Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Macleods Pharmaceuticals Limited
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 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 are 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
Duloxetine delayed-release capsules USP, 20 mg are opaque green cap / opaque green body, size ‘4’ capsules containing, white to off white coloured pellets with “C84” on cap imprinted with black ink. Bottles of 60 NDC 33342-160-09 Bottles of 90 NDC 33342-160-10 Bottles of 1,000 NDC 33342-160-44 100 (10 x 10 Unit-dose Capsules) NDC 33342-160-12 Duloxetine delayed-release capsules USP, 30 mg are opaque blue cap / opaque white body, size ‘3’ capsules containing, white to off white coloured pellets with “C83” on cap imprinted with white ink. Bottles of 30 NDC 33342-161-07 Bottles of 90 NDC 33342-161-10 Bottles of 1,000 NDC 33342-161-44 100 (10 x 10 Unit-dose Capsules) NDC 33342-161-12 Duloxetine delayed-release capsules USP, 60 mg are opaque blue cap / opaque green body, size ‘1’ capsules containing, white to off white coloured pellets with “C81” on cap imprinted with white ink. Bottles of 30 NDC 33342-162-07 Bottles of 90 NDC 33342-162-10 Bottles of 1,000 NDC 33342-162-44 100 (10 x 10 Unit-dose Capsules) NDC 33342-162-12 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DULOXETINE HYDROCHLORIDE - DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE Macleods Pharmaceuticals Limited ---------- SPL MEDGUIDE SECTION 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 i Preberite celoten dokument
DULOXETINE HYDROCHLORIDE - DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE MACLEODS PHARMACEUTICALS LIMITED ---------- 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, 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 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 daily) 60 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults Pedia Preberite celoten dokument