Risperidone

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• SPL INDEXING DATA ELEMENTS
• BOXED WARNING
• INDICATIONS & USAGE
• DOSAGE & ADMINISTRATION
• DOSAGE FORMS & STRENGTHS
• RISPERIDONE CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
• RISPERIDONE ADVERSE REACTIONS
• DRUG INTERACTIONS
• USE IN SPECIFIC POPULATIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• RISPERIDONE DESCRIPTION
• CLINICAL PHARMACOLOGY
• NONCLINICAL TOXICOLOGY
• CLINICAL STUDIES
• HOW SUPPLIED
• STORAGE AND HANDLING
• INFORMATION FOR PATIENTS
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

SPL INDEXING DATA ELEMENTS

• ●Treatment of schizophrenia in adults (1.1)

• ●Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults (1.2)

• ●Due to Janssen Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia, bipolar mania or autistic disorder. (1.1,1.2, 1.3)

• ● DOSAGE AND ADMINISTRATION

• ●Neuroleptic Malignant Syndrome (5.3)

• ●Tardive dyskinesia (5.4)

• ●Hyperglycemia and diabetes mellitus (5.5)

• ●Hyperprolactinemia (5.6)

• ●Orthostatic hypotension (5.7)

• ●Potential for cognitive and motor impairment (5.8)

• ●Seizures (5.9)

• ●Dysphagia (5.10)

• ●Priapism (5.11)

• ●Thrombotic Thrombocytopenic Purpura (TTP) (5.12)

• ●Disruption of body temperature regulation (5.13)

• ●Antiemetic Effect (5.14)

• ●Suicide (5.15)

• ●Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies (5.16)

• ●Diseases or conditions that could affect metabolism or hemodynamic responses (5.16)

• ●

• ●Due to hypotensive effects, hypotensive effects of other drugs with this potential may be enhanced. (7.2)

• ●Effects of levodopa and dopamine agonists may be antagonized. (7.3)

• ●Cimetidine and ranitidine increase the bioavailability of risperidone. (7.5)

• ●Clozapine may decrease clearance of risperidone. (7.6)

• ●Fluoxetine and paroxetine increase plasma concentrations of risperidone. (7.10)

• ●Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone. (7.11)

• ● USE IN SPECIFIC POPULATIONS

• ●Pediatric Use: safety and effectiveness not established for schizophrenia less than 13 years of age, for bipolar mania less than 10 years of age and for autistic disorder less than 5 years of age. (8.4)

• ●Elderly or debilitated; severe renal or hepatic impairment; predisposition to hypotension or for whom hypotension poses a risk: Lower initial dose (0.5 mg twice daily), followed by increases in dose in increments of no more than 0.5 mg twice daily. Increases to dosages above 1.5 mg twice daily should occur at intervals of at least 1 week. (8.5, 2.4)

• ●See17for PATIENT COUNSELING INFORMATION

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

DOSAGE FORMS & STRENGTHS

RISPERIDONE CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

RISPERIDONE ADVERSE REACTIONS

• ●Increased mortality in elderly patients with dementia-related psychosis [seeBoxed WarningandWarnings and Precautions (5.1)]

• ●Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [seeWarnings and Precautions (5.2)]

• ●Neuroleptic malignant syndrome [seeWarnings and Precautions (5.3)]

• ●Tardive dyskinesia [seeWarnings and Precautions (5.4)]

• ●Hyperglycemia and diabetes mellitus [seeWarnings and Precautions (5.5)]

• ●Hyperprolactinemia [seeWarnings and Precautions (5.6)]

• ●Orthostatic hypotension [seeWarnings and Precautions (5.7)]

• ●Potential for cognitive and motor impairment [seeWarnings and Precautions (5.8)]

• ●Seizures [seeWarnings and Precautions (5.9)]

• ●Dysphagia [seeWarnings and Precautions (5.10)]

• ●Priapism [seeWarnings and Precautions (5.11)]

• ●Thrombotic Thrombocytopenic Purpura (TTP) [seeWarnings and Precautions (5.12)]

• ●Disruption of body temperature regulation [seeWarnings and Precautions (5.13)]

• ●Antiemetic effect [seeWarnings and Precautions (5.14)]

• ●Suicide [seeWarnings and Precautions (5.15)]

• ●Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies [seeWarnings and Precautions (5.16)]

• ●Diseases or conditions that could affect metabolism or hemodynamic responses [seeWarnings and Precautions (5.16)]

• ●

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

RISPERIDONE DESCRIPTION

CLINICAL PHARMACOLOGY

NONCLINICAL TOXICOLOGY

CLINICAL STUDIES

HOW SUPPLIED

STORAGE AND HANDLING

INFORMATION FOR PATIENTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION