DULOXETINE capsule delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)

Commercializzato da:

Trigen Laboratories, LLC

INN (Nome Internazionale):

DULOXETINE HYDROCHLORIDE

Composizione:

DULOXETINE 20 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE
TRIGEN LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DULOXETINE DELAYED-RELEASE CAPSULES SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DULOXETINE
DELAYED-RELEASE CAPSULES.
DULOXETINE DELAYED-RELEASE CAPSULES USP FOR ORAL USE.
INITIAL U.S. APPROVAL: 2004
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRASSANTS (5.1)
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
(5.1)
RECENT MAJOR CHANGES
Boxed Warning: Suicidal Thoughts and Behaviors 10/2014
Indications and Usage (1) 10/2014
Dosage and Administration:
Dosage for Treatment of Generalized Anxiety Disorder (2.2) 10/2014
Contraindications Uncontrolled Narrow-Angle Glaucoma (4.2) Removed
07/2014
Warnings and Precautions:
Orthostatic Hypotension, Falls and Syncope (5.3) 11/2014
Angle-Closure Glaucoma (5.9) 07/2014
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI) indicated for: (1)
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
DOSAGE AND ADMINISTRATION
. Take duloxetine delayed-release capsules once daily, with or without
food. Swallow duloxetine delayed-release capsules
whole; do not crush or chew, do not open capsule. Take a missed dose
as soon as it is remembered. Do not take two doses
of duloxetine delayed-release capsules at the same time. (2) (2)
INDICATION
STARTING DOSE
TARGET DOSE
MAXIMUM
DOSE
MDD (2.1)
40 mg/day to
60 mg/day
Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once
daily or as 30 mg twice daily); Maintenance
Treatment: 60 mg/day
120
mg/day
GAD ( 2.2)
Adults
60 mg/day
60 mg/day (once daily)
120
mg/day
DPNP (2.3)
60 mg/day
60 mg/da