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These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993 | RISPERIDONE [WOCKHARDT LIMITED] | BioPortfolio

12:04 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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AdultsRisperidone oral solution is indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)]. AdolescentsDue 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.

Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone. Therefore, risperidone is contraindicated in patients with a known hypersensitivity to the product.

Table 1. Adverse Reactions in ≥1% of Risperidone -Treated Adult Patients with Schizophrenia in Double-Blind, Placebo-Controlled Trials
   Percentage of Patients Reporting Event
Body System
Adverse reaction
Risperidone
2 to 8 mg per day
(N=366)
Risperidone
>8 to 16 mg per day
Placebo
(N=225)
Body as a whole - general disorders


Back pain
3
2
<1
Fatigue
3
1
0
Chest pain
3
1
2
Fever
2
1
1
Asthenia
1
1
<1
Syncope
<1 1
<1
Edema
<1 1
0
Cardiovascular disorders, general


Hypotension postural
2
<1 0
Hypotension
<1 1
  0
Central and peripheral nervous system disorders


Parkinsonism*
12
17
6
Dizziness
10
4
2
Dystonia*
5
5
2
Akathisia*
5
5
2
Dyskinesia
1
1
<1
Gastrointestinal system disorders


Dyspepsia
10
7
6
Nausea
 9
4
4
Constipation
8
  9
7
Abdominal pain
4
3
0
Mouth dry
4
  <1 <1
Saliva increased
3
1
<1
Diarrhea
2
<1 1
Hearing and vestibular disorders



Earache
1
1
  0
Heart rate and rhythm disorders


Tachycardia
2
5
0
Arrhythmia
0
1
0
Metabolic and nutritional disorders


Weight increase
1
<1 0
Creatine phosphokinase increased
<1
2
<1
Musculoskeletal system disorders


Arthralgia
  2
3
<1
Myalgia
1  0
  0
Platelet, bleeding and clotting disorders


Epistaxis
<1 2
0
Psychiatric disorders



Anxiety
16
12
11
Somnolence
14
5
4
Anorexia
2
0
<1
Red blood cell disorders


Anemia
<1 1
0
Reproductive disorders, male


Ejaculation failure
<1 1
0
Respiratory system disorders


Rhinitis
7
11
6
Coughing
3
3
3
Upper respiratory tract infection
2
3
<1
Dyspnea
2
2
0
Skin and appendages disorder


Rash
2
4
2
Seborrhea
<1 2
0
Urinary system disorders


Urinary tract infection
<1  3
0
Vision disorders


Vision abnormal
3
1
<1
Table 2. Adverse Reactions in ≥5% of Risperidone -Treated Pediatric Patients with Schizophrenia in a Double-Blind Trial
                                                      Percentage of Patients Reporting Event
                                                                 Risperidone
Body System
Adverse Reaction

1 to 3 mg per day
(N=55)

4 to 6 mg per day
(N=51)
Placebo
(N=54)

Central and peripheral nervous system disorders


Parkinsonism*
                  13
                 16
        6
Tremor
                  11
                 10
        6
Dystonia*
                   9
                 18
        7
Dizziness
                   7
                 14
        2
Akathisia*
                   7
                 10
        6
Gastrointestinal system disorders


Saliva increased
                  0
                  10
        2
Psychiatric disorders


Somnolence
                  24
                  12
        4
Anxiety
                   7
                    6
        0
Table 3. Adverse Reactions in ≥1% of Risperidone -Treated Adult Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Monotherapy Trials
Percentage of Patients Reporting Event
Body System
Adverse Reaction
Risperidone
1 to 6 mg per day (N=448)    
Placebo (N=424)
Body as a whole - general disorders

Fatigue
                               2
             <1
Fever                                1
             <1
Asthenia                                1
             <1
Edema                                1
             <1
Central and peripheral nervous system disorders 

Parkinsonism*
                             20
               6
Dystonia*
                             11
               3
Akathisia*
                              9
               3
Tremor
                               6
               4
Dizziness                                5
              5
Gastrointestinal system disorders

Nausea
                               5
               2
Dyspepsia
                               4
               2
Saliva increased
                               3
             <1
Diarrhea
                               3
                2
Mouth dry                                1
                1
Heart rate and rhythm disorders

Tachycardia                                1
             <1
Liver and biliary system disorders 

SGOT increased                                1
             <1
Musculoskeletal disorders

Myalgia
                               2
                2
Psychiatric disorders

Somnolence
                              12
                4
Anxiety                                 2
                2
Reproductive disorders, female

Lactation nonpuerperal
                               1
                0
Respiratory disorders

Rhinitis
                               2
                2
Skin and appendages disorders

Acne
                               1
                0
Vision disorders

Vision abnormal                                2
              <1
Table 4. Adverse Reactions in ≥2% of Risperidone -Treated Adult Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Adjuvant Therapy Trials
                  Percentage of Patients Reporting Event
Body System
Adverse Reaction
Risperidone + Mood Stabilizer
(N=127)
Placebo + Mood Stabilizer
(N=126)
Body as a whole – general disorders 


Chest pain
                   2
                  2
Fatigue                    2
                  2
Central and peripheral nervous system disorders 

Parkinsonism*
                   9
                  4
Dizziness
                   8
                  2
Dystonia*
                   6
                  3
Akathisia*
                   6
                  0
Tremor                    5
                  2
Gastrointestinal system disorders

Nausea
                   6
                  5
Diarrhea
                   6
                  4
Saliva increased
                   4
                  0
Abdominal pain                    2
                  0
Heart rate and rhythm disorders


Palpitation                    2
                  0
Metabolic and nutritional disorders


Weight increase                    2
                  2
Psychiatric disorders


Somnolence                    12
                  5
Anxiety
                   4
                  2
Respiratory disorders

Pharyngitis
                   5
                  2
Coughing                    3
                  1
Skin and appendages disorders          


Rash
                   2
                  2
Urinary system disorders

Urinary incontinence
                   2
                  1
Urinary tract infection                    2
                  1
Table 5. Adverse Reactions in ≥5% of Risperidone-Treated Pediatric Patients with Bipolar Mania in Double-Blind, Placebo-Controlled Trials
Percentage of Patients Reporting Event
Body System
Adverse Reaction

Risperidone
0.5 to 2.5 mg per day (N=50)
Risperidone
3 to 6 mg per day (N=61)
Placebo
(N=58)

Body as a whole - general disorders



Fatigue
                        18
                    30
        3
Central and peripheral nervous system disorders



Dizziness
                        16
                     13
        5
Dystonia*
                          8
                     13
        2
Parkinsonism*
                          2
                       7
        2
Akathisia*                           0
                       7
        2 
Gastrointestinal system disorders 


Abdominal pain
                       18
                    15
        5
Dyspepsia
                       16
                      5
        3
Nausea
                       16
                    13
        7
Vomiting
                       12
                    10
        7
Diarrhea                          8
                      7
        2
Heart rate and rhythm disorders


Tachycardia
                         0
                     5
        2
Psychiatric disorders


Somnolence
                       42
                   56
      19
Appetite increased
                         4
                    7
        2
Anxiety                          0
                    8
        3
Reproductive disorders, female


Lactation nonpuerperal
                         2
                    5
        0
Respiratory system disorders


Rhinitis
                       14
                  13
      10
Dyspnea
                         2
                    5
        0
Skin and appendages disorders



Rash
                         0
                    7
        2
Urinary system disorders


Urinary incontinence
                          0
                     5
        0
Vision disorders



Vision abnormal                          4
                    7
        0
Table 6. Adverse Reactions in ≥5% of Risperidone -Treated Pediatric Patients Treated for Irritability Associated with Autistic Disorder in Double-Blind, Placebo-Controlled Trials
                                                                   Percentage Patients Reporting Event
Body System
Adverse Reaction

Risperidone
0.5 to 4.0 mg per day
(N=76)
Placebo
(N=80)
Body as a whole - general disorders                            42
        13
Fatigue
                           20
        19
Fever


Central and peripheral nervous system disorders


Dystonia*
                           12
          6
Tremor
                           12
          1
Dizziness
                             9
          3
Parkinsonism*
                             8
          0
Automatism
                             7
          1
Dyskinesia
                             7
          0
Gastrointestinal system disorders


Vomiting
                             25
          21
Saliva increased
                           22
          6
Constipation
                           21
          8
Mouth dry
                           13
          6
Nausea
                             8
          8
Heart rate and rhythm disorders  
 
Tachycardia
                             7
          0
Metabolic and nutritional disorders


Weight increase
                            5
          0
Psychiatric disorders

Somnolence
                          67
        23
Appetite increased
                          49
         19
Anxiety
                          16
         15
Anorexia
                            8
           8
Confusion
                            5
           0
Respiratory system disorders

Rhinitis
                          36
         23
Upper respiratory tract infection
                          34
         15
Coughing
                          24
         18
Skin and appendages disorders


Rash                           11
          8
Urinary system disorders

Urinary incontinence
                          22
        20
Table 7. Adverse Reactions Associated With Discontinuation in 2 or More Risperidone-Treated Adult Patients in Schizophrenia Trials
Risperidone
Adverse reaction
2 to 8 mg/day
(N=366)
> 8 to 16 mg/day
(N=198)

Placebo
(N=225)
Dizziness
                      1.4%
                            1.0%

          0%
Nausea
                      1.4%
                               0%

          0%
Agitation                       1.1%
                            1.0%

          0%
Parkinsonism
                     0.8%
                               0%

          0%
Somnolence
                     0.8%
                            0.5%

          0%
Dystonia
                     0.5%
                               0%

          0%
Abdominal pain
                     0.5%
                               0%

          0%
Hypotension postural
                     0.3%
                            0.5%

          0%
Tachycardia
                    0.3%
                            0.5%

          0%
Akathisia
                       0%
                             1.0%

          0%
Table 8. Adverse Reactions Associated With Discontinuation in 2 or More Risperidone-Treated Adult Patients in Bipolar Mania Clinical Trials
                  Risperidone
Adverse reactions
1 to 6mg/day
(N=448)

Placebo
(N=424)

Parkinsonism
                        0.4%
                  0%
Somnolence
                        0.2%
                  0%
Dizziness
                        0.2%
                  0%
Dystonia
                        0.2%
                  0%
SGOT increased                         0.2%
                0.2%
SGPT increased                         0.2%
                0.2%
Dose Groups
Placebo
Risperidone
2 mg
Risperidone
6 mg
Risperidone
10 mg
Risperidone
  16 mg
Pakinsonism
1.2
0.9
1.8
2.4
2.6
EPS Incidence
11% 15% 16% 20% 31%
Dose Groups
Risperidone
1 mg
Risperidone
4 mg
Risperidone
8 mg
Risperidone
12 mg
Risperidone
  16 mg
Pakinsonism
0.6
1.7
2.4
2.9
4.1
EPS Incidence
7% 11% 17% 18% 20%

Enter section text here

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 CHFNO and its molecular weight is 410.49. The structural formula is:

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 risperidone orally disintegrating tablets and risperidone oral solution are bioequivalent to risperidone 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 twice daily). 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 to 6 days (measured in extensive metabolizers). Food Effect Food does not affect either the rate or extent of absorption of risperidone. Thus, risperidone can be given with or without meals. Distribution Risperidone is rapidly distributed. The volume of distribution is 1 to 2 L/kg. In plasma, risperidone is bound to albumin and α-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. 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 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% to 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 risperidone and 9-hydroxyrisperidone combined, 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 [see Drug Interactions (7.12)]. 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 (n≅70) of poor metabolizers given risperidone do not suggest important differences between poor and extensive metabolizers. Second, co-administration of known enzyme inducers (e.g., carbamazepine, phenytoin, rifampin, and phenobarbital) with risperidone may cause a decrease in the combined plasma concentrations of risperidone and 9-hydroxyrisperidone [see Drug Interactions (7.11)]. 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 [see Drug Interactions 7.12)]. 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 risperidone and 9-hydroxyrisperidone combined, after single and multiple doses, were similar in extensive and poor metabolizers, with an overall mean elimination half-life of about 20 hours. 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. Risperidone doses should be reduced in patients with renal disease [see Dosage and Administration (2.4) and Warnings and Precautions (5.16)]. 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 α-acid glycoprotein. Risperidone doses should be reduced in patients with liver disease [see Dosage and Administration (2.4) and Warnings and Precautions (5.16)]. 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 (2.4)]. Pediatric Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients withschizophrenia, bipolar mania or irritability associated with autistic disorder. Pharmacokinetic information for pediatric patients with schizophrenia, 13 to 17 years of age, bipolar mania, 10 to 17 years old, and irritability associated with autistic disorder, 5 to 16 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products. 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.

Carcinogenesis Carcinogenicity studies were conducted in Swiss albino mice and Wistar rats. Risperidone was administered in the diet at doses of 0.63 mg/kg, 2.5 mg/kg, and 10 mg/kg for 18 months to mice and for 25 months to rats. These doses are equivalent to 2.4, 9.4, and 37.5 times the maximum recommended human dose (MRHD) for schizophrenia (16 mg/day) on a mg/kg basis or 0.2, 0.75, and 3 times the MRHD (mice) or 0.4, 1.5, and 6 times the MRHD (rats) on a mg/m basis. A maximum tolerated dose was not achieved in male mice. There were statistically significant increases in pituitary gland adenomas, endocrine pancreas adenomas, and mammary gland adenocarcinomas. The following table summarizes the multiples of the human dose on a mg/m(mg/kg) basis at which these tumors occurred.

                                                                           Multiples of Maximum
                                                                           Human Dose in mg/m2
                                                                         (mg/kg)

Tumor Type
Species
Sex
Lowest Effect Level
Highest
No-EffectLevel
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
        rat
        rat

female
female
male

                 0.2 (2.4)
                 0.4 (2.4)
                 6.0 (37.5)

           none
           none
        1.5 (9.4)
Mammary gland neoplasm, Total         rat
male
                 1.5 (9.4)
        0.4 (2.4)

AdultsThe efficacy of risperidone in the treatment of acute manic or mixed episodes was established in two short-term (3-week) placebo-controlled trials in patients who met the DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes. These trials included patients with or without psychotic features. The primary rating instrument used for assessing manic symptoms in these trials was the Young Mania Rating Scale (YMRS), an 11-item clinician-rated scale traditionally used to assess the degree of manic symptomatology (irritability, disruptive/aggressive behavior, sleep, elevated mood, speech, increased activity, sexual interest, language/thought disorder, thought content, appearance, and insight) in a range from 0 (no manic features) to 60 (maximum score). The primary outcome in these trials was change from baseline in the YMRS total score. The results of the trials follow:

PediatricsDue 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.

The efficacy of risperidone with concomitant lithium or valproate in the treatment of acute manic or mixed episodes was established in one controlled trial in adult patients who met the DSM-IV criteria for Bipolar I Disorder. This trial included patients with or without psychotic features and with or without a rapid-cycling course.

Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with irritability associated with autistic disorder. Clinical trial information for pediatric patients with irritability associated with autistic disorder,5 to 16 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products.

Risperidone Oral SolutionRisperidone 1 mg/mL Oral Solution (NDC 64679-692-01) is supplied in 30 mL bottles with a calibrated (in milligrams and milliliters) syringe. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL. Storage and Handling Risperidone 1 mg/mL Oral Solution should be stored at 20-25C (68-77F) [See USP Controlled Room Temperature]. Protect from light and freezing. Keep out of reach of children

Since risperidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that risperidone therapy does not affect them adversely [see Warnings and Precautions (5.9)].

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1)].

Patients should be advised not to breast-feed an infant if they are taking risperidone [see Use in Specific Populations (8.3)].

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions (7)].

Manufacturer

WOCKHARDT LIMITED

Active Ingredients

Source

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Antipsychotic drugs are used to manage symptoms of pediatric psychiatric disorders despite the relative absence of research regarding the long-term effects of these drugs on brain development. Using r...

Is risperidone effective in reducing challenging behaviours in individuals with intellectual disabilities after 1 year or longer use? A placebo-controlled, randomised, double-blind discontinuation study.

Many people with intellectual disabilities use risperidone long term for the management of challenging behaviours, despite its limited proof of effectiveness and its clear association with adverse eve...

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