RISPERIDONE tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Dr. Reddy's Laboratories Limited

INN (Միջազգային անվանումը):

RISPERIDONE

Կազմը:

RISPERIDONE 0.25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 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 tablets are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, t

Ապրանքի ամփոփագիր:

Risperidone tablets USP, 0.25 mg are yellow, round, biconvex film-coated tablets embossed with ‘RDY’ on one side and ‘201’ on other side and are supplied in bottles of 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 60 NDC 55111-201-60 Bottles of 100 NDC 55111-201-01 Bottles of 500 NDC 55111-201-05 Unit dose package of 100 (10 x 10) NDC 55111-201-78   Risperidone tablets USP, 0.5 mg are pink, round, biconvex film-coated tablets embossed with ‘RDY’ on one side and ‘202’ on other side and are supplied in bottles of 60, 100, 500 and unit dose package of 100 (10 x 10).   Bottles of 60 NDC 55111-202-60 Bottles of 100 NDC 55111-202-01 Bottles of 500 NDC 55111-202-05 Unit dose package of 100 (10 x 10) NDC 55111-202-78   Risperidone tablets USP, 1 mg are white, round, biconvex film-coated tablets embossed with ‘RDY’ on one side and ‘203’ on other side and are supplied in bottles of 60, 100, 500 and unit dose package of 100 (10 x 10).   Bottles of 60 NDC 55111-203-60 Bottles of 100 NDC 55111-203-01 Bottles of 500 NDC 55111-203-05 Unit dose package of 100 (10 x 10) NDC 55111-203-78   Risperidone tablets USP, 2 mg are white, round, biconvex film-coated tablets embossed with ‘RDY’ on one side and ‘204’ on other side and are supplied in bottles of 60, 100, 500 and unit dose package of 100 (10 x 10).   Bottles of 60 NDC 55111-204-60 Bottles of 100 NDC 55111-204-01 Bottles of 500 NDC 55111-204-05 Unit dose package of 100 (10 x 10) NDC 55111-204-78   Risperidone tablets USP, 3 mg are white, round, biconvex film-coated tablets embossed with ‘RDY’ on one side and ‘205’ on other side and are supplied in bottles of 60, 100, 500 and unit dose package of 100 (10 x 10).   Bottles of 60 NDC 55111-205-60 Bottles of 100 NDC 55111-205-01 Bottles of 500 NDC 55111-205-05 Unit dose package of 100 (10 x 10) NDC 55111-205-78 Risperidone tablets USP, 4 mg are white, round, biconvex film-coated tablets embossed with ‘RDY’ on one side and ‘206’ on other side and are supplied in bottles of 60, 100, 500 and unit dose package of 100 (10 x 10).     Bottles of 60 NDC 55111-206-60 Bottles of 100 NDC 55111-206-01 Bottles of 500 NDC 55111-206-05 Unit dose package of 100 (10 x 10) NDC 55111-206-78 Risperidone tablets should be stored at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.   Keep out of reach of children

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
DR. REDDY'S LABORATORIES LIMITED
----------
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
_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 (5.8) 02/2017
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent 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 the risperidone, paliperidone, or to
anyexcipients in risperidone tablets (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia-related psychosis.
Risperid