Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Ajanta Pharma 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 and pediatric patients 13 years of age and older - Chronic musculoskeletal pain in adults 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 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)]. Pregnancy
Duloxetine delayed-release capsules are available in the following strengths, colors, imprints, and presentations: a equivalent to duloxetine base Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE Ajanta Pharma USA Inc. ---------- MEDICATION GUIDE Duloxetine Delayed-Release Capsules (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: • 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 worry you. I Прочетете целия документ
DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE AJANTA PHARMA 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 Warnings and Precautions (5.4, 5.5) 08/2023 INDICATIONS AND USAGE Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 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 and pediatric patients 13 years of age and older (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, or 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 Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 years 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 and Pediatrics (13 years to 17 years of age) 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain ( Прочетете целия документ