual Maturation Risperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults [see Warnings and Precautions 5. Increases were dose-dependent and generally greater in females than in males across indications. In clinical trials in children and adolescents, galactorrhea was reported in 0.
The long-term effects of risperidone on growth and sexual maturation have not been fully evaluated. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, a lower starting dose is recommended for an elderly patient, reflecting a decreased pharmacokinetic clearance in the elderly, as well as a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology While elderly patients exhibit a greater tendency to orthostatic hypotension, its risk in the elderly may be minimized by limiting the initial dose to 0.
Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. This drug is substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration 2.
Concomitant use with Furosemide in Elderly Patients with Dementia-Related Psychosis In two of four placebo-controlled trials in elderly patients with dementia-related psychosis, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone when compared to patients treated with risperidone alone or with placebo plus furosemide. No pathological mechanism has been identified to explain this finding, and no consistent pattern for cause of death was observed.
An increase of mortality in elderly patients with dementia-related psychosis was seen with the use of risperidone regardless of concomitant use with furosemide. Risperidone is not approved for the treatment of patients with dementia-related psychosis. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of risperidone misuse or abuse e. In general, reported signs and symptoms were those resulting from an exaggeration of the drug's known pharmacological effects, i.
One case, involving an estimated overdose of mg, was associated with hyponatremia, hypokalemia, prolonged QT, and widened QRS. Another case, involving an estimated overdose of 36 mg, was associated with a seizure. Postmarketing experience includes reports of acute risperidone overdosage, with estimated doses of up to mg.
In general, the most frequently reported signs and symptoms are those resulting from an exaggeration of the drug's known pharmacological effects, i. Other adverse reactions reported since market introduction related to risperidone overdose include prolonged QT interval and convulsions. Torsade de pointes has been reported in association with combined overdose of risperidone and paroxetine.
Gastric lavage after intubation, if patient is unconscious and administration of activated charcoal together with a laxative should be considered. Because of the rapid disintegration of risperidone orally disintegrating tablets, pill fragments may not appear in gastric contents obtained with lavage.
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