Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW)
Macoven Pharmaceuticals
DESVENLAFAXINE
DESVENLAFAXINE 50 mg
ORAL
PRESCRIPTION DRUG
Desvenlafaxine Extended-Release Tablets are indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)] . - Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the Desvenlafaxine Extended-Release Tablets 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 Extended-Release Tablets or within 7 days of stopping treatment with Desvenlafaxine Extended-Release Tablets is contraindicated because of an increased risk of serotonin syndrome. The use of Desvenlafaxine Extended-Release Tablets 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 (5.2)]. - Starting Desvenlafaxine Extended-Release Tablets in a patient who is being treated with MAOIs such as linezolid or intraveno
Desvenlafaxine Extended-Release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 44183-880-31, bottle of 30 tablets in unit-of-use package NDC 44183-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 44183-890-31, bottle of 30 tablets in unit-of-use package NDC 44183-890-90, bottle of 90 tablets in unit-of-use package 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 50 mg or 100 mg Desvenlafaxine Extended-Release Tablets contains 50 or 100 mg of desvenlafaxine, respectively.
New Drug Application Authorized Generic
Macoven Pharmaceuticals ---------- MEDICATION GUIDE Desvenlafaxine Extended-Release Tablets What is the most important information I should know about Desvenlafaxine Extended-Release Tablets? Desvenlafaxine Extended-Release Tablets can cause serious side effects, including: • Increased risk of suicidal thoughts or actions in some children and young adults within the first few months of treatment. Desvenlafaxine Extended-Release Tablets are not for use in children. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. 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 your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling very agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood What is Desvenlafaxine Extended-Release Tablets? • Desvenlafaxine Extended-Release Tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD). Desvenlafaxine Extended-Release Tablets belong to a class of medicines known as serotonin and norepinephrine reuptake inhibitors Olvassa el a teljes dokumentumot
DESVENLAFAXINE EXTENDED-RELEASE- DESVENLAFAXINE TABLET, EXTENDED RELEASE MACOVEN PHARMACEUTICALS ---------- 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 THOUGHTS AND BEHAVIORS IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS TAKING ANTIDEPRESSANTS (5.1). CLOSELY MONITOR FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1). DESVENLAFAXINE EXTENDED-RELEASE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4). RECENT MAJOR CHANGES Dosage and Administration (2.5) 01/2019 Warnings and Precautions (5.2, 5.4, 5.5, 5.7) 01/2019 INDICATIONS AND USAGE Desvenlafaxine Extended-Release Tablets are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (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). 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 50 mg every other day (2.2). Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.3). DOSAGE FORMS AND STRENGTHS Extended-release tablets: 50 mg and 100 mg (3) CONTRAINDICATIONS Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the Desvenlafaxine Extended-Release Tablets formulation (4). _Serotonin syndrome and MAOIs_: Do not use MAOIs intended to treat psychiatric disorder Olvassa el a teljes dokumentumot