Risperidone-injection

Name: RISPERIDONE-INJECTION

How should this medicine be used?

Risperidone extended-release injection comes as a solution to be injected into a muscle by a healthcare provider. Risperidone extended-release injection is usually given once every 2 weeks. Your doctor will prescribe a similar medication to take by mouth for 3 weeks until risperidone extended-release injection is fully working.

Risperidone extended-release injection may help control your symptoms but will not cure your condition. Continue to keep appointments to receive risperidone injection even if you feel well. Talk to your doctor if you do not feel like you are getting better during your treatment with risperidone injection.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to risperidone extended-release injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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).

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, fast/irregular heartbeat, unusual/uncontrolled movements, seizures.

Missed dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • If you are planning to harm yourself or the want to harm yourself gets worse.
  • Very bad dizziness or passing out.
  • Change in how you act.
  • Mood changes.
  • Shakiness, trouble moving around, or stiffness.
  • Not able to pass urine or change in how much urine is passed.
  • Trouble swallowing or speaking.
  • Not able to focus.
  • Seizures.
  • Change in eyesight.
  • Shortness of breath.
  • Drooling.
  • Enlarged breasts.
  • Change in sex ability.
  • Nipple discharge.
  • For women, no period.
  • Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
  • Very bad irritation where the shot was given.

What are some other side effects of Risperidone Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Weight gain.
  • Restlessness.
  • Feeling sleepy.
  • Dizziness.
  • Anxiety.
  • Upset stomach or throwing up.
  • Belly pain.
  • Loose stools (diarrhea).
  • Hard stools (constipation).
  • Dry mouth.
  • More hungry.
  • Feeling tired or weak.
  • Stuffy nose.
  • Runny nose.
  • Nose and throat irritation.
  • Headache.
  • Not able to sleep.
  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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