RISPERIDONE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

State of Florida DOH Central Pharmacy

INN (Միջազգային անվանումը):

RISPERIDONE

Կազմը:

RISPERIDONE 1 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Adults Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)]. Adolescents Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia .Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products. 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 [see Clinical Studies (14.2)]. Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone dru

Ապրանքի ամփոփագիր:

Risperidone Tablets, USP 0.25 mg are yellow, oblong shaped, biconvex film coated tablets debossed with ‘0.25’ on one side and ‘1035’ on other side. Risperidone Tablets, USP 0.5 mg are red, oblong shaped, biconvex film coated tablets debossed with ‘R 0.50’ on one side and ‘1036’ on other side. Risperidone Tablets, USP 1 mg are white to off white, oblong shaped, biconvex film coated tablets debossed with ‘R 1’ on one side and ‘1037’ on other side. Risperidone Tablets, USP 2 mg are light orange, oblong shaped, biconvex film coated tablets debossed with ‘R 2’ on one side and ‘1038’ on other side. Risperidone Tablets, USP 3 mg are yellow, oblong shaped, biconvex film coated tablets debossed with ‘R 3’ on one side and ‘1039’ on other side. Risperidone Tablets, USP 4 mg are yellow, oblong shaped, biconvex film coated tablets debossed with ‘R 4’ on one side and ‘1040’ on other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°- 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. PROTECT FROM MOISTURE. Keep out of reach of children. Dispense in a tight, light-resistant container. Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA. For: TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009. This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

RISPERIDONE - RISPERIDONE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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 TABLET FOR ORAL USE
RISPERIDONE TABLETS, USP
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
Boxed Warning 08/2008
Warnings and Precautions (5.1) 08/2008
Warnings and Precautions, Leukopenia, Neutropenia, and Agranulocytosis
(5.8) 09/2009
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults (1.1)
Alone, or in combination with lithium or valproate, for the short-term
treatment of acute manic or mixed episodes
associated with Bipolar I Disorder in adults (1.2)
Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity
rights; this drug product is not labeled for use in
pediatric patients with schizophrenia, bipolar mania or autistic
disorder. (1.1, 1.2, 1.3)
DOSAGE AND ADMINISTRATION
Initial Dose
T itration
Target Dose
Effective Dose Range
Schizophrenia-adults (2.1)
2 mg/day
1-2 mg daily
4-8 mg daily
4-16 mg/day
Bipolar mania-adults (2.2)
2-3 mg/day
1mg daily
1-6 mg/day
1-6 mg /day
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 the product (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia-related psychosis. Risperidone is not
approved for use in patients with dementia-related psychosis (5.2)
Neuroleptic Malignant Syndrome (5.3)
Tardive dyskinesia (5.4)
Hyperglycemia and diabetes mellit