ADDERALL XR – Extended-Release Treatment for ADHD

ADDERALL XR is an extended-release central nervous system stimulant used to treat attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. It contains mixed amphetamine salts designed to be taken once daily, providing symptom control throughout the day.

ADDERALL XR is approved for the treatment of ADHD in:

• Children aged 6 to 12 years
• Adolescents aged 13 to 17 years
• Adults

It is indicated as part of a comprehensive treatment plan which may include psychological, educational, and social measures. Diagnosis requires symptoms to be present before age 7, causing impairment in at least two settings, and meeting DSM-IV criteria for ADHD.

dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate, amphetamine aspartate

ADDERALL XR contains a mixture of amphetamine salts which act as central nervous system stimulants. They increase the activity of certain neurotransmitters in the brain to improve attention, focus, and impulse control in individuals with ADHD.

Dosage and Administration

ADDERALL XR is taken once daily in the morning, with or without food, to avoid insomnia.

• Children (6-12 years): Start at 10 mg once daily; dose may be adjusted by 5 or 10 mg increments weekly. A lower starting dose of 5 mg may be used if appropriate. Maximum recommended dose is 30 mg/day. Not studied in children under 6 years.
• Adolescents (13-17 years): Start at 10 mg once daily; may increase to 20 mg/day after 1 week if needed.
• Adults: Start and maintain at 20 mg once daily.

The capsule may be swallowed whole or opened and sprinkled on a small amount of applesauce to be consumed immediately without chewing. The dose should not be divided; the entire contents must be taken.

For patients switching from immediate-release Adderall taken multiple times daily, the total daily dose may be given once daily as ADERALL XR with appropriate titration.

Periodic interruption of therapy is recommended to assess the continued need for treatment.

Contraindications

• Advanced arteriosclerosis
• Symptomatic cardiovascular disease
• Moderate to severe hypertension
• Hyperthyroidism
• Known hypersensitivity or idiosyncrasy to sympathomimetic amines
• Glaucoma
• Agitated states
• History of drug abuse
• During or within 14 days following MAOI use

Important Warnings and Precautions

• Abuse potential: ADERALL XR has a high potential for abuse and dependence. Use cautiously and prescribe sparingly.
• Serious cardiovascular risks: Sudden death has been reported in patients with structural heart abnormalities or serious heart problems. Not recommended in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, or known serious heart conditions.
• Blood pressure and heart rate: May cause modest increases; monitor regularly, especially in patients with cardiovascular risk.
• Psychiatric effects: Can cause new or worsening psychotic or manic symptoms; use cautiously in patients with bipolar disorder or pre-existing psychosis. Monitor for aggression or hostility.
• Growth suppression: Chronic use in children may cause slowed height and weight gain; monitor growth periodically.
• Seizures: May lower seizure threshold; discontinue if seizures occur.
• Visual disturbances: Accommodation difficulties and blurred vision have been reported.
• Tics and Tourette's syndrome: May exacerbate motor or vocal tics; evaluate prior to use.
• Monoamine oxidase inhibitors (MAOIs): Contraindicated during or within 14 days after MAOI use due to risk of hypertensive crisis.

Side Effects

Common side effects are not fully listed; however, potential adverse reactions include increased heart rate, elevated blood pressure, insomnia, loss of appetite, and possible psychiatric symptoms such as agitation or aggression. Serious but less common effects include sudden cardiac events and seizures, especially in susceptible individuals.

Drug Interactions

• Monoamine oxidase inhibitors (MAOIs): Use within 14 days is contraindicated due to risk of hypertensive crisis.
• Use caution with other sympathomimetic drugs to minimize the risk of overdosage and additive cardiovascular effects.