OLANZAPINE- olanzapine tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 )].  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 or mixed episodes of

Product summary:

Product: 50090-2827 NDC: 50090-2827-0 10 TABLET, ORALLY DISINTEGRATING in a BLISTER PACK / 3 in a CARTON

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
A-S Medication Solutions
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Medication Guide
Olanzapine 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. In people who do not have
diabetes, sometimes high blood
sugar goes away when olanzapine ora

Summary of Product characteristics

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
A-S MEDICATION SOLUTIONS
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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
_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.
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 6week
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 adults) for weight gain
and dyslipidemia may lead clinicians to consider prescribing other
drugs first i