OLANZAPINE tablet, orally disintegrating

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Teva Pharmaceuticals USA, Inc.

INN:

OLANZAPINE

composition:

OLANZAPINE 5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Olanzapine orally disintegrating 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 to 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 dyslipidemia. 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 — Olanzapine orally disintegrating 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 clin

leaflet_short:

Olanzapine Orally Disintegrating Tablets, USP are available as: 5 mg: Yellow, round, flat-faced, beveled-edge, unscored tablets. Debossed with “TV” over “U1” on one side and “5” on the other side. Available in a blister package of 30 tablets; NDC 0093-5245- 65 10 mg: Yellow, round, flat-faced, beveled-edge, unscored tablets. Debossed with “TV” over “U2” on one side and “10” on the other side. Available in a blister package of 30 tablets; NDC 0093-5246- 65 15 mg: Yellow, round, flat-faced, beveled-edge, unscored tablets. Debossed with “TV” over “U7” on one side and “15” on the other side. Available in a blister package of 30 tablets; NDC 0093-5247- 65 20 mg: Yellow, round, flat-faced, beveled-edge, unscored tablets. Debossed with “TV” over “U4” on one side and “20” on the other side. Available in a blister package of 30 tablets; NDC 0093-5248- 65 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). 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 FROM LIGHT AND MOISTURE. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

authorization_status:

Abbreviated New Drug Application

PIL

OLANZAPINE- olanzapine tablet, orally disintegrating
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Olanzapine (oh lan' za peen)
Orally Disintegrating Tablets
Read the Medication Guide that comes with olanzapine orally
disintegrating tablets before you start taking
them and each time you get a refill. There may be new information.
This Medication Guide does not take the
place of talking to your doctor about your medical condition or
treatment. Talk with your doctor or
pharmacist if there is something you do not understand or you want to
learn more about olanzapine orally
disintegrating tablets.
What is the most important information I should know about olanzapine
orally disintegrating tablets?
Olanzapine orally disintegrating tablets may cause serious side
effects, including:
1. Increased risk of death in elderly people who are confused, have
memory loss and have lost touch with
reality (dementia-related psychosis).
2. High blood sugar (hyperglycemia).
3. High fat levels in your blood (increased cholesterol and
triglycerides), especially in teenagers age 13 to 17
or when used in combination with fluoxetine in children age 10 to 17.
4. Weight gain, especially in teenagers age 13 to 17 or when used in
combination with fluoxetine in children
age 10 to 17.
These serious side effects are described below.
1. Increased risk of death in elderly people who are confused, have
memory loss and have lost touch with
reality (dementia-related psychosis). Olanzapine orally disintegrating
tablets are not approved for treating
psychosis in elderly people with dementia.
2. High blood sugar (hyperglycemia). High blood sugar can happen if
you have diabetes already or if you
have never had diabetes. High blood sugar could lead to:
•
a build up of acid in your blood due to ketones (ketoacidosis)
•
coma
•
death
Your doctor should do tests to check your blood sugar before you start
taking olanzapine orally disintegrating
tablets and during treatment.

SPC

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
OLANZAPINE ORALLY DISINTEGRATING TABLETS.
OLANZAPINE ORALLY DISINTEGRATING 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, 8.5, 17)
WHEN USING OLANZAPINE AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE
BOXED WARNING
SECTION OF THE PACKAGE INSERT FOR SYMBYAX.
INDICATIONS AND USAGE
Olanzapine orally disintegrating tablets are 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 to 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 to 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