ZYPREXA- olanzapine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Olanzapine (UNII: N7U69T4SZR) (Olanzapine - UNII:N7U69T4SZR)

Available from:

Dispensing Solutions, Inc.

INN (International Name):

Olanzapine

Composition:

Olanzapine 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oral ZYPREXA 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 13-17), 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 ZYPREXA is 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 ep

Product summary:

The ZYPREXA 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets are white, round, and imprinted in blue ink with LILLY and tablet number. The 15 mg tablets are elliptical, blue, and debossed with LILLY and tablet number. The 20 mg tablets are elliptical, pink, and debossed with LILLY and tablet number. The tablets are available as follows: a Identi-Dose® (unit dose medication, Lilly). ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) are yellow, round, and debossed with the tablet strength. The tablets are available as follows: ZYPREXA is a registered trademark of Eli Lilly and Company. ZYDIS is a registered trademark of Catalent Pharma Solutions. ZYPREXA IntraMuscular is available in: Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP] for up to 1 hour if necessary. Discard any unused portion of reconstituted ZYPREXA IntraMuscular. 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 ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze.

Authorization status:

New Drug Application

Patient Information leaflet

ZYPREXA - OLANZAPINE TABLET
Dispensing Solutions, Inc.
----------
Medication Guide
ZYPREXA® (zy-PREX-a)
(olanzapine)
Tablet
ZYPREXA® ZYDIS® (zy-PREX-a ZY-dis)
(olanzapine)
Tablet, Orally Disintegrating
Read the Medication Guide that comes with ZYPREXA 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
ZYPREXA.
What is the most important information I should know about ZYPREXA?
ZYPREXA 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). ZYPREXA 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 ZYPREXA and
during treatment. In people who do not have diabetes, sometimes high
blood sugar goes away
when ZYPREXA is stopped. People with diabetes and some people who did
not have diabetes
before taking ZYPREXA need to take medicine for high blood sugar even
after they stop taking
ZYPREXA.
If you have diabetes, follow your doctor's instructions about how
often to check your blood sugar
while taking Z

Summary of Product characteristics

ZYPREXA - OLANZAPINE TABLET
DISPENSING SOLUTIONS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZYPREXA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZYPREXA.
ZYPREXA (OLANZAPINE) TABLET FOR ORAL USE
ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING FOR ORAL USE
ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION FOR
INTRAMUSCULAR 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. ZYPREXA IS NOT APPROVED FOR THE TREATMENT OF PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS.
(5.1, 5.14, 17.2)
WHEN USING ZYPREXA AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE
BOXED WARNING SECTION OF THE
PACKAGE INSERT FOR SYMBYAX.
RECENT MAJOR CHANGES
None .
INDICATIONS AND USAGE
ZYPREXA (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 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 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