RISPERIDONE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Aidarex Pharmaceuticals LLC

SNN (starptautisko nepatentēto nosaukumu):

RISPERIDONE

Kompozīcija:

RISPERIDONE 1 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 short-term 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 is indicated for the short-term 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 s

Produktu pārskats:

Risperidone Tablets, USP 1 mg are white to off white, oblong shaped, biconvex film coated tablets debossed with 'R 1' on one side and '1037' on other side. Bottle of 30                               NDC-33261-0849-30 Bottle of 60                               NDC-33261-0849-60 Bottle of 90                               NDC-33261-0849-90 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 MOISTURE. Keep out of reach of children.  Dispense in a tight, light-resistant container.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

RISPERIDONE- RISPERIDONE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
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, 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes (5.5) September 2011
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic indicated for: (1)
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: (2)
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)
0.5mg
3mg
1 to 6 mg
Bipolar mania: adults (2.2)
2 to 3 mg
1to 6mg
1 to 6 mg
Bipolar mania: in children and adolescents (2.2) 0.5 mg
1 to 2.5mg
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 the respiridone (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia- related