Risperdal Consta (risperidone) is a long-acting injection used in adults to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

Risperdal Consta injection is also used in adults alone, or in combination with lithium (Lithobid) or valproate (Depakene) to treat people who have bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of severe mania, and other abnormal moods).

Risperdal Consta belongs to a class of medications called atypical antipsychotics. Risperidone works by changing the activity of certain natural substances in the brain.

Risperdal Consta is not approved for use in older adults with dementia-related psychosis.

While you are taking Risperdal Consta, 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 this medication.

Risperdal Consta 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.

Before taking this medicine

You should not use Risperdal Consta if you are allergic to risperidone or paliperidone.

Risperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Risperal Consta is safe for you, tell your doctor if you have ever had:

• heart disease or a heart attack;

• dizziness, rapid heartbeats, fainting;

• a stroke, a TIA or "mini-stroke";

• Parkinson's disease or a type of dementia called Lewy body dementia;

• trouble swallowing;

• low white blood cell (WBC) counts;

• a severe nervous system reaction while using medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia;

• diabetes (in you or a family member);

• high cholesterol or triglycerides;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• a seizure;

• low bone mineral density;

• breast cancer;

• dehydration; or

• liver or kidney disease.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop using Risperdal Consta without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risperidone on the baby.

It may be harder for you to get pregnant while you are using Risperdal Consta.

If you are breastfeeding, tell your doctor if you notice drowsiness, irregular growth, tremors and abnormal muscle movements in the nursing baby.

Use Risperal Consta exactly as prescribed by your doctor. If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor's advice.

You may need to take risperidone by mouth (in pill or liquid form) before you start receiving Risperdal Consta injections. Follow your doctor's dosing instructions very carefully.

Risperdal Consta is administered into a muscle by deep intramuscular (IM) injection.

A healthcare provider will give you this injection.

Risperdal Consta is usually given once every 2 weeks.

Your blood may need to be tested often.

Your doctor will need to check your progress on a regular basis and you may need other medical tests.

Usual Adult Dose of Risperdal Consta for Schizophrenia:

Long-acting IM Injection:
Initial dose: 25 mg IM every 2 weeks
-Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
-Maximum dose: 50 mg IM every 2 weeks

Usual Adult Dose of Risperdal Consta for Bipolar Disorder:

Long-acting IM Injection:
Initial dose: 25 mg IM every 2 weeks
-Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
-Maximum dose: 50 mg IM every 2 weeks

Usual Geriatric Dose of Risperdal Consta for Schizophrenia:

Long-acting IM Injection:
Initial dose: 25 mg IM every 2 weeks
-Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
-Maximum dose: 50 mg IM every 2 weeks.

Usual Geriatric Dose of Risperdal Consta for Bipolar Disorder:

Long-acting IM Injection:
Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks.

Comments:
-For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral formulation prior to initiating treatment with long acting injection.
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

You should not use Risperdal Consta if you are allergic to risperidone or paliperidone.

Risperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Risperal Consta is safe for you, tell your doctor if you have ever had:

• heart disease or a heart attack;

• dizziness, rapid heartbeats, fainting;

• a stroke, a TIA or "mini-stroke";

• Parkinson's disease or a type of dementia called Lewy body dementia;

• trouble swallowing;

• low white blood cell (WBC) counts;

• a severe nervous system reaction while using medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia;

• diabetes (in you or a family member);

• high cholesterol or triglycerides;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• a seizure;

• low bone mineral density;

• breast cancer;

• dehydration; or

• liver or kidney disease.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop using Risperdal Consta without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risperidone on the baby.

It may be harder for you to get pregnant while you are using Risperdal Consta.

If you are breastfeeding, tell your doctor if you notice drowsiness, irregular growth, tremors and abnormal muscle movements in the nursing baby.

Call your doctor for instructions if you miss an appointment for your Risperdal Consta injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not drink alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid driving or hazardous activity until you know how Risperdal Consta will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to Risperal Consta: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of risperidone can cause a serious movement disorder that may not be reversible. The longer you use Risperdal Consta, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Risperdal Consta may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• breast swelling and tenderness, nipple discharge, loss of interest in sex, impotence, erectile dysfunction, difficulty having an orgasm, missed menstrual periods;

• feeling unusually hot or cold;

• low blood pressure, fast or pounding heartbeats, fluttering in your chest;

• shortness of breath, sudden dizziness (like you might pass out);

• seizure;

• trouble swallowing;

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• a painful or prolonged erection.

Common Risperal Consta side effects may include:

• headache;

• blurred vision, rash;

• dizziness, drowsiness, tired feeling;

• tremors, twitching or uncontrollable muscle movements, numbness;

• depressed mood, agitation, anxiety, feeling restless;

• back pain, muscle or joint pain, pain in your arms or legs;

• upset stomach, constipation, dry mouth;

• upper stomach pain, nausea, vomiting, diarrhea;

• increased salivation;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• increased appetite, weight gain; or

• itching, bruising, swelling, irritation, warmth, redness, and a hard lump (induration) where the injection was given.

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.

Using Risperdal Consta with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can interact with Risperdal Consta, especially:

• methylphenidate;

• clozapine; or

• blood pressure medications.

This list is not complete and many other drugs may interact with risperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.