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EFFEXOR XR Safely and Effectively

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EFFEXOR XR Safely and Effectively HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EFFEXOR XR safely and effectively. See full prescribing information for ---------------------------CONTRAINDICATIONS--------------------------­ EFFEXOR XR. Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the Effexor XR formulation (4.1). ® EFFEXOR XR (venlafaxine Extended-Release) Capsules Do not use with an MAOI or within 14 days of stopping an MAOI. Initial U.S. Approval: 1997 Allow 7 days after stopping Effexor XR before starting an MAOI, because of the risk of serotonin syndrome (4.2, 5.2, 7.3). WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. -----------------------WARNINGS AND PRECAUTIONS-------------------- Increased risk of suicidal thinking and behavior in children, Clinical Worsening/Suicide Risk: Monitor for clinical worsening adolescents and young adults taking antidepressants (5.1) and suicide risk (5.1). Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1) Serotonin Syndrome: Risk increases with concomitant use of other serotonergic drugs. Discontinue Effexor XR and initiate supportive Effexor XR is not approved for use in pediatric patients (8.4) treatment if serotonin syndrome occurs (4.2, 5.2, 7.3). --------------------------RECENT MAJOR CHANGES------------------------­ Elevations in Blood Pressure: Control hypertension before Warnings and Precautions, Serotonin Syndrome (5.2) 1/2017 initiating treatment. Monitor blood pressure regularly during treatment (5.3). -------------------------- INDICATIONS AND USAGE------------------------------ Abnormal Bleeding: Effexor XR may increase risk of bleeding Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) events. Caution patients about the risk of bleeding associated with indicated for the treatment of: the concomitant use of Effexor XR and NSAIDs, aspirin, or other Major Depressive Disorder (MDD) drugs that affect coagulation (5.4). Generalized Anxiety Disorder (GAD) Angle Closure Glaucoma: Angle closure glaucoma has occurred in Social Anxiety Disorder (SAD) patients with untreated anatomically narrow angles treated with Panic Disorder (PD) antidepressants. (5.5). Activation of Mania/Hypomania: Use cautiously in patients with ---------------------- DOSAGE AND ADMINISTRATION---------------------­ bipolar disorder. Caution patients about the risk of activation of Starting Dose mania/hypomania (5.6). Indication Target Dose Maximum Dose -------------------------ADVERSE REACTIONS-------------------------------­ MDD (2.1) 37.5 -75 mg/day 75 mg/day 225 mg/day Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal GAD (2.2) 37.5 -75 mg/day 75 mg/day 225 mg/day ejaculation, anorexia, constipation, erectile dysfunction, and libido SAD (2.3) 75 mg/day 75 mg/day 75 mg/day decreased (6.1). PD (2.4) 37.5 mg/day 75 mg/day 225 mg/day To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Take once daily with food (2). Capsules should be taken whole; do not Pharmaceuticals Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 divide, crush, chew, or dissolve (2). or www.fda.gov/medwatch. When discontinuing treatment, reduce the dose gradually (2.8, 5.7). Renal impairment: reduce the total daily dose by 25% to 50% in patients --------------------------DRUG INTERACTIONS----------------------------­ with renal impairment. Reduce the total daily dose by 50% or more in Serotonergic Drugs (e.g., MAOIs, triptans, SSRIs, other SNRIs, patients undergoing dialysis or with severe renal impairment (2.6). linezolid, lithium, tramadol, or St. John’s wort): Potential for Hepatic impairment: reduce the daily dose by 50% in patients with mild to serotonin syndrome. Careful patient observation is advised (4.2, 5.2, moderate hepatic impairment. In patients with severe hepatic impairment 7.3). or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% (2.6). ------------------USE IN SPECIFIC POPULATIONS-----------------------­ Pregnancy: Based on animal data, may cause fetal harm (8.1). ----------------------DOSAGE FORMS AND STRENGTHS--------------------­ Nursing Mothers: Discontinue drug or nursing, taking into Effexor XR capsules are available as 37.5 mg, 75 mg and 150 mg consideration importance of drug to mother (8.3) strengths (3). Each capsule contains venlafaxine hydrochloride equivalent to 37.5 mg, See 17 for PATIENT COUNSELING INFORMATION and 75 mg or 150 mg of venlafaxine (3). Medication Guide. Revised: 1/2017 1 Reference ID: 4036390 FULL PRESCRIBING INFORMATION: CONTENTS* 7 DRUG INTERACTIONS 7.1 Central Nervous System (CNS)-Active Drugs WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 7.2 Monoamine Oxidase Inhibitors 1 INDICATIONS AND USAGE 7.3 Serotonergic Drugs 1.1 Major Depressive Disorder 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and 1.2 Generalized Anxiety Disorder Warfarin) 1.3 Social Anxiety Disorder 7.5 Weight Loss Agents 1.4 Panic Disorder 7.6 Effects of Other Drugs on Effexor XR 2 DOSAGE AND ADMINISTRATION 7.7 Effects of Effexor XR on Other Drugs 2.1 Major Depressive Disorder 7.8 Drug-Laboratory Test Interactions 2.2 Generalized Anxiety Disorder 8 USE IN SPECIFIC POPULATIONS 2.3 Social Anxiety Disorder (Social Phobia) 8.1 Pregnancy 2.4 Panic Disorder 8.2 Labor and Delivery 2.5 Switching Patients from Effexor Tablets 8.3 Nursing Mothers 2.6 Specific Populations 8.4 Pediatric Use 2.7 Maintenance Treatment 8.5 Geriatric Use 2.8 Discontinuing Effexor XR 8.6 Age and Gender 2.9 Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) 8.7 Use in Patient Subgroups Intended to Treat Psychiatric Disorders 9 DRUG ABUSE AND DEPENDENCE 3 DOSAGE FORMS AND STRENGTHS 9.1 Controlled Substance 4 CONTRAINDICATIONS 9.2 Abuse 4.1 Hypersensitivity 9.3 Dependence 4.2 Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs) 10 OVERDOSAGE 5 WARNINGS AND PRECAUTIONS 10.1 Human Experience 5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young 10.2 Management of Overdosage Adults 11 DESCRIPTION 5.2 Serotonin Syndrome 12 CLINICAL PHARMACOLOGY 5.3 Elevations in Blood Pressure 12.1 Mechanism of Action 5.4 Abnormal Bleeding 12.2 Pharmacodynamics 5.5 Angle Closure Glaucoma 12.3 Pharmacokinetics 5.6 Activation of Mania/Hypomania 13 NONCLINICAL TOXICOLOGY 5.7 Discontinuation Syndrome 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.8 Seizures 14 CLINICAL STUDIES 5.9 Hyponatremia 14.1 Major Depressive Disorder 5.10 Weight and Height Changes in Pediatric Patients 14.2 Generalized Anxiety Disorder 5.11 Appetite Changes in Pediatric Patients 14.3 Social Anxiety Disorder (also known as Social Phobia) 5.12 Interstitial Lung Disease and Eosinophilic Pneumonia 14.4 Panic Disorder 6 ADVERSE REACTIONS 14.5 Pediatric Patients 6.1 Clinical Studies Experience 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Vital Sign Changes 17 PATIENT COUNSELING INFORMATION 6.3 Laboratory Changes 6.4 Pediatric Patients *Sections or subsections omitted from the full prescribing information are not 6.5 Adverse Reactions Identified During Postapproval Use listed. 2 Reference ID: 4036390 FULL PRESCRIBING INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) and Patient Counseling Information (17)]. 1 INDICATIONS AND USAGE 1.1 Major Depressive Disorder Effexor XR (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. 1.2 Generalized Anxiety Disorder Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. 1.3 Social Anxiety Disorder Effexor XR 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. 1.4 Panic Disorder Effexor XR is indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. 2 DOSAGE AND ADMINISTRATION Effexor XR should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology (12.3)]. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets (spheroids). 2.1 Major Depressive
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