RISPERIDONE- risperidone tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

risperidone (UNII: L6UH7ZF8HC) (risperidone - UNII:L6UH7ZF8HC)

Verfügbar ab:

Cardinal Health

INN (Internationale Bezeichnung):

risperidone

Zusammensetzung:

risperidone 0.25 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Risperidone 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 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 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 is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing

Produktbesonderheiten:

Risperidone Tablets Risperidone Tablets are imprinted " PATR" on one side and either "Ris 0.25", "Ris 0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. 1 mg white, capsule-shaped tablets: Overbagged with 10 tablets per bag, NDC 55154-1413-0 Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. Keep out of reach of children.

Berechtigungsstatus:

New Drug Application

Fachinformation

RISPERIDONE- RISPERIDONE TABLET
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE TABLETS, ORAL SOLUTION, AND
ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RISPERIDONE TABLETS,
ORAL SOLUTION, AND ORALLY DISINTEGRATING TABLETS.
RISPERIDONE TABLETS, RISPERIDONE ORAL SOLUTION, RISPERIDONE ORALLY
DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1993
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic indicated for:
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DOSAGE AND ADMINISTRATION
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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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WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
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)
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 m