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:

Mylan Institutional Inc.

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)]. 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)]. 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 o

उत्पाद समीक्षा:

Risperidone Tablets, USP are available containing 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone, USP. The 0.25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R on the other side. They are available as follows: NDC 51079-460-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 0.5 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R5 on the other side. They are available as follows: NDC 51079-461-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 1 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R11 on the other side. They are available as follows: NDC 51079-462-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 2 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R12 on the other side. They are available as follows: NDC 51079-463-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 3 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R13 on the other side. They are available as follows: NDC 51079-464-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 4 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R14 on the other side. They are available as follows: NDC 51079-465-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
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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 TABLETS ARE 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 tablets are 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 mg
to 8 mg
4 mg
to 16 mg
Schizophrenia:
adolescents ( 2.1)
0.5 mg
3 mg
1 mg
to 6 mg
Bipolar mania:
adults ( 2.2)
2 mg to 3 mg
1 mg
to 6 mg
1 mg
to 6 mg
Bipolar mania: in children and adolescents ( 2.2)
0.5 mg
1 mg
to 2.5 mg
1 mg
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 mg
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 tablets. (4)
WARNINGS AND PRECAUTION