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RISPERDAL CONSTA is a brand name for Risperidone, supplied as a powder for suspension, sustained-release. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Schizophrenia and Related Disorders RISPERDAL CONSTA® (risperidone) powder for injectable prolonged-release suspension is indicated for the management of the manifestations of schizophrenia and related psychotic disorders. RISPERDAL CONSTA® was found to improve both positive and negative symptoms of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations RISPERDAL CONSTA® is a treatment option for patients where the risk of relapse requires intervention according to clinical judgment. For patients who have never taken oral risperidone, tolerability with oral risperidone should be established prior to initiating treatment with RISPERDAL CONSTA®.
Very rare cases of severe hypersensitivity after injection with RISPERDAL CONSTA® have been reported during post-marketing experience in patients who have previously tolerated oral risperidone or oral paliperidone. Care should be taken to avoid exposure to those that are suspected to be hypersensitive or have shown hypersensitivity reactions to any of the excipients (see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
2 Recommended Dose and Dosage Adjustment Schizophrenia The recommended dose is 25 mg IM every 2 weeks. 5 mg or 50 mg. The maximum dose should not exceed 50 mg RISPERDAL CONSTA® every 2 weeks. No additional benefit was observed with dosages greater than 50 mg RISPERDAL CONSTA® in clinical trials in patients with schizophrenia; however, a higher incidence of adverse effects was observed.
Serious Warnings and Precautions Increased Mortality in Elderly Patients with Dementia Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. 6-fold increase in death rate in the drug-treated patients.
, pneumonia) in nature (see WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics, Use in Geriatric Patients with Dementia). 0 Page 6 of 70 Although no controlled studies have been conducted to answer the question of how long patients should be treated with RISPERDAL CONSTA®, oral risperidone has been shown to be effective in maintaining clinical improvement during long-term therapy (1 year) in patients with schizophrenia.
It is recommended that responding patients be continued on treatment with RISPERDAL CONSTA® at the lowest dose needed. Patients should be periodically reassessed to determine the need for continued treatment. Bipolar Disorder The recommended dose is 25 mg IM every 2 weeks.
5 mg or 50 mg. In clinical trials the majority of patients were treated with the 25 mg dose. The maximum dose should not exceed 50 mg RISPERDAL CONSTA® every 2 weeks. Doses above 50 mg have not been studied in this population. It is recommended that responding patients be continued with the lowest dose needed and reassessed periodically to determine the need for continued treatment.
0 Page 28 of 70 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. The prescriber should be aware that the numbers in the tables and tabulations 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 the 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.
Schizophrenia The safety of RISPERDAL CONSTA® was evaluated from a clinical trial database consisting of 1499 patients exposed to one or more doses of RISPERDAL CONSTA® for the treatment of schizophrenia. Of these 1499 patients, 332 were patients who received RISPERDAL CONSTA® while participating in a 12-week, double-blind, placebo-controlled trial.
A total of 202 of the 332 were patients with schizophrenia who received 25 mg or 50 mg RISPERDAL CONSTA®. The conditions and duration of treatment with RISPERDAL CONSTA® in the other clinical trials varied greatly and included (in overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12 weeks) and longer-term (up to 4 years) exposures.
Adverse findings were assessed by spontaneous reports of adverse events, laboratory tests, vital signs, body weight, and ECGs. Adverse events were classified using the World Health Organization preferred terms. Treatment-emergent adverse events were defined as those events with an onset between the first dose and 49 days after the last dose.
, Immune, Skin 12/2020 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 ............................................................................................ 8 5 OVERDOSAGE ..................................................................................................
16 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........... 17 7 WARNINGS AND PRECAUTIONS .................................................................... 1 Special Populations .................................................................................
1 Pregnant Women ..................................................................................... 2 Breast-feeding ......................................................................................... 3 Pediatrics .................................................................................................
4 Geriatrics ................................................................................................. 26 8 ADVERSE REACTIONS .................................................................................... 1 Clinical Trial Adverse Reactions ..............................................................
RISPERDAL CONSTA® is contraindicated in patients who are hypersensitive to risperidone, paliperidone, or to any other ingredient in the formulation or component of the container (see WARNINGS AND PRECAUTIONS, Immune, Hypersensitivity, and ADVERSE REACTIONS, Post-Market Adverse Reactions).
For a complete listing of ingredients, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 0 Page 5 of 70
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Risperidone in Canada.
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RISPERDAL CONSTA® is not indicated as adjunctive treatment in patients with bipolar disorder. 5 mg may be appropriate when clinical factors warrant dose adjustment, such as in patients with hepatic or renal impairment (see below), for certain drug interactions that increase risperidone plasma concentrations (see DRUG INTERACTIONS), or in patients who have a history of poor tolerability to psychotropic medications.
5 mg dose has not been investigated in clinical trials. Oral risperidone (or another antipsychotic medication) should be given with the first injection of RISPERDAL CONSTA® and continued for 3 weeks to ensure that adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection site (see ACTION AND CLINICAL PHARMACOLOGY).
Upward dose adjustment should not be made more frequently than every 4 weeks. The clinical effects of this dose adjustment should not be anticipated earlier than 3 weeks after the first injection with the higher dose. 5 mg may be appropriate.
5 mg dose has not been investigated in clinical trials. Two different dose strengths of RISPERDAL CONSTA® should not be combined in a single administration. Pediatrics RISPERDAL CONSTA® has not been studied in children younger than 18 years old.
Geriatrics For elderly patients treated with RISPERDAL CONSTA®, the recommended dosage is 25 mg IM every 2 weeks. 0 Page 7 of 70 that adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection site (see ACTION AND CLINICAL PHARMACOLOGY).
RISPERDAL CONSTA® has not been studied in elderly patients with bipolar disorder. , sitting on the edge of the bed for several minutes before attempting to stand in the morning and slowly rising from a seated position). These patients should avoid sodium depletion or dehydration, and circumstances that accentuate hypotension […]
5 mg to 50 mg. In the 12- week, placebo-controlled trial in patients with schizophrenia who received 25 mg or 50 mg, the incidence of patients who discontinued treatment due to an adverse event was lower with RISPERDAL CONSTA® (11%; 22/202 patients) than with placebo (13%; 13/98 patients).
The more common adverse events causing discontinuation included: psychiatric (17% vs. 4% vs. 1% placebo): primarily hyperkinesia. No adverse events leading to discontinuation were found to be unexpected nor were considered to be clinically relevant to RISPERDAL CONSTA®.
1 enumerates adverse events that occurred at an incidence of 2% or more, and were at least as frequent among schizophrenic patients treated with 25 mg or 50 mg RISPERDAL CONSTA® as patients treated with placebo in the 12-week, placebo-controlled trial.
This table shows the percentage of patients in each dose group who spontaneously reported at least one episode of an event at some time during double-blind treatment. All patients were titrated to a dose of 4 mg oral risperidone during a one-week run-in period.
Patients who received RISPERDAL CONSTA® were given doses of oral risperidone (2 mg for patients in the 25 mg group, and 4 mg for patients in the 50 mg group) during the 3 weeks after the first injection to provide therapeutic levels until the main release phase of risperidone from the injection site had begun.
Patients who received placebo injections were given placebo tablets. 0 Page 29 of 70 Serious Adverse Events In the 12-week, placebo-controlled trial, the most frequently reported serious adverse events during the double-blind period among schizophrenic patients were psychosis, hallucination, agitation, suicide attempt, and anxiety.
No serious adverse events were found to be unexpected nor were considered to be clinically relevant to RISPERDAL CONSTA®. 1: Treatment-Emergent Adverse Events Reported by ≥ 2% of Patients with Schizophrenia Treated with RISPERDAL CONSTA® and Equal or Greater than Placebo in a 12-Week, Double-Blind, Placebo-Controlled Clinical Trial Percentage of Patients Reporting Event RISPERDAL CONSTA® WHO Body System Disorder/Preferred Term Placebo (n=98) 25 mg (n=99) 50 mg (n=103) Coughing 4 5 2 Sinusitis 0 3 1 Upper respiratory tract infection 1 2 0 Metabolic & nutritional Weight increase 2 5 4 Weight […]
2 Less Common Clinical Trial Adverse Reactions (≤ 1%) ........................... 3 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................
4 Post-Market Adverse Reactions .............................................................. 41 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 ....................................................................... 49 10 ACTION AND CLINICAL PHARMACOLOGY ...................................................
1 Mechanism of Action................................................................................ 2 Pharmacokinetics .................................................................................... 50 11 STORAGE, STABILITY AND DISPOSAL .........................................................
0 Page 3 of 70 12 SPECIAL HANDLING INSTRUCTIONS ............................................................ 52 PART II: SCIENTIFIC INFORMATION ......................................................................... 53 13 PHARMACEUTICAL INFORMATION ...............................................................
53 14 CLINICAL TRIALS ............................................................................................. 53 15 MICROBIOLOGY ............................................................................................... 56 16 NON-CLINICAL TOXICOLOGY .........................................................................
56 17 SUPPORTING PRODUCT MONOGRAPHS ...................................................... 58 PATIENT MEDICATION INFORMATION ..................................................................... 0 Page 4 of 70 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Adults Schizophrenia and Related Disorders RISPERDAL CONSTA® (risperidone) powder for injectable prolonged-release suspension is indicated for the management of the manifestations of schizophrenia and related psychotic disorders.
RISPERDAL CONSTA® was found to improve both positive and negative symptoms of schizophrenia. The efficacy of RISPERDAL CONSTA® is based in part on a 12-week, placebo-controlled trial in schizophrenic inpatients or outpatients, along with extrapolation from the established efficacy of oral risperidone in this population.
The effectiveness of RISPERDAL CONSTA® in longer-term use, that is, more than 12 weeks, has not been systematically evaluated in controlled trials. However, oral risperidone has been shown to be effective in maintaining clinical improvement during long-term therapy (1 year).
Patients should be periodically reassessed to determine the need for continued treatment (see DOSAGE AND ADMINISTRATION). Bipolar Disorder RISPERDAL CONSTA® is indicated as monotherapy maintenance treatment in patients with bipolar I disorder, who have previously responded to oral antipsychotics or other anti-manic treatment, to delay occurrence of manic episodes.
For patients who have never taken oral risperidone, it is recommended to establish tolerability […]