OLANZAPINE injection, powder, for solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

TYA Pharmaceuticals

DCI (Dénomination commune internationale):

OLANZAPINE

Composition:

OLANZAPINE 10 mg in 2 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Olanzapine for Injection  is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania. Efficacy was demonstrated in 3 short-term (24 hours of IM treatment) placebo-controlled trials in agitated adult inpatients with: schizophrenia or bipolar I disorder (manic or mixed episodes) [see   CLINICAL STUDIES ( ) 14.3 ]. “Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. - None with Olanzapine for Injection monotherapy. - For specific information about the contraindications of lithium or valproate, refer to the Contr

Descriptif du produit:

NDC:64725-3159-1 in a VIAL of 10 INJECTION, POWDER, FOR SOLUTIONS Olanzapine for Injection is available in: NDC 0781-3159-72, 10 mg vial (1s) NDC 0781-3159-95, package of 10 vials Store Olanzapine for Injection vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP Controlled Room Temperature]. Reconstituted Olanzapine for Injection may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP Controlled Room Temperature] for up to 1 hour if necessary. 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. see see Discard any unused portion of reconstituted Olanzapine for Injection IntraMuscular. Protect Olanzapine for Injection from light, do not freeze.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

OLANZAPINE- OLANZAPINE INJECTION, POWDER, FOR SOLUTION
TYA PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLANZAPINE FOR
INJECTION. OLANZAPINE FOR INJECTION, POWDER,
FOR SOLUTION FOR INTRAMUSCULAR 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 FOR INJECTION IS NOT APPROVED FOR THE
TREATMENT OF PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS. (5.1, 5.14, 17.2)
RECENT MAJOR CHANGES
None
INDICATIONS AND USAGE
Olanzapine for Injection is an atypical antipsychotic indicated: (1)
Treatment of acute agitation associated with schizophrenia and bipolar
I mania. (1.4)
Efficacy was established in three 1-day trials in adults. (14.3)
DOSAGE AND ADMINISTRATION
Agitation associated with Schizophrenia and Bipolar I Mania
in adults (2.4) (2)
IM: 10 mg (5 mg or 7.5 mg when clinically warranted)
Assess for orthostatic hypotension prior to subsequent
dosing (max. 3 doses 2 to 4 hrs apart)
DOSAGE FORMS AND STRENGTHS
Intramuscular Injection: 10 mg vial (3)
CONTRAINDICATIONS
None with Olanzapine monotherapy.
When using Olanzapine in combination with lithium or valproate, refer
to the Contraindications section of the package
inserts for those products. (4)
WARNINGS AND PRECAUTIONS
Increased risk of death and increased incidence of cerebrovascular
adverse events (e.g., stroke, transient ischemic
attack). (5.1) _Elderly Patients with Dementia-Related Psychosis:_
The possibility of a suicide attempt is inherent in schizophrenia and
in bipolar I disorder, and close supervision of high-
risk patients should accompany drug therapy.(5.2) _Suicide:_
Manage with immediate discontinuation and close monitoring. (5.3)
_Neuroleptic Mali