Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
DESVENLAFAXINE SUCCINATE (UNII: ZB22ENF0XR) (DESVENLAFAXINE - UNII:NG99554ANW)
Mylan Pharmaceuticals Inc.
DESVENLAFAXINE SUCCINATE
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) ] . There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185. There are no published studies on desvenlafaxine extended-release tablets in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see Data) . There are risks associated with untreated depression in pregnancy and with exposure to SNRIs and SSRIs, including desvenlafaxine extended-release tablets, during pregnancy (see Clinical Considerations). In reproductive developmental studies in rats and rabbits treated with desvenlafaxine succinate, there was no evidence of
Desvenlafaxine Extended-Release Tablets are available containing 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. The 50 mg tablets are pink, film-coated, round, unscored tablets debossed with M on one side of the tablet and DF over 50 on the other side. They are available as follows: NDC 0378-4230-93 bottles of 30 tablets NDC 0378-4230-77 bottles of 90 tablets The 100 mg tablets are dark pink, film-coated, round, unscored tablets debossed with M on one side of the tablet and DF over 100 on the other side. They are available as follows: NDC 0378-4231-93 bottles of 30 tablets NDC 0378-4231-77 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Desvenlafaxine Extended-Release Tablets (des ven′′ la fax′ een) 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? o 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. o Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o 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: o thoughts about suicide or dying o attempts to commit suicide o new or worse depression o new or worse anxiety o feeling very agitated or restless o panic attacks o trouble sleeping (insomnia) o new or worse irritability o acting aggressive, being angry, or violent o acting on dangerous impulses o an extreme increase in activity and talking (mania) o other unusual changes in behavior or mood What are 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 inhi Διαβάστε το πλήρες έγγραφο
DESVENLAFAXINE- DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE MYLAN PHARMACEUTICALS INC. ---------- 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._ • • • RECENT MAJOR CHANGES Dosage and Administration (2.5) 2/2018 Warnings and Precautions (5.2, 5.4, 5.5, 5.7) 2/2018 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 • • • • • • • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • INCREASED THE 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). 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 (2.3). Desvenlafaxine Διαβάστε το πλήρες έγγραφο