OLANZAPINE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International namn):

OLANZAPINE

Sammansättning:

OLANZAPINE 20 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Oral olanzapine is 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 hyperlipidemia. 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, 5.6 ) ].  Monotherapy - Oral olanzapine is indicated for 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 manic

Produktsammanfattning:

Olanzapine Tablets USP, 20 mg are white, film coated, oval, biconvex tablets with “R” embossed on one side and “0168” on other side and                                                                                                                                     20 are supplied in blistercards of 30. Blistercards of 30                          NDC 0615-7673-39 Store olanzapine tablets 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 from light and moisture.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
NCS HealthCare of KY, Inc dba Vangard Labs
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Medication Guide
Olanzapine Tablets USP
Read the Medication Guide that comes with olanzapine 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 tablets.
What is the most important information I should know about olanzapine
tablets?
Olanzapine 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 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 tablets and
during treatment. In people who do not have diabetes, sometimes high
blood sugar goes away when
olanzapine tablets are stopped. People with diabetes and some people
who did not have diabetes before
taking olanzapine tablets need to take medicine for high

Produktens egenskaper

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OLANZAPINE.
OLANZAPINE TABLETS USP 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.
RECENT MAJOR CHANGES
Indications and Usage, Olanzapine and Fluoxetine in Combination:
Depressive Episodes Associated with Bipolar I
Disorder (1.5) MM/YYYY
Dosage and Administration, Olanzapine and Fluoxetine in Combination:
Depressive Episodes Associated with Bipolar I Disorder (2.5) MM/YYYY
Dosing in Special Populations (2.7) MM/YYYY
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 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 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