RISPERDAL- risperidone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RISPERDAL ® (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 RISPERDAL ® 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 RISPERDAL ® 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)] . RISPERDAL ® is indicated for the

Product summary:

RISPERDAL ® (risperidone) Tablets RISPERDAL ® (risperidone) Tablets are imprinted " JANSSEN " on one side and either "Ris 0.25", "Ris 0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. 0.25 mg dark yellow, capsule-shaped tablets: bottles of 60 NDC 50458-301-04, bottles of 500 NDC 50458-301-50, and hospital unit dose blister packs of 100 NDC 50458-301-01. 0.5 mg red-brown, capsule-shaped tablets: bottles of 60 NDC 50458-302-06, bottles of 500 NDC 50458-302-50, and hospital unit dose blister packs of 100 NDC 50458-302-01. 1 mg white, capsule-shaped tablets: bottles of 60 NDC 50458-300-06, bottles of 500 NDC 50458-300-50, and hospital unit dose blister packs of 100 NDC 50458-300-01. 2 mg orange, capsule-shaped tablets: bottles of 60 NDC 50458-320-06, bottles of 500 NDC 50458-320-50, and hospital unit dose blister packs of 100 NDC 50458-320-01. 3 mg yellow, capsule-shaped tablets: bottles of 60 NDC 50458-330-06, bottles of 500 NDC 50458-330-50, and hospital unit dose blister packs of 100 NDC 50458-330-01. 4 mg green, capsule-shaped tablets: bottles of 60 NDC 50458-350-06 and hospital unit dose blister packs of 100 NDC 50458-350-01. RISPERDAL ® (risperidone) Oral Solution RISPERDAL ® (risperidone) 1 mg/mL Oral Solution (NDC 50458-305-03) is supplied in 30 mL bottles with a calibrated (in milligrams and milliliters) pipette. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL. RISPERDAL ® M-TAB ® (risperidone) Orally Disintegrating Tablets RISPERDAL ® M-TAB ® (risperidone) Orally Disintegrating Tablets are etched on one side with "R0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. RISPERDAL ® M-TAB ® Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are packaged in blister packs of 4 (2 × 2) tablets. 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 50458-395-28, and long-term care blister packaging of 30 tablets NDC 50458-395-30. 1 mg light coral, square, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-315-28, and long-term care blister packaging of 30 tablets NDC 50458-315-30. 2 mg coral, square, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-325-28. 3 mg coral, round, biconvex tablets: 28 blisters per box, NDC 50458-335-28. 4 mg coral, round, biconvex tablets: 28 blisters per box, NDC 50458-355-28. RISPERDAL ® Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL ® 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL ® M-TAB ® 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

RISPERDAL- RISPERIDONE TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERDAL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RISPERDAL
.
RISPERDAL (RISPERIDONE) TABLETS, FOR ORAL USE
RISPERDAL (RISPERIDONE) ORAL SOLUTION
RISPERDAL M-TAB (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. RISPERDAL IS NOT APPROVED FOR USE IN PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
( 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.4)
07/2018
INDICATIONS AND USAGE
RISPERDAL
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
RANG E
Schizophrenia: adults
( 2.1)
2 mg
4 to 8 mg
4 to 16 mg
Schizophre nia:
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 directly from calibrated pipette or
mixed with beverage (water, coffee, orange juice,
or low-fat milk). ( 2.6)
M-TAB Orally Disintegrating Tablets: Open the blister only