Adderall capsules

Product Overview

Generic Name: Mixed salts of a single-entity amphetamine product (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate, amphetamine aspartate) [citation:1]

Brand Name: Adderall XR®

Manufacturer: Takeda Pharmaceuticals America, Inc. [citation:1]

DEA Schedule: CII (Schedule II Controlled Substance) [citation:1][citation:5]

Initial FDA Approval: 2001 [citation:1][citation:8]

Adderall XR is a long-acting, extended-release capsule formulation of mixed amphetamine salts. The ratio of d-amphetamine to l-amphetamine is 3:1, which is the same as immediate-release Adderall tablets [citation:4][citation:7]. The extended-release formulation uses a dual-bead delivery system that provides an immediate release followed by a delayed release of the remaining medication, resulting in a prolonged duration of action of approximately 12 hours [citation:4].

Indications and Usage

Adderall XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in [citation:1][citation:5][citation:8]:

• Adults (18 years and older)
• Pediatric patients 6 years and older

Limitations of Use: The use of Adderall XR is not recommended in pediatric patients younger than 6 years of age due to higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) compared to patients 6 years and older at the same dosage [citation:1][citation:5][citation:8].

Off-Label Uses: Mixed amphetamine salts may also be used off-label for narcolepsy and exogenous obesity (short-term treatment), though these are not FDA-approved indications for Adderall XR specifically [citation:2][citation:3].

Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mechanism of therapeutic action in ADHD is not fully understood, but amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space [citation:4]. This results in increased concentrations of these neurotransmitters in the neuronal synapse, which helps improve attention, focus, and impulse control while reducing hyperactivity [citation:6].

Dosage Forms and Strengths

Dosage and Administration

Recommended Starting Doses [citation:1][citation:5][citation:8]:

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Administration Instructions [citation:2][citation:3][citation:6]:

• Take once daily in the morning upon awakening. Avoid afternoon doses due to risk of insomnia.
• May be taken with or without food, but consistency is recommended.
• Swallow capsules whole. Do not crush or chew the capsules.
• If unable to swallow whole, capsules may be carefully opened and contents sprinkled onto a small amount of applesauce. Consume immediately without chewing. Do not store the mixture for later use.

Pharmacokinetics

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A high-fat meal prolongs Tmax by approximately 2.5 hours for d-amphetamine and 2.7 hours for l-amphetamine but does not affect the extent of absorption [citation:4].

BOXED WARNING: Abuse, Misuse, and Addiction

Contraindications

Adderall XR is contraindicated in patients with [citation:1][citation:5][citation:8]:

• Known hypersensitivity or idiosyncrasy to amphetamine
• During or within 14 days following the administration of monoamine oxidase inhibitors (MAOIs) — may cause hypertensive crisis

Warnings and Precautions

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Adverse Reactions (Side Effects)

Common Adverse Reactions (≥5% and greater than placebo) [citation:1][citation:5][citation:8]:

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Serious Adverse Reactions Requiring Immediate Medical Attention [citation:2][citation:3][citation:6]:

• Chest pain, shortness of breath, fainting (signs of heart problems)
• Hallucinations, paranoia, new behavior problems, aggression (signs of psychosis)
• Numbness, pain, cold feeling, color changes in fingers or toes (circulation problems)
• Seizures
• Prolonged or painful erections (priapism)
• Fast heartbeat, fever, sweating, muscle stiffness (serotonin syndrome)

Drug Interactions

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Use in Specific Populations

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Overdose Information

Symptoms of Overdose [citation:2][citation:3]:

• Severe headache
• Severe mental/mood changes (agitation, psychosis)
• Seizures
• Severe restlessness
• Fast breathing
• Cardiovascular events (hypertension, tachycardia, cardiac arrest)
• Hyperthermia

Emergency Response: If overdose is suspected, call 911 or poison control (1-800-222-1222) immediately. Provide emergency responders with the medication name, dose taken, and time of ingestion [citation:2].

Storage and Disposal

• Storage: Store at room temperature away from moisture, heat, and light [citation:3]. Keep in a secure, locked cabinet out of reach of children and away from individuals who may misuse it [citation:6].
• Disposal: Dispose of unused medication through a drug take-back program at a DEA-authorized collection site. If no take-back program is available, mix with an undesirable substance (e.g., cat litter, coffee grounds) and dispose in a sealed plastic bag in household trash [citation:7].

Patient Counseling Information

• Abuse and addiction risks: Educate patients and families about high potential for abuse, misuse, and addiction [citation:1][citation:5].
• Morning dosing only: Take in the morning; avoid afternoon doses due to insomnia risk [citation:2][citation:6].
• Consistent administration: Take with or without food consistently [citation:2].
• Do not crush or chew capsules: Swallow whole or sprinkle on applesauce [citation:2][citation:6].
• Avoid alcohol: Alcohol may contribute to adverse effects and impair judgment [citation:2].
• Do not drive until effects known: May impair judgment or reaction skills [citation:6].
• Report symptoms promptly: Chest pain, shortness of breath, fainting, hallucinations, new numbness/color changes in fingers/toes [citation:3][citation:6].

Educational Summary

Adderall XR is a Schedule II CNS stimulant containing mixed amphetamine salts, indicated for ADHD treatment in adults and children ≥6 years. It is available in six strengths (5 mg-30 mg) as extended-release capsules. The medication carries a BOXED WARNING for high potential for abuse, misuse, and addiction. Common side effects include loss of appetite, insomnia, dry mouth, headache, and weight loss. Contraindications include MAOI use within 14 days and hypersensitivity to amphetamines. Pregnancy and lactation require careful consideration. Only prescribe after assessing cardiovascular and psychiatric risks. Adderall XR should be taken once daily in the morning and stored securely.

Note: This information is for educational and pharmacy reference purposes only. Adderall XR is a Schedule II controlled substance available by prescription only. This content does not constitute medical advice. Always consult full prescribing information and treat patients according to individual clinical circumstances.