OLANZAPINE tablet, orally disintegrating

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Par Pharmaceutical, Inc.

Designació comuna internacional (DCI):

OLANZAPINE

Composición:

OLANZAPINE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 dislipidemia. 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 ep

Resumen del producto:

Olanzapine orally disintegrating tablets, USP 5 mg, 10 mg, 15 mg and 20 mg are available in child resistant unit dose packs of 30 tablets (3 blistercards each containing 10 tablets) as follows: Store 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 orally disintegrating tablets from light and moisture.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
Par Pharmaceutical, Inc.
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MEDICATION GUIDE
Olanzapine (oh-LAN-za-peen) Orally Disintegrating Tablets, USP
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.
What is the most important information I should know about olanzapine?
Olanzapine may cause serious side effects, including:
•
Increased risk of death in elderly people who are confused, have
memory loss and have lost touch
with reality (dementia-related psychosis).
•
High blood sugar (hyperglycemia).
•
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.
•
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 taking olanzapine need to
take medicine for high b

Fitxa tècnica

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
PAR PHARMACEUTICAL, INC.
----------
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 ORALLY DISINTEGRATING TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
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 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)
Medication therapy for pediatric patients with schizophrenia or
bipolar I disorder should be undertaken
only after a thorough diagnostic evaluation and with