Risperdal (Risperidone) 2 mg

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Risperdal Brand is manufactured by Johnson & Johnson Ltd.

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Risperdal (Risperidone) 2 mg

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What is Risperdal (Risperidone)?
 Risperdal (Risperidone) is an antipsychotic medication. It is an "atypical antipsychotic". It works by changing the effects of chemicals in the brain. Risperdal (Risperidone) is used to treat schizophrenia and symptoms of bipolar disorder (manic depression). It is also used in autistic children to treat symptoms of irritability. Risperdal (Risperidone) may also be used for purposes other than those listed in this medication guide.


Important information about  Risperdal (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  Risperdal (Risperidone) to a child without a doctor's advice.While you are taking  Risperdal (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 this medication.  Risperdal (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  Risperdal (Risperidone). Stop using this medication 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 this medication. 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.Before taking  Risperdal (Risperidone)
 Risperdal (Risperidone) is not for use in psychotic conditions that are related to dementia.  Risperdal (Risperidone) has caused fatal heart attack and stroke in older adults with dementia-related conditions. You should not use this medication if you are allergic to risperidone.
 


If you have any of these other conditions, you may need a dose adjustment or special tests to safely take  Risperdal (Risperidone):
    * liver disease;    


    * kidney disease;    


    * heart disease, high blood pressure, heart rhythm problems;    


    * a history of heart attack or stroke;    


    * a history of low white blood cell (WBC) counts;    


    * a history of breast cancer;    


    * seizures or epilepsy;    


    * diabetes (risperidone may raise your blood sugar);    


    * a history of suicidal thoughts;    


    * Parkinson's disease; or    


    * trouble swallowing.
 Risperdal (Risperidone) may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking  Risperdal (Risperidone).
FDA pregnancy category C. It is not known whether  Risperdal (Risperidone) is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether risperidone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.


How should I take  Risperdal (Risperidone)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
 Risperdal (Risperidone) can be taken with or without food.


To take risperidone orally disintegrating tablets ( Risperdal (Risperidone) M-Tabs):
    * Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.    


    * Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.    


    * Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.    


    * Swallow several times as the tablet dissolves. If desired, you may drink liquid after the tablet is completely dissolved.


It is important to take  Risperdal (Risperidone) regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.Measure the liquid form of  Risperdal (Risperidone) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Do not mix the liquid form of  Risperdal (Risperidone) with cola or tea. It may take several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve. Store  Risperdal (Risperidone) at room temperature away from moisture, light, and heat. Do not allow the liquid form of  Risperdal (Risperidone) to freeze.


What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical treatment if you think you have used too much of this medicine.Overdose symptoms may include drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck.


What should I avoid while taking  Risperdal (Risperidone)?
While you are taking  Risperdal (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.
 Risperdal (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  Risperdal (Risperidone).


Side effects of  Risperdal (Risperidone): 
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  Risperdal (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  Risperdal (Risperidone) 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. 


What other drugs will affect  Risperdal (Risperidone)?
Before you take  Risperdal (Risperidone), tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by  Risperdal (Risperidone).
Also tell your doctor if you are taking any of the following medicines:
    * carbamazepine (Carbatrol, Tegretol);    


    * phenytoin (Dilantin);    


    * phenobarbital (Luminal, Solfoton);    


    * clozapine (Clozaril);    


    * fluoxetine (Prozac) or paroxetine (Paxil);    


    * rifampin (Rifadin, Rimactane, Rifater); or    


    * medicines used to treat Parkinson's Disease such as levodopa (Dopar, Larodopa, Sinemet, Atamet, others),bromocriptine (Parlodel, others), pergolide (Permax), pramipexole (Mirapex), or ropinirole (Requip).
This list is not complete and there may be other drugs that can interact with  Risperdal (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.


Generic Name Risperidone
Search Name Risperdal Brand 2 mg Tab
Supply Name Risperdal
Brand Generic BRAND NAME
Presentation Foil in Box
Dosage Tab
USA Brand Risperdal
Manufacture Johnson & Johnson Ltd.
Strength 2 mg
Search Terms Risperdal ,Risperdal ,Risperidone
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to risperidone: oral solution, oral tablet, oral tablet disintegrating

Other dosage forms:

intramuscular powder for suspension extended release
Along with its needed effects, risperidone (the active ingredient contained in Risperdal) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking risperidone:

More common
- Aggressive behavior
- agitation
- anxiety
- changes in vision, including blurred vision
- decreased sexual desire or performance
- difficulty concentrating
- difficulty speaking or swallowing
- inability to move the eyes
- loss of balance control
- mask-like face
- memory problems
- menstrual changes
- muscle spasms of the face, neck, and back
- problems with urination or increase in the amount of urine
- restlessness or need to keep moving (severe)
- shuffling walk
- skin rash or itching
- stiffness or weakness of the arms or legs
- tic-like or twitching movements
- trembling and shaking of the fingers and hands
- trouble sleeping
- twisting body movements

Less common
- Back pain
- chest pain
- speech or vision problems
- sudden weakness or numbness in the face, arms, or legs
- unusual secretion of milk

Rare
- Confusion
- dizziness
- drowsiness
- extreme thirst
- fast, shallow breathing
- fast, weak heartbeat
- headache
- increased thirst
- lip smacking or puckering
- loss of appetite
- muscle cramps
- pale, clammy skin
- poor coordination
- prolonged, painful, inappropriate erection of the penis
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- shivering
- talking, feeling, and acting with excitement and activity that cannot be controlled
- uncontrolled chewing movements
- uncontrolled twisting movements of neck, trunk, arms, or legs
- unusual bleeding or bruising
- unusual facial expressions or body positions

Some side effects of risperidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
- Constipation
- cough
- diarrhea
- dry mouth
- headache
- heartburn
- increased dream activity
- increased length of sleep
- nausea
- sleepiness or unusual drowsiness
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- weight gain

Less common
- Body aches or pain
- chills
- dandruff
- darkening of skin color
- dry skin
- ear congestion
- fever
- increase in body movements
- increased watering of the mouth
- joint pain
- loss of voice
- oily skin
- pain or tenderness around the eyes and cheekbones
- shortness of breath or troubled breathing
- sneezing
- stomach pain
- tightness of the chest or wheezing
- toothache
- vomiting
- weight loss
USUAL ADULT DOSE FOR SCHIZOPHRENIA

Initial dose: 1 mg orally twice a day
Titration dose: May increase in increments of 1 mg twice daily on the second and third day. Dosage adjustments after the third day should be done in one week intervals.
Maximum dose: 16 mg per day

Injection:
For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with risperidone long acting injection.

25 mg every 2 weeks by deltoid or deep IM gluteal injection.

Although dose response for effectiveness has not been established for risperidone long acting injection, some patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg every 2 weeks. When clinical factors warrant a dose adjustment, such as in patients with hepatic or renal dysfunction or a possible drug interaction, a lower initial dose of 12.5 mg may be appropriate; however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Oral risperidone (or another antipsychotic medication) should be given with the first injection and continued for 3 weeks to ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection.

USUAL ADULT DOSE FOR BIPOLAR DISORDER

Long-acting injection:
For monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder:

Recommended dose: 25 mg IM every 2 weeks. Some patients may benefit from a higher dose of 37.5 mg or 50 mg.

Dosages above 50 mg have not been studied in this population.

Risperidone long-acting injection for extended periods should periodically reevaluate the long-term risks and benefits of the drug for the individual patient.

Oral:
For use in the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder:

Initial Dose: 2 or 3 mg orally once a day.

If needed, dosage adjustments should occur at intervals of not less than 24 hours in dosage increments/decrements of 1 mg per day.

Clinical trials for short-term (3 week) antimanic use have reported efficacy at a dosage range of 1 to 6 mg per day. Dosages above 6 mg per day have not been studied.

USUAL GERIATRIC DOSE FOR BIPOLAR DISORDER

For use in the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder:

Initial Dose: 0.5 mg twice a day

If needed, dosage adjustments should occur at intervals of not less than 24 hours in dosage increments/decrements of 1 mg per day.

Clinical trials for short-term (3 week) anti- manic use have reported efficacy at a dosage range of 1 to 6 mg per day. Dosages above 6 mg per day have not been studied.

Note: Use of the long acting injectable form of risperidone is not recommended for this indication.

USUAL GERIATRIC DOSE FOR SCHIZOPHRENIA

Initial dose: 0.5 mg orally twice a day.
Maintenance dose: May increase in 0.5 mg twice a day increments. Dosage increases greater than 1.5 mg per day should be done at greater than 1 week intervals.

Many clinicians recommend a daily dosage of 0.5 to 2 mg in elderly patients for the treatment of schizophrenia. The incidence of side effects, especially extrapyramidal symptoms, has been reported to be increased with doses of 2 mg or greater per day in this population.

Injection:
For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with risperidone long acting injection.

25 mg every 2 weeks by deep IM gluteal injection.

Oral risperidone (or another antipsychotic medication) should be given with the first injection and continued for 3 weeks to ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection.

USUAL PEDIATRIC DOSE FOR AUTISM

Risperidone is approved by the FDA for use in pediatric patients for the treatment of irritability associated with autistic disorder in children and adolescents:

5 years to 18 years; 15 kg to 19 kg body weight:
Initial dose: 0.25 mg orally once a day (or 0.125 mg orally twice a day) for a minimum duration of 4 days
Maintenance dose: 0.5 mg orally once a day (or 0.25 mg orally twice a day) for a minimum duration of 14 days. Then, if necessary, the dose may be titrated upwards in increments of no more than 0.25 mg per day at 2 week intervals.
Maximum recommended dose: 1 mg orally per day

5 years to 18 years; 20 kg to 39 kg body weight:
Initial dose: 0.5 mg orally once a day (or 0.25 mg orally twice a day) for a minimum duration of 4 days
Maintenance dose: 1 mg orally once a day (or 0.5 mg orally twice a day) for a minimum duration of 14 days. Then, if necessary, the dose may be titrated upwards in increments of no more than 0.5 mg per day at 2 week intervals.
Maximum recommended dose: 2.5 mg orally per day (3 mg/day in children over 45 Kg).

5 years to 18 years; at least 40 kg:
Initial dose: 0.5 mg orally once a day (or 0.25 mg orally twice a day) for a minimum duration of 4 days
Maintenance dose: 1 mg orally once a day (or 0.5 mg orally twice a day) for a minimum duration of 14 days. Then, if necessary, the dose may be titrated upwards in increments of no more than 0.5 mg per day at 2 week intervals.
Maximum recommended dose: 3 mg orally per day

Once sufficient clinical response is achieved, clinicians may want to consider a gradual reduction in dose keeping in mind the optimal balance of safety and efficacy.

USUAL PEDIATRIC DOSE FOR BIPOLAR DISORDER

Risperidone is approved by the FDA for use in pediatric patients for the treatment of bipolar mania in children and adolescents:

10 to 17 years:
Initial dose: 0.5 mg once a day
Maintenance dose: Initial dose may be titrated upwards to a maximum recommended dose of 2.5 mg per day. If necessary, upward titration may occur in increments of 0.5 to 1 mg per day at intervals not less than 24 hours.

There are data from clinical studies supporting efficacy in doses up to 6 mg per day in pediatric patients with bipolar mania. However, no additional benefit was observed in doses greater than 2.5 mg per day. In addition, higher doses have been associated with more adverse effects.

USUAL PEDIATRIC DOSE FOR SCHIZOPHRENIA

Risperidone is approved by the FDA for use in the treatment of schizophrenia in adolescents:

13 to 17 years:
Initial dose: 0.5 mg orally once a day
Titrated dose: Initial dose may be titrated upwards in increments of 0.5 to 1 mg per day at intervals not less than 24 hours
Maintenance dose: 3 mg per day
Doses up to 6 mg per day have been studied in the treatment of schizophrenia in adolescents. However, no additional benefit was observed at doses greater than 3 mg per day.

There are no clinical data regarding the use of risperidone in adolescents with schizophrenia for periods exceeding 8 weeks.

RENAL DOSE ADJUSTMENTS

Oral:
Initial dose: 0.5 mg orally twice a day.
Maintenance dose: May increase in 0.5 mg twice a day increments. Dosage increases greater than 1.5 mg/day should be done at greater than 1 week intervals.

Injection:
If a total daily dose of at least 2 mg orally is well tolerated, the long acting intramuscular formulation may be used.

Initial dose: 25 mg every 2 weeks by deep IM gluteal injection.

A starting dose of 12.5 mg IM may be considered when clinical factors warrant a dose adjustment; however, it should be noted that the efficacy of the 12.5 mg dose has not been studied in clinical trials.

LIVER DOSE ADJUSTMENTS

Oral:
Initial dose: 0.5 mg orally twice a day.
Maintenance dose: May increase in 0.5 mg twice a day increments. Dosage increases greater than 1.5 mg per day should be done at greater than 1 week intervals.

Injection:
If a total daily dose of at least 2 mg orally is well tolerated, the long acting intramuscular formulation may be used.

Initial dose: 25 mg every 2 weeks by deep IM gluteal injection.

A starting dose of 12.5 mg IM may be considered when clinical factors warrant a dose adjustment; however, it should be noted that the efficacy of the 12.5 mg dose has not been studied in clinical trials.

DOSE ADJUSTMENTS

A reduction in the initial dosage and a slower titration may be necessary in patients who are debilitated, predisposed to hypotension, or hypotension would pose a risk.

PRECAUTIONS

Risperidone is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia. Collective data from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including risperidone, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug- treated patient than in the placebo- treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

In addition, based on data from four placebo controlled trials conducted in elderly patients (n=1230), cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in elderly patients with dementia- related psychosis. In placebo controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. Risperidone has not been shown to be safe or effective in the treatment of patients with dementia- related psychosis. Additional information on these and other clinical trials conducted in elderly patients can be obtained by calling 1-800- JANSSEN (800-526-7736).

The risperidone long acting intramuscular formulation should be administered into the gluteal muscle with careful avoidance of inadvertent injection into the vasculature.

Safety and effectiveness of the risperidone long acting intramuscular formulation have not been established in pediatric patients (less than 18 years of age).

DIALYSIS

Data not available

OTHER COMMENTS

Doses greater than 6 mg per day are associated with more adverse effects and are generally not recommended, but may be necessary in some patients.

Risperidone induced hyperprolactinemia may be especially detrimental to pediatric patients as it may possibly result in irreversible hypogonadism and osteoporosis.

The therapeutically effective risperidone plasma concentration range is 20 to 60 ng/mL. Plasma concentrations above 74 ng/mL appear to be associated with parkinsonian adverse effects.

Development of hyperglycemia and/or diabetes mellitus is common in patients treated with atypical antipsychotics. Periodic monitoring of fasting plasma glucose is recommended in patients receiving risperidone.