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Revised: 11/2013 Reference ID: 3416347 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: POTENTIAL FOR ABUSE and SERIOUS CARDIOVASCULAR ADVERSE REACTIONS 1 INDICATIONS AND USAGE Attention Deficit Hyperactivity Disorder 2 DOSAGE AND ADMINISTRATION 8 USE IN SPECIFIC POPULATIONS Labor and Delivery Dosing Considerations for all Patients 3 DOSAGE FORMS AND STRENGTHS 9 DRUG ABUSE AND DEPENDENCE 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS Controlled Substance Abuse and Dependence Serious Cardiovascular Events Psychiatric Adverse Events Mechanism of Action Long-Term Suppression of Growth Pharmacokinetics 12 CLINICAL PHARMACOLOGY Peripheral Vasculopathy, including Raynaud’s Visual Disturbance 14 CLINICAL STUDIES Prescribing and Dispensing 16 HOW SUPPLIED/STORAGE AND HANDLING 13 NONCLINICAL TOXICOLOGY 6 ADVERSE REACTIONS Carcinogenesis, Mutagenesis, Impairment of Animal Toxicology and/or Pharmacology 17 PATIENT COUNSELING INFORMATION Clinical Studies Experience Information on Medication Guide Adverse Reactions Associated with the Use of Amphetamine, ADDERALL XR, or ADDERALL Controlled Substance Status/Potential for Abuse, Misuse, and Dependence 7 DRUG INTERACTIONS Serious Cardiovascular Risks Agents that Increase Blood Levels of Amphetamines Psychiatric Risks Agents that Lower adderall Blood Levels of Amphetamines Agents whose Effects May be Reduced by Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s Agents whose Effects May be Potentiated by Agents that May Reduce the Effects of Amphetamines Agents that May Potentiate the Effects of Impairment in Ability to Operate Machinery or Proton Pump Inhibitors (PPI) Drug/Laboratory Test Interactions *Sections or subsections omitted from the full prescribing information are not listed Reference ID: 3416347 FULL PRESCRIBING INFORMATION WARNING: POTENTIAL FOR ABUSE Amphetamines have a high potential for abuse .
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