RISPERIDONE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (الاسم الدولي):

RISPERIDONE

تركيب:

RISPERIDONE 0.25 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)] . 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 changi

ملخص المنتج:

Risperidone Tablets Risperidone Tablets, USP are imprinted with "HH" on one side and either "221", "222", "223", "224", "225", or "226" on the other side according to their respective strengths. 0.25 mg dark yellow, round, biconvex film-coated tablets: NDC 0615-8196-39 Blistercards of 30 NDC 0615-8196-05 Blistercards of 15 NDC 0615-8196-30 Unit-Dose Boxes of 30 0.5 mg brownish red, round, biconvex film-coated tablets: NDC 0615-8197-39 Blistercards of 30 NDC 0615-8197-05 Blistercards of 15 NDC 0615-8197-30 Unit-Dose Boxes of 30 Both 0.25 mg and 0.5 mg Risperidone Tablets only have 18 month shelf life, which is shorter than other strength tablets. 1 mg white, round, biconvex film-coated tablets: NDC 0615-8198-39 Blistercards of 30 NDC 0615-8198-05 Blistercards of 15 2 mg orange, round, biconvex film-coated tablets: NDC 0615-8288-39 Blistercards of 30 3 mg yellow, round, biconvex film-coated tablets: NDC 0615-8265-39 Blistercards of 30 4 mg white, round, biconvex film-coated tablets: 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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

RISPERIDONE- RISPERIDONE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE TABLETS.
RISPERIDONE TABLETS, USP, 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)
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
Schiophrenia: 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to Risperidone (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia-related psychosis:
Risperidone is not approved for use in patients with dementia-related
psychosis.