Amphetamine and dextroamphetamine

Immediate-release Adderall is labeled for ADHD and narcolepsy. Its ADHD dosing begins at age 3; use below age 3 is not recommended. Adderall XR is labeled for ADHD in adults and children age 6 years and older; use below age 6 is not recommended because of higher exposure and adverse reactions.

Narcolepsy is not an Adderall XR-labeled indication. These profiles concern the named mixed-salt products, not every amphetamine preparation. Treatment requires a confirmed diagnosis and an individualized care plan.

Both reviewed U.S. products are prescription-only Schedule II medicines. The representative Teva IR label carries marketing application ANDA040422; the Takeda XR label carries NDA021303. Approval does not remove the risks of misuse, addiction, or serious adverse reactions.

The IR label does not provide a separate adult ADHD starting-dose schedule. Individualize adult dosing with the prescriber; do not import XR directions or treat the narcolepsy range as an ADHD allowance. Avoid late-evening IR doses.

The usual labeled range is 5–60 mg/day in divided doses. For age 12 years and older, the label specifies a 10 mg daily start with 10 mg/day weekly increases as needed. Its pediatric wording also suggests 5 mg daily for ages 6–12 with 5 mg/day weekly increments; the age-12 overlap should be resolved with the treating specialist rather than selecting a dose from this summary. Subsequent doses, if prescribed, are 4–6 hours apart; reduce for troublesome insomnia or anorexia.

Use the lowest effective dose and titrate weekly. When switching from divided-dose Adderall IR, the XR label permits the same total daily dose once each morning; conversion requires prescriber review of renal function and the age-specific limits.

Swallow the capsule whole, or open it and sprinkle all beads on applesauce. Consume immediately without chewing and do not store the mixture. Do not divide a capsule’s contents. Take on awakening, with or without food; avoid afternoon doses.

For XR with severe renal impairment (GFR 15 to <30 mL/min/1.73 m²): adults 15 mg each morning; ages 6–17 start at 5 mg each morning, with a maximum of 20 mg/day for ages 6–12. XR is not recommended with GFR <15.

These XR instructions are not an IR renal schedule. The IR label supplies no defined renal or hepatic reduction regimen. Either impairment may prolong amphetamine exposure; hepatic dosing is not quantified in the reviewed labels. Individualize therapy with the prescriber.

• Hypersensitivity to amphetamine or formulation components.
• Concurrent MAOI use, or use within 14 days after stopping an MAOI, including linezolid or IV methylene blue; risk of hypertensive crisis.

Both products have high potential for abuse and misuse, which can cause a substance use disorder, including addiction. Misuse can cause overdose and death, especially with higher doses or unapproved administration. Assess risk before treatment; counsel about locked storage and disposal; reassess risk and monitor for misuse throughout treatment. Physical dependence and withdrawal can also occur; plan changes with the prescriber.

Common reactions vary by age and include reduced appetite, insomnia, abdominal discomfort, weight loss, dry mouth, headache, anxiety, and tachycardia. Serious hypersensitivity, severe psychiatric symptoms, and cardiovascular or neurologic emergencies require assessment.

Suspected overdose needs immediate medical help; XR effects may be prolonged. Contact U.S. Poison Control at 1-800-222-1222. Call 911 for collapse, seizure, trouble breathing, or inability to awaken.

• MAOIs: contraindicated concurrently and for 14 days after discontinuation.
• Serotonergic drugs or CYP2D6 inhibitors: increased serotonin-syndrome risk and possible higher exposure. Consider alternatives; if necessary, initiate at a lower dose and monitor closely during initiation and titration.
• Gastrointestinal or urinary alkalinizing agents: increase exposure. XR labeling advises avoiding both; IR labeling explicitly advises avoiding gastrointestinal alkalinizing agents.
• Acidifying agents, including those used with methenamine: may reduce exposure and efficacy. Adjust only under prescriber supervision based on response.
• Tricyclic antidepressants can potentiate cardiovascular effects; monitor frequently and adjust or use an alternative.
• PPIs may shorten time to peak effect; monitor for a change in clinical response.
• IR label also describes reduced antihypertensive effects and interactions with antihistamines, antipsychotics, anticonvulsants, lithium, and adrenergic medicines; review the full medication list.

Amphetamines can affect corticosteroid and urinary steroid tests. The current XR label also describes interference with ioflupane I-123 dopamine-transporter imaging; coordinate an adequate washout with the imaging and prescribing teams rather than stopping independently.

Review maternal benefit and fetal risk with the obstetric and prescribing clinicians. XR labeling states that available epidemiologic data have not identified a major birth-defect or miscarriage risk, while premature delivery and low birth weight have been reported. This does not establish absence of risk. Monitor exposed newborns for withdrawal or feeding difficulties. The IR label uses older pregnancy wording and advises use only when benefit justifies risk.

Both product labels advise against breastfeeding during treatment. Amphetamine reaches milk; long-term infant neurodevelopmental effects remain uncertain and high doses may reduce milk supply. LactMed reports that some experts allow prescribed therapeutic doses with infant monitoring for irritability, insomnia, and feeding difficulty. This requires an individualized clinical decision; breastfeeding is discouraged with active amphetamine misuse.

Do not substitute IR’s age-3 ADHD directions for XR’s age-6 indication. Monitor pediatric height and weight and consider interruption when growth is inadequate. The reviewed labels state that geriatric use has not been studied; reassess cardiovascular risks and suitability rather than extrapolating pediatric regimens.

Reduced elimination may increase exposure. Follow the explicit XR severe-renal and ESRD instructions; no fixed IR renal or hepatic regimen is supplied. Dialysis does not reliably remove d-amphetamine.

Amphetamines are sympathomimetic CNS stimulants. They increase extracellular norepinephrine and dopamine through effects on release and reuptake; the precise therapeutic mechanism in ADHD is not established.

Peak concentration

About 3 hours for IR; about 7 hours for XR. Food can delay XR peak timing.

Adult half-life

XR data: approximately 10 hours for d-amphetamine and 13 hours for l-amphetamine.

Metabolism / elimination

Hepatic metabolism includes CYP2D6; renal excretion depends strongly on urine pH. Alkaline urine reduces elimination; acidic urine increases it.

• Before treatment: confirm the indication; assess cardiac and family history, examination, bipolar or psychosis risk, tics, and misuse risk.
• During treatment and dose changes: assess function and symptom benefit, blood pressure, pulse, appetite, sleep, mood, tics, growth, and digital circulation.
• Reassess misuse, diversion, and addiction risk frequently; review refill patterns, storage, and all interacting medicines.

• Use exactly as prescribed. Never share; keep in a secure, preferably locked location and follow safe disposal instructions.
• Check the bottle for IR versus XR. Do not crush or chew XR beads or divide a capsule.
• If an XR morning dose is missed, skip it and take the next morning’s scheduled dose; do not take it later or double it. For IR missed doses, follow the prescriber’s timing plan.
• Seek urgent care for chest pain, shortness of breath, unexplained fainting, serotonin-syndrome symptoms, or serious allergy; promptly report hallucinations, mania, or finger/toe wounds.
• Discuss pregnancy, breastfeeding, and stopping or reducing prolonged treatment with the prescriber.

Manufacturer and imprint must match the dispensed packaging; a photograph alone cannot establish identity.

Dosage form / strength

Immediate-release oral tablet · 10 mg mixed salts

Label packager

Teva Pharmaceuticals USA, Inc.

Appearance

Blue, round, biconvex; one full and two partial bisects

Imprint

1 | 0 / dp

Example package NDC

57844-110-01 · 100 tablets

Adderall IR tablets

5, 7.5, 10, 12.5, 15, 20, and 30 mg

Adderall XR capsules

5, 10, 15, 20, 25, and 30 mg

Representative XR 20 mg

Orange/orange capsule, ADDERALL XR 20 mg; NDC 54092-387-01, 100 capsules.

Store at 20–25°C (68–77°F) in a tight, light-resistant container; XR permits excursions to 15–30°C (59–86°F). Store securely, preferably locked, away from children and anyone for whom the medicine is not prescribed.