Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Medsource Pharmaceuticals
DULOXETINE HYDROCHLORIDE
DULOXETINE 30 mg
ORAL
PRESCRIPTION DRUG
Duloxetine delayed-release capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine was established in four short term and one maintenance trial in adults [see CLINICAL STUDIES (14.1) ]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. Duloxetine delayed-release capsules are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine was established in three short-term trials and one maintenance trial in adults [see ]. Duloxetine
Duloxetine delayed-release capsules USP, 20 mg are white to off-white spherical enteric coated pellets filled in size '4' hard gelatin capsules with opaque green colored cap and opaque green colored body, imprinted 'RDY608' on cap and '20mg' on body with black ink. They are supplied in bottles of 60's, 1000's and unit dose package of 30 (3 × 10). Bottles of 60 NDC 55111-608-60 Bottles of 1000 NDC 55111-608-10 Unit-dose Package of 30 (3 × 10) NDC 55111-608-81 Duloxetine delayed-release capsules USP, 30 mg are white to off-white spherical enteric coated pellets filled in size '3' hard gelatin capsules with opaque blue coloured cap and opaque white colored body, imprinted 'RDY609' on cap and '30mg' on body with golden yellow ink. They are supplied in bottles of 30's, 90's, 1000's and unit dose package of 30 (3 x 10). Bottles of 30 NDC 55111-609-30 Bottles of 90 NDC 55111-609-90 Bottles of 1000 NDC 55111-609-10 Unit-dose Package of 30 (3 × 10) NDC 55111-609-81 Duloxetine delayed-release capsules USP, 60 mg are white to off-white spherical enteric coated pellets filled in size '1' hard gelatin capsules with opaque blue colored cap and opaque green colored body, imprinted 'RDY610' on cap and '60mg' on body with white ink. They are supplied in bottles of 30's, 90's, 1000's and unit dose package of 30 (3 × 10). Bottles of 30 NDC 55111-610-30 Bottles of 90 NDC 55111-610-90 Bottles of 1000 NDC 55111-610-10 Unit-dose Package of 30 (3 × 10) NDC 55111-610-81 Store at 20°-25°C (68° - 77°F); [See USP Controlled Room Temperature].
Abbreviated New Drug Application
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PELLETS Medsource Pharmaceuticals ---------- MEDICATION GUIDE DULOXETINE [doh-LOCKS-ah-teen] (Duloxetine Delayed-Release Capsules USP) Read the Medication Guide that comes with duloxetine before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about duloxetine delayed-release capsules? Duloxetine and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Duloxetine 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. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when duloxetine is started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual changes in behavior Pročitajte cijeli dokument
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PELLETS MEDSOURCE PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DULOXETINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DULOXETINE . 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 ANTIDEPRESSANTS ( 5.1) • MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS ( 5.1) • DULOXETINE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS ( 8.4) RECENT MAJOR CHANGES Contraindications: Removed: Uncontrolled Narrow-Angle Glaucoma (4.2) 00/0000 Warnings and Precautions: Angle-Closure Glaucoma (5.9) 00/0000 INDICATIONS AND USAGE Duloxetine delayed-release capsules are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • Major Depressive Disorder (MDD) (1.1) • Generalized Anxiety Disorder (GAD) (1.2) • Diabetic Peripheral Neuropathic Pain (DPNP) (1.3) • Chronic Musculoskeletal Pain (1.5) DOSAGE AND ADMINISTRATION Duloxetine delayed-release capsules should generally be administered once daily without regard to meals. Duloxetine delayed-release capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids (2). INDIC ATIO N STARTING DO SE TARGET DOSE MAXIMUM DO SE MDD ( 2.1, 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 ( 2.1) 60 mg/day 60 mg/day (once daily) 120 mg/day DPNP (2.1) 60 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoske le tal Pain (2.1) 30 mg/day 60 mg/day (once daily) 60 mg/day Some patients may benefit from starting at 30 mg once daily (2.1). There is no ev Pročitajte cijeli dokument