RISPERIDONE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

ATLANTIC BIOLOGICALS CORP.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Risperidone oral solution is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)] . Monotherapy Risperidone oral solution is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)] . Adjunctive Therapy Risperidone oral solution adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)] . Risperidone oral solution is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate se

Resumen del producto:

risperiDONE Oral Solution USP   1 mg/mL oral solution is supplied as a clear colorless solution with a calibrated (in milligrams and milliliters) pipette. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL. NDC 17856-0063-01 risperiDONE Oral Solution USP 1MG/1ML DELIVER 1ML  NDC 17856-0063-02 risperiDONE Oral Solution USP 2MG/2ML DELIVER 2ML  NDC 17856-0063-03 risperiDONE Oral Solution USP 3MG/3ML DELIVER 3ML  NDC 17856-0063-04 risperiDONE Oral Solution USP 4MG/4ML DELIVER 4ML  Stored at 20° to 25°C (68° to 77°F). [See USP controlled Room Temperature.] Protect from light and freezing. Keep out of reach of children.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

RISPERIDONE- RISPERIDONE SOLUTION
ATLANTIC BIOLOGICALS CORP.
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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
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 ORAL SOLUTION IS NOT
APPROVED FOR USE IN
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1)
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Risperidone oral solution is an atypical antipsychotic indicated for:
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•
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DOSAGE AND ADMINISTRATION
•
INITIAL DOSE
TARGET DOSE
EFFECTIVE DOSE
RANGE
SCHIZOPHRENIA: ADULTS (2.1)
2 mg
4 to 8 mg
4 to 16 mg
SCHIZOPHRENIA: ADOLESCENTS (2.1)
0.5 mg
3 mg
1 to 6 mg
BIPOLAR MANIA: ADULTS (2.2)
2 to 3 mg
1 to 6 mg
1 to 6 mg
BIPOLAR MANIA: IN CHILDREN AND
ADOLESCENTS (2.2)
0.5 mg
1 to 2.5 mg
1 to 6 mg
IRRITABILITY ASSOCIATED WITH AUTISTIC
DISORDER (2.3)
0.25 mg
(Weight <20 kg)
0.5 mg
(Weight ≥20 kg)
0.5 mg
(<20 kg)
1 mg (≥20 kg)
0.5 to 3 mg
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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Warnings and Precautions (5.4) 07/2018
Treatment of schizophrenia (1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for
the treatment of acute manic or
mixed episodes associated with Bipolar I Disorder (1.2)
Treatment of irritability associated with autistic disorder (1.3)
Recommended Daily Dosage:
Severe Renal or Hepatic Impairment in Adults: Use a lower starting
dose of 0.5 mg twice daily. May
increase to dosages above 1.5 mg twice daily at intervals of at least
one week. (2.4)
Oral Solution: Can be administered directly from calibrated pipette or
mixed with beverage (water,
coffee, orange juice, or low-fat milk). (2.6)
Oral Solution: 1 mg per mL (3)
Known hy