Risperdal

DRUG DESCRIPTION

RISPERDAL® contains risperidone, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-l,2-benzisoxazol-3-yl)-l-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[l,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:

RISPERDAL®
  (risperidone) Structural Formula Illustration

Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HC1.

RISPERDAL® Tablets are available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. RISPERDAL® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg tablets also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.

RISPERDAL® is also available as a 1 mg/mL oral solution. RISPERDAL® Oral Solution contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide, and purified water.

RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB® Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 2 mg, 3 mg, and 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablets contain xanthan gum.

What are the possible side effects of risperidone (Risperdal, Risperdal M-Tab)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using risperidone and call your doctor at once if you have any of these serious side effects:

  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • fever, chills, body aches, flu symptoms;
  • ...

Read All Potential Side Effects and See Pictures of Risperdal »

What are the precautions when taking risperidone (Risperdal)?

Before taking risperidone, tell your doctor or pharmacist if you are allergic to it; 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, low blood pressure, seizures, Parkinson's disease, memory problems (dementia), difficulty swallowing (especially in patients with dementia or Alzheimer's disease), strokes (cerebrovascular disease), dehydration, breast cancer, low white blood cell count.

(See also Side Effects section.) Also tell your doctor or pharmacist if either you or a family member has a history of the following:...

Read All Potential Precautions of Risperdal »


Risperdal Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, fatigue, nausea, constipation, runny nose, increased appetite, weight gain, nervousness, acne, dry skin, difficulty concentrating, decreased sexual ability/desire or difficulty sleeping may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: severe dizziness, fast/pounding/irregular heartbeat, mental/mood changes, fever, muscle stiffness/spasms/twitching, sweating, uncontrolled muscle movements (e.g., tongue and facial muscles), drooling, difficulty swallowing, seizures, frequent falls, signs of infection (such as fever, persistent sore throat).

Seek immediate medical attention if any of these unlikely but serious side effects occur: chest pain, fainting, weakness on one side of the body, numbness in the face/arms/legs, sudden vision changes, slurred speech, confusion, breast lumps, change in amount of urine.

This medication may in rare instances increase your blood level of a certain hormone (prolactin). In females, an increase in prolactin levels may result in unwanted breast milk, the end of menstruation or difficulty becoming pregnant. In males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

This drug may infrequently make your blood sugar level rise, therefore causing or worsening diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking risperidone, tell your doctor or pharmacist if you are allergic to it; 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, low blood pressure, seizures, Parkinson's disease, memory problems (dementia), difficulty swallowing (especially in patients with dementia or Alzheimer's disease), strokes (cerebrovascular disease), dehydration, breast cancer, low white blood cell count.

(See also Side Effects section.) Also tell your doctor or pharmacist if either you or a family member has a history of the following: diabetes, heart disease (e.g., heart attacks or ischemia, arrhythmias), 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 require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using risperidone, tell your doctor or pharmacist 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.

This medication can reduce sweating. Heatstroke may occur if you become overheated during exercise or other physical activity or in hot weather. Drink plenty of liquids to avoid the risk of heatstroke.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the lowering of blood pressure.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking 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.


Risperdal Patient Information Including Side Effects

Brand Names: Risperdal, Risperdal M-Tab

Generic Name: risperidone (oral) (Pronunciation: ris PER i done)

  • What is risperidone (Risperdal)?
  • What are the possible side effects of risperidone (Risperdal)?
  • What is the most important information I should know about risperidone (Risperdal)?
  • What should I discuss with my healthcare provider before taking risperidone (Risperdal)?
  • How should I take risperidone (Risperdal)?
  • What happens if I miss a dose (Risperdal)?
  • What happens if I overdose (Risperdal)?
  • What should I avoid while taking risperidone (Risperdal)?
  • What other drugs will affect risperidone (Risperdal)?
  • Where can I get more information?

What is risperidone (Risperdal)?

Risperidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Risperidone is used to treat schizophrenia and symptoms of bipolar disorder (manic depression). Risperidone is also used in autistic children to treat symptoms of irritability.

Risperidone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of risperidone (Risperdal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using risperidone and call your doctor at once if you have any of these serious side effects:

  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • trouble swallowing; or
  • feeling light-headed, fainting.

Less serious side effects may include:

  • mild restlessness, drowsiness, or tremor;
  • sleepiness, dreaming more than usual;
  • blurred vision;
  • dizziness or headache;
  • weight gain;
  • problems with urination;
  • nausea, dry mouth, constipation; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about risperidone (Risperdal)?

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

Do not give this medication to a child without a doctor's advice.

While you are taking risperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking risperidone.

Risperidone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of risperidone.

Stop using risperidone and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

There may be other drugs not listed that can affect risperidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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