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ADDERALL-XR (AMPHETAMINE, DEXTROAMPHETAMINE): PATIENT COUNSELING INFORMATION

Information on Medication Guide

Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Adderall-XR (Amphetamines) and should counsel them in its appropriate use. A patient Medication Guide is available for Adderall-XR capsules. Instruct patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. Give patients the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The link to complete text of the Medication Guide is placed at the homepage of this website.

Controlled Substance Status / Potential for Abuse, Misuse, and Dependence

Advise patients that Adderall-XR (Amphetamine, Dextroamphetamine mixed salts) is a federally controlled substance because it can be abused or lead to dependence. Additionally, emphasize that Adderall-XR should be stored in a safe place to prevent misuse and/or abuse. Evaluate patient history (including family history) of abuse or dependence on alcohol, prescription medicines, or illicit drugs.

Serious Cardiovascular Risks

Advise patients of serious cardiovascular risk (including sudden death, stroke, myocardial infarction, and hypertension) with Amphetamines (Adderall-XR). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during treatment should undergo a prompt cardiac evaluation.

Psychiatric Risks

Prior to initiating treatment with Adderall-XR extended release capsules, adequately screen patients with comorbid depressive symptoms to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and/or depression.

Additionally, Adderall-XR (Amphetamines with Dextroamphetamines) therapy at usual doses may cause treatment-emergent psychotic or manic symptoms in patients without prior history of psychotic symptoms or mania.

Growth

Monitor growth in children during treatment with Amphetamine with Dextroamphetamine (Adderall-XR), and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

Pregnancy

Advise patients to notify their physicians if they become pregnant or intend to become pregnant during treatment with Amphetamines and Dextroamphetamines (Adderall-XR).

Nursing

Advise patients not to breast feed if they are taking mixed salts of Amphetamine and Dextroamphetamine (Adderall-XR).

Impairment in Ability to Operate Machinery or Vehicles

Adderall-XR (Amphetamine, Dextroamphetamine) may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.

Manufactured and distributed by Shire, Duramed Pharmaceuticals and their divisions.

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