RISPERIDONE tablet, orally disintegrating

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

RISPERIDONE

Sammensetning:

RISPERIDONE 0.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Risperidone orally disintegrating tablets are 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 orally disintegrating tablets are 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 orally disintegrating tablets 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 orally disintegrating tablets are indicated for the treatment of irritability associated with autistic disord

Produkt oppsummering:

Risperidone oral disintegrating tablets 0.5 mg are available as pink colored, round, flat faced, beveled edged tablets, debossed with “RE ” on one side and “8 ” on the other side. NDC 63304-949-30 Bottles of 30 NDC 63304-949-05 Bottles of 500 NDC 63304-949-17 Box of 10 Unit-Dose pouches Risperidone oral disintegrating tablets 1 mg are available as pink colored, round, flat faced, beveled edged tablets, debossed with “RE ” on one side and “9 ” on the other side. NDC 63304-950-30 Bottles of 30 NDC 63304-950-05 Bottles of 500 NDC 63304-950-17 Box of 10 Unit-Dose pouches Risperidone oral disintegrating tablets 2 mg are available as pink colored, round, flat faced, beveled edged tablets, debossed with “RE ” on one side and “10 ” on the other side. NDC 63304-951-30 Bottles of 30 NDC 63304-951-05 Bottles of 500 NDC 63304-951-17 Box of 10 Unit-Dose pouches Risperidone oral disintegrating tablets 3 mg are available as pink colored, round, flat faced, beveled edged tablets, debossed with “RE ” and “43 ” on one side and plain on the other side. NDC 63304-643-30 Bottles of 30 NDC 63304-643-05 Bottles of 500 NDC 63304-643-69 Blister of 10 NDC 63304-643-17 Box of 10 Unit-Dose pouches Risperidone oral disintegrating tablets 4 mg are available as pink colored, round, flat faced, beveled edged tablets, debossed with “RE ” and “44 ” on one side and plain on the other side. NDC 63304-644-30 Bottles of 30 NDC 63304-644-05 Bottles of 500 NDC 63304-644-69 Blister of 10 NDC 63304-644-17 Box of 10 Unit-Dose pouches Risperidone orally disintegrating tablets should be stored at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

RISPERIDONE- RISPERIDONE TABLET, ORALLY DISINTEGRATING
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
RISPERIDONE ORALLY DISINTEGRATING TABLETS.
RISPERIDONE ORALLY DISINTEGRATING TABLETS, 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._
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Risperidone orally disintegrating tablet is an atypical antipsychotic
indicated for: (1)
•
•
•
DOSAGE AND ADMINISTRATION
•
INITIAL DOSE
TARGET DOSE
EFFECTIVE DOSE
RANGE
Schizophrenia: adults (2.1) (2)
2 mg (2)
4 to 8 mg (2)
4 to 16 mg (2)
Schizophrenia: adolescents (2.1)
(2)
0.5 mg (2)
3 mg (2)
1 to 6 mg (2)
Bipolar mania: adults (2.2) (2)
2 to 3 mg (2)
1 to 6 mg (2)
1 to 6 mg (2)
Bipolar mania: in children and
adolescents (2.2) (2)
0.5 mg (2)
1 to 2.5 mg (2)
1 to 6 mg (2)
Irritability associated with autistic
disorder (2.3) (2)
0.25 mg (Weight < 20 kg) 0.5
mg (Weight ≥ 20 kg) (2)
0.5 mg (< 20 kg) 1
mg (≥ 20 kg) (2)
0.5 to 3 mg (2)
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS
ARE AT AN INCREASED RISK OF DEATH.
RISPERIDONE IS NOT APPROVED FOR USE IN PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS.
(5.1)
Warnings and Precautions (5.3, 5.4) 2/2021
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 interval