OLANZAPINE tablet, orally disintegrating

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Bryant Ranch Prepack

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Olanzapine orally disintegrating 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 — Olanzapine orally disintegrating 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 cl

Product samenvatting:

16.1 How Supplied Olanzapine orally disintegrating tablets, USP, 20 mg are yellow, round, flat faced radial edge tablets, engraved “APO” on one side, “OL” over “20” on the other side. They are supplied as follows: Bottles of 30s (NDC 63629-8719-1) 16.2 Storage and Handling Store olanzapine orally disintegrating tablets, USP 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 orally disintegrating tablets from light and moisture.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
Bryant Ranch Prepack
----------
Medication Guide
Olanzapine Orally Disintegrating Tablets, USP
(oh lan' za peen)
Medication Guide available at www1.apotex.com/products/us
Read the Medication Guide that comes with olanzapine orally
disintegrating 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
orally disintegrating tablets.
What is the most important information I should know about olanzapine
orally disintegrating tablets?
Olanzapine orally disintegrating 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 orally disintegrating
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 orally
disintegrating tablets and during treatment. In people who do no

Productkenmerken

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
OLANZAPINE ORALLY DISINTEGRATING TABLETS.
OLANZAPINE TABLET, ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING
TABLETS ARE NOT
APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS. (5.1, 8.5,
17)
WHEN USING OLANZAPINE ORALLY DISINTEGRATING 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 orally disintegrating 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