מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Preferred Pharmaceuticals Inc.
DULOXETINE HYDROCHLORIDE
DULOXETINE 30 mg
ORAL
PRESCRIPTION DRUG
Duloxetine is indicated for the treatment of: Monoamine Oxidase Inhibitors (MAOIs) -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 also 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 Category C Risk Summary — There are no adequate and well-controlled studies of duloxetine administration in pregnant women. In animal studies with duloxetine, fetal weights were decreased but there was no evidence of teratogenicity in pregnant rats and rabbits at oral do
Duloxetine delayed-release capsules USP are available in the following strengths, colors, imprints, and presentations: Features Strength 30 mga Body color Clear transparent Cap color Opaque white Cap imprint 298 Body imprint Cipla Container Size Presentations and NDC Codes Bottles of 6 68788-6427-0 Bottles of 10 68788-6427-1 Bottles of 20 68788-6427-2 Bottles of 30 68788-6427-3 Bottles of 60 Bottles of 90 68788-6427-6 68788-6427-9 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [seeUSP Controlled Room Temperature].
Abbreviated New Drug Application
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE Preferred Pharmaceuticals Inc. ---------- SPL MEDGUIDE DULOXETINE (doo-LOX-e-teen) delayed-release capsules USP Read this Medication Guide before you start taking duloxetine delayed-release capsule USPand 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 capsule USPand 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? 4. 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. 5. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. ] 6. 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 y קרא את המסמך השלם
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PREFERRED PHARMACEUTICALS INC. ---------- 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, FOR ORAL USE. INITIAL U.S. APPROVAL:2004 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE Duloxetine delayed-release capsules USP is 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 • • • • • DOSAGE FORMS AND STRENGTHS 20 mg, 30 mg, and 60 mg delayed-release capsules (3) CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • • • • • • • • • ADVERSE REACTIONS • 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 USP once daily, with or without food. Swallow duloxetine delayed-release capsules USP 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 USP at the same time. (2) Some patients may benefi קרא את המסמך השלם