RISPERDAL® (risperidone) is used for the treatment of irritability
associated with autistic disorder in children ages 5-17; the treatment of
schizophrenia in adults; and the treatment of bipolar mania associated with
Bipolar I Disorder in adults.
IMPORTANT SAFETY INFORMATION FOR RISPERDAL
Elderly Patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death compared to placebo.
RISPERDAL (risperidone) is not approved for the treatment of patients with
dementia-related psychosis.
The most common adverse reactions observed in all clinical trials with
RISPERDAL occurring at a rate of at least 10% were somnolence, increased
appetite, fatigue, rhinitis, upper respiratory tract infection, vomiting,
coughing, urinary incontinence, increased saliva, constipation, fever,
tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry
mouth, rash, restlessness, and indigestion.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side
effect reported with RISPERDAL and similar medicines. Call your doctor
immediately if the person being treated develops symptoms such as high fever;
stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate,
or blood pressure; or muscle pain and weakness. Treatment should be stopped
if the person being treated has NMS.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect
reported with RISPERDAL and similar medications. TD includes uncontrollable
movements of the face, tongue, and other parts of the body. The risk of
developing TD and the chance that it will become permanent is thought to
increase with the length of therapy and the overall dose taken by the
patient. This condition can develop after a brief period of therapy at low
doses, although this is much less common. There is no known treatment for TD,
but it may go away partially or completely if therapy is stopped.
RISPERDAL and similar medications can raise the blood levels of a hormone
known as prolactin, causing a condition known as hyperprolactinemia. Blood
levels of prolactin remain elevated with continued use. Some side effects
seen with these medications include the absence of a menstrual period;
breasts producing milk; the development of breasts by males; and the
inability to achieve an erection. The connection between prolactin levels
and side effects is unknown.
High blood sugar and diabetes have been reported with RISPERDAL and similar
medications. If the person being treated has diabetes or risk factors such
as being overweight or a family history of diabetes, blood sugar testing
should be performed at the beginning and throughout treatment. Complications
of diabetes can be serious and even life threatening. If signs of high blood
sugar or diabetes develop, such as being thirsty all the time, going to the
bathroom a lot, or feeling weak or hungry, contact your doctor.
RISPERDAL should be used cautiously in people with a seizure disorder, who
have had seizures in the past, or who have conditions that increase their
risk for seizures.
Some people taking RISPERDAL may feel faint or lightheaded when they stand
up or sit up too quickly. By standing up or sitting up slowly and following
your healthcare professional's dosing instructions, this side effect may be
reduced or it may go away over time.
Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or
muscle disturbances, such as restlessness, tremors, and muscle stiffness. If
you observe any of these symptoms, talk to your healthcare professional.
Some medications interact with RISPERDAL. Please inform your healthcare
professional of any medications or supplements that you are taking. Avoid
alcohol while taking RISPERDAL.
Inform your healthcare professional if you are pregnant or if you are
planning to get pregnant while taking RISPERDAL. Do not breast-feed if you
are taking RISPERDAL.
RISPERDAL may affect your driving ability; therefore, do not drive or
operate machinery before talking to your healthcare professional.
RISPERDAL may affect alertness and motor skills; use caution until the
effect of RISPERDAL is known.
(http://www.risperdal.com/risperdal/ ) What is
Risperdal?
Risperdal is an antipsychotic medication. It is an "atypical antipsychotic".
It works by changing the effects of chemicals in the brain.
Risperdal 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 may also be used for purposes other than those listed in this
medication guide.
Important information about Risperdal
Risperdal is not for use in psychotic conditions that are related to
dementia. Risperdal has caused fatal heart attack and stroke in older adults
with dementia-related conditions.
Do not give this medication to a child without a doctor's advice.
While you are taking Risperdal, 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 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 using other medicines that make you sleepy (such as cold medicine,
pain medication, muscle relaxers, and medicine for seizures, depression or
anxiety). They can add to sleepiness caused by Risperdal.
Avoid drinking alcohol. It can increase some of the side effects of
Risperdal. 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
Risperdal is not for use in psychotic conditions that are related to
dementia. Risperdal 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.
Before taking this medication, tell your doctor if you are allergic to any
drugs, or if you have:
liver disease;
kidney disease;
heart disease, high blood pressure, heart rhythm problems;
a history of heart attack or stroke;
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 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.
The risperidone orally disintegrating tablet may contain phenylalanine. Talk
to your doctor before using this form of risperidone if you have
phenylketonuria (PKU).
FDA pregnancy category C. This medication may be harmful to an unborn baby.
Tell your doctor if you are pregnant or plan to become pregnant during
treatment. It is not known whether this medication 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.
Do not give this medication to a child without a doctor's advice.
How should I take Risperdal?
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 can be taken with or without food.
To take risperidone orally disintegrating tablets (Risperdal 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 regularly to get the most benefit. Get
your prescription refilled before you run out of medicine completely.
Measure the liquid form of Risperdal 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 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 at room temperature away from
moisture, light, and heat. Do not allow the liquid form of Risperdal to
freeze. |
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 (light 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 3 mg and 4 mg RISPERDAL® M-TAB® Orally
Disintegrating Tablets contain xanthan gum.
INDICATIONS
Schizophrenia
Adults
RISPERDAL® (risperidone) is indicated for the acute and maintenance
treatment of schizophrenia
Adolescents
RISPERDAL® is indicated for the treatment of schizophrenia in adolescents
aged 13-17 years
Bipolar Mania
Monotherapy - Adults and Pediatrics
RISPERDAL® is indicated for the short-term treatment of acute manic or mixed
episodes associated with Bipolar I Disorder in adults and in children and
adolescents aged 10-17 years
Combination Therapy -Adults
The combination of RISPERDAL® with lithium or valproate is indicated for the
short-term treatment of acute manic or mixed episodes associated with
Bipolar I Disorder
Irritability Associated with Autistic Disorder
Pediatrics
RISPERDAL® is indicated for the treatment of irritability associated with
autistic disorder in children and adolescents aged 5-16 years, including
symptoms of aggression towards others, deliberate self-injuriousness, temper
tantrums, and quickly changing moods [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Schizophrenia
Adults
Usual Initial Dose
RISPERDAL® can be administered once or twice daily. Initial dosing is
generally 2 mg/day. Dose increases should then occur at intervals not less
than 24 hours, in increments of 1-2 mg/day, as tolerated, to a recommended
dose of 4-8 mg/day. In some patients, slower titration may be appropriate.
Efficacy has been demonstrated in a range of 4-16 mg/day [see Clinical
Studies]. However, doses above 6 mg/day for twice daily dosing were not
demonstrated to be more efficacious than lower doses, were associated with
more extrapyramidal symptoms and other adverse effects, and are generally
not recommended. In a single study supporting once-daily dosing, the
efficacy results were generally stronger for 8 mg than for 4 mg. The safety
of doses above 16 mg/day has not been evaluated in clinical trials.
Maintenance Therapy
While it is unknown how long a patient with schizophrenia should remain on
RISPERDAL®, the effectiveness of RISPERDAL® 2 mg/day to 8 mg/day at delaying
relapse was demonstrated in a controlled trial in patients who had been
clinically stable for at least 4 weeks and were then followed for a period
of 1 to 2 years[see Clinical Studies]. Patients should be periodically
reassessed to determine the need for maintenance treatment with an
appropriate dose.
Adolescents
The dosage of RISPERDAL® should be initiated at 0.5 mg once daily,
administered as a single-daily dose in either the morning or evening. Dosage
adjustments, if indicated, should occur at intervals not less than 24 hours,
in increments of 0.5 or 1 mg/day, as tolerated, to a recommended dose of 3
mg/day. Although efficacy has been demonstrated in studies of adolescent
patients with schizophrenia at doses between 1 and 6 mg/day, no additional
benefit was seen above 3 mg/day, and higher doses were associated with more
adverse events. Doses higher than 6 mg/day have not been studied.
Patients experiencing persistent somnolence may benefit from administering
half the daily dose twice daily.
There are no controlled data to support the longer term use of RISPERDAL®
beyond 8 weeks in adolescents with schizophrenia. The physician who elects
to use RISPERDAL® for extended periods in adolescents with schizophrenia
should periodically re-evaluate the long-term usefulness of the drug for the
individual patient.
Reinitiation of Treatment in Patients Previously Discontinued
Although there are no data to specifically address reinitiation of treatment,
it is recommended that after an interval off RISPERDAL®, the initial
titration schedule should be followed.
Switching From Other Antipsychotics
There are no systematically collected data to specifically address switching
schizophrenic patients from other antipsychotics to RISPERDAL®, or treating
patients with concomitant antipsychotics. While immediate discontinuation of
the previous antipsychotic treatment may be acceptable for some
schizophrenic patients, more gradual discontinuation may be most appropriate
for others. The period of overlapping antipsychotic administration should be
minimized. When switching schizophrenic patients from depot antipsychotics,
initiate RISPERDAL® therapy in place of the next scheduled injection. The
need for continuing existing EPS medication should be re-evaluated
periodically.
Bipolar Mania
Usual Dose Adults
RISPERDAL® should be administered on a once-daily schedule, starting with 2
mg to 3 mg per day. Dosage adjustments, if indicated, should occur at
intervals of not less than 24 hours and in dosage increments/decrements of 1
mg per day, as studied in the short-term, placebo-controlled trials. In
these trials, short-term (3 week) anti-manic efficacy was demonstrated in a
flexible dosage range of 1-6 mg per day [see Clinical Studies]. RISPERDAL®
doses higher than 6 mg per day were not studied.
Pediatrics
The dosage of RISPERDAL® should be initiated at 0.5mg once daily,
administered as a single-daily dose in either the morning or evening. Dosage
adjustments, if indicated, should occur at intervals not less than 24 hours,
in increments of 0.5 or 1 mg/day, as tolerated, to a recommended dose of 2.5
mg/day. Although efficacy has been demonstrated in studies of pediatric
patients with bipolar mania at doses between 0.5 and 6 mg/day, no additional
benefit was seen above 2.5 mg/day, and higher doses were associated with
more adverse events. Doses higher than 6 mg/day have not been studied.
Patients experiencing persistent somnolence may benefit from administering
half the daily dose twice daily.
Maintenance Therapy
There is no body of evidence available from controlled trials to guide a
clinician in the longer-term management of a patient who improves during
treatment of an acute manic episode with RISPERDAL®. While it is generally
agreed that pharmacological treatment beyond an acute response in mania is
desirable, both for maintenance of the initial response and for prevention
of new manic episodes, there are no systematically obtained data to support
the use of RISPERDAL® in such longer-term treatment (i.e., beyond 3 weeks).
The physician who elects to use RISPERDAL® for extended periods should
periodically re-evaluate the long-term risks and benefits of the drug for
the individual patient.
Irritability Associated with Autistic Disorder - Pediatrics (Children and
Adolescents)
The safety and effectiveness of RISPERDAL® in pediatric patients with
autistic disorder less than 5 years of age have not been established.
The dosage of RISPERDAL® should be individualized according to the response
and tolerability of the patient. The total daily dose of RISPERDAL® can be
administered once daily, or half the total daily dose can be administered
twice daily.
Dosing should be initiated at 0.25 mg per day for patients < 20 kg and 0.5
mg per day for patients ≥ 20 kg. After a minimum of four days from treatment
initiation, the dose may be increased to the recommended dose of 0.5 mg per
day for patients < 20 kg and 1 mg per day for patients ≥ 20 kg. This dose
should be maintained for a minimum of 14 days. In patients not achieving
sufficient clinical response, dose increases may be considered at ≥ 2-week
intervals in increments of 0.25 mg per day for patients < 20 kg or 0.5 mg
per day for patients ≥ 20 kg. Caution should be exercised with dosage for
smaller children who weigh less than 15 kg.
In clinical trials, 90% of patients who showed a
response (based on at least 25% improvement on ABC-I, [see Clinical Studies]
received doses of RISPERDAL® between 0.5 mg and 2.5 mg per day. The maximum
daily dose of RISPERDAL® in one of the pivotal trials, when the therapeutic
effect reached plateau, was 1 mg in patients < 20 kg, 2.5 mg in patients ≥
20 kg, or 3 mg in patients > 45 kg. No dosing data is available for children
who weighed less than 15 kg.
Once sufficient clinical response has been achieved and maintained,
consideration should be given to gradually lowering the dose to achieve the
optimal balance of efficacy and safety. The physician who elects to use
RISPERDAL® for extended periods should periodically re-evaluate the long-term
risks and benefits of the drug for the individual patient.
Patients experiencing persistent somnolence may benefit from a once-daily
dose administered at bedtime or administering half the daily dose twice
daily, or a reduction of the dose.
Dosage in Special Populations
The recommended initial dose is 0.5 mg twice daily in patients who are
elderly or debilitated, patients with severe renal or hepatic impairment,
and patients either predisposed to hypotension or for whom hypotension would
pose a risk. Dosage increases in these patients should be in increments of
no more than 0.5 mg twice daily. Increases to dosages above 1.5 mg twice
daily should generally occur at intervals of at least 1 week. In some
patients, slower titration may be medically appropriate.
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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?
While you are taking Risperdal, 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 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 using other medicines that make you sleepy (such as cold medicine,
pain medication, muscle relaxers, and medicine for seizures, depression or
anxiety). They can add to sleepiness caused by Risperdal.
Avoid drinking alcohol. It can increase some of the side effects of
Risperdal.
Risperdal side effects
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 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);
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. Tell your
doctor about any unusual or bothersome side effect.
What other drugs will affect Risperdal?
Before taking this medication, 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. 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.
( http://www.drugs.com/risperdal.html ) |
Elderly or debilitated patients, and patients with renal impairment, may
have less ability to eliminate RISPERDAL® than normal adults. Patients with
impaired hepatic function may have increases in the free fraction of
risperidone, possibly resulting in an enhanced effect [see CLINICAL
PHARMACOLOGY]. Patients with a predisposition to hypotensive reactions or
for whom such reactions would pose a particular risk likewise need to be
titrated cautiously and carefully monitored [see Warnings and PRECAUTIONS].
If a once-daily dosing regimen in the elderly or debilitated patient is
being considered, it is recommended that the patient be titrated on a twice-daily
regimen for 2-3 days at the target dose. Subsequent switches to a once-daily
dosing regimen can be done thereafter.
Co-Administration of RISPERDAL® with Certain Other Medications
Co-administration of carbamazepine and other enzyme inducers (e.g.,
phenytoin, rifampin, phenobarbital) with RISPERDAL® would be expected to
cause decreases in the plasma concentrations of the sum of risperidone and
9-hydroxyrisperidone combined, which could lead to decreased efficacy of
RISPERDAL® treatment. The dose of RISPERDAL® needs to be titrated
accordingly for patients receiving these enzyme inducers, especially during
initiation or discontinuation of therapy with these inducers
Fluoxetine and paroxetine have been shown to increase the plasma
concentration of risperidone 2.5-2.8 fold and 3-9 fold, respectively.
Fluoxetine did not affect the plasma concentration of 9-hydroxyrisperidone.
Paroxetine lowered the concentration of 9-hydroxyrisperidone by about 10%.
The dose of RISPERDAL® needs to be titrated accordingly when fluoxetine or
paroxetine is co-administeredAdministration of RISPERDAL® Oral
Solution
RISPERDAL® Oral Solution can be administered directly from the calibrated
pipette, or can be mixed with a beverage prior to administration. RISPERDAL®
Oral Solution is compatible in the following beverages: water, coffee,
orange juice, and low-fat milk; it is NOT compatible with either cola or tea.
Directions for Use of RISPERDAL® M-TAB® Orally Disintegrating Tablets
Tablet Accessing
RISPERDAL® M-TAB® Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg
RISPERDAL® M-TAB® Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are
supplied in blister packs of 4 tablets each.
Do not open the blister until ready to administer. For single tablet removal,
separate one of the four blister units by tearing apart at the perforations.
Bend the corner where indicated. Peel back foil to expose the tablet. DO NOT
push the tablet through the foil because this could damage the tablet.
RISPERDAL® M-TAB® Orally Disintegrating Tablets 3 mg and 4 mg
RISPERDAL® M-TAB® Orally Disintegrating Tablets 3 mg and 4 mg are supplied
in a child-resistant pouch containing a blister with 1 tablet each.
The child-resistant pouch should be torn open at the notch to access the
blister. Do not open the blister until ready to administer. Peel back foil
from the side to expose the tablet. DO NOT push the tablet through the foil,
because this could damage the tablet.
Tablet Administration
Using dry hands, remove the tablet from the blister unit and immediately
place the entire RISPERDAL® M-TAB® Orally Disintegrating Tablet on the
tongue. The RISPERDAL® M-TAB® Orally Disintegrating Tablet should be
consumed immediately, as the tablet cannot be stored once removed from the
blister unit. RISPERDAL® M-TAB® Orally Disintegrating Tablets disintegrate
in the mouth within seconds and can be swallowed subsequently with or
without liquid. Patients should not attempt to split or to chew the tablet.
Dosage Forms And Strengths
RIPSERDAL® Tablets are available in the following strengths and colors: 0.25
mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow),
and 4 mg (green). All are capsule shaped, and imprinted with “JANSSEN” on
one side and either “Ris 0.25”, “Ris 0.5”, “R1”, “R2”, “R3”, or “R4” on the
other side according to their respective strengths.
RISPERDAL® Oral Solution is available in a 1 mg/mL strength.
RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in the
following strengths, colors, and shapes: 0.5 mg (light coral, round), 1 mg (light
coral, square), 2 mg (light coral, round), 3 mg (coral, round), and 4 mg (coral,
round). All are biconvex and etched on one side with “R0.5”, “R1”, “R2”,
“R3”, or “R4” according to their respective strengths.
(http://www.rxlist.com/cgi/generic/risperid_ids.htm )
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SIDE EFFECTS
The following findings are based on the short-term, placebo-controlled,
North American, premarketing trials for schizophrenia and acute bipolar
mania, and are followed by a description of adverse events and other safety
measures in short-term, placebo-controlled trials in pediatric patients
treated for irritability associated with autistic disorder. In patients with
Bipolar I Disorder, treatment-emergent adverse events are presented
separately for risperidone as monotherapy and as adjunctive therapy to mood
stabilizers.
Certain portions of the discussion below relating to objective or numeric
safety parameters, namely dose-dependent adverse events, vital sign changes,
weight gain, laboratory changes, and ECG changes are derived from studies in
patients with schizophrenia. However, this information is also generally
applicable to bipolar mania and pediatric patients with autistic disorder.
Associated With Discontinuation of Treatment
Schizophrenia
Approximately 9% (244/2607) of RISPERDAL® (risperidone)-treated patients in
Phase 2 and 3 studies discontinued treatment due to an adverse event,
compared with about 7% on placebo and 10% on active control drugs. The more
common events (≥0.3%) associated with discontinuation and considered to be
possibly or probably drug-related included (http://www.rxlist.com/cgi/generic/risperid_ad.htm
Description
Risperidone is a antipsychotic medication and is used to treat patients that
suffer from delusions, hallucinations, unorganized thought and hostility.
This is a psychiatric medication that works by helping ot restore the
balance of certain natural substances in the brain (neurotransmitters).
General Information
This information is for educational purposes only. Not every known side
effect, adverse effect, or drug interaction is in this database. If you have
questions about your medicines, talk to your healthcare provider.
Proper use of this medicine
Take this medicine exactly as directed by your doctor or pharmacist. This
medicine should be taken continually, even if you are feeling better. Follow
the directions on your prescription label. Do not take more or less of this
medicine that prescribed. Do not share this medicine with other people. This
medicine may come in a blister pack. Do not remove the tablet fro the
packaging until you are ready to take the dose. Tear apart the package at
the perforation. Bend the corner of the package where directed and peel back
the foil to show the tablet. Do not try to push the tablet through the foil,
this can damage the tablet. Remove the tablet from the foil package with dry
hands and place it immediately on your tongue. Do not split or chew the
tablet. The tablet will melt on your tongue in a few seconds. After the
tablet melts on your tongue, it can be swallowed with or without water or
liquid.
Missed Dose
Take your next dose as soon as you remember. If it is time for your next
dose, skip the missed dose and go back to your regular schedule. Do not
double doses.
Storage
Keep this medication in the container it came in, tightly closed, and out of
reach of children. Store it at room temperature and away from excess heat
and moisture. Throw away any medication that is outdated or no longer needed.
Possible Side Effects
This medicine can cause the following side effects:
constipation
dizziness
drowsiness
dry mouth
headache
weight gain
restlessness
mild thirst
frequent urination
drowsiness
fine hand tremor
mild nausea
Check with your doctor AS SOON AS POSSIBLE if you experience diarrhea,
vomiting, unsteadiness, difficulty walking, or unusual muscle weakness.
This medicine may increase blood sugar (hyperglycemia). Diabetic patients
should be cautious of this and regularly check their blood sugar.
Warnings/Precautions
Several days to weeks may pass before you feel the the full effects of this
medicine.
Before taking this medicine, notify your doctor if you are allergic to it;
or if you have any other allergies to medications.
Before using this medicine, tell your doctor if you have a history of:
liver disease
kidney disease
low blood pressure
seizures
difficulty swallowing (especially in patients with dementia or Alzheimer's
disease)
stroke
dehydration
breast cancer
diabetes
Alcoholic beverages can increase the effects of this medicine and should be
avoided.
Be cautious when driving or performing other hazardous activities. This
medicine can impair judgment.
This medication contains aspartame. If you have phenylketonuria (PKU) or any
other condition where you must restrict your intake of aspartame (or
phenylalamine), consult with your doctor before taking this medicine.
Overdose
Seek medical attention immediately. U.S. residents can call the national
poison hotline at 1-800-222-1222. Canadian residents should call their local
poison control center directly.
Drug Interactions
Let your doctor know if you are taking any of the following types of
medications:
antacids
antihistamines
diet pills
benztropine (Cogentin)
bromocriptine (Parlodel)
carbamazepine (Tegretol)
dicyclomine (Bentyl)
fluoxetine (Prozac)
guanethidine (Ismelin)
lithium
meperidine (Demerol)
methyldopa (Aldomet)
phenytoin (Dilantin)
propranolol (Inderal)
sedatives
trihexyphenidyl (Artane)
valproic acid (Depakene)
cold medications
medications for depression
vitamins and herbs
Inform your doctor of all the medications you may use (both prescription and
nonprescription), especially if you are taking any of the following:
anti-depressant
anti-anxiety drugs
sparfloxacin
grepafloxacin
guanethidine
guanadrel
lithium
metrizamide
cabergoline
tranquilizers
barbiturates
sleeping pills
narcotic pain
medication (e.g. codeine)
other medicines that make you drowsy.
Many cough-and-cold products contain ingredients that may add a drowsiness
effect. Before you use cough-and-cold medications, ask your doctor or
pharmacist about the safe use of those products.
Pregnancy/Nursing
Tell your doctor if you are pregnant or planning to become pregnant. For
women: since this medicine is excreted in human breast milk, you should NOT
breastfeed while taking this medicine.
More Information
There may be a slightly increased risk of serious, possibly fatal side
effects (e.g., stroke, heart failure) when this medicaion is used in elderly
patients with dementia. Discuss the risks and benefits of this medication
with your doctor. ( http://psychcentral.com/meds/risperdal.html ) |
How does Risperdal work? What will it do for me?
Risperidone belongs to the group of medications known as antipsychotic
agents. These medications are used to treat mental and emotional problems
such as schizophrenia and bipolar disorder. Schizophrenia can cause symptoms
such as hallucinations (e.g., hearing, seeing, or sensing things that are
not there), delusions, unusual suspiciousness, and emotional withdrawal.
People with this condition may also feel depressed, anxious, or tense.
Bipolar disorder was previously referred to as manic depressive illness and
causes alternating episodes of mania and depression.
Risperidone is also used for the short-term treatment of behavioural
problems (such as verbal or physical aggression, suspiciousness, and
agitation) in people with severe dementia. Medications like risperidone are
thought to work by correcting the function of nerve pathways in certain
areas of the brain.
Your doctor may have suggested this medication for conditions other than the
ones listed in these drug information articles. If you have not discussed
this with your doctor or are not sure why you are taking this medication,
speak to your doctor. Do not stop taking this medication without consulting
your doctor.
Do not give this medication to anyone else, even if they have the same
symptoms as you do. It can be harmful for people to take this medication if
theortheir doctor has not prescribed it.
How should I use Risperdal?
For adults with schizophrenia, the dose is usually started at 1 mg to 2 mg
per day (given either once or twice per day) and increased slowly over
several days to 4 mg to 6 mg per day. Lower doses are often used for people
with low blood pressure, kidney problems, or liver disease.
For seniors with schizophrenia, the dose is usually 0.25 mg given twice
daily to a maximum daily dose of 3 mg.
For behavioural problems in people with severe dementia, the usual starting
dose is 0.5 mg per day (0.25 mg twice a day). This dose is slowly increased
to a usual dose of 1 mg per day (0.5 mg twice a day). The safety of
risperidone has not been established beyond a maximum dose of 16 mg per day
(8 mg given twice daily).
Risperidone can be taken with or without meals. Risperdal M-Tabs should not
be split into halves. The oral solution should not be taken with cola or tea.
Many things can affect the dose of medication that a person needs, such as
body weight, other medical conditions, and other medications. If your doctor
has recommended a dose different from the ones listed here, do not change
the way that you are taking the medication without consulting your doctor.
The dose of risperidone varies according to needs and the condition being
treated.
It is important to use this medication exactly as prescribed by your doctor.
If you miss a dose, take it as soon as possible and continue with your
regular schedule. If it is almost time for your next dose, skip the missed
dose and continue with your regular dosing schedule. Do not take a double
dose to make up for a missed one.
Store risperidone at room temperature in a dry place (not the bathroom),
protect it from light, and keep it out of the reach of children.
What form(s) does Risperdal come in?
0.25 mg
Each yellow, oblong, biconvex tablet, marked "JANSSEN" on one side and "Ris
0.25" on the other side, contains risperidone 0.25 mg. Nonmedicinal
ingredients: colloidal silicon dioxide, cornstarch, hydroxypropyl
methylcellulose, lactose, magnesium stearate, microcrystalline cellulose,
propylene glycol, sodium lauryl sulfate, talc, titanium dioxide and yellow
ferric oxide.
0.5 mg
Each brownish-red, half-scored, oblong, biconvex tablet, marked "JANSSEN" on
one side and "Ris 0.5" on the other side, contains risperidone 0.5 mg.
Nonmedicinal ingredients: colloidal silicon dioxide, cornstarch,
hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline
cellulose, propylene glycol, red ferric oxide, sodium lauryl sulfate, talc
and titanium dioxide.
1 mg
Each white, unscored, oblong, biconvex tablet, marked "Ris" and "1" on one
side, contains risperidone 1 mg. Nonmedicinal ingredients: colloidal silicon
dioxide, cornstarch, hydroxypropyl methylcellulose, lactose, magnesium
stearate, microcrystalline cellulose, propylene glycol and sodium lauryl
sulfate.
2 mg
Each orange, scored, oblong, biconvex tablet, marked "Ris" and "2" on one
side, contains risperidone 2 mg. Nonmedicinal ingredients: colloidal silicon
dioxide, cornstarch, FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl
methylcellulose, lactose, magnesium stearate, microcrystalline cellulose,
propylene glycol, sodium lauryl sulfate, talc and titanium dioxide.
3 mg
Each yellow, scored, oblong, biconvex tablet, marked "Ris" and "3" on one
side, contains risperidone 3 mg. Nonmedicinal ingredients: colloidal silicon
dioxide, cornstarch, D&C Yellow No. 10, hydroxypropyl methylcellulose,
lactose, magnesium stearate, microcrystalline cellulose, propylene glycol,
sodium lauryl sulfate, talc and titanium dioxide.
4 mg
Each green, scored, oblong, biconvex tablet, marked "Ris" and "4" on one
side, contains risperidone 4 mg. Nonmedicinal ingredients: colloidal silicon
dioxide, cornstarch, D&C Yellow No. 10, FD&C Blue No. 2 Aluminum Lake,
hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline
cellulose, propylene glycol, sodium lauryl sulfate, talc and titanium
dioxide.
Some medications may have other generic brands available. Always ask your
doctor or pharmacist about the safety of switching between brands of the
same medication.
Who should NOT take Risperdal?
Anyone allergic to this medication or the ingredients of the medication
should not use it.
What side effects are possible with Risperdal?
Many medications can cause side effects. A side effect is an unwanted
response to a medication when it is taken in normal doses. Side effects can
be mild or severe, temporary or permanent. The side effects listed below are
not experienced by everyone who takes this medication. If you are concerned
about side effects, discuss the risks and benefits of this medication with
your doctor.
The following side effects have been reported by at least 1% of people
taking this medication.
Contact your doctor if you experience these side effects and they are severe
or bothersome. Your pharmacist may be able to advise you on managing side
effects.
In people with schizophrenia, the most common side effects are:
agitation
anxiety
difficulty sleeping
headache
runny nose
Check with your doctor as soon as possible if any of the following side
effects occur:
muscle twitching or spasms (of the face, neck, or body)
abnormal movements of the face or tongue
large changes in body temperature
fainting
twisting movements of the body
trouble speaking or swallowing
difficulty moving eyes
changes in vision
loss of balance control
mask-like face
menstrual changes
mood or mental changes |
Stop taking the medication and seek immediate medical
attention if any of the following occur:
confusion
difficult or fast breathing
an erection that lasts more than 4 hours without sexual stimulation
fast or irregular heart beat
high fever
increased sweating
loss of bladder control
reduced consciousness
seizures
severe muscle stiffness
signs of a stroke:
sudden weakness or numbness in the face, arms, or legs (often on one side of
the body)
speech problems
vision problems
balance problems or dizziness
confusion
sudden severe headache with no known cause
signs of a heart attack:
discomfort or pain in the chest, back, neck, jaw, arms, or stomach
sweating
shortness of breath
nausea
lightheadedness
feeling of impending doom
suicidal thoughts
unusually high or low blood pressure
unusually pale skin
Some people may experience side effects other than those listed. Check with
your doctor if you notice any symptom that worries you while you are taking
this medication.
Are there any other precautions or warnings for Risperdal?
Be sure to inform your physician of all your medical conditions before you
begin taking a medication. Some conditions can affect how you should take
this medication.
Drowsiness/reduced alertness: Risperidone may interfere with activities
requiring mental alertness. Those taking this medication should not to drive
or operate machinery until they have determined whether or not it affects
them in this way.
Low blood pressure: Risperidone may cause a lowering of blood pressure when
rising from a sitting or lying position, or a racing heart rate, especially
during the few weeks of treatment. If you feel dizzy or lightheaded or feel
your pulse is racing, call your doctor. Because this medication can cause
dizziness or lightheadedness, do not get up too quickly after you have been
sitting or lying for prolonged periods. You should not drive or operate
machinery until you are reasonably certain that risperidone does not affect
your ability to carry out these activities.
Neuroleptic malignant syndrome (NMS): Risperidone, like other antipsychotic
medications, can cause a potentially fatal syndrome known as neuroleptic
malignant syndrome (NMS). If you notice the symptoms of NMS, get immediate
medical attention. Symptoms include high fever, muscle stiffness, confusion
or loss of consciousness, sweating, racing or irregular heartbeat, and
fainting.
Parkinson's disease: Risperidone may cause a deterioration in the condition
of people with Parkinson's disease and should therefore be used with caution.
Seizures: Risperidone may increase the risk of seizures, especially in
people who have had seizures in the past. People who are at risk of seizures
who take this medication should be closely monitored by their doctor.
Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially
irreversible, involuntary, repetitive movements of the face and tongue
muscles, may develop in people who take certain antipsychotic medications.
Although TD appears most commonly in seniors, especially women, it is
impossible to predict who will develop TD. The risk of developing TD
increases with higher doses and long-term treatment.
If signs and symptoms of TD develop during treatment with risperidone,
contact your doctor as soon as possible.
Weight gain: With long-term treatment, weight gain (averaging 2.3 kg) has
occurred in those who take this medication.
Pregnancy: The safety of risperidone for use during pregnancy has not been
established. Risperidone should not be used during pregnancy unless the
expected benefits outweigh the potential risks.
Breast-feeding: It is not known whether risperidone passes into breast milk.
Women taking risperidone should not breast-feed.
Children and adolescents: The safety and effectiveness of risperidone for
use by children and adolescents under 18 years old have not been established.
Seniors: There may be a higher risk of strokes, heart attacks, and deaths
associated with the use of risperidone by people with dementia. Talk to your
doctor about the risks and benefits of using this medication. If you notice
the following signs and symptoms, get medical attention immediately:
signs of a stroke: sudden weakness or numbness in the face, arms or legs (often
on one side of the body); speech problems; vision problems; balance problems
or dizziness; confusion; sudden severe headache with no known cause
signs of a heart attack: discomfort or pain in the chest, back, neck, jaw,
arms, or stomach; sweating; shortness of breath; nausea; lightheadedness;
feeling of impending doom.
What other drugs could interact with Risperdal?
The following may affect the way that risperidone works or
increase the risk of side effects:
alcohol
amiodarone
blood pressure-lowering medications
carbamazepine
cimetidine
clomipramine
clozapine
desipramine
fluoxetine
fluphenazine
haloperidol paroxetine
propafenone
quinidine
ritonavir
sedating medications
sertraline
thioridazine
valproic acid
venlafaxine
The following medications may be affected by risperidone or increase the
risk of side effects:
alcohol
blood pressure-lowering medications
clomipramine
desipramine
dopamine agonists (e.g., pramipexole, ropinirole)
fluphenazine
levodopa
propafenone
quinidine
ritonavir
sedating medications
sertraline
thioridazine
valproic acid
venlafaxine
If you are taking any of these medications, speak with your doctor or
pharmacist. Depending on your specific circumstances, your doctor may want
you to:
stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
leave everything as is.
An interaction between two medications does not always mean that you must
stop taking one of them. Speak to your doctor about how any drug
interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication.
Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription),
and herbal medications you are taking. Also tell them about any supplements
you take. Since caffeine, alcohol, the nicotine from cigarettes, or street
drugs can affect the action of many medications, you should let your
prescriber know if you use them. (http://chealth.canoe.ca/drug_info_details.asp?channel_
d=0&relation_id=0&brand_name_id=970&page_no=2 )
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