OLANZAPINE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

ECI PHARMACEUTICALS LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Oral olanzapine 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 13-17), 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 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 clinical trials in adult patients

Dettagli prodotto:

The olanzapine 2.5 mg tablets are oval, biconvex, white to off white coloured film coated tablets debossed with '45' on one side and ‘I’ on other side, 5 mg, tablets are  round, biconvex, white to off white coloured film coated tablets debossed with '46' on one side and ‘I’ on other side, 7.5 mg tablets are round, biconvex, white to off white coloured film coated tablets debossed with '47' on one side and ‘I’ on other side, and 10 mg tablets are round, biconvex, white to off white coloured film coated tablets debossed with '48' on one side and ‘I’ on other side . The 15 mg tablets are capsule shaped, biconvex, blue coloured, film coated tablets debossed with '49' on one side and ‘I’ on other side. The 20 mg tablets are oval, biconvex, pink coloured, film coated tablets debossed with '50' on one side and ‘I’ on other side. The tablets are available as follows: Store olanzapine tablets at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. 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 from light and moisture.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

OLANZAPINE - olanzapine tablet
ECI PHARMACEUTICALS LLC
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MEDICATION GUIDE
Olanzapine Tablets USP
(oh lan' za peen)
Read the Medication Guide that comes with olanzapine 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.
What is the most important information I should know aboutolanzapine
tablets?
Olanzapinetablets 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 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 tablets and during
treatment. In people who do not have diabetes, sometimes high blood
sugar goes away when olanzapine
tablets is stopped. People with diabetes and some people who did not
have diabetes before taking olanzapine
tablets need to take medicine for high blood sugar even af

Scheda tecnica

OLANZAPINE - OLANZAPINE TABLET
ECI PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE TABLETS,
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OLANZAPINE TABLETS.
OLANZAPINE 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 TABLETS 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
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 I disorder: two 3- to 4-week trials and one maintenance trial.
(14.2)
Adolescents (ages 13-17): Efficacy was established in one 3-week trial
in patient