RISPERIDONE - risperidone tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Citron Pharma LLC

INN (nume internaţional):

RISPERIDONE

Compoziție:

RISPERIDONE 0.25 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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)] . Monotherapy 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)] .  Adjunctive Therapy 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 one short-term trial in adults [see Clinical Studies (14.3)] . Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate se

Rezumat produs:

Risperidone Tablets USP, 0.25 mg are yellow colored, film-coated, biconvex circular tablets, debossed on one side with “A” and on the other side with “49”. Bottles of 60 NDC                 57237-226-60 Bottles of 500 NDC               57237-226-05 Risperidone Tablets USP, 0.5 mg are green colored, film-coated, biconvex caplets, debossed on one side with “A” and on the other side with “70”.         Bottles of 60 NDC                 57237-227-60         Bottles of 500 NDC               57237-227-05 Risperidone Tablets USP, 1 mg are white colored, film-coated, biconvex caplets, debossed on one side with “A” and on the other side with “71”.         Bottles of 60 NDC                 57237-228-60         Bottles of 500 NDC               57237-228-05 Risperidone Tablets USP, 2 mg are light orange colored, film-coated, biconvex caplets, debossed on one side with “A” and on the other side with “72”.         Bottles of 60 NDC                 57237-229-60         Bottles of 500 NDC               57237-229-05 Risperidone Tablets USP, 3 mg are yellow colored, film-coated, biconvex caplets, debossed on one side with “A” and on the other side with “73”.         Bottles of 60 NDC                 57237-230-60         Bottles of 500 NDC               57237-230-05 Risperidone Tablets USP, 4 mg are green colored, film-coated, biconvex caplets, debossed on one side with “A” and on the other side with “74”.         Bottles of 60 NDC                 57237-231-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

RISPERIDONE - RISPERIDONE TABLET, FILM COATED
CITRON PHARMA LLC
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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 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 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)
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 PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia-related psychosis: Risperidone is not
approved f