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:

Zydus Pharmaceuticals USA Inc.

INN (الاسم الدولي):

RISPERIDONE

تركيب:

RISPERIDONE 0.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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)] . Pediatrics Risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickl

ملخص المنتج:

Risperidone Orally Disintegrating Tablets, 0.5 mg are white to off-white, round, tablets debossed with "ZD 22" on one side and plain on the other side and are supplied as follows:   NDC 68382-154-06 in bottle of 30 tablets   Risperidone Orally Disintegrating Tablets, 1 mg are white to off-white, round, tablets debossed with "ZD 21" on one side and plain on other side and are supplied as follows:   NDC 68382-155-06 in bottle of 30 tablets   Risperidone Orally Disintegrating Tablets, 2 mg are white to off-white, round, tablets debossed with "ZD 20" on one side and plain on the other side and are supplied as follows:   NDC 68382-156-06 in bottle of 30 tablets   Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.   Dispense in a tight, light-resistant container.   Keep out of reach of children.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.  

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

RISPERIDONE - RISPERIDONE TABLET, ORALLY DISINTEGRATING
ZYDUS PHARMACEUTICALS USA INC.
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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
INITIAL U.S. APPROVAL: 1993
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIARELATED
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
Warnings and Precautions (5.4)07/2018
INDICATIONS AND USAGE
Risperidone is an 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
without liquid. (2.7)
DOSAGE FORMS AND STRENGTHS
Orall