OLANZAPINE- olanzapine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

OLANZAPINE

Composition:

OLANZAPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 ) ]. 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 manic or mixed epi

Product summary:

Olanzapine Tablets USP, 2.5 mg are available as off-white, round, unscored, film-coated tablets, debossed with “TEVA” on one side and “5767” on the other side, containing 2.5 mg olanzapine, and packaged in bottles of 30 (NDC 0093-5767-56), 100 (NDC 0093-5767-01) and 1000 (NDC 0093-5767-10) tablets. Olanzapine Tablets USP, 5 mg are available as off-white, round, unscored, film-coated tablets, debossed with “TEVA” on one side and "5768” on the other side, containing 5 mg olanzapine, and packaged in bottles of 30 (NDC 0093-5768-56), 100 (NDC 0093-5768-01) and 1000 (NDC 0093-5768-10) tablets. Olanzapine Tablets USP, 7.5 mg are available as off-white, round, unscored, film-coated tablets, debossed with “TEVA” on one side and "5769” on the other side, containing 7.5 mg olanzapine, and packaged in bottles of 30 (NDC 0093-5769-56) and 100 (NDC 0093-5769-01) tablets. Olanzapine Tablets USP, 10 mg are available as off-white, round, unscored, film-coated tablets, debossed with “TEVA” on one side and "5770” on the other side, containing 10 mg olanzapine, and packaged in bottles of 30 (NDC 0093-5770-56) and 100 (NDC 0093-5770-01) tablets. Olanzapine Tablets USP, 15 mg are available as blue, capsule-shaped, unscored, film-coated tablets, debossed with “TEVA” on one side and “5771” on the other side, containing 15 mg olanzapine, and packaged in bottles of 30 (NDC 0093-5771-56), 100 (NDC 0093-5771-01) and 1000 (NDC 0093-5771-10) tablets. Store at 20° to 25°C (68° to 77°F) [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 CONTAINER TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Olanzapine (oh LAN za peen) Tablets
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 blood sugar

Summary of Product characteristics

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
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.
RECENT MAJOR CHANGES
Warnings and Precautions:
Drug Reaction with Eosinophilia and Systemic 10/2016
Symptoms (DRESS) ( 5.4)
Falls ( 5.8) 02/2017
INDICATIONS AND USAGE
Olanzapine 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 increas