RISPERIDONE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Mylan Pharmaceuticals Inc.

INN (Nama Internasional):

RISPERIDONE

Komposisi:

RISPERIDONE 0.25 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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)]. 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)]. 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 quickly changin

Ringkasan produk:

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 0378-3502-91 bottles of 60 tablets NDC 0378-3502-05 bottles of 500 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 0378-3505-91 bottles of 60 tablets NDC 0378-3505-05 bottles of 500 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 0378-3511-91 bottles of 60 tablets NDC 0378-3511-05 bottles of 500 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. They are available as follows: NDC 0378-3512-91 bottles of 60 tablets NDC 0378-3512-05 bottles of 500 tablets 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. They are available as follows: NDC 0378-3513-91 bottles of 60 tablets NDC 0378-3513-05 bottles of 500 tablets 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. They are available as follows: NDC 0378-3514-91 bottles 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 as defined in the USP using a child-resistant closure. Keep out of reach of children.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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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 TABLETS ARE NOT APPROVED FOR USE IN PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS. (5.1)
INDICATIONS AND USAGE
Risperidone tablets are an atypical antipsychotic indicated for:
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DOSAGE AND ADMINISTRATION
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Initial
Dose
T arge t
Dose
Effe ctive
Dose
Range
Schizophre nia:
adults (2.1)
2 mg
4 to 8 mg
4 to 16 mg
Schizophre nia:
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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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 hypersensitivity to risperidone, paliperidone, or to any
excipients in risperidone tablets. (4)
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ADVERSE REACTIONS
The