Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Zydus Pharmaceuticals (USA) Inc.
DULOXETINE HYDROCHLORIDE
DULOXETINE 20 mg
ORAL
PRESCRIPTION DRUG
Duloxetine delayed-release capsules are indicated for the treatment of: - Major depressive disorder in adults - Generalized anxiety disorder in adults and pediatric patients 7 years of age and older - Diabetic peripheral neuropathic pain in adults - Fibromyalgia in adults - Chronic musculoskeletal pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. The use of MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4)] . Starting duloxetine in a patient who i
Duloxetine Delayed-Release Capsules, USP equivalent to 20 mg of duloxetine are white to off-white free flowing pellets filled in size '4' hard gelatin capsules with green colored cap printed with "241" in golden ink and white body printed with "20 mg" in golden ink and are supplied as follows: NDC 68382-385-06 in bottle of 30 capsules with child-resistant closure NDC 68382-385-14 in bottle of 60 capsules with child-resistant closure NDC 68382-385-16 in bottle of 90 capsules with child-resistant closure Duloxetine Delayed-Release Capsules, USP equivalent to 30 mg of duloxetine are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with blue-colored cap printed with "242" in golden ink and green-colored body printed with "30 mg" in golden ink and are supplied as follows: NDC 68382-386-06 in bottle of 30 capsules with child-resistant closure NDC 68382-386-16 in bottle of 90 capsules with child-resistant closure NDC 68382-386-10 in bottle of 1,000 capsules Duloxetine Delayed-Release Capsules, USP equivalent to 60 mg of duloxetine are white to off-white free flowing pellets filled in size '1' hard gelatin capsules with blue-colored cap printed with "243" in golden ink and white-colored body printed with "60 mg" in golden ink and are supplied as follows: NDC 68382-387-06 in bottle of 30 capsules with child-resistant closure NDC 68382-387-16 in bottle of 90 capsules with child-resistant closure NDC 68382-387-10 in bottle of 1,000 capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
Abbreviated New Drug Application
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE Zydus Pharmaceuticals (USA) Inc. ---------- Medication Guide Duloxetine (doo lox' e teen) Delayed-Release Capsules, USP Read this Medication Guide before you start taking duloxetine delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your 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, other serious mental illnesses, and suicidal thoughts or actions? 1. Duloxetine delayed-release capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or 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). 3. How can I watch for and try to prevent suicidal thoughts and actions? • Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed. • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or Läs hela dokumentet
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE ZYDUS PHARMACEUTICALS (USA) INC. ---------- 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, 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 ANTIDEPRESSANTS (5.1) MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1) RECENT MAJOR CHANGES Dosage and Administration (2.5) 04/2020 Warnings and Precautions (5.5) 10/2019 INDICATIONS AND USAGE Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: (1) Major Depressive Disorder (MDD) in adults (1) Generalized Anxiety Disorder (GAD) in adults and pediatric patients 7 years of age and older (1) Diabetic Peripheral Neuropathic Pain (DPNP) in adults (1) Fibromyalgia (FM) in adults (1) Chronic musculoskeletal pain in adults (1) DOSAGE AND ADMINISTRATION Take duloxetine delayed-release capsules once daily, with or without food. Swallow whole; do not crush, chew, or open capsule (2.1) INDICATION STARTING DOSE TARGET DOSE MAXIMUM DOSE MDD (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 (2.3) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Ge riatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 to 17 years of age ) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.6) 30 mg/day 60 mg/day (once daily) 60 mg/day Discontinuing duloxetine delayed Läs hela dokumentet