OLANZAPINE - olanzapine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ajanta Pharma Limited

INN (International Name):

OLANZAPINE

Composition:

OLANZAPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- None with olanzapine monotherapy. None with olanzapine monotherapy. - When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax® . When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax® . - For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products.            When using olanzapine and fluoxetine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax® .             Teratogenic Effects, Pregnancy Category C — In oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the maxi

Product summary:

           Olanzapine Tablets, USP 2.5 mg tablets are white colored, round, biconvex, film-coated tablets debossed ‘OL1’ on one side and plain on other side. The 5 mg tablets are white colored, round, biconvex, film-coated tablets debossed ‘OL2’ on one side and plain on other side. The 7.5 mg tablets are white colored, capsule shaped, biconvex, film-coated tablets debossed ‘OL3’ on one side and plain on other side.  The 10 mg tablets are white colored, round, biconvex, film-coated tablets debossed ‘OL4’ on one side and plain on other side. The 15 mg tablets are blue colored, oval shaped, biconvex, film-coated tablets debossed ‘OL5’ on one side and plain on other side. The 20 mg tablets are pink colored, capsule shaped, biconvex, film-coated tablets debossed ‘OL6’ on one side and plain on other side. The tablets are available as follows:            Store olanzapine tablets at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].                      Dispense in a tight, light-resistant container.            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 olanzapine tablets from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OLANZAPINE - OLANZAPINE TABLET
Ajanta Pharma Limited
----------
MEDICATION GUIDE
Medication Guide
OlanzapineTablets, USP
(oh lan' za peen)
Read the Medication Guide that comes with olanzapine tablets before
youstart 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 aboutyour medical condition or treatment. Talk with your
doctor or pharmacist ifthere 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
olanzapinetablets?
Olanzapinetablets 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.
Theseserious 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
starttaking olanzapine tablets and
during treatment. In people who do not havediabetes, sometimes high
blood sugar goes away when
olanzapine tablets arestopped. People with diabetes and some people
who did not have diabetes
beforetaking olanzapine tablets need to take medicine for high blood
suga

Summary of Product characteristics

OLANZAPINE - OLANZAPINE TABLET
AJANTA PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 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
.
RECENT MAJOR CHANGES
Warnings and Precautions:
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (5.4)
10/2016
Falls (5.8) 02/2017
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 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 (14.2). The increased potential (in
adoles