RISPERIDONE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)

Available from:

WOCKHARDT USA LLC.

INN (International Name):

RISPERIDONE

Composition:

RISPERIDONE 1 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults Risperidone oral solution is indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)]. Adolescents Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone. Therefore, risperidone is contraindicated in patients with a known hypersensitivity to the product.

Product summary:

Risperidone Oral Solution Risperidone 1 mg/mL Oral Solution (NDC 64679-692-01) is supplied in 30 mL bottles with a calibrated (in milligrams and milliliters) syringe. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL. Storage and Handling Risperidone 1 mg/mL Oral Solution should be stored at 200 -250 C (680 -770 F) [See USP Controlled Room Temperature]. Protect from light and freezing. Keep out of reach of children

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE - RISPERIDONE SOLUTION
WOCKHARDT USA LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE ORAL
SOLUTION. RISPERIDONE ORAL SOLUTION FOR ORAL
USE. INITIAL U.S. APPROVAL:1993
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK
OF DEATH. RISPERIDONE IS NOT APPROVED FOR PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS. (5.1)
RECENT MAJOR CHANGES
Boxed Warning 08/2008
Warnings and Precautions (5.1) 08/2008
Warnings and Precautions, Leucopenia, Neutropenia, and Agranulocytosis
(5.8) 09/2009
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
(1)
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)
(1)
DOSAGE AND ADMINISTRATION
INITIAL DOSE
T ITRATIO N
TARGET DOSE
EFFECTIVE DOSE RANGE
Schizophrenia – adults (2.1)
2 mg/day
1 to 2 mg daily
4 to 8 mg daily
4 to 16 mg / day
Bipolar mania- adults (2.2)
2 to 3 mg / day
1 mg daily
1 to 6 mg / day
1 to 6 mg / day
DOSAGE FORMS AND STRENGTHS
Oral solution: 1 mg/mL (3)
CONTRAINDICATIONS
Known hypersensitivity to the product (4)
WARNINGS AND PRECAUTIONS
(5)
Cerebrovascular events, including stroke, in elderly patients with
dementia-related psychosis. Risperidone is not
approved for use in patients with dementia-related psychosis (5.2)
Neuroleptic Malignant Syndrome (5.3)
Tardive dyskinesia (5.4)
Hyperglycemia and diabetes mellitus (