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:

Torrent Pharmaceuticals Limited

INN (Међународно име):

OLANZAPINE

Састав:

OLANZAPINE 2.5 mg

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 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 di

Резиме производа:

For Olanzapine Tablets, USP The tablets are available as follows : 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.                                                                            Bottles of 30                         NDC 13668-166-30                                      Bottles of 60                         NDC 13668-166-60                                      Bottles of 100                        NDC 13668-166-01                                      Bottles of 500                        NDC 13668-166-05                                      Bottles of 1000                       NDC 13668-166-10                                      Bottles of 3000                       NDC 13668-166-43 Olanzapine 5 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "5" on one side and "67" on other side.                                       Bottles of 30                         NDC 13668-167-30                                      Bottles of 60                         NDC 13668-167-60                                      Bottles of 100                        NDC 13668-167-01                                      Bottles of 500                        NDC 13668-167-05                                      Bottles of 1000                       NDC 13668-167-10                                      Bottles of 2000                       NDC 13668-167-20 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.                                        Bottles of 30                         NDC 13668-168-30                                      Bottles of 60                         NDC 13668-168-60                                      Bottles of 100                        NDC 13668-168-01                                      Bottles of 500                        NDC 13668-168-05                                      Bottles of 1000                       NDC 13668-168-10                                      Bottles of 2000                       NDC 13668-168-20 Olanzapine 10 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "10" on one side and "169" on other side.                                      Bottles of 30                          NDC 13668-169-30                                      Bottles of 60                          NDC 13668-169-60                                      Bottles of 100                         NDC 13668-169-01                                      Bottles of 500                         NDC 13668-169-05                                      Bottles of 1000                        NDC 13668-169-10                                      Bottles of 1500                        NDC 13668-169-15  Olanzapine 15 mg tablets, USP are yellow colored, oval shaped, biconvex, uncoated tablets, debossed with "15" on one side and "1170" on other side.                                      Bottles of 30                          NDC 13668-170-30                                      Bottles of 60                          NDC 13668-170-60                                      Bottles of 100                         NDC 13668-170-01                                      Bottles of 500                         NDC 13668-170-05                                      Bottles of 1000                       NDC 13668-170-10 Olanzapine 20 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "20" on one side and "1171" on other side.                                      Bottles of 30                          NDC 13668-171-30                                      Bottles of 60                          NDC 13668-171-60                                      Bottles of 100                         NDC 13668-171-01                                      Bottles of 500                         NDC 13668-171-05                                      Bottles of 1000                        NDC 13668-171-10 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.                                       Bottles of 30                          NDC 13668-086-30                                       Bottles of 90                          NDC 13668-086-90                                       Bottles of 500                         NDC 13668-086-05 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.                                        Bottles of 30                            NDC 13668-088-30                                       Bottles of 90                            NDC 13668-088-90                                       Bottles of 500                          NDC 13668-088-05 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.                                          Bottles of 30                            NDC 13668-089-30                                       Bottles of 90                            NDC 13668-089-90                                       Bottles of 500                          NDC 13668-089-05 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.                                          Bottles of 30                            NDC 13668-090-30                                       Bottles of 90                            NDC 13668-090-90                                       Bottles of 500                          NDC 13668-090-05 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.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

OLANZAPINE- OLANZAPINE TABLET
OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
Torrent Pharmaceuticals Limited
----------
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. 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. 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 olan

Карактеристике производа

OLANZAPINE- OLANZAPINE TABLET
OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
TORRENT PHARMACEUTICALS LIMITED
----------
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 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, 8.5, 17)
WHEN USING OLANZAPINE AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE
BOXED WARNING
SECTION OF THE PACKAGE INSERT FOR OLANZAPINE AND FLUOXETINE
HYDROCHLORIDE CAPSULES.
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 mix