RISPERIDONE tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Wockhardt USA LLC.

INN (इंटरनेशनल नाम):

RISPERIDONE

रचना:

RISPERIDONE 0.25 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Risperidone 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 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 tablets adjunctive therapy with lithium or valproate are 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 tablets are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temp

उत्पाद समीक्षा:

Risperidone tablets 0.25 mg are yellow, capsule shaped, film-coated tablets, debossed with "W" on one side and "R" on another side. Bottle pack of 30 tablets                       NDC 64679-553-01 Bottle pack of 500 tablets                     NDC 64679-553-02 Unit dose pack of 100 tablets               NDC 64679-553-03 Bottle pack of 60 tablets                       NDC 64679-553-04 Risperidone tablets 0.5 mg are brown, capsule shaped, film-coated tablets, debossed with "W" on one side and "554" on another side. Bottle pack of 30 tablets                       NDC 64679-554-01 Bottle pack of 500 tablets                     NDC 64679-554-02 Unit dose pack of 100 tablets               NDC 64679-554-03 Bottle pack of 60 tablets                       NDC 64679-554-04 Risperidone tablets 1 mg are white, capsule shaped, film-coated tablets, debossed with "W555" on one side and plain on other side. Bottle pack of 30 tablets                       NDC 64679-555-01 Bottle pack of 500 tablets                     NDC 64679-555-02 Unit dose pack of 100 tablets               NDC 64679-555-03 Bottle pack of 60 tablets                       NDC 64679-555-04 Risperidone tablets 2 mg are orange, capsule shaped, film-coated tablets, debossed with "W557" on one side and plain on other side. Bottle pack of 30 tablets                       NDC 64679-557-01 Bottle pack of 500 tablets                     NDC 64679-557-02 Unit dose pack of 100 tablets               NDC 64679-557-03 Bottle pack of 60 tablets                       NDC 64679-557-04 Risperidone tablets 3 mg are yellow, capsule shaped, film-coated tablets, debossed with "W571" on one side and plain on other side. Bottle pack of 30 tablets                       NDC 64679-571-01 Bottle pack of 500 tablets                     NDC 64679-571-02 Unit dose pack of 100 tablets               NDC 64679-571-03 Bottle pack of 60 tablets                       NDC 64679-571-04 Risperidone tablets 4 mg are green, capsule shaped, film-coated tablets, debossed with "W572" on one side and plain on other side. Bottle pack of 30 tablets                       NDC 64679-572-01 Bottle pack of 500 tablets                     NDC 64679-572-02 Unit dose pack of 100 tablets               NDC 64679-572-03 Bottle pack of 60 tablets                       NDC 64679-572-04 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
WOCKHARDT USA LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE TABLETS.
RISPERIDONE 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
Warnings and Precautions (5.8) 02/2017
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)
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, paliperidone, or to any
excipients in risperidone formulation (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patien