দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
DESVENLAFAXINE SUCCINATE (UNII: ZB22ENF0XR) (DESVENLAFAXINE - UNII:NG99554ANW)
Lake Erie Medical DBA Quality Care Products LLC
DESVENLAFAXINE SUCCINATE
DESVENLAFAXINE 50 mg
ORAL
PRESCRIPTION DRUG
Desvenlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies (14) and Dosage and Administration (2.1)] . The efficacy of desvenlafaxine has been established in four short-term (8-week, placebo-controlled studies) and two maintenance studies in adult outpatients who met DSM-IV criteria for major depressive disorder. - Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine formulation. Angioedema has been reported in patients treated with desvenlafaxine[see Adverse Reactions (6.1)] . - The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine is contraindicated because of an increased risk of serotonin syndrome. The use of desvenlafaxine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.6) and
Desvenlafaxine Extended-Release Tablets are available as follows: 50 mg, light pink colored, round, biconvex tablets, debossed with ‘L349’ on one side and plain on other side. 100 mg, dark brown to red colored, round, biconvex tablets, debossed with ‘L350’ on one side and plain on other side. 55700-577-30 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]. Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.
Abbreviated New Drug Application
Lake Erie Medical DBA Quality Care Products LLC ---------- MEDICATION GUIDE Desvenlafaxine Extended-Release Tablets (des VEN la FAX een) Read this Medication Guide before you start taking desvenlafaxine 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. Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions 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 and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and 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) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: সম্পূর্ণ নথি পড়ুন
DESVENLAFAXINE- DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DESVENLAFAXINE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE EXTENDED-RELEASE TABLETS, FOR ORAL USE. INITIAL U.S. APPROVAL: 2008 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). • DESVENLAFAXINE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4). RECENT MAJOR CHANGES Warnings and Precautions – Serotonin Syndrome (5.2) 1/2017 INDICATIONS AND USAGE Desvenlafaxine, is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder (MDD) (1). (1) DOSAGE AND ADMINISTRATION •Recommended dose: 50 mg once daily with or without food (2.1). •There was no evidence that doses greater than 50 mg per day confer any additional benefit (2.1). •The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients (2.1). •Discontinuation: Reduce dose gradually whenever possible (2.1). •Take tablets whole; do not divide, crush, chew, or dissolve (2.1). •Moderate renal impairment: Maximum dose 50 mg per day (2.2). •Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day (2.2). •Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.2). (2) DOSAGE FORMS AND STRENGTHS Desvenlafaxine extended-release tablets are available as 50 mg and 100 mg (3). Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg সম্পূর্ণ নথি পড়ুন