Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Medsource Pharmaceuticals
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
Venlafaxine hydrochloride extended-release capsules are available as follows: 37.5 mg, grey cap/peach body with " W " and "Effexor XR" on the cap and "37.5" on the body. NDC 60505-3778-3, bottle of 30 capsules in unit-of-use package. NDC 60505-3778-9, bottle of 90 capsules in unit-of-use package. 75 mg, peach cap and body with " W " and "Effexor XR" on the cap and "75" on the body. NDC 60505-3779-3, bottle of 30 capsules in unit-of-use package. NDC 60505-3779-9, bottle of 90 capsules in unit-of-use package. 150 mg, dark orange cap and body with " W " and "Effexor XR" on the cap and "150" on the body. NDC 60505-3780-3, bottle of 30 capsules in unit-of-use package. NDC 60505-3780-9, bottle of 90 capsules in unit-of-use package. 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 Medsource Pharmaceuticals ---------- MEDICATION GUIDE VENLAFAXINE XR (venlafaxine hydrochloride) (Extended-Release Capsules) Read the Medication Guide that comes with venlafaxine hydrochloride extended-release capsules 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 venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may cause serious side effects, including: • Suicidal thoughts or actions: • Venlafaxine hydrochloride extended-release capsules 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 venlafaxine hydrochloride extended- release capsulesis 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 anxie Lue koko asiakirja
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE MEDSOURCE PHARMACEUTICALS ---------- 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 ( 2). Capsules should be taken whole; do not divide, crush, chew, or dissolve ( 2). When discontinuing treatment, reduce the dose gradually ( 2.8, 5.7). 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 STRENGTHS Venlafaxine h Lue koko asiakirja