OLANZAPINE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Proficient Rx LP

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 was established in three clinical trials in adult patients with ma

Přehled produktů:

Olanzapine tablets, USP 15 mg tablets are blue coloured, oval shaped biconvex film coated tablets having ‘CL 43’ debossed on one side and plain on other side.  The tablets are available as follows:   TABLET STRENGTH   15 mg Identification CL 43 NDC Codes: Bottles 30s NDC  71205-487-30 Bottles 60s -- -- -- NDC  71205-487-60 Bottles 90s NDC 71205- 487-90 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.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Proficient Rx LP
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SPL MEDGUIDE SECTION
.
Revised: 10/2020
Document Id: 61424fa3-b09a-4267-a208-a7c7c3f69fe5
34391-3
Set id: 61424fa3-b09a-4267-a208-a7c7c3f69fe5
Version: 1
Effective Time: 20201001
Proficient Rx LP

Charakteristika produktu

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
WHEN USING OLANZAPINE AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE
BOXED WARNING SECTION OF THE
PACKAGE INSERT FOR SYMBYAX.
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 dyslipidemia 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 lead clinicians to consider prescribing other
drugs first in adolescents. (1.2)
· Medication therapy for pediatric patients with schizophrenia or
bipolar I disorder should be undertaken only after a
thorough diagnostic evaluation and with careful consideration of the
potential risks. (1.3)
· Adjunct to valproate or lithium in the treatment of manic or mixed
ep