RISPERIDONE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International ime):

RISPERIDONE

Sastav:

RISPERIDONE 0.25 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in four short-term trials in adults, two short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)]. Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in two short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)]. 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 self-injuriousness, temper tantrums, and quick

Proizvod sažetak:

Risperidone Tablets, USP are available containing 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone, USP. The 0.25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R on the other side. They are available as follows: NDC 0615-7505-39 blisterpacks of 30 tablets NDC 0615-7505-05 blisterpacks of 15 tablets NDC 0615-7505-30 unit-dose boxes of 30 tablets The 0.5 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R5 on the other side. They are available as follows: NDC 0615-7506-39 blisterpacks of 30 tablets NDC 0615-7506-05 blisterpacks of 15 tablets NDC 0615-7506-30 unit-dose boxes of 30 tablets The 1 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R11 on the other side. They are available as follows: NDC 0615-7507-39 blisterpacks of 30 tablets NDC 0615-7507-05 blisterpacks of 15 tablets The 2 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R12 on the other side. The 3 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R13 on the other side. The 4 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R14 on the other side. 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 as defined in the USP using a child-resistant closure. Keep out of reach of children.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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
de ath.
Risperidone is not approved for use in patients with dementia-related
psychosis. (5.1)
INDICATIONS AND USAGE
Risperidone tablets are 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 (2)
TARGET DOSE (2)
EFFECTIVE DOSE RANGE
(2)
Schizophrenia: Adults (2.1) (2)
2 mg (2)
4 mg to 8 mg (2)
4 mg (2)
to 16 mg (2)
Schizophrenia: Adolescents (2.1) (2)
0.5 mg (2)
3 mg (2)
1 mg (2)
to 6 mg (2)
Bipolar mania: Adults (2.2) (2)
2 mg to 3 mg (2)
1 mg to 6 mg (2)
1 mg (2)
to 6 mg (2)
Bipolar mania: in children and adolescents
(2.2) (2)
0.5 mg (2)
1 mg to 2.5 mg (2)
1 mg (2)
to 6 mg (2)
Irritability associated with autistic disorder
(2.3) (2)
0.25 mg (2)
(Weight < 20 kg) (2)
0.5 mg (2)
(Weight ≥ 20 kg)
(2)
0.5 mg (< 20 kg)
(2)
1 mg (≥ 20 kg) (2)
0.5 mg (2)
to 3 mg (2)
• 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) (2)
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 risperid