Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Proficient Rx LP
DULOXETINE HYDROCHLORIDE
DULOXETINE 60 mg
ORAL
PRESCRIPTION DRUG
Duloxetine delayed-release capsules are indicated for the treatment of: Monoamine Oxidase Inhibitors (MAOIs) — 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 also 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)] . Teratogenic Effects Pregnancy Category C Risk Summary — There are no adequate and well-controlled studies of duloxetine delayed-release capsules administr
Duloxetine Delayed-Release Capsules USP, 60 mg are blue opaque/green opaque, size ‘1’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘03’ on green opaque body with black ink. Bottles of 30 NDC 63187-666-30 Bottles of 60 NDC 63187-666-60 Bottles of 90 NDC 63187-666-90 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- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE Proficient Rx LP ---------- 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: • 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 worr Prečítajte si celý dokument
DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DULOXETINE DELAYED-RELEASE CAPSULES USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DULOXETINE DELAYED-RELEASE CAPSULES USP. DULOXETINE DELAYED-RELEASE CAPSULES USP FOR ORAL USE. INITIAL U.S. APPROVAL: 2004 _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • 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 USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • • • • DOSAGE AND ADMINISTRATION • 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/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.5) 30 mg/day 60 mg/day (once daily) 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) (1) Generalized Anxiety Disorder (GAD) (1) Diabetic Peripheral Neuropathic Pain (DPNP) (1) Chronic Musculoskeletal Pain (1) 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 Prečítajte si celý dokument