CYMBALTA- duloxetine hydrochloride capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp.

INN (International Name):

Duloxetine hydrochloride

Composition:

Duloxetine 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short term and one maintenance trial in adults [see Clinical Studies (14.1)] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Cymbalta was established in three short-term trials and one maintenance trial in adults [see Clinical Studies (14.2)] . Generalized anxiety disorder is defined by the DSM

Product summary:

Cymbalta is available as delayed release capsules in the following strengths, colors, imprints, and presentations: a equivalent to duloxetine base † Identi-Dose® (unit dose medication, Lilly) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg      Bottles of 15 tablets.              NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg      Bottles of 15 tablets.              NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: Eli Lilly and Company Indianapolis, IN 46285 Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320

Authorization status:

New Drug Application

Patient Information leaflet

CYMBALTA- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
Rebel Distributors Corp.
----------
Medication Guide
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with your or your family member's
antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member's, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
2.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts
and actions. Some people may have a particularly high risk of having
suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness) or suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant
medicine is started or
when the dose is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new, worse, or wo

Summary of Product characteristics

CYMBALTA- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
REBEL DISTRIBUTORS CORP.
----------
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) CAPSULE, DELAYED RELEASE 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
Dosage and Administration, Maintenance/Continuation/Extended Treatment
(2.2) 11/2009
Warnings and Precautions, Serotonin Syndrome or Neuroleptic Malignant
Syndrome (NMS)-like Reactions (5.4)
01/2009
INDICATIONS AND USAGE
Cymbalta
is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated
for:
Major Depressive Disorder (MDD) (1.1)
Efficacy was established in 4 short-term and one maintenance trial in
adults (14.1).
Generalized Anxiety Disorder (GAD) (1.2)
Efficacy was established in 3 short-term and one maintenance trial in
adults (14.2).
Diabetic Peripheral Neuropathic Pain (DPNP) (1.3)
Fibromyalgia (FM) (1.4)
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).
INDIC ATIO N
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 daily); Maintenance
Treatment: 60 mg/day
120 mg/day
GAD (2.1)
60 mg/day
60 mg/day (once daily)
120 mg/day
DPNP (2.1)
60 mg/day
60 mg/day (on