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:

Macleods Pharmaceuticals Limited

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 13-17), 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 trials in adult patients with m

Product summary:

Olanzapine tablets, USP 2.5 mg, are white to off white coloured, round shaped, biconvex, film coated tablets debossed ‘CL’ on one side, and ‘39’ on other side, 5 mg, are white to off white coloured, round shaped, biconvex, film coated tablets debossed ‘CL 40’ on one side and plain on other side 7.5 mg are white to off white coloured, round shaped, biconvex, film coated tablets debossed ‘CL 41’ on one side and plain on other side, 10 mg are white to off white coloured, round shaped, biconvex, film coated tablets debossed ‘CL 42’ on one side and plain on other side. The 15 mg tablets are blue coloured, oval shaped biconvex film coated tablets having ‘CL 43’ debossed on one side and plain on other side. The 20 mg tablets are  pink coloured, oval shaped biconvex film coated tablets having ‘CL 44’ debossed on one side and plain on other side.  The tablets are available as follows: Store olanzapine tablets, USP at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. 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, USP from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OLANZAPINE - OLANZAPINE TABLET, FILM COATED
Macleods Pharmaceuticals Limited
----------
SPL MEDGUIDE SECTION
Olanzapine Tablets
(oh lan’za peen)
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 diabetes before
taking olanzapine tablets need to
take medicine

Summary of Product characteristics

OLANZAPINE - OLANZAPINE TABLET, FILM COATED
MACLEODS PHARMACEUTICALS 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. (5.1,8.5, 17)
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 13-17): 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 13-17): 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 dr