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Risperidone

Gen-Source Rx
Aurolife Pharma LLC

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone tablets.Risperidone Tablets, USPInitial U.S. Approval: 1993 BOXED WARNING WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone is not approved for use in patients with dementia-related psychosis. (5.1) INDICATIONS AND USAGERisperidone is an atypical antipsychotic agent indicated for: Treatment of schizophrenia in adults (1.1) Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults (1.2) Treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years (1.3) Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia or bipolar mania. (1.1, 1.2) DOSAGE AND ADMINISTRATION   InitialDose Titration TargetDose EffectiveDose Range Schizophrenia- adults (2.1) 2 mg/day 1 to 2 mg daily 4 to 8 mgdaily 4 to 16 mg/day Bipolar mania– adults (2.2) 2 to 3 mg/day 1 mg daily 1 to 6 mg/day 1 to 6 mg/day Irritability Associated with autistic disorder (2.3) 0.25 mg/day (


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS


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 )]

1 INDICATIONS AND USAGE

1.1 Schizophrenia




[see Clinical Studies (14.1)]



Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products.

1.2 Bipolar Mania




[see Clinical Studies (14.2)]

Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products.



[see Clinical Studies (14.3)]

1.3 Irritability Associated with Autistic Disorder




[see Clinical Studies (14.4)]

2 DOSAGE AND ADMINISTRATION

2.1 Schizophrenia






[see Clinical Studies (14.1)]



[see Clinical Studies (14.1)]



Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Dosage and administration information for pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug product.







2.2 Bipolar Mania






[see Clinical Studies (14.2 14.3)]



Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Dosage and administration information for the treatment of pediatric patients with bipolar disorder is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products.




2.3 Irritability Associated with Autistic Disorder – Pediatrics (Children and Adolescents)








[see Clinical Studies (14.4)]



2.4 Dosage in Special Populations




[see Clinical Pharmacology (12.3)][see Warnings and Precautions (5.2 5.7 5.17)]

2.5 Coadministration of Risperidone with Certain Other Medications


[see Drug Interactions (7.11)]

[see Drug Interactions (7.10)]

3 DOSAGE FORMS AND STRENGTHS


4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis


Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone is not approved for the treatment of dementia-related psychosis [see Boxed Warning].

5.2 Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia-Related Psychosis


[See also Boxed Warnings and Warnings and Precautions (5.1)]

5.3 Neuroleptic Malignant Syndrome (NMS)








5.4 Tardive Dyskinesia










5.5 Hyperglycemia and Diabetes Mellitus




5.6 Hyperprolactinemia


2



in vitro[see Non-Clinical Toxicology (13.1)]

5.7 Orthostatic Hypotension


[see Dosage and Administration (2.1 2.4)]

5.8 Leukopenia, Neutropenia, and Agranulocytosis


Class Effect:



3

5.9 Potential for Cognitive and Motor Impairment


5.10 Seizures


5.11 Dysphagia


[See also Boxed Warning and Warnings and Precautions (5.1)]

5.12 Priapism


[see Adverse Reactions (6.9)]

5.13 Thrombotic Thrombocytopenic Purpura (TTP)


5.14 Body Temperature Regulation


5.15 Antiemetic Effect


5.16 Suicide


5.17 Use in Patients with Concomitant Illness






2[see Dosage and Administration (2.4)]

5.18 Monitoring: Laboratory Tests


6 ADVERSE REACTIONS


  • Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1)]  
  • Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2)]
  • Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)]
  • Tardive dyskinesia [see Warnings and Precautions (5.4)]
  • Hyperglycemia and diabetes mellitus [see Warnings and Precautions (5.5)]
  • Hyperprolactinemia [see Warnings and Precautions (5.6)]
  • Orthostatic hypotension [see Warnings and Precautions (5.7)]
  • Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions (5.8)]  
  • Potential for cognitive and motor impairment [see Warnings and Precautions (5.9)]
  • Seizures [see Warnings and Precautions (5.10)]
  • Dysphagia [see Warnings and Precautions (5.11)]
  • Priapism [see Warnings and Precautions (5.12)]
  • Thrombotic Thrombocytopenic Purpura (TTP) [see Warnings and Precautions (5.13)]
  • Disruption of body temperature regulation [see Warnings and Precautions (5.14)]
  • Antiemetic effect [see Warnings and Precautions (5.15)]
  • Suicide [see Warnings and Precautions (5.16)]
  • Increased sensitivity in patients with Parkinson’s disease or those with dementia with Lewy bodies [see Warnings and Precautions (5.17)]
  • Diseases or conditions that could affect metabolism or hemodynamic responses [see Warnings and Precautions (5.17)]  



[see Adverse Reactions (6.5)]







6.1 Commonly-Observed Side Effects in Double-Blind, Placebo-Controlled Clinical Trials – Schizophrenia


Adult Patients with Schizophrenia

Table 1. Adverse Reactions in ≥1% of Risperidone-Treated Adult Patients with Schizophrenia in Double-Blind, Placebo-Controlled Trials
System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Event
Risperidone
2 to 8 mg
per day
(N=366)
>8 to 16 mg
per day
(N=198)
Placebo
(N=225)
* Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness, parkinsonism, cogwheel rigidity, akinesia, bradykinesia, hypokinesia, masked facies, muscle rigidity, and Parkinson’s disease. Akathisia includes akathisia and restlessness. Dystonia includes dystonia, muscle spasms, muscle contractions involuntary, muscle contracture, oculogyration, tongue paralysis. Tremor includes tremor and parkinsonian rest tremor. Dyskinesia includes dyskinesia, muscle twitching, chorea, and choreoathetosis.
   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

Pediatric Patients with Schizophrenia



Table 2. Adverse Reactions in ≥5% of Risperidone-Treated Pediatric Patients with Schizophrenia in a Double-Blind Trial
System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Event
Risperidone
1 to 3 mg per day
(N=55)
4 to 6 mg per day
(N=51)
Placebo
(N=54)
* Parkinsonism includes extrapyramidal disorder, muscle rigidity, musculoskeletal stiffness, and hypokinesia. Akathisia includes akathisia and restlessness. Dystonia includes dystonia and oculogyration.
   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

6.2 Commonly-Observed Side Effects in Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Mania


Adult Patients with Bipolar Mania


Table 3. Adverse Reactions in ≥1% of Risperidone-Treated Adult Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Monotherapy Trials
System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Event
Risperidone
1 to 6 mg per day
(N=448)
Placebo

(N=424)
* Parkinsonism includes extrapyramidal disorder, parkinsonism, musculoskeletal stiffness, hypokinesia, muscle rigidity, muscle tightness, bradykinesia, cogwheel rigidity. Akathisia includes akathisia and restlessness. Tremor includes tremor and parkinsonian rest tremor. Dystonia includes dystonia, muscle spasms, oculogyration, torticollis. Dyskinesia includes muscle twitching and dyskinesia.
   Cardiac Disorders
      Tachycardia
1
<1
   Eye Disorders
      Vision blurred
2
1
   Gastrointestinal Disorders
      Nausea
5
2
      Diarrhea
3
2
      Salivary hypersecretion
3
1
      Dyspepsia
2
2
      Stomach discomfort
2
<1
   General Disorders
      Fatigue
2
1
      Asthenia
1
1
      Pyrexia
1
1
   Infections and Infestations
      Nasopharyngitis
1
1
   Investigations
      Aspartate aminotransferase increased
1
<1
   Nervous System Disorders
      Parkinsonism*
25
9
      Akathisia*
9
3
      Tremor*
6
3
      Dizziness
6
5
      Sedation
6
2
      Somnolence
5
2
      Dystonia*
5
1
      Lethargy
2
1
      Dyskinesia*
1
<1
   Reproductive System and Breast Disorders
      Galactorrhea
1
0
   Skin and Subcutaneous Tissue Disorders
      Acne
1
0

Table 4. Adverse Reactions in ≥2% of Risperidone-Treated Adult Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Adjuvant Therapy Trials
System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Event
Risperidone + Mood Stabilizer
(N=127)
Placebo +
Mood Stabilizer
(N=126)
* Parkinsonism includes extrapyramidal disorder, hypokinesia and bradykinesia. Akathisia includes hyperkinesia and akathisia.
   Cardiac Disorders
      Palpitations
2
0
   Gastrointestinal Disorders
      Dyspepsia
9
8
      Nausea
6
4
      Diarrhea
6
4
      Dry mouth
4
4
      Vomiting
4
6
      Constipation
3
3
      Salivary hypersecretion
2
0
   General Disorders
      Chest pain
2
1
      Fatigue
2
2
   Infections and Infestations
      Nasopharyngitis
2
3
      Urinary tract infection
2
1
   Investigations
      Weight increased
2
2
   Nervous System Disorders
      Parkinsonism*
14
4
      Headache
14
15
      Akathisia*
8
0
      Dizziness
7
2
      Sedation
6
3
      Tremor
6
2
      Somnolence
3
1
      Lethargy
2
1
   Psychiatric Disorders
      Insomnia
4
8
      Anxiety
3
2
   Respiratory, Thoracic and Mediastinal Disorders
      Pharyngolaryngeal pain
5
2
      Cough
2
0

Pediatric Patients with Bipolar Mania
 


Table 5. Adverse Reactions in ≥5% of Risperidone-Treated Pediatric Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Trials

System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Event
Risperidone
0.5 to 2.5 mg
per day
(N=50)
3 to 6 mg
per day
(N=61)
Placebo
(N=58)
* Parkinsonism includes musculoskeletal stiffness, extrapyramidal disorder, bradykinesia, and nuchal rigidity. Dystonia includes dystonia, laryngospasm, and muscle spasms. Akathisia includes restlessness and akathisia.
   Eye Disorders
      Vision blurred
4
7
0
   Gastrointestinal Disorders
      Abdominal pain upper
16
13
5
      Nausea
16
13
7
      Vomiting
10
10
5
      Diarrhea
8
7
2
      Dyspepsia
10
3
2
      Stomach discomfort
6
0
2
   General Disorders
      Fatigue
18
30
3
   Metabolism and Nutrition Disorders
      Increased appetite
4
7
2
   Nervous System Disorders
      Somnolence
22
30
12
      Sedation
20
23
7
      Dizziness
16
13
5
      Parkinsonism*
6
12
3
      Dystonia*
6
5
0
      Akathisia*
0
8
2
   Psychiatric Disorders
      Anxiety
0
8
3
   Respiratory, Thoracic and Mediastinal Disorders
      Pharyngolaryngeal pain
10
3
5
   Skin and Subcutaneous Tissue Disorders
      Rash
0
7
2

6.3 Commonly-Observed Side Effects in Double-Blind, Placebo-Controlled Clinical Trials - Autistic Disorder




Table 6. Adverse Reactions in ≥5% of Risperidone-Treated Pediatric Patients Treated for Irritability Associated with Autistic Disorder in Double-Blind, Placebo-Controlled Trials
System/Organ Class
Adverse Reaction
Percentage of Patients Reporting Event
Risperidone
0.5 to 4 mg per day
(N=76)
 
Placebo
(N=80)
* Parkinsonism includes musculoskeletal stiffness, extrapyramidal disorder, muscle rigidity, cogwheel rigidity, and muscle tightness.
   Cardiac Disorders
      Tachycardia
5
0
   Gastrointestinal Disorders
      Vomiting
25
21
      Constipation
21
8
      Dry mouth
15
6
      Salivary hypersecretion
9
0
      Nausea
8
6
   General Disorders
      Fatigue
42
13
      Feeling abnormal
5
0
   Infections and Infestations
      Nasopharyngitis
21
10
      Rhinitis
13
10
      Upper respiratory tract infection
8
3
   Investigations
      Weight increased
5
0
   Metabolism and Nutrition Disorders
      Increased appetite
47
19
   Nervous System Disorders
      Somnolence
49
18
      Sedation
29
3
      Drooling
16
5
      Tremor
12
1
      Parkinsonism*
11
1
      Dizziness
9
3
      Dyskinesia
7
3
      Lethargy
5
3
   Respiratory, Thoracic and Mediastinal Disorders
      Cough
24
18
      Rhinorrhea
16
13
      Nasal congestion
13
5
   Skin and Subcutaneous Tissue Disorders
      Rash
11
8

6.4 Other Side Effects Observed During the Premarketing Evaluation of Risperidone








































6.5 Discontinuations Due to Side Effects




Table 7. Adverse Reactions Associated With Discontinuation in 2 or More Risperidone-Treated Adult Patients in Schizophrenia Trials
Adverse Reaction Risperidone  
2 to 8 mg/day
(N=366)
>8 to 16 mg/day
(N=198)
Placebo
(N=225)
   Dizziness
1.4%
1%
0%
   Nausea
1.4%
0%
0%
   Vomiting
0.8%
0%
0%
   Parkinsonism
0.8%
0%
0%
   Somnolence
0.8%
0%
0%
   Dystonia
0.5%
0%
0%
   Agitation
0.5%
0%
0%
   Abdominal pain
0.5%
0%
0%
   Orthostatic hypotension
0.3%
0.5%
0%
   Akathisia
0.3%
2%
0%








Table 8. Adverse Reactions Associated With Discontinuation in 2 or More Risperidone-Treated Adult Patients in Bipolar Mania Clinical Trials
Adverse Reaction Risperidone
1 to 6 mg/day
(N=448)
 
Placebo
(N=424)
   Parkinsonism
0.4%
0%
   Lethargy
0.2%
0%
   Dizziness
0.2%
0%
   Alanine aminotransferase increased
0.2%
0.2%
   Aspartate aminotransferase increased
0.2%
0.2%






6.6 Dose Dependency of Side Effects in Clinical Trials






Dose Groups Placebo Risperidone
2 mg
Risperidone
6 mg
Risperidone
10 mg
Risperidone
16 mg
   Parkinsonism 1.2
0.9
1.8
2.4
2.6
   EPS Incidence 13%
17%
21%
21%
35%
 Dose Groups  Risperidone 
1 mg
 Risperidone 
4 mg
 Risperidone 
8 mg
 Risperidone 
12 mg
 Risperidone 
16 mg
 Parkinsonism
0.6
1.7
2.4
2.9
4.1
 EPS Incidence
7%
12%
17%
18%
20%


Class Effect:




6.7 Changes in Body Weight




[see Use in Specific Populations (8.4)]

6.8 Changes in ECG






Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia or bipolar mania. Information regarding changes in ECG during the treatment of pediatric patients with schizophrenia, 13 to 17 years of age and the treatment of pediatric patients with bipolar mania, 10 to 17 years of age is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products.

6.9 Postmarketing Experience




7 DRUG INTERACTIONS

7.1 Centrally-Acting Drugs and Alcohol


7.2 Drugs with Hypotensive Effects


7.3 Levodopa and Dopamine Agonists


7.4 Amitriptyline


7.5 Cimetidine and Ranitidine


7.6 Clozapine


7.7 Lithium


max

7.8 Valproate


max

7.9 Digoxin


7.10 Drugs That Inhibit CYP 2D6 and Other CYP Isozymes


[see Clinical Pharmacology (12.3)]Risperidone

In vitro








7.11 Carbamazepine and Other Enzyme Inducers


7.12 Drugs Metabolized by CYP 2D6


In vitro

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy




2222

22

in utero

8.2 Labor and Delivery


8.3 Nursing Mothers


8.4 Pediatric Use







[see Indications and Usage (1.3) Adverse Reactions (6.3) and Clinical Studies (14.4)]



Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia or bipolar mania. Information on clinical trials and risperidone use for pediatric patients with schizophrenia, 13 to 17 years of age and the bipolar mania, 10 to 17 years of age is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products.



[see also Warnings and Precautions (5.4)]









[See also Adverse Reactions (6.7)]



[See also Adverse Reactions (6.1, 6.2, 6.3)] [see Dosage and Administration (2.1, 2.2, 2.3)]



[see Warnings and Precautions (5.6)]



8.5 Geriatric Use


[see Clinical Pharmacology (12.3) and Dosage and Administration (2.4, 2.5)][see Warnings and Precautions (5.7)]

[see Dosage and Administration (2.4)]



[See Boxed Warning and Warnings and Precautions (5.1)]

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance


9.2 Abuse


9.3 Dependence


10 OVERDOSAGE

10.1 Human Experience




10.2 Management of Overdosage






11 DESCRIPTION


232742
Risperidone
N

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action


22

221211C1D1A1-512

12.2 Pharmacodynamics


[see Clinical Pharmacology (12.3)]2[see Clinical Pharmacology (12.1)]

12.3 Pharmacokinetics

Absorption






Food Effect


Distribution


1

Metabolism and Drug Interactions


N



[see Drug Interactions (7.12)]Risperidone[see Drug Interactions (7.11)][see Drug Interactions (7.12)]

Excretion


14

Renal Impairment


[see Dosage and Administration (2.4) and Warnings and Precautions (5.17)]

Hepatic Impairment


1[see Dosage and Administration (2.4) and Warnings and Precautions (5.17)]

Elderly


[see Dosage and Administration (2.4)]

Pediatric


Race and Gender Effects


13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis


22
Multiples of Maximum
 Human Dose in mg/m2
(mg/kg)
Tumor Type  Species  Sex Lowest
 Effect  Level 
Highest No-
 Effect Level 
   Pituitary adenomas
 mouse 
female
0.75 (9.4)
0.2 (2.4)
   Endocrine pancreas adenomas
rat
male
1.5 (9.4)
0.4 (2.4)
   Mammary gland adenocarcinomas
mouse
female
0.2 (2.4)
none
rat
female
0.4 (2.4)
none
rat
male
6 (37.5)
1.5 (9.4)
   Mammary gland neoplasm, Total
rat
male
1.5 (9.4)
0.4 (2.4)
[see Warnings and Precautions (5.6)]

Mutagenesis


in vitroin vivoDrosophila

Impairment of Fertility


22

14 CLINICAL STUDIES

14.1 Schizophrenia











  • In a 6-week, placebo-controlled trial (n=160) involving titration of risperidone in doses up to 10 mg/day (twice-daily schedule), risperidone was generally superior to placebo on the BPRS total score, on the BPRS psychosis cluster, and marginally superior to placebo on the SANS.
  • In an 8-week, placebo-controlled trial (n=513) involving 4 fixed doses of risperidone (2 mg/day, 6 mg/day, 10 mg/day, and 16 mg/day, on a twice-daily schedule), all 4 risperidone groups were generally superior to placebo on the BPRS total score, BPRS psychosis cluster, and CGI severity score; the 3 highest risperidone dose groups were generally superior to placebo on the PANSS negative subscale. The most consistently positive responses on all measures were seen for the 6 mg dose group, and there was no suggestion of increased benefit from larger doses.
  • In an 8-week, dose comparison trial (n=1356) involving 5 fixed doses of risperidone (1 mg/day, 4 mg/day, 8 mg/day, 12 mg/day, and 16 mg/day, on a twice-daily schedule), the four highest risperidone dose groups were generally superior to the 1 mg risperidone dose group on BPRS total score, BPRS psychosis cluster, and CGI severity score. None of the dose groups were superior to the 1 mg group on the PANSS negative subscale. The most consistently positive responses were seen for the 4 mg dose group.
  • In a 4-week, placebo-controlled dose comparison trial (n=246) involving 2 fixed doses of risperidone (4 and 8 mg/day on a once-daily schedule), both risperidone dose groups were generally superior to placebo on several PANSS measures, including a response measure (>20% reduction in PANSS total score), PANSS and the BPRS psychosis cluster (derived from PANSS). The results were generally stronger for the 8 mg than for the 4 mg dose group.







Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Clinical trial information for pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products.

14.2 Bipolar Mania – Monotherapy







  • In one 3-week placebo-controlled trial (n=246), limited to patients with manic episodes, which involved a dose range of risperidone 1 to 6 mg/day, once daily, starting at 3 mg/day (mean modal dose was 4.1 mg/day), risperidone was superior to placebo in the reduction of YMRS total score.
  • In another 3-week placebo-controlled trial (n=286), which involved a dose range of 1 to 6 mg/day, once daily, starting at 3 mg/day (mean modal dose was 5.6 mg/day), risperidone was superior to placebo in the reduction of YMRS total score.



Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Clinical trial information for pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products.

14.3 Bipolar Mania – Combination Therapy



  • In this 3-week placebo-controlled combination trial, 148 in- or outpatients on lithium or valproate therapy with inadequately controlled manic or mixed symptoms were randomized to receive risperidone, placebo, or an active comparator, in combination with their original therapy. Risperidone, in a dose range of 1 to 6 mg/day, once daily, starting at 2 mg/day (mean modal dose of 3.8 mg/day), combined with lithium or valproate (in a therapeutic range of 0.6 mEq/L to 1.4 mEq/L or 50 mcg/mL to 120 mcg/mL, respectively) was superior to lithium or valproate alone in the reduction of YMRS total score.
  • In a second 3-week placebo-controlled combination trial, 142 in- or outpatients on lithium, valproate, or carbamazepine therapy with inadequately controlled manic or mixed symptoms were randomized to receive risperidone or placebo, in combination with their original therapy. Risperidone, in a dose range of 1 to 6 mg/day, once daily, starting at 2 mg/day (mean modal dose of 3.7 mg/day), combined with lithium, valproate, or carbamazepine (in therapeutic ranges of 0.6 mEq/L to 1.4 mEq/L for lithium, 50 mcg/mL to 125 mcg/mL for valproate, or 4 to 12 mcg/mL for carbamazepine, respectively) was not superior to lithium, valproate, or carbamazepine alone in the reduction of YMRS total score. A possible explanation for the failure of this trial was induction of risperidone and 9-hydroxyrisperidone clearance by carbamazepine, leading to subtherapeutic levels of risperidone and 9-hydroxyrisperidone.

14.4 Irritability Associated with Autistic Disorder









  • In one of the 8-week, placebo-controlled trials, children and adolescents with autistic disorder (n=101), aged 5 to 16 years, received twice daily doses of placebo or risperidone 0.5 to 3.5 mg/day on a weight-adjusted basis. Risperidone, starting at 0.25 mg/day or 0.5 mg/day depending on baseline weight (< 20 kg and ≥ 20 kg, respectively) and titrated to clinical response (mean modal dose of 1.9 mg/day, equivalent to 0.06 mg/kg/day), significantly improved scores on the ABC-I subscale and on the CGI-C scale compared with placebo.
  • In the other 8-week, placebo-controlled trial in children with autistic disorder (n=55), aged 5 to 12 years, risperidone 0.02 to 0.06 mg/kg/day given once or twice daily, starting at 0.01 mg/kg/day and titrated to clinical response (mean modal dose of 0.05 mg/kg/day, equivalent to 1.4 mg/day), significantly improved scores on the ABC-I subscale compared with placebo.





16 HOW SUPPLIED/STORAGE AND HANDLING


Risperidone Tablets USP, 0.25 mg




Risperidone Tablets USP, 0.5 mg




Risperidone Tablets USP, 1 mg




Risperidone Tablets USP, 2 mg




Risperidone Tablets USP, 3 mg




Risperidone Tablets USP, 4 mg



Storage and Handling


Store at

17 PATIENT COUNSELING INFORMATION


17.1 Orthostatic Hypotension


[see Warnings and Precautions (5.7)]

17.2 Interference with Cognitive and Motor Performance


[see Warnings and Precautions (5.9)]

17.3 Pregnancy


[see Use in Specific Populations (8.1)]

17.4 Nursing


[see Use in Specific Populations (8.3)]

17.5 Concomitant Medication


[see Drug Interactions (7)]

17.6 Alcohol


[see Drug Interactions (7.1)]



Aurolife Pharma LLC




Gen-Source Rx

620 Gotham Parkway





PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.25 mg (500 Tablet Bottle)


NDC 52343-003-05
Risperidone Tablets, USP
0.25 mg
Rx only                   500 Tablets
GEN-SOURCE

Risperidone

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5 mg (500 Tablet Bottle)


NDC 52343-004-05
Risperidone Tablets, USP
0.5 mg
Rx only                   500 Tablets
GEN-SOURCE

Risperidone

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg (500 Tablet Bottle)


NDC 52343-005-05
Risperidone Tablets, USP
1 mg
Rx only                   500 Tablets
GEN-SOURCE

Risperidone

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (500 Tablet Bottle)


NDC 52343-006-05
Risperidone Tablets, USP
2 mg
Rx only                   500 Tablets
GEN-SOURCE

Risperidone

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg (500 Tablet Bottle)


NDC 52343-007-05
Risperidone Tablets, USP
3 mg
Rx only                   500 Tablets
GEN-SOURCE

Risperidone

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg (60 Tablet Bottle)


NDC 52343-008-60
Risperidone Tablets, USP
4 mg
Rx only                   60 Tablets
GEN-SOURCE

Risperidone

Risperidone

Risperidone TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-003
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RISPERIDONE RISPERIDONE 0.25 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
YELLOW 5 mm A;49 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-003-60 60 in 1 BOTTLE
2 NDC:52343-003-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078269 2009-10-25


Risperidone

Risperidone TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-004
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RISPERIDONE RISPERIDONE 0.5 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400
D&C YELLOW NO. 10
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
GREEN 8 mm A;70 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-004-60 60 in 1 BOTTLE
2 NDC:52343-004-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078269 2009-10-25


Risperidone

Risperidone TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-005
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RISPERIDONE RISPERIDONE 1 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm A;71 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-005-60 60 in 1 BOTTLE
2 NDC:52343-005-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078269 2009-10-25


Risperidone

Risperidone TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-006
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RISPERIDONE RISPERIDONE 2 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400
FERRIC OXIDE YELLOW
ferric oxide red
FERROSOFERRIC OXIDE

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Light Orange) 11 mm A;72 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-006-60 60 in 1 BOTTLE
2 NDC:52343-006-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078269 2009-10-25


Risperidone

Risperidone TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-007
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RISPERIDONE RISPERIDONE 3 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
YELLOW 14 mm A;73 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-007-60 60 in 1 BOTTLE
2 NDC:52343-007-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078269 2009-10-25


Risperidone

Risperidone TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-008
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RISPERIDONE RISPERIDONE 4 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400
D&C YELLOW NO. 10
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
GREEN 15 mm A;74 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-008-60 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078269 2009-10-25


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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