Risperdal Consta

Risperdal Consta

What is Risperdal Consta?

Risperdal Consta injection is also used in adults, alone or in combination with lithium (Lithobid) or valproate (Depakene), to treat people with bipolar disorder (manic-depressive disorder; an illness that causes episodes of depression, episodes of severe mania, etc., 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.

Warnings

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

While you are taking Risperdal Consta, you may become more sensitive to extreme temperatures, such as very hot or cold conditions. Avoid freezing, overheating, or becoming dehydrated. Drink plenty of fluids, especially in hot weather and when exercising. Dangerous overheating and dehydration are more likely to occur while taking this medication.

Risperdal Consta may cause side effects that may affect your thinking or reactions. Be careful when driving or doing anything that requires you to be awake and alert.

Before you take 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 heart attack;

• dizziness, fast heartbeat, fainting;

• a stroke, TIA or “mini-stroke”;

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

• difficulty swallowing;

• low white blood cell (WBC) count;

• a severe nervous system reaction while taking medicines to treat anxiety, mood disorders or mental illnesses such as schizophrenia;

• diabetes (if you or a family member);

• high cholesterol or triglyceride levels;

• uncontrolled muscle movements in your face (chewing, smacking, frowning, moving your tongue, blinking, or moving your eyes);

• a seizure;

• low bone mineral density;

• breast cancer;

• dehydration; or

• Liver or kidney disease.

Taking antipsychotics in the last three months of pregnancy can cause serious problems in the newborn. Tell your doctor immediately if you become 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 more difficult for you to get pregnant while you are using Risperdal Consta.

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

How is Risperdal Consta administered?

Use Risperal Consta exactly as your doctor has told you. If you are already taking other antipsychotic medications, you may need to continue taking them for a short time. Do not change your dose or dosing schedule without your doctor's advice.

You may need to take risperidone orally (in pill or liquid form) before you start injecting Risperdal Consta. Follow your doctor's dosage instructions very carefully.

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

A doctor will give you this injection.

Risperdal Consta is usually given every two weeks.

Your blood may need to be tested frequently.

Your doctor will need to check your progress regularly and further medical tests may be required.

Dosage information

Usual adult dose of Risperdal Consta for schizophrenia:

Long-acting IM injection:
Initial dose: 25 mg IM every 2 weeks
-Titration dose: May be increased to 37.5 mg or 50 mg if necessary; Dose titration should not occur more frequently than every 4 weeks as drug release is expected to begin 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 be increased to 37.5 mg or 50 mg if necessary; Dose titration should not occur more frequently than every 4 weeks as drug release is expected to begin 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 be increased to 37.5 mg or 50 mg if necessary; Dose titration should not occur more frequently than every 4 weeks as drug release is expected to begin 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 be increased to 37.5 mg or 50 mg if necessary; Dose titration should not occur more frequently than every 4 weeks as drug release is expected to begin 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks.

Comments:

-For patients who have never taken oral risperidone, it is recommended that the tolerability of the oral formulation be determined before starting treatment with long-term injection.
-Should be administered by a healthcare professional as a deep intramuscular deltoid or gluteal injection; do not administer intravenously.
-Older patients are more prone to orthostatic hypotension. Careful titration with monitoring of orthostatic vital signs should be considered.
-To ensure that adequate therapeutic plasma concentrations are maintained prior to the main drug release phase from the injection, oral risperidone (or other antipsychotic) should be administered for 3 weeks after the first injection.
-Some patients who do not respond 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 tolerance to psychotropic medications may benefit from a lower starting dose of 12.5 mg, however the effectiveness of the 12.5 mg dose has not been evaluated in clinical trials.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking Risperdal Consta?

Don't drink alcohol.Dangerous side effects could occur.

Avoid overheating or dehydration during exercise, in hot weather, or from not drinking enough fluids. Follow your doctor's instructions about the type and amount of fluids you should drink. In some cases, drinking too much fluid can be just as dangerous as drinking too little.

Avoid driving and dangerous activities until you know how Risperdal Consta affects you. Avoid getting up too quickly from sitting or lying down as this could cause you to feel dizzy. Dizziness or drowsiness can lead to falls, accidents or serious injury.

Side effects of Risperdal Consta

If necessary, get emergency medical helpSigns of an allergic reaction to Risperal Consta: Hives, difficulty breathing, swelling of the face, lips, tongue or throat.

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

Risperdal Consta can cause serious side effects. Call your doctor immediately if you have:

• uncontrolled muscle movements in your face (chewing, smacking, frowning, moving your tongue, blinking, or moving your eyes);

• Breast swelling and tenderness, nipple discharge, loss of interest in sex, impotence, erectile dysfunction, difficulty in orgasm, absence of menstruation;

• feeling unusually hot or cold;

• low blood pressure, fast or rapid heartbeat, fluttering in the chest;

• shortness of breath, sudden feeling of dizziness (as if you might faint);

• Seizure;

• difficulty swallowing;

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

• severe nervous system reaction - very stiff muscles, high fever, sweating, confusion, fast or irregular heartbeat, shaking, feeling like you might faint;

• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath smell;

• low blood cell count - fever, chills, tiredness, mouth sores, sore skin, easy bruising, unusual bleeding, pale skin, cold hands and feet, lightheadedness or shortness of breath; or

• a painful or persistent erection.

Common side effects of Risperal Consta may include:

• Headache;

• blurred vision, rash;

• dizziness, drowsiness, feeling tired;

• tremors, twitches or uncontrollable muscle movements, numbness;

• depressed mood, restlessness, fear, feeling of restlessness;

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

• upset stomach, constipation, dry mouth;

• Upper abdominal 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 (hardening) at the injection site.

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

What other drugs will affect Risperdal Consta?

Using Risperdal Consta with other medicines that make you sleepy may worsen this effect. Consult your doctor before taking opioid medications, sleeping pills, muscle relaxants, or anti-anxiety or seizure medications.

Sometimes it is not safe to use certain medicines together. Some medications can affect the blood levels of other medications you are taking, which may increase side effects or make the medications less effective.

Tell your doctor about all medications you are currently taking. Many medications can interact with Risperdal Consta, particularly:

• methylphenidate;

• clozapine; or

• Blood pressure medications.

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

Manufacturer

Janssen Pharmaceuticals Inc.Titusville, NJ 08560, USA.

• Was ist der Unterschied zwischen Perseris und Risperdal Consta?

References

1. Risperdal Consta-Produktetikett

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use Risperal Consta only for the prescribed indication.