ADDERALL 10
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADDERALL 10 (ADDERALL 10).
Adderall 10 contains a mixture of amphetamine salts (dextroamphetamine and levoamphetamine). Amphetamines are non-catecholamine sympathomimetic amines that promote the release of dopamine and norepinephrine from presynaptic neurons, inhibit their reuptake, and inhibit monoamine oxidase activity, thereby increasing extracellular levels of these neurotransmitters in the central nervous system.
| Metabolism | Amphetamine is metabolized primarily in the liver via cytochrome P450 enzymes, including CYP2D6, and undergoes deamination and oxidation to form inactive metabolites including 4-hydroxyamphetamine and norephedrine. |
| Excretion | Renal: 70-80% (30-40% as unchanged amphetamine; remainder as deaminated and hydroxylated metabolites). Fecal: minimal (<5%). Biliary: negligible. Urinary pH affects excretion: acidic urine increases elimination, alkaline urine decreases. |
| Half-life | Terminal elimination half-life: dextroamphetamine 9-11 hours, levoamphetamine 11-14 hours (Adderall is a mixed salt). In adults, mean half-life ~10 hours; in children, slightly shorter (6-8 hours). Clinical context: steady-state reached in 2-3 days; dosing interval typically 4-6 hours for immediate-release. |
| Protein binding | Amphetamine: 15-40% bound to plasma proteins (primarily albumin). Binding is not extensive, thus significant free fraction available for distribution. |
| Volume of Distribution | Apparent Vd: 3.0-4.0 L/kg (for total amphetamine). High Vd indicates extensive tissue distribution, including brain. Clinical meaning: loading dose may be needed for rapid effect; distribution half-life ~1 hour. |
| Bioavailability | Oral immediate-release: 100% (well-absorbed; first-pass metabolism minimal). Food delays absorption but does not affect extent. Extended-release: bioavailability similar to immediate-release with modified release profile. |
| Onset of Action | Oral immediate-release: 30-60 minutes (peak plasma concentration at 3 hours). Readily absorbed after oral administration. |
| Duration of Action | Immediate-release: 4-6 hours (clinical effect persists 3-6 hours; duration correlates with dose and individual metabolism). Extended-release (Adderall XR): 10-12 hours. Note: tolerance may reduce apparent duration with chronic use. |
10 mg orally once daily in the morning, with or without food; may increase by 5-10 mg weekly based on tolerability and response; usual effective dose 10-40 mg/day divided into 2-3 doses; maximum 60 mg/day.
| Dosage form | TABLET |
| Renal impairment | eGFR 15-29 mL/min: reduce dose by 50% and monitor for toxicity; eGFR <15 mL/min or dialysis: avoid use due to risk of accumulation; consider alternative therapy. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use due to decreased clearance and increased risk of toxicity. |
| Pediatric use | Children 3-5 years: 2.5 mg orally once daily; may increase by 2.5 mg weekly; usual range 2.5-20 mg/day divided 1-2 times. Children 6 years and older: initial 5 mg once daily; may increase by 5 mg weekly; usual range 5-40 mg/day divided 1-3 times; maximum 40 mg/day. |
| Geriatric use | Initiate at 2.5-5 mg orally once daily; titrate slowly in increments of 2.5-5 mg weekly; monitor for cardiovascular effects, insomnia, and weight loss; maximum 40 mg/day. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ADDERALL 10 (ADDERALL 10).
| Breastfeeding | Excreted into breast milk; relative infant dose estimated at 2-4% of maternal weight-adjusted dose. M/P ratio not well established. Manufacturer recommends caution; potential for infant agitation, insomnia, and growth suppression. |
| Teratogenic Risk | Pregnancy Category C. First trimester: potential increased risk of congenital malformations (e.g., gastroschisis, oral clefts) based on limited human data. Second and third trimesters: risk of fetal growth restriction, preterm delivery, and neonatal withdrawal symptoms (irritability, poor feeding). |
■ FDA Black Box Warning
Potential for abuse and dependence. Amphetamines have a high potential for abuse, which may lead to dependence and serious cardiovascular adverse events. Misuse may cause sudden death and serious cardiovascular events.
| Serious Effects |
["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 the administration of monoamine oxidase inhibitors (hypertensive crises may occur)"]
| Precautions | ["Serious cardiovascular events including sudden death in patients with pre-existing structural cardiac abnormalities or other serious heart problems.","Blood pressure and heart rate increase; caution in hypertension and other cardiovascular conditions.","Psychiatric adverse events including exacerbation of psychosis, mania, and aggression.","Long-term suppression of growth in pediatric patients.","Peripheral vasculopathy including Raynaud's phenomenon.","Seizures: may lower seizure threshold.","Serotonin syndrome risk when co-administered with serotonergic drugs."] |
| Food/Dietary |
Loading safety data…
| Fetal Monitoring |
| Monitor maternal blood pressure, heart rate, weight gain, and signs of preeclampsia. Fetal monitoring includes serial ultrasound for growth (fundal height, estimated fetal weight) and nonstress test or biophysical profile in third trimester if concerns arise. |
| Fertility Effects | No well-controlled studies; potential for reversible changes in sperm parameters (e.g., decreased counts/motility) based on animal data. In females, limited data suggest possible ovulatory dysfunction (e.g., menstrual irregularities) that resolves with discontinuation. |
| High-fat meals can delay absorption; avoid acidic foods (e.g., citrus, cola) within 1 hour of dosing as they decrease absorption. Avoid caffeine; may increase stimulant effects. |
| Clinical Pearls | Adderall 10 mg contains immediate-release amphetamine salts. Onset of action is 30-60 minutes, duration 4-6 hours. Monitor for appetite suppression, insomnia, and cardiovascular effects. Avoid in patients with structural cardiac abnormalities or history of substance abuse. Use with caution in hypertension or hyperthyroidism. Drug holidays may reduce tolerance. |
| Patient Advice | Take exactly as prescribed; do not crush or chew tablets. · Take early in the day to prevent insomnia. · May cause weight loss; monitor growth in children. · Avoid alcohol and decongestants (risk of hypertensive crisis). · Report chest pain, palpitations, or shortness of breath immediately. · Do not drive if you feel dizzy or impaired. |