OLANZAPINE tablet OLANZAPINE tablet, orally disintegrating

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

PharmTak, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 13-17), 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 hyperlipidemia. 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 mixed e

Резиме производа:

For Olanzapine Tablets, USP The tablets are available as follows: 2.5 mg Olanzapine Tablets, USP are yellow, round, convex tablets, debossed with "HU" on one side, and "2.5" on the other side. Bottles of 30 NDC 59392-6031-1 Bottles of 90 NDC 59392-6031-4 Bottles of 500 NDC 59392-6031-7 5 mg Olanzapine Tablets, USP are yellow, round, convex tablets, debossed with "HU" on one side, and "5" on the other side. Bottles of 30 NDC 59392-6032-1 Bottles of 90 NDC 59392-6032-4 Bottles of 500 NDC 59392-6032-7 7.5 mg Olanzapine Tablets, USP are yellow, round, convex tablets, debossed with "HU" on one side, and "7.5" on the other side. Bottles of 30 NDC 59392-6033-1 Bottles of 90 NDC 59392-6033-4 Bottles of 500 NDC 59392-6033-7 10 mg Olanzapine Tablets, USP are yellow, round, convex tablets, debossed with "HU" on one side, and "10" on the other side. Bottles of 30 NDC 59392-6034-1 Bottles of 90 NDC 59392-6034-4 Bottles of 500 NDC 59392-6034-7 15 mg Olanzapine Tablets, USP are yellow, modified capsule convex tablets, debossed with "HU" on one side, and "15" on the other side. Bottles of 30 NDC 59392-6035-1 Bottles of 90 NDC 59392-6035-4 Bottles of 500 NDC 59392-6035-7 20 mg Olanzapine Tablets, USP are yellow, oval tablets, debossed with "HU" on one side, and "20" on the other side. Bottles of 30 NDC 59392-6036-1 Bottles of 90 NDC 59392-6036-4 Bottles of 500 NDC 59392-6036-7 For olanzapine orally disintegrating tablets 5 mg olanzapine orally disintegrating tablets are yellow, round, convex tablets, debossed with "H603" on one side, and "05" on the other side. Bottles of 30 NDC 59392-6191-1 Bottles of 90 NDC 59392-6191-4 Bottles of 500 NDC 59392-6191-7 10 mg olanzapine orally disintegrating tablets are yellow, round, convex tablets, debossed with "H603" on one side, and "010" on the other side. Bottles of 30 NDC 59392-6192-1 Bottles of 90 NDC 59392-6192-4 Bottles of 500 NDC 59392-6192-7 15 mg olanzapine orally disintegrating tablets are yellow, modified capsule shaped convex tablets, debossed with "H603" on one side, and "015" on the other side. Bottles of 30 NDC 59392-6193-1 Bottles of 90 NDC 59392-6193-4 Bottles of 500 NDC 59392-6193-7 20 mg olanzapine orally disintegrating tablets are yellow, oval convex tablets, debossed with "H603" on one side, and "020" on the other side. Bottles of 30 NDC 59392-6194-1 Bottles of 90 NDC 59392-6194-4 Bottles of 500 NDC 59392-6194-7 Store olanzapine tablets and olanzapine orally disintegrating 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 and olanzapine orally disintegrating tablets from light and moisture.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

OLANZAPINE- OLANZAPINE TABLET
OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
PharmTak, Inc.
----------
MEDICATION GUIDE
Medication Guide
Olanzapine (oh lan’ za peen) Tablets
Olanzapine (oh lan’ za peen) Orally Disintegrating Tablets
Rx Only
Read the Medication Guide that comes with olanzapine 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.
What is the most important information I should know about olanzapine?
Olanzapine 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 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 and during
treatment. In people who do not have diabetes, sometimes high blood
sugar goes away when olanzapine is
stopped. People with diabetes and some people who did not have
diabetes before ta

Карактеристике производа

OLANZAPINE- OLANZAPINE TABLET
OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
PHARMTAK, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OLANZAPINE.
OLANZAPINE TABLETS, FOR ORAL USE
OLANZAPINE ORALLY DISINTEGRATING 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.
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
Warnings and Precautions, Risks in Patients with Phenylketonuria
(5.18)
11/2020
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