OLANZAPINE tablet, orally disintegrating

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

AvPAK

INN (Internationale Bezeichnung):

OLANZAPINE

Zusammensetzung:

OLANZAPINE 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

           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 w

Produktbesonderheiten:

For Olanzapine Tablets, USP Olanzapine 2.5 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "2.5" on one side and "66" on other side. Olanzapine 5 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "5" on one side and "67" on other side. Olanzapine 7.5 mg tablets, USP are yellow colored, capsule shaped, biconvex, uncoated tablets, debossed with "7.5" on one side and "168" on other side. Olanzapine 10 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "10" on one side and "169" on other side. Olanzapine 15 mg tablets, USP are yellow colored, oval shaped, biconvex, uncoated tablets, debossed with "15" on one side and "1170" on other side. Olanzapine 20 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "20" on one side and "1171" on other side. For Olanzapine Orally Disintegrating Tablets, USP The tablets are available as follows : Olanzapine orally disintegrating 5 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with "86" on one side and "5" on other side. NDC 50268-615-13 (10 Tablets per card, 3 cards per carton) Olanzapine orally disintegrating 10 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with "88" on one side and "10" on other side. NDC 50268-616-13 (10 Tablets per card, 3 cards per carton) Olanzapine orally disintegrating 15 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with "89" on one side and "15" on other side. NDC 50268-617-13 (10 Tablets per card, 3 cards per carton) Olanzapine orally disintegrating 20 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with "90" on one side and "20" on other side. Dispensed in Unit Dose package. For Institutional Use Only.             Store olanzapine tablets or 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 or orally disintegrating tablets from light and moisture.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
AvPAK
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SPL MEDGUIDE
Medication Guide
Olanzapine (oh-LAN-za-peen) Tablets, USP
Olanzapine (oh-LAN-za-peen) Orally Disintegrating Tablets, USP
Read the Medication Guide that comes with olanzapine tablets or 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 tablets or orally disintegrating tablets.
What is the most important information I should know about olanzapine
tablets or orally disintegrating
tablets?
Olanzapine tablets or 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.
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 or
orally disintegrating tablets
are not approved for treating psychosis in elderly people with
dementia.
2.
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 or orally
disintegrati

Fachinformation

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OLANZAPINE ORALLY DISINTEGRATING TABLETS, USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLANZAPINE.
OLANZAPINE TABLETS USP, FOR ORAL USE
OLANZAPINE ORALLY DISINTEGRATING TABLETS, USP 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, 5.14, 17.2)
WHEN USING OLANZAPINE AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE
BOXED WARNING
SECTION OF THE PACKAGE INSERT FOR OLANZAPINE AND FLUOXETINE
HYDROCHLORIDE CAPSULES.
INDICATIONS AND USAGE
Olanzapine is an atypical antipsychotic indicated: (1)
As oral formulation for the: (1)
• Treatment of schizophrenia. (1.1) (1)
• Adults: Efficacy was established in three clinical trials in
patients with schizophrenia: two 6-week
trials and one maintenance trial. (14.1) (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) (1)
• Acute treatment of manic or mixed episodes associated with bipolar
I disorder and maintenance
treatment of bipolar I disorder. (1.2) (1)
• 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) (1)
• Adolescents (ages 13 to 17): Efficacy was established in one
3-week trial in patients with manic or
mixed episodes associated with bipo