Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Trigen Laboratories, LLC
DULOXETINE HYDROCHLORIDE
DULOXETINE 20 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE TRIGEN LABORATORIES, LLC ---------- 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 USP 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 ANTIDEPRASSANTS (5.1) MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1) RECENT MAJOR CHANGES Boxed Warning: Suicidal Thoughts and Behaviors 10/2014 Indications and Usage (1) 10/2014 Dosage and Administration: Dosage for Treatment of Generalized Anxiety Disorder (2.2) 10/2014 Contraindications Uncontrolled Narrow-Angle Glaucoma (4.2) Removed 07/2014 Warnings and Precautions: Orthostatic Hypotension, Falls and Syncope (5.3) 11/2014 Angle-Closure Glaucoma (5.9) 07/2014 INDICATIONS AND USAGE Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: (1) Major Depressive Disorder (MDD) (1) Generalized Anxiety Disorder (GAD) (1) Diabetic Peripheral Neuropathic Pain (DPNP) (1) Chronic Musculoskeletal Pain (1) DOSAGE AND ADMINISTRATION . Take duloxetine delayed-release capsules once daily, with or without food. Swallow duloxetine delayed-release capsules whole; do not crush or chew, do not open capsule. Take a missed dose as soon as it is remembered. Do not take two doses of duloxetine delayed-release capsules at the same time. (2) (2) INDICATION STARTING DOSE TARGET DOSE MAXIMUM DOSE MDD (2.1) 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 ( 2.2) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day DPNP (2.3) 60 mg/day 60 mg/da Đọc toàn bộ tài liệu