Country: United States
Language: English
Source: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Lake Erie Medical DBA Quality Care Products LLC
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 capsules are 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 with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicat
Venlafaxine hydrochloride extended-release capsules USP are available as follows: 37.5 mg - light-gray opaque cap/buff opaque body with “93” and “7384” on both body and cap. 55700-083-30 55700-083-60 75 mg - buff opaque cap/buff opaque body with “93” and “7385” on both body and cap. 55700-102-30 55700-102-60 150 mg - light-orange opaque cap/light-orange opaque body with “93” and “7386” on both body and cap. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE Lake Erie Medical DBA Quality Care Products LLC ---------- MEDICATION GUIDE Venlafaxine (VEN la fax een) Hydrochloride Extended-release Capsules USP Read the Medication Guide that comes with venlafaxine hydrochloride extended-release capsules before you start taking them 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: 1. 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 capsules are 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 depress Read the complete document
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, 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 VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • INDICATIONS AND USAGE Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: (1) • • DOSAGE AND ADMINISTRATION INDIC ATIO N STARTING DOSE TARGET DOSE MAXIMUM DOSE MDD (2.1) 37.5 to 75 mg/day 75 mg/day 225 mg/day PD (2.4) 37.5 mg/day 75 mg/day 225 mg/day • • • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • 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 CAPSULES ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8 .4 ) Major Depressive Disorder (MDD) Panic Disorder (PD) 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). Read the complete document