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ADDERALL XR™ is a once daily extended-release, single-entity amphetamine product. ADDERALL XR™
combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of
amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The ADDERALL XR™ capsule contains
two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs
the release of amphetamine from ADDERALL XR™ compared to the conventional ADDERALL® (immediaterelease)
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ADDERALL XR® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).
The efficacy of ADDERALL XR™ in the treatment of ADHD was established on the basis of two controlled
trials in children aged 6 to 12 and one controlled trial in adults who met DSM-IV criteria for ADHD (see
CLINICAL PHARMACOLOGY), along with extrapolation from the known efficacy of ADDERALL®, the
immediate-release formulation of this substance.
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactiveimpulsive
or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms
must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be
present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted
for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor
listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort;
loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following
symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate
running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn;
intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
WHAT ARE POSSIBLE SIDE EFFECTS OF ADDERALL®?
SEE “WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ADDERALL®?” FOR
INFORMATION ON REPORTED HEART AND MENTAL PROBLEMS.
OTHER SERIOUS SIDE EFFECTS INCLUDE:
• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision
COMMON SIDE EFFECTS INCLUDE:
• stomach ache
• trouble sleeping
• decreased appetite
ADDERALL® MAY AFFECT YOUR OR YOUR CHILD’S ABILITY TO DRIVE OR DO OTHER DANGEROUS ACTIVITIES.
TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAVE SIDE EFFECTS THAT ARE BOTHERSOME OR DO NOT GO
THIS IS NOT A COMPLETE LIST OF POSSIBLE SIDE EFFECTS. ASK YOUR DOCTOR OR PHARMACIST FOR MORE
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Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension,
hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may
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