OLANZAPINE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Quality Care Products, LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Olanzapine tablets, USP 2.5 mg, are white to off white coloured, round shaped, biconvex, film coated tablets debossed ‘CL’ on one side and ‘39’ on other side, 5 mg, are white to off white coloured, round shaped, biconvex, film coated tablets debossed ‘CL 40’ on one side and plain on other side 7.5 mg are white to off white coloured, round shaped, biconvex, film coated tablets debossed ‘CL 41’ on one side and plain on other side, and 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 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 20 mg tablets are pink coloured, oval shaped biconvex film coated tablets having ‘CL 44’ debossed on one side and plain on other side. 55700-809-30 White, Round, CL;39 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.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Quality Care Products, LLC
----------
SPL MEDGUIDE SECTION
.
Revised: 11/2019
Document Id: 6b4b0802-096f-4102-a072-398052a73fe5
34391-3
Set id: ee9b807f-d57b-4999-8f3d-857cc86d695f
Version: 1
Effective Time: 20191114
Quality Care Products, LLC

Lastnosti izdelka

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
QUALITY CARE PRODUCTS, LLC
----------
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
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)
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