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These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Tablets Initial U.S. Approval : 1993 | RISPERIDONE

05:00 EDT 27th August 2014 | BioPortfolio
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Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death 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. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Risperidone is not approved for the treatment of patients with dementia-related psychosis. [See Warnings and Precautions (5.1)]

Table 1a. Change in Random Glucose from Seven Placebo-Controlled, 3- to 8-Week, Fixed- or Flexible-Dose Studies in Adult Subjects with Schizophrenia or Bipolar Mania
Risperidone
Placebo 1 to 8 mg/day >8 to 16 mg/day
Mean change from baseline (mg/dL)
n=555 n=748 n=164
Serum Glucose -1.4 0.8 0.6
Proportion of patients with shifts
Serum Glucose 0.6% 0.4% 0%
(<140 mg/dL to ≥220 mg/dL) (3/525) (3/702) (0/158)
Table 1b. Change in Fasting Glucose from Three Placebo-Controlled, 3- to 6-Week, Fixed-Dose Studies in Children and Adolescents with Schizophrenia (13 to 17 years of age), Bipolar Mania (10 to 17 years of age), or Autistic Disorder (5 to 17 years of age)
Risperidone
Placebo 0.5 to 6 mg/day
Mean change from baseline (mg/dL)
n=76 n=135
Serum Glucose -1.3 2.6
Proportion of patients with shifts
Serum Glucose 0% 0.8%
(<100 mg/dL to ≥126 mg/dL) (0/64) (1/120)
Table 2a. Change in Random Lipids From Seven Placebo-Controlled, 3- to 8-Week, Fixed- or Flexible-Dose Studies in Adult Subjects With Schizophrenia or Bipolar Mania
Risperidone
Placebo 1 to 8 mg/day >8 to 16 mg/day
Mean change from baseline (mg/dL)
Cholesterol n=559 n=742 n=156
Change from baseline 0.6 6.9 1.8
Triglycerides n=183 n=307 n=123
Change from baseline -17.4 -4.9 -8.3
Proportion of patients With Shifts
Cholesterol 2.7% 4.3% 6.3%
(<200 mg/dL to ≥240 mg/dL) (10/368) (22/516) (6/96)
Triglycerides 1.1% 2.7% 2.5%
(<500 mg/dL to ≥500 mg/dL) (2/180) (8/301) (3/121)
Table 2b. Change in Fasting Lipids From Three Placebo-Controlled, 3- to 6-Week, Fixed-Dose Studies in Children and Adolescents With Schizophrenia (13 to 17 Years of Age), Bipolar Mania (10 to 17 Years of Age), or Autistic Disorder (5 to 17 Years of Age)
Risperidone
Placebo 0.5 to 6 mg/day
Mean change from baseline (mg/dL)
Cholesterol n=74 n=133
Change from baseline 0.3 -0.3
LDL n=22 n=22
Change from baseline 3.7 0.5
HDL n=22 n=22
Change from baseline 1.6 -1.9
Triglycerides n=77 n=138
Change from baseline -9.0 -2.6
Proportion of patients with shifts
Cholesterol 2.4% 3.8%
(<170 mg/dL to ≥200 mg/dL) (1/42) (3/80)
LDL 0% 0%
(<110 mg/dL to ≥130 mg/dL) (0/16) (0/16)
HDL 0% 10%
(≥40 mg/dL to <40 mg/dL) (0/19) (2/20)
Triglycerides 1.5% 7.1%
(<150 mg/dL to ≥200 mg/dL) (1/65) (8/113)
Table 3a. Mean Change in Body Weight (kg) and the Proportion of Subjects with ≥7% Gain in Body Weight From Seven Placebo-Controlled, 3- to 8-Week, Fixed- or Flexible-Dose Studies in Adult Subjects With Schizophrenia or Bipolar Mania
Risperidone
Placebo
(n=597)
1 to 8 mg/day
(n=769)
>8 to 16 mg/day
(n=158)
Weight (kg)
Change from baseline -0.3 0.7 2.2
Weight Gain
≥7% increase from baseline 2.9% 8.7% 20.9%
Table 3b. Mean Change in Body Weight (kg) and the Proportion of Subjects With ≥7% Gain in Body Weight From Nine Placebo-Controlled, 3- to 8-Week, Fixed-Dose Studies in Children and Adolescents With Schizophrenia (13 to 17 Years of Age), Bipolar Mania (10 to 17 Years of Age), Autistic Disorder (5 to 17 Years of Age) or Other Psychiatric Disorders (5 to 17 Years of Age)
Placebo
(n=375)
Risperidone 0.5 to 6 mg/day
(n=448)
Weight (kg)
Change from baseline 0.6 2.0
Weight Gain
≥7% increase from baseline 6.9% 32.6%

Risperidone may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period, probably reflecting its alpha-adrenergic antagonistic properties. Syncope was reported in 0.2% (6/2607) of risperidone- treated patients in Phase 2 and 3 studies in adults with schizophrenia. The risk of orthostatic hypotension and syncope may be minimized by limiting the initial dose to 2 mg total (either once daily or 1 mg twice daily) in normal adults and 0.5 mg twice daily in the elderly and patients with renal or hepatic impairment [see Dosage and Administration (2.1, 2.4)]. Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. A dose reduction should be considered if hypotension occurs. Risperidone should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension, e.g., dehydration and hypovolemia. Clinically significant hypotension has been observed with concomitant use of risperidone and antihypertensive medication.

Table 4. Adverse Reactions in ≥ 1% of Risperidone-Treated Adult Patients with Schizophrenia in Double-Blind, Placebo-Controlled Trials
Percentage of Patients Reporting Event
Risperidone
System/Organ Class Adverse Reaction 2 to 8 mg per day (N = 366) >8 to 16 mg per day (N = 198) Placebo (N = 225)
Blood and Lymphatic System Disorders
Anemia < 1 1 0
Cardiac Disorders
Tachycardia 1 3 0
Ear and Labyrinth Disorders
Ear pain < 1 1 0
Eye Disorders
Vision blurred 3 1 1
Gastrointestinal Disorders
Nausea 9 4 4
Constipation 8 9 6
Dyspepsia 8 6 5
Vomiting 7 5 7
Dry mouth 4 0 1
Abdominal discomfort 3 1 1
Salivary hypersecretion 2 1 < 1
Diarrhea 2 1 1
Abdominal pain 1 1 0
Abdominal pain upper 1 1 0
Stomach discomfort 1 1 1
General Disorders
Fatigue 3 1 0
Chest pain 2 2 1
Asthenia 2 1 < 1
Immune System Disorders
Hypersensitivity < 1 1 0
Infections and Infestations
Nasopharyngitis 3 4 3
Upper respiratory tract infection 2 3 1
Sinusitis 1 2 1
Urinary tract infection 1 3 0
Investigations
Weight increased 1 1 0
Blood creatine phosphokinase increased 1 2 < 1
Heart rate increased < 1 2 0
Metabolism and Nutrition Disorders
Decreased appetite 1 0 < 1
Musculoskeletal and Connective Tissue Disorders
Back pain 4 1 1
Arthralgia 2 3 < 1
Pain in extremity 2 1 1
Joint stiffness 1 1 0
Nervous System Disorders
Parkinsonism* 14 17 8
Akathisia* 10 10 3
Dizziness 7 4 2
Somnolence 7 2 1
Dystonia* 3 4 2
Sedation 3 3 1
Tremor* 2 3 1
Dizziness postural 2 0 0
Dyskinesia* 1 2 2
Syncope 1 1 0
Psychiatric Disorders
Insomnia 32 25 27
Anxiety 16 11 11
Nervousness 1 1 < 1
Renal and Urinary Disorders
Urinary incontinence 1 1 0
Reproductive System and Breast Disorders
Ejaculation failure < 1 1 0
Respiratory, Thoracic and Mediastinal Disorders
Nasal congestion 4 6 2
Dyspnea 1 2 0
Epistaxis < 1 2 0
Skin and Subcutaneous Tissue Disorders
Rash 1 4 1
Dry skin 1 3 0
Dandruff 1 1 0
Seborrheic dermatitis < 1 1 0
Hyperkeratosis 0 1 1
Vascular Disorders
Orthostatic hypotension 2 1 0
Hypotension 1 1 0
Table 5. Adverse Reactions in ≥ 5% of Risperidone-Treated Pediatric Patients with Schizophrenia in a Double-Blind Trial
Percentage of Patients Reporting Event
System/Organ Class Adverse Reaction Risperidone Placebo (N = 54)
1 to 3 mg per day (N = 55) 4 to 6 mg per day (N = 51)
Gastrointestinal Disorders
Salivary hypersecretion 0 10 2
Nervous System Disorders
Parkinsonism* 16 28 11
Sedation 13 8 2
Somnolence 11 4 2
Tremor 11 10 6
Akathisia* 9 10 4
Dizziness 7 14 2
Dystonia* 2 6 0
Psychiatric Disorders
Anxiety 7 6 0

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