Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Major Pharmaceuticals
DULOXETINE HYDROCHLORIDE
DULOXETINE 20 mg
ORAL
PRESCRIPTION DRUG
Duloxetine delayed-release capsules are indicated for the treatment of: The use of MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine delayed-release capsules 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 delayed-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9) and Warnings and Precautions (5.4)] . Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Dat
Duloxetine Delayed-release Capsules, USP are supplied as: 20 mg capsules: Hard gelatin capsule with a green opaque body and green opaque cap. Imprinted “APO D20” in black ink. Filled with white to off-white granules. Carton of 30 Capsules (10 capsules per blister pack x 3), NDC 0904-6452-04 Cartons of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-6452-61 30 mg capsules : Hard gelatin capsule with a white opaque body and blue opaque cap. Imprinted “APO D30” in green ink. Filled with white to off-white granules. Cartons of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-6453-61 60 mg capsules : Hard gelatin capsules with a green opaque body and blue opaque cap. Imprinted “APO D60” in white ink. Filled with white to off-white granules. Cartons of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-6454-61 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DULOXETINE HYDROCHLORIDE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE Major Pharmaceuticals ---------- MEDICATION GUIDE Duloxetine Delayed-release Capsules, USP (doo-LOX-e-teen) 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: 1. all risks and benefits of treatment with antidepressant medicines 2. 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? 1. 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. 2. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. 1. 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, Прочитать полный документ
DULOXETINE HYDROCHLORIDE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE MAJOR PHARMACEUTICALS ---------- 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_. • • RECENT MAJOR CHANGES Dosage and Administration (2.5) 04/2020 INDICATIONS AND USAGE Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 6. 7. 8. 9. 10. DOSAGE AND ADMINISTRATION • 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 Geriatric Pediatrics (7 to 17 years of age) 60 mg/day 30 mg/day 30 mg/day 60 mg/day (once daily) 60 mg/day (once daily) 30 to 60 mg/day (once daily) 120 mg/day 120 mg/day 120 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once 60 mg/day 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) 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) Take duloxetine once daily, with or without food. Swallow duloxetine whole; do not crush or open capsule (2.1). DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults and Pediatrics (7 to 17 years of age) Elderly Children and Adolescents (7 to 17 years of age) 330 mg Прочитать полный документ