RISPERIDONE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Risperdal
• Risperdal M-Tab

In Canada?

• Risperdal

Category

• Antipsychotic

Description

Risperidone (ris-PER-i-done) is used to treat the symptoms of psychoticdisorders, such as schizophrenia. This medicine should NOT be used to treatbehavioral problems in older adult patients who have dementia.

Risperidone is available only with your doctor's prescription, in the followingdosage forms:

Oral
• Oral solution (U.S. and Canada)
• Tablets, Orally disintegrating (U.S.)
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For risperidone, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to risperidone. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Studies with risperidone have not been done in pregnantwomen. One baby whose mother took risperidone during pregnancy was born witha serious brain problem. However, it is not known whether this problem wascaused by risperidone. Some unwanted effects have been reported in animalstudies, but the risk to human babies is not clear. Before taking this medicine,make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?Risperidone passes into human milk and may causeunwanted effects, such as behavior changes, in nursing babies. It may be necessaryfor you to take another medicine or to stop breast-feeding during treatment.Be sure you have discussed the risks and benefits of the medicine with yourdoctor.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of risperidonein children with use in other age groups.

Older adults?Elderly people may be especially sensitive to theeffects of risperidone. This may increase the chance of having side effectsduring treatment. This medicine should not be used for behavioralproblems in older adults with dementia.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingrisperidone, it is especially important that your health care professionalknow if you are taking any of the following:

• Amiodarone [e.g., Cordarone] or
• Amitriptyline [e.g., Elavil] or
• Arsenic trioxide [e.g., Trisenox] or
• Bepridil [e.g., Vascor] or
• Chlorpromazine [e.g., Thorazine] or
• Cisapride [e.g., Propulsid] or
• Clarithromycin [e.g., Biaxin] or
• Clomipramine [e.g., Anafranil] or
• Clozapine [e.g., Clozaril] or
• Desipramine [e.g., Norpramin] or
• Disopyramide [e.g., Norpace] or
• Dofetilide [e.g., Tikosyn] or
• Dolasetron [e.g., Anzemet] or
• Droperidol [e.g., Inapsine] or
• Erythromycin [e.g., E-mycin] or
• Gatifloxacin [e.g., Tequin] or
• Halofantrin [e.g., Halfan] or
• Haloperidol [e.g., Haldol] or
• Ibutilide intravenous injection [e.g., Covert] or
• Levofloxacin [e.g., Levaquin] or
• Levomethadyl [e.g., Orlaam] or
• Mefloquine [e.g., Lariam] or
• Mesoridazine [e.g., Serentil] or
• Moxifloxacin [e.g., Avelox] or
• Ondansetron [e.g., Zofran] or
• Pimozide [e.g., Orap] or
• Procainamide [e.g., Procainbid, Pronestyl] or
• Propafenone [e.g., Rythmol] or
• Quinidine [e.g., Quinaglute, Quinidex] or
• Sotalol [e.g., Betapace, Sorine] or
• Sumatriptan [e.g., Imitrex] or
• Thioridazine [e.g., Mellaril] or
• Ziprasidone [e.g., Geodon] or
• Zolmitriptan [e.g., Zomig]?These medicines may increase thechance of serious side effects and should not be taken with risperidone

• Alcohol or
• Antihypertensives (high blood pressure medicine) or
• Central nervous system (CNS) depressants (medicine that makes youdrowsy or less alert) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine[e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin],doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g.,Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])?Risperidonemay add to the effects of these medicines, causing unwanted effects such asincreased drowsiness or low blood pressure

• Bromocriptine (e.g., Parlodel) or
• Levodopa (e.g., Larodopa, Sinemet) or
• Pergolide (e.g., Permax)?Risperidone may interfere with theeffects of these medicines so that they do not work properly

• Carbamazepine (e.g., Epitol, Tegretol) or
• Clozapine (e.g., Clozaril) or
• Fluoxetine (e.g., Prozac, Sarafem) or
• Paroxetine (e.g., Paxil)?These medicines may affect the bloodlevels of risperidone so that risperidone does not work properly or causesunwanted effects. Your doctor may need to change your dose of risperidone.

Other medical problems?The presence of other medicalproblems may affect the use of risperidone. Make sure you tell your doctorif you have any other medical problems, especially:

• Aspiration pneumonia, risk or history of?may increase riskof adverse events

• Breast cancer or
• Heart or blood vessel problems, including stroke and unusual heartbeatsor
• Parkinson's disease?Risperidone may make these conditions worse

• Dehydration or
• Blood circulation problems?These conditions may increase thechance of side effects from the medicine

• Dementia, such as decreasing mental ability or
• Difficulty swallowing?These conditions may increase the chanceof side effects from the medicine

• Diabetes or family history of diabetes?May make condition worseand cause serious side effects

• Drug abuse problems in the past?These patients should be observedfor any signs of abuse of this medicine.

• Epilepsy or other seizure disorders?Risperidone may increasethe risk of having seizures

• Kidney disease or
• Liver disease?Higher blood levels of risperidone may occur,increasing the chance of side effects

• Other medical problems causing vomiting [e.g., brain tumor, bowelblockage, drug overdose, Reye's syndrome]?Risperidone may prevent vomitingand hide these medical problems from you and your doctor

• Phenylketonuria (PKU)?The oral disintegrating tablets may containaspartame, which can make your condition worse.

Proper Use of This Medicine

Take this medicine only as directed by your doctor to benefit yourcondition as much as possible. Do not take more or less of it, do not takeit more or less often, and do not take it for a longer or shorter time thanyour doctor ordered.

Dosing?The dose of risperidone will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of risperidone. If your dose is different,do not change it unless your doctor tells you to do so.

• For symptoms of psychotic disorder:
  • For oral solution dosage form?
    • Adults?At first, 1 milligram (mg) [1 milliliter (mL)] per day.The medicine can be given on a once a day or twice a day schedule. Your doctormay increase your dose as needed. However, the dose usually is not more than16 mg (16 mL) a day.
    • Children younger than 18 years of age?Use and dose must bedetermined by the doctor.
    • Older adults?At first, 0.25 mg or 0.5 mg (0.5 mL) two timesa day. The medicine can be given on a once a day schedule after your doctorhas found the correct dose for you. Your doctor may increase your dose asneeded. However, the dose usually is not more than 3 mg (3 mL) a day.
  • For oral tablet and orally disintegrating tablet dosage forms?
    • Adults?At first, 1 milligram (mg) per day. The medicine canbe given on a once a day or twice a day schedule. Your doctor may increaseyour dose as needed. However, the dose usually is not more than 16 mg a day.
    • Children younger than 18 years of age?Use and dose must bedetermined by the doctor.
    • Older adults?At first, 0.25 mg or 0.5 mg two times a day. Themedicine can be given on a once a day schedule after your doctor has foundthe correct dose for you. Your doctor may increase your dose as needed. However,the dose usually is not more than 3 mg a day.

For patients taking the oral solution form ofrisperidone:

• Measure the dose with the measuring device provided with your medicine.Stir the dose into a small glass (3 to 4 ounces) of water, coffee, orangejuice, or low-fat milk just before taking it. Do not mix this medicine withcola or tea.
• Rinse the empty measuring device with water and place it back inits storage case. Put the plastic cap back on the bottle of medicine.

For patients taking the orally disintegrating tablet form of risperidone:

• Do not open the package until you are ready to take your medicine.To remove one tablet, separate one of the four tablets by tearing apart onperforations. Bend the corner as shown on the package. Peel back the foilto get to the tablet, do not push the tablet throughthe foil because that could damage the tablet.
• Use dry hands and take the tablet out of the package and immediately place it on your tongue. The tablet needs to be used immediatelybecause it can not be stored once it is taken out of the package. Once thetablet is on your tongue it will disintegrate in seconds. You can swallowit with or without liquid. It is important not to splitor chew the tablet.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, nearthe kitchen sink, or in other damp places. Heat or moisture may cause themedicine to break down.
• Keep the solution form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits,especially during the first few months of treatment with this medicine. Thiswill allow the dosage to be changed if necessary to meet your needs.

Do not stop taking this medicine without first checkingwith your doctor. Your doctor may want you to reduce gradually theamount you are taking before stopping completely. This is to prevent sideeffects and to keep your condition from becoming worse.

This medicine may add to the effects of alcohol andother CNS depressants (medicine that makes you drowsy or less alert).Some examples of CNS depressants are antihistamines or medicine for hay fever,other allergies, or colds; sedatives, tranquilizers, or sleeping medicine;prescription pain medicine or narcotics; barbiturates; medicine for seizures;muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above whileyou are using this medicine.

Before having any kind of surgery, dental treatment,or emergency treatment, tell the medical doctor or dentist in charge thatyou are using this medicine. Taking risperidone together with medicinesthat are used during surgery, dental, or emergency treatments may increasethe CNS depressant effects.

This medicine may cause blurred vision, dizziness, or drowsiness. Make sure you know how you react to this medicine before youdrive, use machines, or do anything else that could be dangerous if you arenot alert or able to see clearly.

Dizziness, lightheadedness, or fainting may occur,especially when you get up from a lying or sitting position. Getting up slowlymay help. If the problem continues or gets worse, check with your doctor.

Risperidone may cause your skin to be more sensitive to sunlight than itis normally. Exposure to sunlight, even for brief periods of time, may causea skin rash, itching, redness or other discoloration of the skin, or a severesunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF)of at least 15. You may require a product with a higher SPF number, especiallyif you have a fair complexion. If you have any questions about this, checkwith your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check withyour doctor.

This medicine may make it more difficult for your body to keep a constanttemperature. Use extra care not to become overheated during exercise or hotweather while you are taking this medicine, since overheating may result inheatstroke. Hot baths or saunas may make you feel dizzy or faint while youare taking this medicine. Also, use extra care not to become too cold whileyou are taking risperidone. If you become too cold, you may feel drowsy, confused,or clumsy.

Side Effects of This Medicine

Along with its needed effects, risperidonecan sometimes cause serious side effects. Tardive dyskinesia (a movement disorder)may occur and may not go away after you stop using the medicine. Signs oftardive dyskinesia include fine, worm-like movements of the tongue, or otheruncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs.Other serious but rare side effects may also occur. These include neurolepticmalignant syndrome (NMS), which may cause severe muscle stiffness, fever,severe tiredness or weakness, fast heartbeat, difficult breathing, increasedsweating, loss of bladder control, or seizures. You andyour doctor should discuss the good this medicine will do as well as the risksof taking it.

Stop taking risperidoneand get emergency help immediately if any of the following side effectsoccur:

Rare

Convulsions (seizures); difficult orfast breathing; fast heartbeat or irregular pulse; fever (high); high orlow blood pressure; increased sweating; loss of bladder control; muscle stiffness(severe); unusually pale skin; unusual tiredness or weakness (severe)

Check with your doctor immediately if any ofthe following side effects occur:

More common

Difficulty in speaking or swallowing; inability to move eyes; muscle spasms of face, neck,and back; twisting movements of body

Less common

speech or vision problems; sudden weaknessor numbness in the face, arms or legs

Rare

High body temperature (dizziness; fast, shallow breathing; fast,weak heartbeat; headache; muscle cramps; pale, clammy skin; increased thirst); lip smacking or puckering; low body temperature (confusion, drowsiness, poor coordination, shivering); prolonged, painful, inappropriate erection of thepenis; puffing of cheeks; rapid or worm-like movements of tongue; uncontrolledchewing movements; uncontrolled movements of armsand legs

Check with your doctor as soon as possible if any of the followingside effects occur:

More common

Anxiety or nervousness; changes in vision,including blurred vision; decreased sexual desireor performance; loss of balance control; mask-like face; menstrual changes; mood or mental changes, including aggressive behavior, agitation,difficulty in concentration, and memory problems; problems in urination or increase in amount of urine; restlessness or need to keep moving (severe); shufflingwalk; skin rash or itching; stiffness or weakness of arms or legs; tic-like ortwitching movements; trembling and shaking of fingersand hands; trouble in sleeping

Less common

Back pain; chest pain; unusual secretion of milk

Rare

Extreme thirst; increased blinking orspasms of eyelid; loss of appetite; talking, feeling, and acting with excitement and activity thatcannot be controlled; uncontrolled twisting movementsof neck, trunk, arms, or legs; unusual bleeding orbruising; unusual facial expressions or body positions

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

More common

Constipation; coughing; diarrhea; drowsiness; dryness of mouth; headache; heartburn; increased dream activity; increased length of sleep; nausea; sleepiness or unusual drowsiness; sorethroat; stuffy or runny nose; unusual tiredness or weakness; weight gain

Less common

Back pain; body aches or pain; chills; dandruff; darkening of skin color; dry skin; ear congestion; fever; increase in body movements; increased sensitivityof the skin to sun; increased watering of mouth; joint pain; loss of voice; nasal congestion; oily skin; pain or tenderness around eyes and cheekbones; shortness of breath or troubled breathing; sneezing; stomach pain; toothache; tightness of chest or wheezing; vomiting; weight loss

Some side effects, such asuncontrolled movements of the mouth, tongue, and jaw, or uncontrolled movementsof arms and legs, may occur after you have stopped taking this medicine. Ifyou notice any of these effects, check with your doctor as soon as possible.

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.