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:

Golden State Medical Supply, Inc.

INN (International Name):

OLANZAPINE

Composition:

OLANZAPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oral 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)]. Monotherapy — Oral 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 tr

Product summary:

Olanzapine tablets, USP 2.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “2.5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-620-30) Bottles of 1,000s (NDC 60429-620-10) Olanzapine tablets, USP 5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-621-30) Bottles of 1,000s (NDC 60429-621-10) Olanzapine tablets, USP 7.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “7.5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-622-30) Bottles of 1,000s (NDC 60429-622-10) Olanzapine tablets, USP 10 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “10” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-623-30) Bottles of 1,000s (NDC 60429-623-10) Olanzapine tablets, USP 15 mg are light blue, elliptical, biconvex film-coated tablets, engraved “APO” on one side, “OLA 15” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-624-30) Bottles of 1,000s (NDC 60429-624-10) Olanzapine tablets, USP 20 mg are light pink, elliptical, biconvex film-coated tablets, engraved “APO” on one side, “OLA 20” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-625-30) Bottles of 1,000s (NDC 60429-625-10) Store olanzapine tablets 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 tablets from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
Golden State Medical Supply, Inc.
----------
Medication Guide
Olanzapine Tablets, USP
(oh lan′ za peen)
Medication Guide available at www1.apotex.com/products/us
Read the Medication Guide that comes with olanzapine 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
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 diabete

Summary of Product characteristics

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
OLANZAPINE TABLETS. 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 TABLETS ARE NOT APPROVED
FOR THE
TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. ( 5.1, 8.5, 17)
WHEN USING OLANZAPINE TABLETS AND FLUOXETINE IN COMBINATION, ALSO
REFER TO THE
BOXED WARNING SECTION OF THE PACKAGE INSERT FOR SYMBYAX .
RECENT MAJOR CHANGES
Warnings and Precautions, Tardive Dyskinesia ( 5.6) 10/2019
Warnings and Precautions, Use in Patients with Concomitant Illness (
5.14) Removed 4/2020
Warnings and Precautions, Anticholinergic (antimuscarinic) Effects (
5.14) 4/2020
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)
Adolesce