RISPERIDONE- risperidone tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

RISPERIDONE

Composition:

RISPERIDONE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults RISPERIDONE (risperidone) is indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)]. Adolescents RISPERIDONE is indicated for the treatment of schizophrenia in adolescents aged 13–17 years [see Clinical Studies (14.1)]. Monotherapy Adults and Pediatrics RISPERIDONE is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10-17 years [see Clinical Studies (14.2)]. Combination Therapy Adults The combination of RISPERIDONE with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)]. Pediatrics RISPERIDONE is indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see CLINIC

Product summary:

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: Risperidone Tablets USP, 0.5 mg are red-brown colored, round, biconvex film-coated tablets debossed with "Z" on one side and "6" on other side and are supplied as follows: Risperidone Tablets USP, 1 mg are white to off-white, round, biconvex film-coated tablets debossed with "ZC 75" on one side and plain on other side and are supplied as follows: Risperidone Tablets USP, 2 mg are orange, round, biconvex film-coated tablets debossed with "ZC 76" on one side and plain on other side and are supplied as follows: NDC: 55700-017-30  Bottles of 30 NDC: 55700-017-60  Bottles of 60 NDC: 55700-017-90  Bottles of 90 Risperidone Tablets USP, 3 mg are yellow, round, biconvex film-coated tablets debossed with "ZC 77"on one side and plain on other side and are supplied as follows: Risperidone Tablets USP, 4 mg are green, round, biconvex film-coated tablets debossed with "ZC 78" on one side and plain on other side and are supplied as follows: Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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.
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 IS NOT APPROVED FOR USE IN PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes (5.5) September 2011
INDICATIONS AND USAGE
RISPERIDONE is an atypical antipsychotic agent indicated for:
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DOSAGE AND ADMINISTRATION
INITIAL DOSE
TITRATION
TARGET DOSE
EFFECTIVE DOSE RANGE
Schizophrenia – adults (2.1)
2 mg/day
1-2 mg daily
4-8 mg daily
4-16 mg/day
Schizophrenia – adolescents (2.1)
0.5 mg /day
0.5-1 mg
daily
3 mg /day
1-6 mg /day
Bipolar mania –adults (2.2)
2-3 mg/day
1 mg daily
1-6 mg/day
1-6 mg/day
Bipolar mania in children/adolescents (2.2)
0.5 mg /day
0.5-1mg
daily
2.5 mg/day
0.5-6 mg/day
Irritability associated with autistic disorder (2.3) 0.25 mg/day (< 20
kg) 0.5 mg/day (≥ 20 kg)
0.25-
0.5 mg at ≥ 2 weeks
0.5 mg/day (< 20 kg) 1 mg/day (≥ 20 kg)
0.5-3 mg/day
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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• _Hyperglycemia and Diabetes Mellitus: _Monitor patients for
symptoms of hyperglycemia including polydipsia,
polyuria, polyphagia, and weakness. Monitor glucose regularly in
patients with diabetes or at risk for diabetes. (5.5)
• _Dyslipidemia: _Undesirable alterations have been observed in
patients treated with atypical antipsychotics. (5.5)
• _Weight Gain: _Significant weight gain has been reported. Monitor
weight gain. (5.5)
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ADVERSE REACTIONS