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:

Rebel Distributors Corp

INN (International Name):

Olanzapine

Composition:

Olanzapine 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Olanzapine Tablets USP 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 [see Clinical Studies (14.1) ]. When deciding among the alternative treatments 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) ]. Information describing the use of olanzapine tablets in pediatric patients with schizophrenia is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Monotherapy Olanzapine Tablets USP are indicated for the acute

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 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. 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. 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

Patient Information leaflet

Rebel Distributors Corp
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MEDICATION GUIDE
Olanzapine Tablets USP
Read the Medication Guide that comes with olanzapine before you start
taking it 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.
What is the most important information I should know about olanzapine?
Olanzapine 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.
4. Weight gain, especially in teenagers age 13 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 is 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 and during
treatment. In people who do not have diabetes, sometimes high blood
sugar goes away when olanzapine
is stopped. People with diabetes and some people who did not have
diabetes before taking olanzapine
need to take medicine for high blood sugar even after they stop taking
olanzapine.
If you have diabetes, follow your doctor’s instructions about how
often to check your blood sugar while
taking olanzapine.
Call your doctor if you have any of these symptoms of high blood sugar
(hyperglycemia) whi

Summary of Product characteristics

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLANZAPINE TABLETS
USP. 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 OLANZAPINE AND FLUOXETINE IN COMBINATION.
INDICATIONS AND USAGE
Olanzapine USP 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)
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)
Adjunct to valproate or lithium in the treatment of manic or mixed
episodes associated with bipolar I disorder. (1.2)
Efficacy was established in two 6-week clinical trials in adults
(14.2). Maintenance efficacy has not been
systematically evaluated.
_As olanzapine and fluoxetine in combination for the_:
Treatment of depressive episodes associated with bipolar I disorder
(1.5)
Efficacy was established with olanzapine and fluoxetine in combination
in adults; refer to the product label for
olanzapine and fluoxetine in combination.
DOSAGE AND ADMINISTRATION
Schiz