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:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Olanzapine orally disintegrating 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)] . Monotherapy — Olanzapine orally disintegrating 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 thre

Product summary:

Olanzapine orally disintegrating tablets, USP, 5 mg are yellow, round, flat faced radial edge tablets, engraved “APO” on one side, “OL” over “5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60505-3275-3) Bottles of 1,000s (NDC 60505-3275-8) Blisters of 100 Unit Dose (NDC 60505-3275-0)  Olanzapine orally disintegrating tablets, USP, 10 mg are yellow, round, flat faced radial edge tablets, engraved “APO” on one side, “OL” over “10” on the other side. They are supplied as follows: Bottles of 30s (NDC 60505-3276-3) Bottles of 1,000s (NDC 60505-3276-8) Blisters of 100 Unit Dose (NDC 60505-3276-0)  Olanzapine orally disintegrating tablets, USP, 15 mg are yellow, round, flat faced radial edge tablets, engraved “APO” on one side, “OL” over “15” on the other side. They are supplied as follows: Bottles of 30s (NDC 60505-3277-3) Bottles of 1,000s (NDC 60505-3277-8) Blisters of 100 Unit Dose (NDC 60505-3277-0)  Olanzapine orally disintegrating tablets, USP, 20 mg are yellow, round, flat faced radial edge tablets, engraved “APO” on one side, “OL” over “20” on the other side. They are supplied as follows: Bottles of 30s (NDC 60505-3278-3) Bottles of 1,000s (NDC 60505-3278-8) Blisters of 100 Unit Dose (NDC 60505-3278-0) Store olanzapine orally disintegrating tablets, USP at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [ see USP Controlled Room Temperature]. Protect olanzapine orally disintegrating tablets from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
REMEDYREPACK INC.
----------
Medication Guide
Olanzapine Orally Disintegrating Tablets, USP
(oh lan' za peen)
Read the Medication Guide that comes with olanzapine orally
disintegrating tablets 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 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 ol

Summary of Product characteristics

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
REMEDYREPACK INC.
----------
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 TABLET, ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING TABLETS ARE NOT
APPROVED FOR THE TREATMENT OF PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.14, 17.2)
WHEN USING OLANZAPINE ORALLY DISINTEGRATING TABLETS AND FLUOXETINE IN
COMBINATION, ALSO REFER TO THE
BOXED WARNING SECTION OF THE PACKAGE INSERT FOR SYMBYAX
.
INDICATIONS AND USAGE
Olanzapine orally disintegrating 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 (