RISPERIDONE- risperidone tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Risperidone (UNII: L6UH7ZF8HC) (Risperidone - UNII:L6UH7ZF8HC)

Available from:

Ratiopharm Inc

INN (International Name):

Risperidone

Composition:

Risperidone .25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults Risperidone tablets are  indicated  for  the  acute  and  maintenance  treatment  of schizophrenia [see Clinical Studies (14.1)] . Adolescents Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Pediatric use information  for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products. Monotherapy - Adults Risperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in Adults [see Clinical Studies (14.2)] . Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information  for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperido

Product summary:

Risperidone Tablets, 0.25 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n28 on the other and are available in: bottles of 100                                                                                                                   NDC 58165-028-01 bottles of 500                                                                                                                   NDC 58165-028-02 blisters (10 x 15 tablets cards)                                                                                       NDC 58165-028-03. Risperidone Tablets, 0.5 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n29 on the other and are available in: bottles of 100                                                                                                                   NDC 58165-029-01 bottles of 500                                                                                                                   NDC 58165-029-02 blisters (10 x 15 tablets cards)                                                                                       NDC 58165-029-03. Risperidone Tablets, 1 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n30 on the other and are available in: bottles of 100                                                                                                                   NDC 58165-030-01 bottles of 500                                                                                                                   NDC 58165-030-02 blisters (10 x 15 tablets cards)                                                                                       NDC 58165-030-03. Risperidone Tablets, 2 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n31 on the other and are available in: bottles of 100                                                                                                                   NDC 58165-031-01 bottles of 500                                                                                                                   NDC 58165-031-02 blisters (10 x 15 tablets cards)                                                                                       NDC 58165-031-03. Risperidone Tablets, 3 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n32 on the other and are available in: bottles of 100                                                                                                                   NDC 58165-032-01 bottles of 500                                                                                                                   NDC 58165-032-02 blisters (10 x 15 tablets cards)                                                                                       NDC 58165-032-03. Risperidone Tablets, 4 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n33 on the other and are available in: bottles of 100                                                                                                                   NDC 58165-033-01 bottles of 500                                                                                                                   NDC 58165-033-02 blisters (10 x 15 tablets cards)                                                                                       NDC 58165-033-03. Storage and Handling Risperidone Tablets should be stored at controlled room temperature 15°-25°C (59°-77°F). Protect from light and moisture. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE - RISPERIDONE TABLET, COATED
RATIOPHARM 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.
RISPERIDONE 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 TABLETS ARE NOT APPROVED FOR USE IN PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS. (5.1)
RECENT MAJOR CHANGES
_Boxed Warning_ _08/2008_
_Warnings and Precautions (_5.1_) 08/2008_
_Warnings and Precautions, Leucopenia, Neutropenia, and
Agranulocytosis (_5.8_) 07/2009_
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults (1.1)
Alone, or in combination with lithium or valproate, for the short-term
treatment of acute manic or mixed episodes
associated with Bipolar I Disorder in adults (1.2)
Treatment of irritability associated with autistic disorder in
children and adolescents aged 5-16 years (1.3)
_Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity
rights, this product is not labeled for use in_
_pediatric patients with schizophrenia or bipolar mania. (_1.1_,
_1.2_)_
DOSAGE AND ADMINISTRATION
Initial Dose
T itration
Target Dose
Effective Dose Range
Schizophrenia-adults (2.1 )
2 mg/day
1 to 2 mg daily
4 to 8 mg daily
4 to 16 mg/day
Bipolar mania-adults (2.2 )
2 to 3 mg /day
1mg daily
1 to 6mg /day
1 to 6 mg /day
Irritability associated with autistic
disorder (2.3 )
0.25 mg/day
(<20 kg)
0.5 mg/day (≥20
kg)
0.25 to 0.5 mg at
≥2 weeks
0.5 mg/day (<20
kg) 1 mg/day
(≥20kg)
0.5 to 3 mg/day
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 the product (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular