देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Duloxetine delayed-release capsules are indicated for the treatment of: - Major Depressive Disorder [see Clinical Studies (14.1)] - Generalized Anxiety Disorder [see Clinical Studies (14.2)] - Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] - Fibromyalgia [see Clinical Studies (14.4)] - Chronic Musculoskeletal Pain [see Clinical Studies (14.5)] 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 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 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 contra
Duloxetine hydrochloride, USP is available as delayed-release capsules in the following strengths: 20 mg – Each capsule with blue opaque cap and body, printed with and 2890 on both cap and body in black ink contains 22.4 mg of duloxetine hydrochloride, USP equivalent to 20 mg of duloxetine. Capsules are supplied in bottles of 60 (NDC 0228-2890-06). 30 mg – Each capsule with gray opaque body and blue opaque cap, printed with and 2891 on both cap and body in black ink contains 33.7 mg of duloxetine hydrochloride, USP equivalent to 30 mg of duloxetine. Capsules are supplied in bottles of 30 (NDC 0228-2891-03) and bottles of 500 (0228-2891-50). 60 mg – Each capsule with gray opaque body and white opaque cap, printed with and 2892 on both cap and body in black ink contains 67.3 mg of duloxetine hydrochloride, USP equivalent to 60 mg of duloxetine. Capsules are supplied in bottles of 30 (NDC 0228-2892-03) and bottles of 1000 (0228-2892-96). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PELLETS REMEDYREPACK INC. ---------- MEDICATION GUIDE Duloxetine (doo lox' e teen) Delayed-Release Capsules Rx Only 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 पूरा दस्तावेज़ पढ़ें
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PELLETS REMEDYREPACK 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: SUICIDALTHOUGHTS AND BEHAVIORS 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) INDICATIONS AND USAGE Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1) Generalized Anxiety Disorder (GAD) ( 1) Diabetic Peripheral Neuropathic Pain (DPNP) ( 1) Fibromyalgia (FM) ( 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) INDIC ATIO N STARTING DO SE TARGET DO SE MAXIMUM DO SE 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 FM ( 2.4) 30 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 Some patients may benefit from starting at 30 mg once daily ( 2) There is no evidence that doses greater than 60 mg/day confers additional benefit, while some adverse reactions were observed to be dose-dependent ( 2) Discontinuing duloxetine delayed-release capsules: Gradually reduc पूरा दस्तावेज़ पढ़ें