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:

Proficient Rx LP

INN (Միջազգային անվանումը):

RISPERIDONE

Կազմը:

RISPERIDONE 0.25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

RISPERIDONE (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 RISPERIDONE 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 RISPERIDONE 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) ]. Pediatrics RISPERIDONE is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantru

Ապրանքի ամփոփագիր:

Risperidone Tablets USP, 0.25 mg are dark yellow, round, biconvex film-coated tablets debossed with "Z" on one side and "4" on the other side and are supplied as follows: NDC 63187-418-60 in bottle of 60 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Keep out of reach of children. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
PROFICIENT RX LP
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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 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.
•
•
INDICATIONS AND USAGE
RISPERIDONE is an atypical antipsychotic indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
•
SUMMARY OF HEART PROTECTION STUDY RESULTS
Initial Dose
(2)
Target Dose
(2)
Effective Dose
(2)
Range
(2)
Schizophrenia:
adults (2.1)
(2)
2 mg
(2)
4 to 8 mg
(2)
4 to 16 mg
(2)
Schizophrenia:
adolescents
(2.1)
(2)
0.5 mg
(2)
3 mg
(2)
1 to 6 mg
(2)
Bipolar mania: Adults (2.2)
(2)
2 to 3 mg
(2)
1 to 6 mg
(2)
1 to 6 mg
(2)
Bipolar mania: in
children and
adolescents
(2.2)
(2)
0.5 mg
(2)
1 to 2.5 mg
(2)
1 to 6 mg
(2)
Irritability
associated with
autistic disorder
(2)
0.25 mg
(Weight < 20
kg)
(2)
0.5 mg
(<20 kg)
(2)
0.5 to 3 mg
(2)
(2.3)
(2)
1 mg
(2)
0.5 mg
(Weight ≥ 20
kg)
(2)
(≥ 20 kg)
(2)
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
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)
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)
Recommended daily dosage:
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)
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3)
Known