RISPERIDONE tablet, orally disintegrating

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Risperidone (UNII: L6UH7ZF8HC) (Risperidone - UNII:L6UH7ZF8HC)

متاح من:

Jubilant Cadista Pharmaceuticals Inc.

INN (الاسم الدولي):

Risperidone

تركيب:

Risperidone 0.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 w

ملخص المنتج:

Risperidone Orally Disintegrating Tablets, USP 0.5 mg are yellow colored, mottled, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘01’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets             NDC 59746-010-22 3 Blister cards each containing 10 tablets           NDC 59746-010-32  Risperidone Orally Disintegrating Tablets, USP 1 mg are white, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘02’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets             NDC 59746-020-22 3 Blister cards each containing 10 tablets           NDC 59746-020-32 Risperidone Orally Disintegrating Tablets, USP 2 mg are blue colored, mottled, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘03’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets             NDC 59746-030-22  Risperidone Orally Disintegrating Tablets, USP 3 mg are orange colored, mottled, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘04’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets             NDC 59746-040-22 Risperidone Orally Disintegrating Tablets, USP 4 mg are pink colored, mottled, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘05’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets             NDC 59746-050-22 Risperidone Orally Disintegrating Tablets, USP: Store at room temperature between 20°C to 25°C (68°C to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

RISPERIDONE - RISPERIDONE TABLET, ORALLY DISINTEGRATING
JUBILANT CADISTA PHARMACEUTICALS 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._
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)
RECENT MAJOR CHANGES
Dosage and Administration (2.6) 3/2022
INDICATIONS AND USAGE
Risperidone orally disintegrating tablets are atypical antipsychotic
indicated for:
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)
DOSAGE AND ADMINISTRATION
Recommended daily dosage:
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
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)
Risperidone Orally Disintegrating Tablets: Open the blister only when
ready to administer, and
immediately place tablet on the tongue. Can be swallowed with or
wit