CYMBALTA duloxetine hydrochloride capsule delayed release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Duloxetine hydrochloride (UNII: 9044SC542W) (Duloxetine - UNII:O5TNM5N07U)

Beschikbaar vanaf:

St Marys Medical Park Pharmacy

INN (Algemene Internationale Benaming):

Duloxetine hydrochloride

Samenstelling:

Duloxetine 30 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

New Drug Application

Productkenmerken

CYMBALTA - DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
ST MARYS MEDICAL PARK PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYMBALTA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CYMBALTA.
CYMBALTA (DULOXETINE HYDROCHLORIDE) DELAYED-RELEASE CAPSULES FOR ORAL
USE.
INITIAL U.S. APPROVAL: 2004
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS. CYMBALTA IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS (5.1).
RECENT MAJOR CHANGES
Indications and Usage, Generalized Anxiety Disorder (1.2) 11/2009
Indications and Usage, Chronic Musculoskeletal Pain (1.5) 11/2010
Dosage and Administration, Chronic Musculoskeletal Pain (2.1, 2.2)
11/2010
Dosage and Administration, Maintenance/Continuation/Extended
Treatment (2.2) 11/2009
Warnings and Precautions, Effect on Blood Pressure (5.9) 11/2010
INDICATIONS AND USAGE
Cymbalta
is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated
for:
Major Depressive Disorder (MDD) (1.1)
Efficacy was established in four short-term and one maintenance trial
in adults (14.1).
Generalized Anxiety Disorder (GAD) (1.2)
Efficacy was established in three short-term and one maintenance trial
in adults (14.2).
Diabetic Peripheral Neuropathic Pain (DPNP) (1.3)
Fibromyalgia (FM) (1.4)
Chronic Musculoskeletal Pain (1.5)
DOSAGE AND ADMINISTRATION
Cymbalta should generally be administered once daily without regard to
meals. Cymbalta should be swallowed whole
and should not be chewed or crushed, nor should the capsule be opened
and its contents be sprinkled on food or mixed
with liquids (2.1).
INDICATION
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD (2.1, 2.2)
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