ADDERALL 20
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADDERALL 20 (ADDERALL 20).
Adderall 20 is a combination of amphetamine and dextroamphetamine, which are central nervous system stimulants. They increase the levels of norepinephrine and dopamine in synaptic clefts by inhibiting their reuptake and promoting their release from presynaptic neurons.
| Metabolism | Primarily hepatic via CYP2D6 and, to a lesser extent, CYP2C19, CYP3A4, and CYP2C9. Metabolites include 4-hydroxyamphetamine, alpha-hydroxyamphetamine, and norephedrine. |
| Excretion | Renal: ~90% unchanged; ~10% as deaminated metabolites; fecal <5%. |
| Half-life | d-Amphetamine: 10-13h; l-Amphetamine: 13-16h. Clinical steady-state reached in 2-3 days. |
| Protein binding | 16% (primarily albumin). |
| Volume of Distribution | 3.2-5.6 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Oral IR: ~90%; ER: ~90%. |
| Onset of Action | IR: 30-60 min; ER: 60-90 min. |
| Duration of Action | IR: 4-6h; ER: 10-12h. |
| Molecular Weight | 238.3 |
Initial: 5 mg orally once or twice daily; may increase by 5 mg increments at weekly intervals. Usual effective dose: 20-40 mg/day divided into 1-2 doses. Maximum: 40 mg/day (immediate-release); 60 mg/day (extended-release).
| Dosage form | TABLET |
| Renal impairment | eGFR 15-29 mL/min: 50% of usual dose. eGFR < 15 mL/min: avoid use due to accumulation risk. Hemodialysis: not recommended. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50%. Child-Pugh Class C: avoid use. |
| Pediatric use | Children 3-5 years: 2.5 mg orally once daily; increase by 2.5 mg weekly. Children 6 years and older: 5 mg once or twice daily; increase by 5 mg weekly. Maximum dose: 40 mg/day (immediate-release). Weight-based: 0.3-1.5 mg/kg/day (immediate-release). |
| Geriatric use | Initial: 2.5 mg once or twice daily; increase slowly by 2.5 mg increments at weekly intervals. Use lowest effective dose due to increased sensitivity and risk of cardiovascular adverse effects. |
| 1st trimester | Associated with increased risk of congenital malformations, particularly cardiovascular defects, if used during the first trimester. Use only if potential benefit justifies risk. |
| 2nd trimester | May cause fetal CNS stimulation, reduced fetal growth, and increased risk of preterm delivery. Use only if clearly needed. |
| 3rd trimester | Potential neonatal withdrawal symptoms (e.g., irritability, poor feeding) and growth restriction. Avoid in late pregnancy unless essential. |
Clinical note
Comprehensive clinical and safety monograph for ADDERALL 20 (ADDERALL 20).
| Placental transfer | Amphetamines cross the placenta via passive diffusion and active transport. Cord blood concentrations approximate maternal levels. Evidence of significant transfer with potential fetal effects. |
| Breastfeeding | Amphetamine salts are excreted into breast milk in small amounts. Peak milk concentration occurs 2-4 hours after maternal dose. Relative infant dose is approximately 2-5% of maternal weight-adjusted dose. Monitor infant for irritability, poor feeding, and insomnia. Generally discouraged unless clear benefit outweighs risk. |
■ FDA Black Box Warning
Abuse and dependence: Amphetamines have a high potential for abuse, which can lead to dependence and serious cardiovascular events. Misuse may cause sudden death or serious cardiovascular adverse events.
| Serious Effects |
Hypersensitivity to amphetamines or other sympathomimetic aminesConcurrent use of MAO inhibitors (or within 14 days)GlaucomaAgitated statesHistory of drug abuseCardiovascular disease (e.g., symptomatic CVD, advanced arteriosclerosis, hypertension with target organ damage)
| Precautions | Cardiovascular: Serious cardiovascular events including sudden death in patients with pre-existing structural cardiac abnormalities., Psychiatric: Exacerbation of pre-existing psychosis, mania, or aggression; new-onset psychosis or mania., Growth suppression: Long-term use in children may suppress growth., Seizures: May lower seizure threshold in patients with seizure disorders., Serotonin syndrome: Risk when used with other serotonergic drugs., Peripheral vasculopathy: Including Raynaud's phenomenon. |
| Food/Dietary | High-fat meals can delay absorption of Adderall. Acidic foods (e.g., citrus fruits, juices) and vitamin C may decrease absorption; avoid within 1 hour of dosing. Caffeine and other stimulants may increase side effects. Alcohol should be avoided. Grapefruit juice may increase amphetamine levels, so limit or avoid. |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | First trimester: Increased risk of premature delivery and low birth weight; possible association with cardiovascular malformations (limited data). Second/third trimester: Risk of fetal growth restriction, preterm birth, neonatal withdrawal syndrome (irritability, poor feeding), and persistent pulmonary hypertension. Chronic use may impair fetal development. |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and weight; fetal growth ultrasound every 4–6 weeks; nonstress test or biophysical profile in third trimester; neonatal monitoring for withdrawal symptoms (e.g., jitteriness, poor feeding) for 48–72 hours after delivery. |
| Fertility Effects | No definitive evidence of direct impairment; however, amphetamines may reduce fertility due to appetite suppression and weight loss (which can affect menstrual regularity). Use may be associated with decreased sperm count in males. |
| Clinical Pearls | Adderall 20 mg is a mixed amphetamine salt formulation (75% dextroamphetamine, 25% levoamphetamine). Monitor for cardiovascular adverse effects; consider baseline ECG in patients with cardiac risk factors. Avoid in patients with structural cardiac abnormalities, cardiomyopathy, or arrhythmias. Use with caution in patients with hypertension, hyperthyroidism, or glaucoma. May exacerbate tics and Tourette syndrome. Administer first dose upon awakening; avoid afternoon doses due to insomnia risk. Monitor growth in children; may cause weight loss and growth suppression. Assess for potential for abuse and dependence; use lowest effective dose. |
| Patient Advice | Take exactly as prescribed; do not crush or chew extended-release capsules. · Take early in the morning to avoid trouble sleeping. · Avoid taking with high-fat meals as it may delay absorption. · Do not drink alcohol while taking this medication. · Report any chest pain, shortness of breath, or fainting immediately. · Avoid driving or operating heavy machinery until you know how Adderall affects you. · Store at room temperature away from moisture and heat. · Keep out of reach of children and pets. · Do not share your medication with others; it is a controlled substance. · Inform your doctor if you have a history of heart disease, high blood pressure, seizures, or mental health conditions. |