OLANZAPINE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)

Beschikbaar vanaf:

Contract Pharmacy Services-PA

INN (Algemene Internationale Benaming):

OLANZAPINE

Samenstelling:

OLANZAPINE 10 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Oral olanzapine tablets are indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see Clinical Studies ( 14.1)].  When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidema. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions ( 5.5)]. Monotherapy — Oral olanzapine tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy

Product samenvatting:

Olanzapine tablets, USP 10 mg are white to off white coloured, round shaped, biconvex, film coated tablets debossed ‘CL 42’ on one side and plain on other side. . The tablets are available as follows: NDC 67046-525-07 blisterpacks of 7 NDC 67046-525-14 blisterpacks of 14 NDC 67046-525-15 blisterpacks of 15 NDC 67046-525-20 blisterpacks of 20 NDC 67046-525-21 blisterpacks of 21 NDC 67046-525-28 blisterpacks of 28 NDC 67046-525-30 blisterpacks of 30 NDC 67046-525-60 blisterpacks of 60 Store olanzapine tablets, USP at controlled room temperature, 20° to 25°C (68° to 77°F) [ see USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect olanzapine tablets, USP from light and moisture.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Contract Pharmacy Services-PA
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SPL MEDGUIDE SECTION
.
Revised: 10/2017
Document Id: 5abc92df-b330-c421-e053-2a91aa0a109d
34391-3
Set id: 5abc92df-b32f-c421-e053-2a91aa0a109d
Version: 1
Effective Time: 20171004
Contract Pharmacy Services-PA

Productkenmerken

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
525 OLANZAPINE 10 MG
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLANZAPINE TABLETS.
OLANZAPINE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
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. OLANZAPINE IS NOT APPROVED FOR THE TREATMENT OF
PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS. ( 5.1, 5.14, 17.2)
RECENT MAJOR CHANGES
Warnings and Precautions:
Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS) ( 5.4) 10/2016
Falls( 5.8) 02/2017
INDICATIONS AND USAGE
Olanzapine is an atypical antipsychotic indicated:
_As oral formulation for the:_
· Treatment of schizophrenia. ( 1.1)
· Adults: Efficacy was established in three clinical trials in
patients with schizophrenia: two 6-week trials and one
maintenance trial. ( 14.1)
· Adolescents (ages 13-17): Efficacy was established in one 6-week
trial in patients with schizophrenia ( 14.1). The
increased potential (in adolescents compared with adults) for weight
gain and hyperlipidemia may lead clinicians to
consider prescribing other drugs first in adolescents. ( 1.1)
· Acute treatment of manic or mixed episodes associated with bipolar
I disorder and maintenance treatment of bipolar I
disorder. ( 1.2)
· Adults: Efficacy was established in three clinical trials in
patients with manic or mixed episodes of bipolar I disorder: two
3- to 4-week trials and one maintenance trial. ( 14.2)
· Adolescents (ages 13-17): Efficacy was established in one 3-week
trial in patients with manic or mixed episodes
associated with bipolar I disorder ( 14.2). The increased potential
(in adolescents compared with adults) for weight gain
and dyslipidemia may le