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PMS-RISPERIDONE is a brand name for Risperidone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Schizophrenia pms-RISPERIDONE (risperidone) is indicated for the acute treatment and maintenance treatment of schizophrenia and related psychotic disorders. In controlled clinical trials, risperidone was found to improve both positive and negative symptoms of schizophrenia. Risperidone has been shown to be…
Verbatim from this product's HC label. Tap a section to expand.
d. d. schedule, generally beginning with 1 to 2 mg per day. The dose should be adjusted gradually over several days based on clinical response to a target dose of 4 to 6 mg per day. Some patients may benefit from lower initial doses and/or a slower adjustment schedule.
Further dosage adjustments, if indicated, should generally occur at intervals of not less than one week since steady state for the active metabolite would not be achieved for approximately one week in the typical patient. When dosage adjustments are necessary, small increments/decrements of 1 mg are recommended.
In controlled clinical trials, optimal therapeutic effects were seen in the 4 to 8 mg per day dose range. However, clinical experience indicates that in the majority of patients , adequate therapeutic effect is achieved at the 6 mg per day dose.
Doses above 10 mg per day have not been shown to be more efficacious than lower doses and were associated with more extrapyramidal symptoms and other adverse events. The safety of risperidone has not been established above 16 mg total daily dose, administered twice daily.
If administered once daily, safety has not been established beyond a single dose of 8 mg. pms-RISPERIDONE Product Monograph Page 6 of 77 Switching from Other Antipsychotics When medically appropriate, gradual discontinuation of the previous treatment, while pms-RISPERIDONE therapy is initiated, is recommended.
In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients from depot antipsychotics, initiate pms-RISPERIDONE therapy in place of the next scheduled injection. The need for continuing existing antiparkinsonian medications should be re -evaluated periodically.
Maintenance Therapy It is recommended that responding patients be continued on pms-RISPERIDONE at the lowest dose needed to maintain remission. Patients should be reassessed periodically to determine the need for maintenance treatment.
While there is no body of evidence available to answer the question of how long the patient should be treated with pms-RISPERIDONE, the effectiveness of maintenance treatment is well established for many other antipsychotic drugs. Severe Dementia of the Alzheimer Type Physicians are advised to assess the risks and benefits of the use of pms-RISPERIDONE in elderly patients with dementia of the Alzheimer type, taking into account risk predictors for stroke or existing cardiovascular comorbidities in the individual patient (see INDICATIONS; WARNINGS AND PRECAUTIONS; and ADVERSE REACTIONS).
1 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Schizophrenia and Related Psychotic Disorders Adverse Events Associated with Discontinuation of Treatment An estimated 9% of approximately 1,800 patients who received risperidone in controlled clinical trials discontinued treatment due to adverse reactions.
2%): primarily hypotension. 3%). 4). In some instances, it has been difficult to differentiate adverse events from symptoms of the underlying psychosis. Serious Adverse Events The most serious adverse reactions reported were rare cases of syncope, cardiac arrhythmias, first degree AV-block, and seizures.
Extrapyramidal Symptoms Parkinsonian side effects reported were usually mild, but dose related; they were reversible upon dose reduction and/or administration of antiparkinsonian medication. pms-RISPERIDONE Product Monograph Page 21 of 77 Vital Sign Changes Hypotension (including orthostatic) and tachycardia (including reflex tachycardia) have been observed following the administration of risperidone (see WARNINGS AND PRECAUTIONS, Cardiovascular).
ECG Changes Electrocardiograms were evaluated in patients treated with risperidone (N = 380), haloperidol (N = 126) and placebo (N = 120). In the risperidone group, eight patients had a slight increase in QTc intervals from less than 450 msec at baseline to intervals ranging from 450 to 474 msec during treatment.
Changes of this type were not seen in placebo-treated patients but were observed in three haloperidol-treated subjects. Hyperprolactinemia Risperidone elevated plasma prolactin levels. Associated manifestations, namely amenorrhea, galactorrhea, and menorrhagia, have occurred.
, Skin, August 2021 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................................. 4 1 INDICATIONS..................................................................................................................
1 Pediatrics................................................................................................................. 2 Geriatrics.................................................................................................................
4 2 CONTRAINDICATIONS.................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................................ 5 4 DOSAGE AND ADMINISTRATION ...................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment.......................................................... 3 Administration ..........................................................................................................
4 Missed Dose............................................................................................................ 8 5 OVERDOSAGE................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING............................... 9 7 WARNINGS AND PRECAUTIONS.................................................................................. 1 Special Populations ...............................................................................................
1 Pregnant Women.............................................................................................. 2 Breast-feeding .................................................................................................. 3 Pediatrics .........................................................................................................
pms-RISPERIDONE is contraindicated in patients who are hypersensitive to risperidone paliperidone, or to any ingredients in the formulation or component of the container. For a pms-RISPERIDONE Product Monograph Page 5 of 77 complete listing of ingredients, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Discontinuation should be considered if signs and symptoms of cerebrovascular adverse events occur. d. is recommended. 25 mg per day approximately every 2 to 4 days. d. 0 mg per day) for most patients. d. 0 mg per day). Periodic dosage adjustments (increase or decrease) or discontinuation of treatment should be considered because of the instability of the symptoms treated.
Since there is no experience in younger patients, dosage recommendations cannot be made. Bipolar Mania pms-RISPERIDONE should be administered on a once-daily schedule, starting with 2 mg to 3 mg per day. Dosage adjustments, based on clinical response and tolerability, should occur at intervals of not less than 24 hours and in dosage increments or decreme nts of 1 mg per day.
Risperidone doses higher than 6 mg per day were not studied in patients with bipolar disorder. In two controlled trials, the most common daily dose was 1 - 4 mg/day. In each of the three controlled trials, risperidone was effective across the dose range used, although the effect size in the 3 - 4 mg/day mean modal dose group was larger than in the 5 - 6 mg/day mean modal dose group (mean modal dose is the average of the most frequent daily dose across the three trials).
The safety and effectiveness of risperidone for long-term use and for prophylactic use in bipolar disorder have not been evaluated. Physicians who elect to use pms-RISPERIDONE for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
pms-RISPERIDONE Product Monograph Page 7 of 77 Special Populations Pediatrics pms-RISPERIDONE has not been studied in children younger than 18 years old. Geriatrics Risperidone is substantially excreted by the kidneys. Thus, the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, caution should be taken in dose selection and titration. It may also be useful to monitor renal function in these patients (see WARNINGS AND PRECAUTIONS, Special Populations; and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
d. starting dose to a maximum daily dose of 3 mg. Since the elimination of risperidone is somewhat slower in these patients, the potential for accu mulation should be considered (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
d. should be considered. Patients with Hepatic Impairment pms-RISPERIDONE should be used with caution in patients with hepatic impairment. […]
In controlled clinical trials prolactin levels were higher in patients treated with risperidone than in haloperidol-treated patients; however, the incidence of solicited adverse events considered to be possibly prolactin-related in patients treated with risperidone (≤ 10 mg / day) was low (< 6%), and similar to that in haloperidol-treated patients.
2: Prolactin-Related Adverse Events Solicited from Women and Men in the Two Fixed- Dose Schizophrenia Trials Risperidone (mg/day) Placebo 1-2 4-6 8-10 Women n = 78 n = 90 n = 98 n = 14 Amenorrhea 5 (6%) 4 (4%) 6 (6%) 1 (7%) Galactorrhea 1 (1%) 2 (2%) 2 (2%) 0 Men n = 238 n = 223 n = 219 n = 74 Ejaculatory dysfunction 7 (3%) 6 (3%) 9 (4%) 2 (3%) Erectile dysfunction 6 (2%) 9 (4%) 6 (3%) 1 (1%) Gynecomastia 2 (1%) 0 1 (<1%) 1 (1%) Note: Adverse events w ere solicited using the UKU questionnaire.
See Kleinberg DL, Davis JM, De Coster R, Van Baelen B, Brecher M. Prolactin levels and adverse events in patients treated w ith risperidone. J Clin Psychopharmacol 1999; 19(1):57-61. Weight Gain In a pool of 6- to 8-week placebo-controlled clinical trials, which compared risperidone and placebo in the treatment of schizophrenia, 18% of patients treated with risperidone and 9% of placebo-treated patients met a weight gain criterion of ≥ 7% of baseline body weight.
This difference was statistically significant. 3 kg in long-term studies) has been seen. Other Adverse Events Erectile dysfunction, ejaculatory dysfunction, orgastic dysfunction, and rash have also been reported during treatment with risperidone.
As with other antipsychotics, cases of water intoxication, either due to polydipsia or to syndrome of inappropriate secretion of antidiuretic hormone (SIADH), have occasionally been reported during treatment with risperidone. 3 enumerates adverse events that occurred at an incidence of 1% or more, and were at least as frequent among patients treated with risperidone receiving doses of ≤ 10 mg/day as among placebo-treated patients in the pooled results of two 6- to 8-week controlled trials.
Patients received risperidone at fixed 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 flexible dose study. 3 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 substantially in these rates. Reported adverse events were classified using the World Health Organization preferred terms. 3: Treatment-Emergent Adverse Experience Incidence in 6- to 8-Week Controlled Clinical Trials in Schizophrenia1 Body System / Preferred Term Risperidone Placebo (N = 142) ≤ 10 mg/day (N = 324) 16 mg/day (N = 77) Psychiatric Insomnia Agitation Anxiety Somnolence Aggressive reaction 26% 22% 12% 3% 1% 23% 26% 20% 8% 3% 19% 20% 9% 1% 1% Neurological Extrapyramidal symptoms2 Headache Dizziness 17% 14% 4% 34% 12% 7% 16% 12% 1% Gastrointestinal Constipation Nausea Dyspepsia Vomiting Abdominal pain Saliva increased Toothache 7% 6% 5% 5% 4% 2% 2% 13% 4% 10% 7% 1% 0% 0% 3% 3% 4% 4% 0% 1% 0% Respiratory […]
4 Geriatrics.......................................................................................................... 19 8 ADVERSE REACTIONS.................................................................................................
1 Clinical Trial Adverse Reactions ............................................................................. 2 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...........................................................................................................
3 Post-Market Adverse Reactions ............................................................................. 29 9 DRUG INTERACTIONS.................................................................................................. 1 Overview ...............................................................................................................
2 Drug-Drug Interactions........................................................................................... 3 Drug-Food Interactions .......................................................................................... 4 Drug-Herb Interactions...........................................................................................
5 Drug-Laboratory Test Interactions .......................................................................... 6 Drug-Lifestyle Interactions...................................................................................... 36 10 ACTION AND CLINICAL PHARMACOLOGY ..................................................................
1 Mechanism of Action.............................................................................................. 2 Pharmacokinetics ..................................................................................................
36 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 38 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 38 PART II: SCIENTIFIC INFORMATION ....................................................................................
39 13 PHARMACEUTICAL INFORMATION.............................................................................. 39 pms-RISPERIDONE Product Monograph Page 3 of 77 14 CLINICAL TRIALS .........................................................................................................
1 Comparative Bioavailability Studies ........................................................................ 43 15 MICROBIOLOGY ...........................................................................................................
45 16 NON CLINICAL TOXICOLOGY ....................................................................................... 45 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 52 PATIENT MEDICATION INFORMATION ................................................................................
53 PATIENT MEDICATION INFORMATION ................................................................................ 65 pms-RISPERIDONE Product Monograph Page 4 of 77 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Adults Schizophrenia pms-RISPERIDONE (risperidone) is indicated for the acute treatment and maintenance treatment of schizophrenia and related psychotic disorders.
In controlled clinical trials, risperidone was found to improve both positive and negative symptoms of schizophrenia. Risperidone has been shown to be effective in maintaining clinical improvement during long-term therapy (1 year). Severe Dementia of the Alzheimer type – Symptomatic management of aggression and psychotic symptoms pms-RISPERIDONE is […]