ADDERALL XR – Extended-Release Capsules for ADHD Treatment

ADDERALL XR is a central nervous system stimulant capsule containing mixed amphetamine salts designed for once-daily extended-release use. It is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults meeting DSM-IV criteria.

The medication helps manage behavioral symptoms of ADHD, improving attention and reducing impulsivity and hyperactivity when used as part of a comprehensive treatment program.

ADDERALL XR is indicated for the treatment of ADHD in the following populations:

• Children (6-12 years): To improve attention and reduce hyperactivity and impulsivity.
• Adolescents (13-17 years): For symptom control of ADHD.
• Adults: To manage ADHD symptoms meeting diagnostic criteria.

The diagnosis of ADHD requires symptoms causing impairment before age 7, present in two or more settings, not better explained by another disorder. ADDERALL XR is to be used as part of a total treatment program including psychological, educational, and social measures where appropriate.

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate, Amphetamine Aspartate

ADDERALL XR contains a combination of amphetamine salts that stimulate the central nervous system. This stimulation helps increase attention and focus and reduces impulsive and hyperactive behavior in individuals with ADHD by affecting neurotransmitter activity in the brain.

Adults:

Start with 20 mg once daily in the morning.

Adolescents (13-17 years):

Start with 10 mg once daily in the morning. Dose may be increased to 20 mg/day after one week if needed.

Children (6-12 years):

Start with 10 mg once daily in the morning. Dose may be adjusted in increments of 5 or 10 mg weekly. Lower starting dose of 5 mg can be considered. Maximum dose is 30 mg/day. Safety and efficacy not established in children under 6 years.

Administration:

• Take once daily in the morning upon awakening; avoid afternoon doses to prevent insomnia.
• Capsules can be swallowed whole or opened and sprinkled on applesauce (consume immediately without chewing the beads).
• May be taken with or without food.
• Dose should not be divided; entire capsule contents must be taken.
• Therapy interruptions may be considered to assess need for continued treatment.
• Patients switching from immediate-release formulations may switch to the same total daily dose once daily, titrating weekly for efficacy and tolerability.

• Advanced arteriosclerosis
• Symptomatic cardiovascular disease
• Moderate to severe hypertension
• Hyperthyroidism
• Known hypersensitivity to sympathomimetic amines (e.g., anaphylaxis, angioedema, serious skin rashes)
• Glaucoma
• Agitated states
• History of drug abuse
• Use during or within 14 days following monoamine oxidase inhibitors (MAOIs)

Potential for Abuse and Dependence

ADDERALL XR is a Schedule II controlled substance with high potential for abuse. Prolonged use may lead to dependence. Prescribe and dispense sparingly and monitor for misuse.

Serious Cardiovascular Events

• Sudden death has occurred in children and adolescents with structural heart abnormalities or serious heart problems.
• Adults with serious cardiac problems may be at increased risk of sudden death, stroke, or myocardial infarction.
• Use with caution in patients with pre-existing hypertension, heart failure, recent myocardial infarction, or arrhythmias.
• Monitor blood pressure and heart rate regularly during treatment.
• Perform cardiac history and physical exam prior to treatment; further cardiac evaluation if indicated.

Psychiatric Effects

• May exacerbate pre-existing psychosis or bipolar disorder.
• Monitor for new onset psychotic or manic symptoms; discontinue if such symptoms occur.
• Monitor for aggressive behavior or hostility, especially in children and adolescents.

Growth Suppression in Children

• Monitor height and weight periodically.
• Prolonged use may temporarily slow growth velocity; consider treatment interruption if growth suppression occurs.

Seizures

• May lower convulsive threshold; caution in patients with a history of seizures or EEG abnormalities.
• Discontinue if seizures occur.

Other

• Possible visual disturbances including blurred vision or accommodation difficulties.
• May worsen tics or Tourette's syndrome; evaluate prior to treatment.

Common side effects:

• Loss of appetite
• Weight loss
• Insomnia
• Dry mouth
• Headache
• Nervousness
• Abdominal pain

Serious side effects:

• Cardiovascular events including sudden death, myocardial infarction, and stroke
• New or worsening psychiatric symptoms such as psychosis, mania, or aggression
• Seizures
• Serious allergic reactions including anaphylaxis and angioedema

Concurrent use with monoamine oxidase inhibitors (MAOIs) is contraindicated due to risk of hypertensive crisis. Avoid use during or within 14 days following MAOI therapy.

Caution with other sympathomimetic drugs due to additive cardiovascular effects.

Manifestations may include restlessness, tremor, rapid breathing, confusion, hallucinations, panic, aggressiveness, muscle pain or weakness, fever, sweating, and seizures. Management is supportive. Use the smallest feasible quantity at one time to minimize overdosage risk.

Store at controlled room temperature. Protect from moisture and light. Do not store sprinkles mixed with applesauce for later use; consume immediately.