Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1951
Predicate | Object |
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rdf:type | |
rdfs:label |
Risperdal (Tablet, Orally Disintegrating)
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dailymed-instance:dosage |
Schizophrenia:<br/>Usual Initial Dose: RISPERDAL (risperidone) can be
administered on either a BID or a QD schedule. In early clinical trials, RISPERDAL was
generally administered at 1 mg BID initially, with increases in increments
of 1 mg BID on the second and third day, as tolerated, to a target dose of
3 mg BID by the third day. Subsequent controlled trials have indicated that
total daily risperidone doses of up to 8 mg ona QD regimen are also safe
and effective. However, regardless of which regimen is employed, in some patients
a slower titration may be medically appropriate. Further dosage adjustments,
if indicated, should generally occur at intervals of not less than 1 week,
since steady state for the active metabolite would not be achieved for approximately
1 week in the typical patient. When dosage adjustments are necessary, small
dose increments/decrements of 1���2 mg are recommended. Efficacy in schizophrenia was demonstrated in a dose range
of 4 to 16 mg/day in the clinical trials supporting effectiveness of RISPERDAL;
however, maximal effect was generally seen in a range of 4 to 8 mg/day. Doses
above 6 mg/day for BID dosing were not demonstrated to be more efficacious
than lower doses, were associated with more extrapyramidal symptoms and other
adverse effects, and are not generally recommended. In a single study supporting
QD 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.<br/>Maintenance Therapy: While there is no body of evidence available to
answer the question of how long the schizophrenic patient treated with RISPERDAL should
remain on it, 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. In this trial, RISPERDAL was
administered on a QD schedule, at 1 mg QD initially, with increases to 2 mg
QD on the second day, and to a target dose of 4 mg QD on the third day (see CLINICAL PHARMACOLOGY���Clinical
Trials). Nevertheless, patients should be periodically reassessed
to determine the need for maintenance treatment with an appropriate dose.<br/>Reinitiation of Treatment in Patients Previously Discontinued: Although there are no data to specifically address
reinitiation of treatment, it is recommended that when restarting patients
who have had an interval off RISPERDAL, the initial titration
schedule should be followed.<br/>Switching From Other Antipsychotics: There are no systematically collected data to
specifically address switching schizophrenic patients from other antipsychotics
to RISPERDAL, or concerning concomitant administration with
other 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. In all cases, the period
of overlapping antipsychotic administration should be minimized. Whenswitching
schizophrenic patients from depot antipsychotics, if medically appropriate,
initiate RISPERDAL therapy in place of the next scheduled
injection. The need for continuing existing EPS medication should be re-evaluated
periodically.<br/>Pediatric Use: The safety and effectiveness of RISPERDAL in
pediatric patients with schizophrenia have not been established.<br/>Bipolar Mania:<br/>Usual Dose: Risperidone 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
PHARMACOLOGY���Clinical Trials). RISPERDAL doses
higher than 6 mg per day were not studied.<br/>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 risperidone. 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 supportthe use of risperidone in such longer-term treatment (i.e., beyond
3 weeks).<br/>Pediatric Use: The safety and effectiveness of RISPERDAL in
pediatric patients with bipolar mania have not been established.<br/>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 PHARMACOLOGY���Clinical Trials) 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
1.0 mg in patients<20 kg, 2.5 mg in patients���20 kg, or 3.0 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. 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.<br/>Dosage in Special Populations: The recommended initial dose is 0.5 mg BID 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 BID. Increases to dosages above 1.5 mg BID should generally
occur at intervals of at least 1 week. In some patients, slower titration
may be medically appropriate. 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 .
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 . If a
once-a-day dosing regimen in the elderly or debilitated patient is being considered,
it is recommended that the patient be titrated on a twice-a-day regimen for
2���3 days at the target dose. Subsequent switches to a once-a-day dosing
regimen can be done thereafter.<br/>Co-Administration of RISPERDAL with Certain Other
Medications: Co-administration of carbamazepine and other enzyme
inducers (e.g., phenytoin, rifampin, phenobarbital) with risperidone would
be expected to cause decreases in the plasma concentrations of active moiety
(the sum of risperidone and 9-hydroxyrisperidone), which could lead to decreased
efficacy of risperidone treatment. The dose of risperidone 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 risperidone needs to be
titrated accordingly when fluoxetine or paroxetine is co-administered .<br/>Directions for Use of RISPERDAL' M-TAB' Orally Disintegrating
Tablets:<br/>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 tablet units 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-resistent 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 put the tablet through the foil, because
this could damage the tablet.<br/>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.
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dailymed-instance:descripti... |
RISPERDAL (risperidone) is a psychotropic
agent belonging to the chemical class of benzisoxazole derivatives. The chemical
designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-
6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular
formula is CHFNOand its
molecular weight is 410.49. The structural formula is: Risperidone is
a white to slightly beige powder. It is practically insoluble in water, freely
soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. 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. Inactive ingredients
are colloidal silicon dioxide, hypromellose, lactose, magnesium stearate,
microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch
(corn). Tablets of 0.25, 0.5, 2, 3, and 4 mg 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. The inactive ingredients for this
solution are 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.
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dailymed-instance:clinicalP... |
Pharmacodynamics: The mechanism of action of RISPERDAL (risperidone),
as with other drugs used to treat schizophrenia, is unknown. However, it has
been proposed that the drug's therapeutic activity in schizophrenia is
mediated through a combination of dopamine Type 2 (D) and serotonin
Type 2 (5HT) receptor antagonism. Antagonism at receptors other
than Dand 5HTmay explain some of the other effects
of RISPERDAL. RISPERDAL is
a selective monoaminergic antagonist with high affinity (Ki of 0.12 to 7.3
nM) for the serotonin Type 2 (5HT), dopamine Type 2 (D),��and��adrenergic, and Hhistaminergic
receptors. RISPERDAL acts as an antagonist at other receptors,
but with lower potency. RISPERDAL has low to moderate affinity
(Ki of 47 to 253 nM) for the serotonin 5HT, 5HT,
and 5HTreceptors, weak affinity (Ki of 620 to 800 nM) for the
dopamine Dand haloperidol-sensitive sigma site, and no affinity
(when tested at concentrations>10M) for cholinergic muscarinic
or��and��adrenergic receptors.<br/>Pharmacokinetics:<br/>Absorption: Risperidone is well absorbed. The absolute oral
bioavailability of risperidone is 70% (CV=25%). The relative oral bioavailability
of risperidone from a tablet is 94% (CV=10%) when compared to a solution. Pharmacokinetic studies showed that RISPERDAL M-TAB Orally
Disintegrating Tablets and RISPERDAL Oral Solution are bioequivalent
to RISPERDAL Tablets. Plasma
concentrations of risperidone, its major metabolite, 9-hydroxyrisperidone,
and risperidone plus 9-hydroxyrisperidone are dose proportional over the dosing
range of 1 to 16 mg daily (0.5 to 8 mg BID). Following oral administration
of solution or tablet, mean peak plasma concentrations of risperidone occurred
at about 1 hour. Peak concentrations of 9-hydroxyrisperidone occurred at about
3 hours in extensive metabolizers, and 17 hours in poor metabolizers.Steady-state
concentrations of risperidone are reached in 1 day in extensive metabolizers
and would be expected to reach steady-state in about 5 days in poor metabolizers.
Steady-state concentrations of 9-hydroxyrisperidone are reached in 5���6
days (measured in extensive metabolizers).<br/>Distribution: Risperidone is rapidly distributed. The volume
of distribution is 1���2 L/kg. In plasma, risperidone is bound to albumin
and��-acid glycoprotein. The plasma protein binding of risperidone
is 90%, and that of its major metabolite, 9-hydroxyrisperidone, is 77%. Neither
risperidone nor 9-hydroxyrisperidone displaces each other from plasma binding
sites. High therapeutic concentrations of sulfamethazine (100 mcg/mL), warfarin
(10 mcg/mL), and carbamazepine (10 mcg/mL) caused only a slight increase in
the free fraction of risperidone at 10 ng/mL and 9-hydroxyrisperidone at 50
ng/mL, changes of unknown clinical significance.<br/>Metabolism and Drug Interactions: Risperidone is extensively metabolized in the
liver. The main metabolic pathway is through hydroxylation of risperidone
to 9-hydroxyrisperidone by the enzyme, CYP 2D6. A minor metabolic pathway
is through N-dealkylation. The main metabolite, 9-hydroxyrisperidone, has
similar pharmacological activity as risperidone. Consequently, the clinical
effect of the drug (e.g., the active moiety) results from the combined concentrations
of risperidone plus 9-hydroxyrisperidone. CYP
2D6, also called debrisoquin hydroxylase, is the enzyme responsible for metabolism
of many neuroleptics, antidepressants, antiarrhythmics, and other drugs. CYP
2D6 is subject to genetic polymorphism (about 6%���8% of Caucasians,
and a very low percentage of Asians, have little or no activity and are "poor
metabolizers") and to inhibition by a variety of substrates and some non-substrates,
notably quinidine. Extensive CYP 2D6 metabolizers convert risperidone rapidly
into 9-hydroxyrisperidone, whereas poor CYP 2D6 metabolizers convert it much
more slowly. Although extensive metabolizers have lower risperidone and higher
9-hydroxyrisperidone concentrations than poor metabolizers, the pharmacokinetics
of the active moiety, after single and multiple doses, are similar in extensive
and poor metabolizers. Risperidone could
be subject to two kinds of drug-drug interactions . First, inhibitors of CYP 2D6 interfere
with conversion of risperidone to 9-hydroxyrisperidone. This occurs with quinidine,
giving essentially all recipients a risperidone pharmacokinetic profile typical
of poor metabolizers. The therapeutic benefits and adverse effects of risperidone
in patients receiving quinidine have not been evaluated, but observations
in a modest number (n70)
of poor metabolizers given risperidone do not suggest important differences
between poor and extensive metabolizers. Second, co-administration of known
enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital) with risperidone
may cause a decrease in the combined plasma concentrations of risperidone
and 9-hydroxyrisperidone. It would also be possible for risperidone to interfere
with metabolism of other drugs metabolized by CYP 2D6. Relatively weak binding
of risperidone to the enzyme suggests this is unlikely. In a drug interaction study in schizophrenic patients, 11 subjects
received risperidone titrated to 6 mg/day for 3 weeks, followed by concurrent
administration of carbamazepine for an additional 3 weeks. During co-administration,
the plasma concentrations of risperidone and its pharmacologically active
metabolite, 9-hydroxyrisperidone, were decreased by about 50%. Plasma concentrations
of carbamazepine did not appear to be affected. Co-administration of other
known enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital) with
risperidone may cause similar decreases in the combined plasma concentrations
of risperidone and 9-hydroxyrisperidone, which could lead to decreased efficacy
of risperidonetreatment (see PRECAUTIONS���Drug Interactions and DOSAGE
AND ADMINISTRATION���Co-Administration of RISPERDAL' with Certain
Other Medications). Fluoxetine
(20 mg QD) and paroxetine (20 mg QD) 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%
. Repeated oral doses of risperidone (3 mg BID) did not
affect the exposure (AUC) or peak plasma concentrations (C)
of lithium (n=13) . Repeated
oral doses of risperidone (4 mg QD) did not affect the pre-dose or average
plasma concentrations and exposure (AUC) of valproate (1000 mg/day in three
divided doses) compared to placebo (n=21). However, there was a 20% increase
in valproate peak plasma concentration (C) after concomitant
administration of risperidone . There
were no significant interactions between risperidone (1 mg QD) and erythromycin
(500 mg QID) (see PRECAUTIONS���Drug Interactions). Cimetidine
and ranitidine increased the bioavailability of risperidone by 64% and 26%,
respectively. However, cimetidine did not affect the AUC of the active moiety,
whereas ranitidine increased the AUC of the active moiety by 20%. Amitriptyline did not affect the pharmacokinetics of risperidone
or the active moiety. In drug interaction
studies, risperidone did not significantly affect the pharmacokinetics of
donepezil and galantamine, which were metabolized by CYP 2D6. RISPERDAL' (0.25 mg BID) did not show a clinically
relevant effect on the pharmacokinetics of digoxin.<br/>Excretion: Risperidone and its metabolites are eliminated
via the urine and, to a much lesser extent, via the feces. As illustrated
by a mass balance study of a single 1 mg oral dose of 14C-risperidone administered
as solution to three healthy male volunteers, total recovery of radioactivity
at 1 week was 84%, including 70% in the urine and 14% in the feces. The apparent half-life of risperidone was 3 hours (CV=30%)
in extensive metabolizers and 20 hours (CV=40%) in poor metabolizers. The
apparent half-life of 9-hydroxyrisperidone was about 21 hours (CV=20%) in
extensive metabolizers and 30 hours (CV=25%) in poor metabolizers. The pharmacokinetics
of the active moiety, after single and multiple doses, were similar in extensive
and poor metabolizers, with an overall mean elimination half-life of about
20 hours.<br/>Special Populations:<br/>Renal Impairment: In patients with moderate to severe renal disease,
clearance of the sum of risperidone and its active metabolite decreased by
60% compared to young healthy subjects. RISPERDAL doses should
be reduced in patients with renal disease .<br/>Hepatic Impairment: While the pharmacokinetics of risperidone in subjects
with liver disease were comparable to those in young healthy subjects, the
mean free fraction of risperidone in plasma was increased by about 35% because
of the diminished concentration of both albumin and��-acid
glycoprotein. RISPERDAL doses should be reduced in patients
with liver disease .<br/>Elderly: In healthy elderly subjects, renal clearance of
both risperidone and 9-hydroxyrisperidone was decreased, and elimination half-lives
were prolonged compared to young healthy subjects. Dosing should be modified
accordingly in the elderly patients (see DOSAGE
AND ADMINISTRATION).<br/>Pediatric: The pharmacokinetics of risperidone and 9-hydroxyrisperidone
in children were similar to those in adults after correcting for the difference
in body weight.<br/>Race and Gender Effects: No specific pharmacokinetic study was conducted
to investigate race and gender effects, but a population pharmacokinetic analysis
did not identify important differences in the disposition of risperidone due
to gender (whether corrected for body weight or not) or race.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
RISPERDAL (risperidone) is contraindicated
in patients with a known hypersensitivity to the product.
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dailymed-instance:supply |
RISPERDAL (risperidone) tablets are
imprinted "JANSSEN", and either "Ris" and the strength "0.25", "0.5", or "R"
and the strength "1", "2", "3", or "4". 0.25
mg dark yellow tablet: bottles of 60 NDC 50458-301-04, bottles of 500 NDC
50458-301-50, hospital unit dose packs of 100 NDC 50458-301-01. 0.5 mg red-brown tablet: bottles of 60 NDC 50458-302-06, bottles
of 500 NDC 50458-302-50, hospital unit dose packs of 100 NDC 50458-302-01. 1 mg white tablet: bottles of 60 NDC 50458-300-06, blister
pack of 100 NDC 50458-300-01, bottles of 500 NDC 50458-300-50. 2 mg orange tablet: bottles of 60 NDC 50458-320-06, blister
pack of 100 NDC 50458-320-01, bottles of 500 NDC 50458-320-50. 3 mg yellow tablet: bottles of 60 NDC 50458-330-06, blister
pack of 100 NDC 50458-330-01, bottles of 500 NDC 50458-330-50. 4 mg green tablet: bottles of 60 NDC 50458-350-06, blister
pack of 100 NDC 50458-350-01. RISPERDAL (risperidone)
1 mg/mL oral solution (NDC 50458-305-03) is supplied in 30 mL bottles with
a calibrated (in milligrams and milliliters) pipette. The minimum calibrated
volume is 0.25 mL, while the maximum calibrated volume is 3 mL. Tests indicate that RISPERDAL (risperidone)
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, however. RISPERDAL M-TAB (risperidone)
Orally Disintegrating Tablets are etched on one side with "R0.5", "R1", "R2",���R3���, and���R4���, respectively. RISPERDAL M-TAB (risperidone)
Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are packaged in blister
packs of 4 (2 X 2) tablets. RISPERDAL M-TAB (risperidone)
Orally Disintegrating Tablets 3 mg and 4 mg are packaged in a child-resistant
pouch containing a blister with 1 tablet. 0.5
mg light coral, round, biconvex tablets: 7 blister packages per box, NDC 50458-395-28,
long-term care packaging of 30 tablets NDC 50458-395-30. 1 mg light coral, square, biconvex tablets: 7 blister packages
per box, NDC 50458-315-28, long-term care packaging of 30 tablets NDC 50458-315-30. 2 mg light coral, round, biconvex tablets: 7 blister packages
per box, NDC 50458-325-28. 3 mg coral, round,
biconvex tablets: 28 blisters per box, NDC 50458-335-28. 4 mg coral, round, biconvex tablets: 28 blisters per box, NDC
50458-355-28.<br/>Storage and Handling: RISPERDAL tablets should be stored
at controlled room temperature 15�����25��C (59�����77��F).
Protect from light and moisture. Keep out of
reach of children. RISPERDAL 1
mg/mL oral solution should be stored at controlled room temperature 15�����25��C
(59�����77��F). Protect from light and freezing. Keep out of reach of children. RISPERDAL M-TAB Orally
Disintegrating Tablets should be stored at controlled room temperature 15�����25��C
(59�����77��F). Keep out of reach
of children.
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dailymed-instance:genericDr... | |
dailymed-instance:boxedWarn... |
Increased Mortality in Elderly Patients with Dementia���Related
Psychosis: Elderly patients
with dementia-related psychosis treated with atypical antipsychotic drugs
are at an increased risk of death compared to placebo. Analyses of seventeen
placebo controlled trials (modal duration of 10 weeks) in these patients revealed
a risk of death in the drug-treated patients of between 1.6 to 1.7 times that
seen in placebo-treated patients. Over the course of a typical 10 week controlled
trial, the rate of death in drug-treated patients was about 4.5%, compared
to a rate of about 2.6% in the placebo group. Although the causes of death
were varied, most of the deaths appeared to be either cardiovascular (e.g.,
heart failure, sudden death) or infectious (e.g., pneumonia) in nature. RISPERDAL (risperidone) is not approved for the treatment of patients
with Dementia-Related Psychosis.
|
dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... |
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:hypromellose,
dailymed-ingredient:lactose,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:propylene_glycol,
dailymed-ingredient:sodium_lauryl_sulfate,
dailymed-ingredient:starch_(corn),
dailymed-ingredient:talc,
dailymed-ingredient:titanium_dioxide,
dailymed-ingredient:yellow_iron_oxide
|
dailymed-instance:possibleD... |
diseasome-diseases:1025,
diseasome-diseases:1032,
diseasome-diseases:1377,
diseasome-diseases:1460,
diseasome-diseases:1984,
diseasome-diseases:2216,
diseasome-diseases:261,
diseasome-diseases:3423,
diseasome-diseases:347,
diseasome-diseases:3734,
diseasome-diseases:3841,
diseasome-diseases:3852,
diseasome-diseases:54,
diseasome-diseases:852,
diseasome-diseases:94,
diseasome-diseases:989
|
dailymed-instance:overdosag... |
Human Experience: Premarketing experience included eight reports of
acute RISPERDAL (risperidone) overdosage with estimated doses
ranging from 20 to 300 mg and no fatalities. In general, reported signs and
symptoms were those resulting from an exaggeration of the drug's known
pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension,
and extrapyramidal symptoms. One case, involving an estimated overdose of
240 mg, was associated with hyponatremia, hypokalemia, prolonged QT, and widened
QRS. Another case, involving an estimated overdose of 36 mg, was associated
with a seizure. Postmarketing experience includes
reports of acute RISPERDAL overdosage, with estimated doses
of up to 360 mg. In general, the most frequently reported signs and symptoms
are those resulting from an exaggeration of the drug's known pharmacological
effects, i.e., drowsiness, sedation, tachycardia, hypotension, and extrapyramidal
symptoms. Other adverse events reported since market introduction which were
temporally (but not necessarily causally) related to RISPERDAL overdose,
include torsade de pointes, prolonged QT interval, convulsions, cardiopulmonary
arrest, and rare fatality associated with multiple drug overdose.<br/>Management of Overdosage: In case of acute overdosage, establish and maintain
an airway and ensure adequate oxygenation and ventilation. Gastric lavage
(after intubation, if patient is unconscious) and administration of activated
charcoal together with a laxative should be considered. Because of the rapid
disintegration of RISPERDAL M-TABOrally
Disintegrating Tablets, pill fragments may not appear in gastric contents
obtained with lavage. The possibility of obtundation,
seizures, or dystonic reaction of the head and neck following overdose may
create a risk of aspiration with induced emesis. Cardiovascular monitoring
should commence immediately and should include continuous electrocardiographic
monitoring to detect possible arrhythmias. If antiarrhythmic therapy is administered,
disopyramide, procainamide, and quinidine carry a theoretical hazard of QT-prolonging
effects that might be additive to those of risperidone. Similarly, it is reasonable
to expect that the alpha-blocking properties of bretylium might be additive
to those ofrisperidone, resulting in problematic hypotension. There is no specific antidote to RISPERDAL.
Therefore, appropriate supportive measures should be instituted. The possibility
of multiple drug involvement should be considered. Hypotension and circulatory
collapse should be treated with appropriate measures, such as intravenous
fluids and/or sympathomimetic agents (epinephrine and dopamine should not
be used, since beta stimulation may worsen hypotension in the setting of risperidone-induced
alpha blockade). In cases of severe extrapyramidal symptoms, anticholinergic
medication should be administered. Close medical supervision and monitoring
should continue until the patient recovers.
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dailymed-instance:genericMe... |
risperidone
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dailymed-instance:fullName |
Risperdal (Tablet, Orally Disintegrating)
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dailymed-instance:adverseRe... |
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 adjunctivetherapy 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.<br/>Associated With Discontinuation of Treatment:<br/>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: Suicide attempt was associated with discontinuation
in 1.2% of RISPERDAL-treated patients compared to 0.6% of
placebo patients, but, given the almost 40-fold greater exposure time in RISPERDAL compared
to placebo patients, it is unlikely that suicide attempt is a RISPERDAL-related
adverse event .
Discontinuation for extrapyramidal symptoms was 0% in placebo patients, but
3.8% in active-control patients in the Phase 2 and 3 trials.<br/>Bipolar Mania: In
the US placebo-controlled trial with risperidone as adjunctive therapy to
mood stabilizers, there was no overall difference in the incidence of discontinuation
due to adverse events (4% for RISPERDAL vs. 4% for placebo).<br/>Incidence in Controlled Trials:<br/>Commonly Observed Adverse Events in Controlled Clinical Trials:<br/>Adverse Events Occurring at an Incidence of 1% or More Among RISPERDAL-Treated
Patients - Schizophrenia: The table that follows enumerates adverse events
that occurred at an incidence of 1% or more, and were more frequent among
RISPERDAL-treated patients treated at doses of���10
mg/day than among placebo-treated patients in the pooled results of two 6-
to 8-week controlled trials. Patients received RISPERDAL doses
of 2, 6, 10, or 16 mg/day in the dose comparison trial, or up to a maximum
dose of 10 mg/day in the titration study. This table shows the percentage
of patients in each dose group (���10 mg/day or 16 mg/day) who spontaneously
reported at least one episode of an event at some time during their treatment.
Patients given doses of 2, 6, or 10 mg did not differ materially in these
rates. Reported adverse events were classified using the World Health Organization
preferred terms. The prescriber should be
aware that these figures cannot be used to predict the incidence of side effects
in the course of usual medical practice where patient characteristics and
other factors differ from those which prevailed in this clinical trial. Similarly,
the cited frequencies cannot be compared with figures obtained from other
clinical investigations involving different treatments, uses, and investigators.
The cited figures, however, do provide the prescribing physician with some
basis for estimating the relative contribution of drug and non-drug factors
to the side effect incidence rate in the population studied.<br/>Adverse Events Occurring at an Incidence of 2% or More Among RISPERDAL-Treated
Patients - Bipolar Mania: Tables 2 and 3 display adverse events that occurred at an incidence
of 2% or more, and were more frequent among patients treated with flexible
doses of RISPERDAL (1���6 mg daily as monotherapy and
as adjunctive therapy to mood stabilizers, respectively) than among patients
treated with placebo. Reported adverse events were classified using the World
Health Organization preferred terms.<br/>Dose Dependency of Adverse Events:<br/>Other Adverse Events: Adverse event data elicited by a checklist for
side effects from a large study comparing 5 fixed doses of RISPERDAL (1,
4, 8, 12, and 16 mg/day) were explored for dose-relatedness of adverse events.
A Cochran-Armitage Test for trend in these data revealed a positive trend
(p<0.05) for the following adverse events: sleepiness, increased duration
of sleep, accommodation disturbances, orthostatic dizziness, palpitations,
weight gain, erectile dysfunction, ejaculatory dysfunction, orgastic dysfunction,
asthenia/lassitude/increased fatigability, and increased pigmentation.<br/>Vital Sign Changes: RISPERDAL is associated with
orthostatic hypotension and tachycardia .<br/>Weight Changes: The proportions of RISPERDAL and
placebo-treated patients meeting a weight gain criterion of���7% of
body weight were compared in a pool of 6- to 8-week, placebo-controlled trials,
revealing a statistically significantly greater incidence of weight gain for
RISPERDAL (18%) compared to placebo (9%).<br/>Laboratory Changes: A between-group comparison for 6- to 8-week placebo-controlled
trials revealed no statistically significant RISPERDAL/placebo
differences in the proportions of patients experiencing potentially important
changes in routine serum chemistry, hematology, or urinalysis parameters.
Similarly, there were no RISPERDAL/placebo differences in
the incidence of discontinuations for changes in serum chemistry, hematology,
or urinalysis. However, RISPERDAL administration was associated
with increases in serum prolactin .<br/>ECG Changes: Between-group comparisons for pooled placebo-controlled
trials revealed no statistically significant differences between risperidone
and placebo in mean changes from baseline in ECG parameters, including QT,
QTc, and PR intervals, and heart rate. When all RISPERDAL doses
were pooled from randomized controlled trials in several indications, there
was a mean increase in heart rate of 1 beat per minute compared to no change
for placebo patients. In short-term schizophrenia trials, higher doses of
risperidone (8���16 mg/day) were associated with a higher mean increase
in heart rate compared to placebo (4���6 beats per minute).<br/>Adverse Events and Other Safety Measures in Pediatric Patients With
Autistic Disorder: In the two 8-week, placebo-controlled trials in pediatric
patients treated for irritability associated with autistic disorder (n=156),
two patients (one treated with RISPERDAL and one treated
with placebo) discontinued treatment due to an adverse event. In
addition to spontaneous reporting, in one of the studies, adverse events were
also elicited from a checklist for detecting selected events, a method that
is more sensitive than spontaneous reporting. The most
common adverse events with RISPERDAL that occurred at an
incidence equal to or greater than 5% and at a rate of at least twice that
of placebo are shown in Table 4. Weight increase was reported more frequently with RISPERDAL than
with placebo. The average weight increase over 8 weeks was 2.6 kg in patients
treated with RISPERDAL compared with 0.9 kg in patients treated
with placebo. There
was a higher incidence of adverse events reflecting extrapyramidal symptoms
(EPS) in the RISPERDAL group (27.6%) compared with the placebo
group (10.0%). In addition, between-group comparison of the severity of EPS
were assessed objectively by the following rating instruments: the Simpson-Angus
Rating Scale (SARS) and the Abnormal Involuntary Movement Scale (AIMS) in
one study, and the Extrapyramidal Symptom Rating Scale (ESRS) in the other
study. The mean changes between baseline and endpoint in the total ESRS score
were���0.3 in the RISPERDAL group and���0.4 in
the placebo group. The median change from baseline to endpoint was 0 in both
treatment groups for each EPS rating scale. Somnolence
was the most frequent adverse event, and was reported at a higher incidence
in the RISPERDAL group compared with the placebo group. The
vast majority of cases (96%) were either mild or moderate in severity. These
events were most often of early onset with peak incidence occurring during
the first 2 weeks of treatment, and median duration was 16 days. Patients
experiencing persistent somnolence may benefit from a change in dosing regimen
(see DOSAGE AND ADMINISTRATION���Irritability Associated with Autistic Disorder���Pediatrics
[Children and Adolescents]).<br/>Other Events Observed During the Premarketing Evaluation of RISPERDAL: During its premarketing assessment, multiple doses
of RISPERDAL were administered to 2607 adult patients with
schizophrenia and 1923 pediatric patients in Phase 2 and 3 studies. The conditions
and duration of exposure to RISPERDAL varied greatly, and
included (in overlapping categories) open-label and double-blind studies,
uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose
and titration studies, and short-term or longer-term exposure. In most studies,
untoward events associated with this exposure were obtained by spontaneous
report and recorded by clinical investigators using terminology of their own
choosing. Consequently, it is not possible to provide a meaningful estimate
of the proportion of individuals experiencing adverse events without first
grouping similar types of untoward events into a smaller number of standardized
event categories. In two large studies, adverse events were also elicited
utilizing the UKU (direct questioning) side effect rating scale, and these
events were not further categorized using standard terminology. (Note: These
events are marked with an asterisk in the listings that follow.) In the listings that follow, spontaneously reported adverse
events were classified using World Health Organization (WHO) preferred terms.
The frequencies presented, therefore, represent the proportion of the 2607
adult or 1923 pediatric patients exposed to multiple doses of RISPERDAL who
experienced anevent of the type cited on at least one occasion while receiving
RISPERDAL. All reported events are included, except those
already listed in Table 1, those events
for which a drug cause was remote, and those event terms which were so general
as to be uninformative. It is important to emphasize that, although the events
reported occurred during treatment with RISPERDAL, they were
not necessarily caused by it. Serious adverse reactions experienced by the
pediatric population were similar to those seen in theadult population (see WARNINGS, PRECAUTIONS,
and ADVERSE REACTIONS). Events are further categorized by body system and listed
in order of decreasing frequency according to the following definitions: frequent
adverse events are those occurring in at least 1/100 patients (only those
not already listed in the tabulated results from placebo-controlled trials
appear in this listing); infrequent adverse events are those occurring in
1/100 to 1/1000 patients; rare events are those occurringin fewer than 1/1000
patients.<br/>Psychiatric Disorders: Frequent: increased dream activity, diminished sexual desire,
nervousness. Infrequent: impaired concentration,
depression, apathy, catatonic reaction, euphoria, increased libido, amnesia. Rare: emotional lability, nightmares, delirium,
withdrawal syndrome, yawning.<br/>Central and Peripheral Nervous System Disorders: Frequent: increased sleep duration. Infrequent: dysarthria, vertigo, stupor, paraesthesia,
confusion. Rare: aphasia, cholinergic
syndrome, hypoesthesia, tongue paralysis, leg cramps, torticollis, hypotonia,
coma, migraine, hyperreflexia, choreoathetosis.<br/>Gastrointestinal Disorders: Frequent: anorexia, reduced salivation. Infrequent: flatulence, diarrhea, increased
appetite, stomatitis, melena, dysphagia, hemorrhoids, gastritis. Rare: fecal incontinence, eructation, gastroesophageal
reflux, gastroenteritis, esophagitis, tongue discoloration, cholelithiasis,
tongue edema, diverticulitis, gingivitis, discolored feces, GI hemorrhage,
hematemesis.<br/>Body as a Whole/General Disorders: Frequent: fatigue. Infrequent: edema,
rigors, malaise, influenza-like symptoms. Rare: pallor, enlarged abdomen, allergic reaction, ascites, sarcoidosis,
flushing.<br/>Respiratory System Disorders: Infrequent: hyperventilation, bronchospasm, pneumonia, stridor. Rare : asthma, increased sputum, aspiration.<br/>Skin and Appendage Disorders: Frequent: increased pigmentation, photosensitivityInfrequent:
increased sweating, acne, decreased sweating, alopecia, hyperkeratosis, pruritus,
skin exfoliation. Rare: bullous eruption,
skin ulceration, aggravated psoriasis, furunculosis, verruca, dermatitis lichenoid,
hypertrichosis, genital pruritus, urticaria.<br/>Cardiovascular Disorders: Infrequent: palpitation, hypertension, hypotension, AV block, myocardial
infarction. Rare: ventricular tachycardia,
angina pectoris, premature atrial contractions, T wave inversions, ventricular
extrasystoles, ST depression, myocarditis.<br/>Vision Disorders: Infrequent: abnormal accommodation, xerophthalmia. Rare: diplopia, eye pain, blepharitis, photopsia, photophobia, abnormal
lacrimation.<br/>Metabolic and Nutritional Disorders: Infrequent: hyponatremia, weight increase, creatine phosphokinase increase,
thirst, weight decrease, diabetes mellitus. Rare: decreased serum iron, cachexia, dehydration, hypokalemia, hypoproteinemia,
hyperphosphatemia, hypertriglyceridemia, hyperuricemia, hypoglycemia.<br/>Urinary System Disorders: Frequent: polyuria/polydipsia. Infrequent: urinary incontinence, hematuria,
dysuria. Rare: urinary retention, cystitis,
renal insufficiency.<br/>Musculo-Skeletal System Disorders: Infrequent: myalgia. Rare: arthrosis,
synostosis, bursitis, arthritis, skeletal pain.<br/>Reproductive Disorders, Female: Frequent: menorrhagia, orgastic dysfunction, dry vaginaInfrequent: nonpuerperal lactation,
amenorrhea, female breast pain, leukorrhea, mastitis, dysmenorrhea, female
perineal pain, intermenstrual bleeding, vaginal hemorrhage.<br/>Liver and Biliary System Disorders: Infrequent: increased SGOT, increased SGPT. Rare: hepatic failure, cholestatic hepatitis, cholecystitis, cholelithiasis,
hepatitis, hepatocellular damage.<br/>Platelet, Bleeding, and Clotting Disorders: Infrequent: epistaxis, purpura. Rare:
hemorrhage, superficial phlebitis, thrombophlebitis, thrombocytopenia.<br/>Hearing and Vestibular Disorders: Rare: tinnitus, hyperacusis, decreased hearing.<br/>Red Blood Cell Disorders: Infrequent: anemia, hypochromic anemia. Rare: normocytic anemia.<br/>Reproductive Disorders, Male: Frequent: erectile dysfunctionInfrequent:
ejaculation failure.<br/>White Cell and Resistance Disorders: Infrequent:
granulocytopenia Rare: leukocytosis,
lymphadenopathy, leucopenia, Pelger-Huet anomaly.<br/>Endocrine Disorders: Rare: gynecomastia, male breast pain, antidiuretic hormone disorder.<br/>Special Senses: Rare: bitter taste.<br/>Postintroduction Reports: Adverse events reported since market introduction
which were temporally (but not necessarily causally) related to RISPERDAL therapy,
include the following: anaphylactic reaction, angioedema, apnea, atrial fibrillation,
cerebrovascular disorder, including cerebrovascular accident, diabetes mellitus
aggravated, including diabetic ketoacidosis, hyperglycemia, intestinal obstruction,
jaundice, mania, pancreatitis, Parkinson's disease aggravated, pituitary
adenomas, pulmonary embolism, precocious puberty, and QT prolongation. There
have been rare reports of sudden death and/or cardiopulmonary arrest in patients
receiving RISPERDAL. A causal relationship with RISPERDAL has
not been established. It is important to note that sudden and unexpected death
may occur in psychotic patients whether they remain untreated or whether they
are treated with other antipsychotic drugs.
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dailymed-instance:warning |
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: 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 dementia-related psychosis (see Boxed Warning).<br/>Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred
to as Neuroleptic Malignant Syndrome (NMS) has been reported in association
with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia,
muscle rigidity, altered mental status, and evidence of autonomic instability
(irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac
dysrhythmia). Additional signs may include elevated creatinine phosphokinase,
myoglobinuria (rhabdomyolysis), and acute renal failure. The diagnostic evaluation of patients with this syndrome is
complicated. In arriving at a diagnosis, it is important to identify cases
in which the clinical presentation includes both serious medical illness (e.g.,
pneumonia, systemic infection, etc.) and untreated or inadequately treated
extrapyramidal signs and symptoms (EPS). Other important considerations in
the differential diagnosis include central anticholinergic toxicity, heat
stroke, drug fever, and primary central nervous system pathology. The management of NMS should include: (1) immediate discontinuation
of antipsychotic drugs and other drugs not essential to concurrent therapy;
(2) intensive symptomatic treatment and medical monitoring; and (3) treatment
of any concomitant serious medical problems for which specific treatments
are available. There is no general agreement about specific pharmacological
treatment regimens for uncomplicated NMS. If
a patient requires antipsychotic drug treatment after recovery from NMS, the
potential reintroduction of drug therapy should be carefully considered. The
patient should be carefully monitored, since recurrences of NMS have been
reported.<br/>Tardive Dyskinesia: A syndrome of potentially
irreversible, involuntary, dyskinetic movements may develop in patients treated
with antipsychotic drugs. Although the prevalence of the syndrome appears
to be highest among the elderly, especially elderly women, it is impossible
to rely upon prevalence estimates to predict, at the inception of antipsychotic
treatment, which patients are likely to develop the syndrome. Whether antipsychotic
drug products differ in their potential to cause tardive dyskinesia is unknown. The risk of developing tardive dyskinesia and the likelihood
that it will become irreversible are believed to increase as the duration
of treatment and the total cumulative dose of antipsychotic drugs administered
to the patient increase. However, the syndrome can develop, although much
less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive
dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic
treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress
(or partially suppress) the signs and symptoms of the syndrome and thereby
may possibly mask the underlying process. The effect that symptomatic suppression
has upon the long-term course of the syndrome is unknown. Given these considerations, RISPERDAL (risperidone)
should be prescribed in a manner that is most likely to minimize the occurrence
of tardive dyskinesia. Chronic antipsychotic treatment should generally be
reserved for patients who suffer from a chronic illness that: (1) is known
to respond to antipsychotic drugs, and (2) for whom alternative, equally effective,
but potentially less harmful treatments are not available or appropriate.
In patients who do require chronic treatment, the smallest dose and the shortest
duration of treatment producing a satisfactory clinical response should be
sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a
patient treated with RISPERDAL, drug discontinuation should
be considered. However, some patients may require treatment with RISPERDAL despite
the presence of the syndrome.<br/>Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients
With Dementia-Related Psychosis: Cerebrovascular adverse events (e.g., stroke, transient
ischemic attack), including fatalities, were reported in patients (mean age
85 years; range 73���97) in trials of risperidone 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. RISPERDAL is
not approved for the treatment of patients with dementia-related psychosis.
(See also Boxed
WARNING, WARNINGS:
Increased Mortality in Elderly Patients with Dementia-Related Psychosis.)<br/>Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated
with ketoacidosis or hyperosmolar coma or death, has been reported in patients
treated with atypical antipsychotics including RISPERDAL.
Assessment of the relationship between atypical antipsychotic use and glucose
abnormalities is complicated by the possibility of an increased background
risk of diabetes mellitus in patients with schizophrenia and the increasing
incidence of diabetes mellitus in the general population. Given these confounders,
the relationship between atypical antipsychotic use and hyperglycemia-related
adverse events is not completely understood. However, epidemiological studies
suggest an increased risk of treatment-emergent hyperglycemia-related adverse
events in patients treated with the atypical antipsychotics. Precise risk
estimates for hyperglycemia-related adverse events in patients treated with
atypical antipsychotics are not available. Patients
with an established diagnosis of diabetes mellitus who are started on atypical
antipsychotics should be monitored regularly for worsening of glucose control.
Patients with risk factors for diabetes mellitus (e.g., obesity, family history
of diabetes) who are starting treatment with atypical antipsychotics should
undergo fasting blood glucose testing at the beginning of treatment and periodically
during treatment. Any patient treated with atypical antipsychotics should
be monitored for symptoms of hyperglycemia including polydipsia, polyuria,
polyphagia, andweakness. Patients who develop symptoms of hyperglycemia during
treatment with atypical antipsychotics should undergo fasting blood glucose
testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic
was discontinued; however, some patients required continuation of anti-diabetic
treatment despite discontinuation of the suspect drug.
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dailymed-instance:indicatio... |
Schizophrenia: RISPERDAL (risperidone) is indicated for
the treatment of schizophrenia. The efficacy of RISPERDAL in
schizophrenia was established in short-term (6- to 8-weeks) controlled trials
of schizophrenic inpatients (see CLINICAL
PHARMACOLOGY). The efficacy of RISPERDAL in
delaying relapse was demonstrated in schizophrenic patients who had been clinically
stable for at least 4 weeks before initiation of treatment with RISPERDAL or
an active comparator and who were then observed for relapse during a period
of 1 to 2 years (see CLINICAL
PHARMACOLOGY - Clinical Trials). Nevertheless, the physician who
elects to use RISPERDAL for extended periods should periodically
re-evaluate the long-term usefulness of the drug for the individual patient
.<br/>Bipolar Mania:<br/>Monotherapy: RISPERDAL is indicated for the short-term
treatment of acute manic or mixed episodes associated with Bipolar I Disorder. The
efficacy of RISPERDAL was established in two placebo-controlled
trials (3-week) with patients meeting DSM-IV criteria for Bipolar I Disorder
who currently displayed an acute manic or mixed episode with or without psychotic
features .<br/>Combination Therapy: 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. The efficacy
of RISPERDAL in combination with lithium or valproate was
established in one placebo-controlled (3-week) trial with patients meeting
DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic
or mixed episode with or without psychotic features (see CLINICAL
PHARMACOLOGY). The effectiveness of RISPERDAL for
longer-term use, that is, for more than 3 weeks of treatment of an acute episode,
and for prophylactic use in mania, has not been systematically evaluated in
controlled clinical trials. Therefore, physicians who elect to use RISPERDAL for
extended periods should periodically re-evaluate the long-term risks and benefits
of the drug for the individual patient (see DOSAGE
AND ADMINISTRATION).<br/>Irritability Associated with Autistic Disorder: RISPERDAL is indicated for the treatment
of irritability associated with autistic disorder in children and adolescents,
including symptoms of aggression towards others, deliberate self-injuriousness,
temper tantrums, and quickly changing moods. The efficacy
of RISPERDAL was established in two 8-week, placebo controlled
trials in children and adolescents (aged 5 to 16 years) who met the DSM-IV
criteria for autistic disorder. The benefit of maintaining patients with irritability
associated with autistic disorder on therapy with RISPERDAL after
achieving a responder status for an average duration of about 140 days was
demonstrated in acontrolled trial (see CLINICAL
PHARMACOLOGY - Clinical Trials.) Physicians who elect to use RISPERDAL for
extended periods should periodically re-evaluate the long-term risks and benefits
of the drug for the individual patient.
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dailymed-instance:name |
Risperdal
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