Risperidone (Injection)

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Risperidone injection is an atypical antipsychotic indicated: For the treatment of schizophrenia. As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder.

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Known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperidone

The mechanism of action of risperidone in schizophrenia is unclear. The drug’s therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major active metabolite, 9-hydroxyrisperidone (paliperidone). Antagonism at receptors other than D2 and 5HT 2 may explain some of the other effects of risperidone

Due to CNS effects, use caution when administering with other centrally-acting drugs. Avoid alcohol. Due to hypotensive effects, hypotensive effects of other drugs with this potential may be enhanced. Effects of levodopa and dopamine agonists may be antagonized. Cimetidine and ranitidine increase the bioavailability of risperidone. Clozapine may decrease clearance of risperidone. Fluoxetine and paroxetine increase plasma concentrations of risperidone. Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone.

Increased mortality in elderly patients with dementia-related psychosis Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis Neuroleptic malignant syndrome Tardive dyskinesia Metabolic changes Hyperprolactinemia Orthostatic hypotension Falls Leukopenia/Neutropenia and Agranulocytosis Potential for cognitive and motor impairment Seizures Dysphagia Priapism Thrombotic Thrombocytopenic Purpura (TTP)  Disruption of body temperature regulation Avoidance of inadvertent injection into a blood vessel

Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with RisperidoneLactation: Advise breastfeeding women using Risperidone to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia-Related Psychosis Neuroleptic Malignant Syndrome Tardive Dyskinesia Hyperprolactinemia Orthostatic Hypotension

Renal or Hepatic Impairment: dose appropriately with oral Risperidone prior to initiating treatment with Risperidone. A lower starting dose of Risperidone of 12.5 mg may be appropriate in some patients.Pediatric Use: safety and effectiveness not established in patients less than 18 years of age.Elderly: dosing for otherwise healthy elderly patients is the same as for healthy nonelderly. Elderly may be more predisposed to orthostatic effects than nonelderly.