Country: United States
Language: English
Source: NLM (National Library of Medicine)
Duloxetine hydrochloride (UNII: 9044SC542W) (Duloxetine - UNII:O5TNM5N07U)
Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC
Duloxetine hydrochloride
Duloxetine 30 mg
ORAL
PRESCRIPTION DRUG
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
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].
New Drug Application
CYMBALTA- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC ---------- 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, Read the complete document
CYMBALTA- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE LAKE ERIE MEDICAL SURGICAL & SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- 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: Chronic Musculoskeletal Pain (1.5) 11/2010 Dosage and Administration: Chronic Musculoskeletal Pain (2.1, 2.2) 11/2010 Dosing in Special Populations, Pregnancy (2.3) 11/2010 Warnings and Precautions: Hepatotoxicity (5.2) 04/2011 Activation of Mania/Hypomania (5.7) 04/2011 Seizures (5.8) 04/2011 Effect on Blood Pressure (5.9) 04/2011 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 6 Read the complete document