Pharmacy & Therapeutics - June 2008 - (Page 316)

IMPORTANT SAFETY INFORMATION • Vyvanse should not be taken by patients who have: • advanced arteriosclerosis • symptomatic cardiovascular disease • moderate to severe hypertension • hyperthyroidism • known hypersensitivity or idiosyncrasy to sympathomimetic amines • agitated states • glaucoma • a history of drug abuse • or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs) • Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam, to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate. • New psychosis, mania, aggression, growth suppression, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of psychosis, seizures or EEG abnormalities, bipolar disorder, or depression. Growth monitoring is advised during prolonged treatment. • Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic uses or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. • The most common adverse events reported in clinical studies of Vyvanse were: pediatric—decreased appetite, insomnia, abdominal pain, and irritability; adult— decreased appetite, insomnia, and dry mouth. MEDICATION GUIDE A medication guide for Vyvanse should be dispensed to all Vyvanse patients. Medication guides for Vyvanse can be downloaded from www.vyvanse.com, or ordered as a tear pad of 50 by calling Shire at 1-866-463-0708. Please see Brief Summary of Full Prescribing Information, including Boxed Warning, at the end of this ad. http://www.vyvanse.com

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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