OLANZAPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, LLC

INN (International Name):

OLANZAPINE

Composition:

OLANZAPINE 2.5 mg

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)]. Monotherapy — Oral olanzapine is 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 manic or mi

Product summary:

Olanzapine tablets 2.5 mg USP   White to off white colored, film-coated, round shaped, biconvex tablets, imprinted “2.5” with black ink on one side and plain on the other side. Carton pack of 30  (3 x 10 Unit-dose) tablets                      NDC 67877-172-85 Carton pack of 100 (10 x 10 Unit-dose) tablets                   NDC 67877-172-35 Bottles of 7 tablets                                                                NDC 67877-172-32 Bottles of 30 tablets                                                              NDC 67877-172-30 Bottles of 100 tablets                                                            NDC 67877-172-01 Bottles of 1000 tablets                                                          NDC 67877-172-10 Olanzapine tablets5 mg USP White to off white colored film-coated, round shaped, biconvex tablets, imprinted “5” with black ink on one side and plain on the other side. Carton pack of 30 (3 x 10 Unit-dose) tablets                       NDC 67877-173-85 Carton pack of 100 (10 x 10 Unit-dose) tablets                   NDC 67877-173-35 Bottles of 7 tablets                                                                NDC 67877-173-32 Bottles of 30 tablets                                                              NDC 67877-173-30 Bottles of 100 tablets                                                            NDC 67877-173-01 Bottles of 1000 tablets                                                          NDC 67877-173-10 Olanzapine tablets7.5 mg USP White to off white colored, film-coated, round shaped, biconvex tablets, imprinted “7.5” with black ink on one side and plain on the other side. Carton pack of 30 (3 x 10 Unit-dose) tablets                       NDC 67877-174-85 Carton pack of 100 (10 x 10 Unit-dose) tablets                   NDC 67877-174-35 Bottles of 7 tablets                                                                NDC 67877-174-32 Bottles of 30 tablets                                                              NDC 67877-174-30 Bottles of 100 tablets                                                            NDC 67877-174-01 Bottles of 1000 tablets                                                          NDC 67877-174-10   Olanzapine tablets10 mg USP White to off white colored, film-coated, round shaped, biconvex tablets, imprinted “10” with black ink on one side and plain on the other side. Carton pack of 30 (3 x 10 Unit-dose) tablets                       NDC 67877-175-85 Carton pack of 100 (10 x 10 Unit-dose) tablets                   NDC 67877-175-35 Bottles of 7 tablets                                                               NDC 67877-175-32 Bottles of 30 tablets                                                             NDC 67877-175-30 Bottles of 100 tablets                                                           NDC 67877-175-01 Bottles of 1000 tablets                                                         NDC 67877-175-10   Olanzapine tablets 15 mg USP Blue colored, film-coated, elliptical shaped, biconvex tablets, imprinted “15” with black ink on one side and plain on the other side. Carton pack of (3 x 10 Unit-dose) tablets                            NDC 67877-176-85 Carton pack of 100 (10 x 10 Unit-dose) tablets                   NDC 67877-176-35 Bottles of 7 tablets                                                                NDC 67877-176-32 Bottles of 30 tablets                                                              NDC 67877-176-30 Bottles of 100 tablets                                                            NDC 67877-176-01 Bottles of 1000 tablets                                                          NDC 67877-176-10   Olanzapine tablets USP 20 mg Pink colored, film-coated, elliptical shaped, biconvex tablets, imprinted “20” with black ink on one side and plain on the other side. Carton pack of 30 (3 x 10 Unit-dose) tablets                       NDC 67877-177-85 Carton pack of 100 (10 x 10 Unit-dose) tablets                   NDC 67877-177-35 Bottles of 7 tablets                                                                NDC 67877-177-32 Bottles of 30 tablets                                                              NDC 67877-177-30 Bottles of 100 tablets                                                            NDC 67877-177-01 Bottles of 1000 tablets                                                          NDC 67877-177-10 Store olanzapine tablets, 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 from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ascend Laboratories, LLC
----------
MEDICATION GUIDE
Olanzapine(oh-LAN-za-peen) Tablets USP
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 is 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 is stopped. People with diabetes and some
people who did not have
diabetes before taking olanzapine tablets need to take medicine for
high blood sugar even after they
stop taking olanzapi

Summary of Product characteristics

OLANZAPINE - OLANZAPINE TABLET
ASCEND LABORATORIES, LLC
----------
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 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 adolescents
compared with adults) for weight gain and dyslipidemia may lead
clinicians to consider prescribing other
drugs first in adolescents. (1.2)
Me