RISPERIDONE- risperidone tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

RISPERIDONE

Composition:

RISPERIDONE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Risperidone orally disintegrating tablets, USP are indicated for the treatment of schizophrenia. Efficacy was established in four short-term trials in adults, two short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)] . Risperidone orally disintegrating tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in two 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 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 with autistic disorder, including s

Product summary:

Risperidone Orally Disintegrating Tablets, USP are available containing 1 mg, 2 mg or 3 mg of risperidone, USP. The 1 mg tablets are white, round, unscored tablets debossed with M over RN1 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-345-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each). The 2 mg tablets are peach, round, unscored tablets debossed with M over RN2 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-346-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each). The 3 mg tablets are green, round, unscored tablets debossed with M over RN3 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-347-05 – Unit dose blister packages of 20 (2 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE TABLET, ORALLY DISINTEGRATING
MYLAN INSTITUTIONAL INC.
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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 ORALLY DISINTEGRATING TABLETS.
RISPERIDONE ORALLY DISINTEGRATING 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 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)
Risperidone Orally Disintegrating Tablets: Open the bottle only when
ready to administer, and immediately place tablet
under tongue. Can be swallowed with or without liquid. ( 2.7)
DOSAGE FORMS AND STRENGTHS
Orally disintegrating tablets: 0.25 mg, 0.5 mg,