RISPERIDONE tablet RISPERIDONE solution RISPERIDONE M-TAB- 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:

Janssen Pharmaceutical, Inc.

INN (International Name):

risperidone

Composition:

risperidone 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 changing

Product summary:

Risperidone Tablets Risperidone Tablets are imprinted "PATR" on one side and either "Ris 0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. 0.5 mg red-brown, capsule-shaped tablets: bottles of 60 NDC 50458-591-60, bottles of 500 NDC 50458-591-50, and hospital unit dose blister packs of 100 NDC 50458-591-10. 1 mg white, capsule-shaped tablets: bottles of 60 NDC 50458-592-60, bottles of 500 NDC 50458-592-50, and hospital unit dose blister packs of 100 NDC 50458-592-10. 2 mg orange, capsule-shaped tablets: bottles of 60 NDC 50458-593-60, bottles of 500 NDC 50458-593-50, and hospital unit dose blister packs of 100 NDC 50458-593-10. 3 mg yellow, capsule-shaped tablets: bottles of 60 NDC 50458-594-60, bottles of 500 NDC 50458-594-50, and hospital unit dose blister packs of 100 NDC 50458-594-10. 4 mg green, capsule-shaped tablets: bottles of 60 NDC 50458-595-60 and hospital unit dose blister packs of 100 NDC 50458-595-10. Risperidone Oral Solution Risperidone 1 mg/mL Oral Solution (NDC 50458-596-01) is supplied in 30 mL bottles with a calibrated (in milliliters) oral dosing syringe. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL. Risperidone Orally Disintegrating Tablets Risperidone Orally Disintegrating Tablets are etched on one side with "P0.5", "P1", "P2", "P3", or "P4" according to their respective strengths. Risperidone Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are packaged in blister packs of 4 (2 × 2) tablets. Risperidone Orally Disintegrating Tablets 3 mg and 4 mg are packaged in a child-resistant pouch containing a blister with 1 tablet. 0.5 mg light coral, round, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-601-28. 1 mg light coral, square, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-602-28. 2 mg coral, square, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-603-28. 3 mg coral, round, biconvex tablets: 28 blisters per box, NDC 50458-604-28. 4 mg coral, round, biconvex tablets: 28 blisters per box, NDC 50458-605-28. Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE TABLET
RISPERIDONE- RISPERIDONE SOLUTION
RISPERIDONE M-TAB- RISPERIDONE TABLET, ORALLY DISINTEGRATING
JANSSEN PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE TABLETS, ORAL
SOLUTION, AND ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR RISPERIDONE TABLETS, ORAL SOLUTION, AND ORALLY
DISINTEGRATING TABLETS.
RISPERIDONE TABLETS, RISPERIDONE ORAL SOLUTION, RISPERIDONE ORALLY
DISINTEGRATING TABLETS
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
Dosage and Administration (2.6)
3/2022
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)
Oral Solution: Can be administered direct