Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Carilion Materials Management
VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE 37.5 mg
ORAL
PRESCRIPTION DRUG
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. Venlafaxine hydrochloride extended-release is indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. Venlafaxine hydrochloride extended-release is indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials. Venlafaxine hydrochloride extended-release is indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation The use of MAOIs (intended to treat psychiatric disorders) concomitantly wit
NDC:68151-3659-7 in a CUP of 1 CAPSULE, EXTENDED RELEASES Store at controlled room temperature, 20° to 25°C (68° to 77°F). The unit-of-use package is intended to be dispensed as a unit.
New Drug Application Authorized Generic
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE Carilion Materials Management ---------- MEDICATION GUIDE (venlafaxine hydrochloride) (Extended-Release Capsules) VENLAFAXINE XR Read the Medication Guide that comes with 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. venlafaxine hydrochloride extended- release What is the most important information I should know about venlafaxine hydrochloride extended-release? and other antidepressant medicines may cause serious side effects, including: Venlafaxine hydrochloride extended-release 1. Suicidal thoughts or actions: • in some children, teenagers, or young adults Venlafaxine hydrochloride extended-release and other antidepressant medicines may increase suicidal thoughts or actionswithin 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: Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when is started or when the dose is changed. venlafaxine hydrochloride extended-release 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, Կարդացեք ամբողջական փաստաթուղթը
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE CARILION MATERIALS MANAGEMENT ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE. VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES INITIAL U.S. APPROVAL: 1997 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 VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS ( ) 8.4 INDICATIONS AND USAGE Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: (1) Major Depressive Disorder (MDD) Generalized Anxiety Disorder (GAD) Social Anxiety Disorder (SAD) Panic Disorder (PD) DOSAGE AND ADMINISTRATION INDIC ATIO N STARTING DOSE TARGET DOSE MAXIMUM DOSE MDD ( ) 2.1 37.5 –75 mg/day 75 mg/day 225 mg/day GAD ( ) 2.2 37.5 –75 mg/day 75 mg/day 225 mg/day SAD ( ) 2.3 75 mg/day 75 mg/day 75 mg/day PD ( ) 2.4 37.5 mg/day 75 mg/day 225 mg/day Take once daily with food ( ). Capsules should be taken whole; do not divide, crush, chew, or dissolve ( ). 22 When discontinuing treatment, reduce the dose gradually ( , ). 2.85.7 Renal impairment: reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment ( ). 2.6 Hepatic impairment: reduce the daily dose by 50% in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% ( ). 2.6 DOSAGE FORMS AND STRENGTH Կարդացեք ամբողջական փաստաթուղթը