RISPERIDONE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Adı):

RISPERIDONE

Kompozisyon:

RISPERIDONE 1 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 quickly ch

Ürün özeti:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 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 0378-3502-01 bottles of 100 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 0378-3505-01 bottles of 100 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 0378-3511-01 bottles of 100 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 0378-3512-01 bottles of 100 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 0378-3513-01 bottles of 100 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 NDC 0378-3514-01 bottles of 100 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 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_
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RECENT MAJOR CHANGES
Warnings and Precautions: Metabolic Changes (5.5) 09/2011
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic indicated for:
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DOSAGE AND ADMINISTRATION
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Initial
Dose
Target
Dose
Effective
Dose
Range
Schizophrenia:
Adults (2.1)
2 mg
4 mg
to 8 mg
4 mg
to 16 mg
Schizophrenia:
Adolescents (2.1)
0.5 mg
3 mg
1 mg
to 6 mg
Bipolar mania
Adults (2.2)
2 mg to 3 mg
1 mg
to 6 mg
1 mg
to 6 mg
Bipolar mania: in children/adolescents (2.2)
0.5 mg
1 mg
to 2.5 mg
1 mg
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 mg
to 3 mg
•
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
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)
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)
•
WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
The