Last updated on Mar 3, 2023. After a single intramuscular (gluteal) injection of Risperdal Consta, there is a small initial release of the drug (< 1% of the dose), followed by a lag time of 3 weeks. Do not administer intravenously. The efficacy of the 12.5 mg dose has not been investigated in clinical trials. Risperdal Consta should be used with particular caution in (1) patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension, e.g., dehydration and hypovolemia, and (2) in the elderly and patients with renal or hepatic impairment. No comparison of effectiveness in the two groups has been made. In patients with moderate to severe renal disease treated with oral RISPERDAL, clearance of the sum of risperidone and its active metabolite decreased by 60% compared with young healthy subjects. The recommended starting dose is 0.5 mg oral RISPERDAL twice daily during the first week, which can be increased to 1 mg twice daily or 2 mg once daily during the second week. However, it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. V. Dosage and Administration Drug Name Indication Dosing Regimen Maximum Dose Risperidone (Risperdal Consta) Bipolar disorder, Schizophrenia 25 mg IM every 2 weeks. Risperidone is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The patient had 20/20 visual acuity in both eyes. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The electrocardiograms of 202 schizophrenic patients treated with 25 mg or 50 mg Risperdal Consta and 98 schizophrenic patients treated with placebo in the 12-week double-blind, placebo-controlled trial were evaluated. Risperidone has an antiemetic effect in animals; this effect may also occur in humans, and may mask signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye's syndrome, and brain tumor. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology. Drug class: Atypical antipsychotics Patients may be placed on a lower dose of Risperdal Consta between 2 to 4 weeks before the planned discontinuation of carbamazepine or other CYP 3A4 enzyme inducers to adjust for the expected increase in plasma concentrations of risperidone plus 9-hydroxyrisperidone. The effect dose for osteodystrophy and the tumor findings is 8 times the IM maximum recommended human dose (MRHD) (50 mg) on a mg/m2 basis and is associated with a plasma exposure (AUC) 2 times the expected plasma exposure (AUC) at the IM MRHD. Monitoring of orthostatic vital signs should be considered [see Warnings and Precautions (5.7)]. Amitriptyline did not affect the pharmacokinetics of risperidone or of risperidone and 9-hydroxyrisperidone combined following concomitant administration with oral RISPERDAL. Our mission is to advance the use of a person-centered approach to care that ensures people who have SMI find the RISPERDAL CONSTA support. RISPERDAL has low to moderate affinity (Ki of 47 to 253 nM) for the serotonin 5HT1C, 5HT1D, and 5HT1A receptors, weak affinity (Ki of 620 to 800 nM) for the dopamine D1 and haloperidol-sensitive sigma site, and no affinity (when tested at concentrations >10-5 M) for cholinergic muscarinic or 1 and 2 adrenergic receptors. The mean intensity of injection pain reported by patients with schizophrenia using a visual analog scale (0 = no pain to 100 = unbearably painful) decreased in all treatment groups from the first to the last injection (placebo: 16.7 to 12.6; 25 mg: 12.0 to 9.0; 50 mg: 18.2 to 11.8). Composition of the diluent includes citric acid anhydrous, disodium hydrogen phosphate dihydrate, polysorbate 20, sodium carboxymethyl cellulose, sodium chloride, sodium hydroxide, and water for injection. Description Clinical Pharmacology Nonclinical Toxicology Clinical Studies How Supplied/Storage and Handling Patient Counseling 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. Patients who reached remission at the end of this 16-week open-label treatment phase (N=139) were then randomized into a 52-week double-blind, placebo-controlled phase in which they received Risperdal Consta (N=72) or placebo (n=67) as adjunctive treatment in addition to continuing their treatment as usual. If last Trinza dose was 819 mg, give Invega Sustenna 156 mg on day 1, and 156 mg on day 8 (both deltoid), then administer Trinza 819 mg one month after day 8 (gluteal or deltoid). For breakthrough psychotic symptoms, an oral antipsychotic should be added to quickly control symptoms. Risperdal Consta is provided as a dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a West-Medimop Vial Adapter, and two Terumo SurGuard 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration). Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. Patients should be advised not to breast-feed an infant during treatment and for at least 12 weeks after the last injection of Risperdal Consta [see Use in Specific Populations (8.3)]. A total of 501 patients were treated during a 26-week open-label period with Risperdal Consta (starting dose of 25 mg, and titrated, if deemed clinically desirable, to 37.5 mg or 50 mg; in patients not tolerating the 25 mg dose, the dose could be reduced to 12.5 mg). Risperdal Consta is not approved for the treatment of patients with dementia-related psychosis. Patients maintaining a stable dose and treatment response during the last 8-weeks of the open-label stabilization phase entered a double-blind treatment phase and were randomized to either their current dose of RISPERDAL CONSTA (n=154) or placebo (n=149). When either concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dose of Risperdal Consta. Do not combine two different dose strengths of Risperdal Consta in a single administration. Given the primary CNS effects of risperidone, caution should be used when Risperdal Consta is administered in combination with other centrally-acting drugs or alcohol. Available for Android and iOS devices. Children younger than 10 years of ageUse and dose must be determined by your doctor. Abilify Maintena (aripiprazole monohydrate monthly LAI): Aristada (aripiprazole lauroxil monthly, every 6 week, or 2-month LAI): Haldol Decanoate (haloperidol monthly LAI): Invega Hafyera (paliperidone palmitate 6-month LAI): Invega Sustenna (paliperidone palmitate monthly LAI): Invega Trinza (paliperidone palmitate 3-month LAI): Prolixin Decanoate (fluphenazine 2-4 week LAI): Risperdal Consta (risperidone 2-week LAI): Patients who have missed doses of their LAI and present outside the window of administration as described in this policy will require consultation with Medical Staff. During a 1-week run-in period, patients were discontinued from other antipsychotics and were titrated to a dose of 4 mg oral RISPERDAL. A causal association for Risperdal Consta often cannot be reliably established in individual cases. A control group received injections of 0.9% NaCl, and a vehicle control group was injected with placebo microspheres. Patients randomized to receive placebo injections were given oral placebo supplementation. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown [see Warnings and Precautions (5.6)]. 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 treatment with Risperdal Consta does not affect them adversely. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy. The effect appeared to be in females, since impaired mating behavior was not noted in the mating and fertility study in which males only were treated. Subgroup analyses did not indicate any differences in treatment outcome as a function of age, race, or gender. The renal tubular and adrenomedullary tumors in male rats and other tumor findings are described in more detail in Section 13.1 (Carcinogenicity, Mutagenesis, Impairment of Fertility). Consider increasing the dose of RISPERDAL CONSTA if the symptoms are severe and persist with an adequate dose of oral antipsychotic supplementation or return when the oral antipsychotic is discontinued. Weight gain has been observed with atypical antipsychotic use. 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. Risperidone orally disintegrating tablets will dissolve in your mouth within seconds and can be swallowed with or without liquid. If the last dose of Invega Hafyera was 1,560 mg, give Invega Sustenna 156 mg in the deltoid muscle on day 1, Invega Sustenna 156 mg in the deltoid muscle on day 8, and then administer Invega Hafyera 1,560 mg into the gluteal muscle one month after day 8. Oral RISPERDAL (or another antipsychotic medication) should be given with the first injection of RISPERDAL CONSTA and continued for 3 weeks (and then discontinued) to ensure that adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection site [see Clinical Pharmacology (12.3)]. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. evidence-based treatment decisions. A literature search of MEDLINE and an internal database pertaining to this topic was conducted through February 11, 2022. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. If you have trouble accessing any of the website's resources, please call us at 202-559-3900 for assistance. Generic name: risperidone While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. This occurs with quinidine, giving essentially all recipients a risperidone pharmacokinetic profile typical of poor metabolizers. 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