ADDERALL 5
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADDERALL 5 (ADDERALL 5).
Adderall 5 is a combination of dextroamphetamine and amphetamine, which are central nervous system stimulants. They increase the levels of dopamine and norepinephrine in the synaptic cleft by inhibiting their reuptake and promoting their release from presynaptic neurons.
| Metabolism | Amphetamine is metabolized via CYP2D6, with deamination and oxidation as major pathways. |
| Excretion | Renal (90% as unchanged drug and metabolites; ~30% unchanged), minor fecal elimination (<5%). |
| Half-life | Immediate-release: 9–11 hours (mean 10 hours for dextroamphetamine); extended-release: 10–13 hours. Terminal half-life may be prolonged with urinary pH >7. |
| Protein binding | ~16% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | 3.5–4.5 L/kg; indicates extensive tissue distribution (e.g., brain, lungs). |
| Bioavailability | Oral immediate-release: 96–100% (first-pass metabolism minimal); extended-release: approximately 96% relative to immediate-release. |
| Onset of Action | Immediate-release: 30–60 minutes; extended-release: 1–2 hours. |
| Duration of Action | Immediate-release: 4–6 hours; extended-release: up to 12 hours (clinical effect may wane earlier in some patients). |
| Molecular Weight | 368.5 Da (as a mixture of amphetamine and dextroamphetamine salts) |
Initial: 5 mg orally once or twice daily; increase by 5 mg increments at weekly intervals. Maximum: 40 mg/day in divided doses.
| Dosage form | TABLET |
| Renal impairment | GFR 15-29 mL/min: reduce dose by 50%; GFR <15 mL/min: use maximum of 50% of usual dose; not recommended in ESRD. |
| 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: initial 2.5 mg daily, increase by 2.5 mg weekly; max 40 mg/day. Children ≥6 years: initial 5 mg once or twice daily, increase by 5 mg weekly; max 40 mg/day (or 20 mg/day for extended-release). |
| Geriatric use | Initiate at 2.5 mg once or twice daily; increase by 2.5-5 mg weekly; monitor for cardiovascular effects and confusion. |
| 1st trimester | Mixed amphetamine salts are associated with a small increased risk of congenital malformations, particularly cardiac defects, when used in the first trimester. Use only if potential benefit justifies risk to fetus. |
| 2nd trimester | Use with caution; may cause fetal growth restriction, preterm delivery, and neonatal withdrawal. Monitor fetal growth and adjust dose as needed. |
| 3rd trimester | Use in third trimester may lead to neonatal withdrawal symptoms (e.g., agitation, dysphoria, poor feeding). Avoid near term unless clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for ADDERALL 5 (ADDERALL 5).
| Placental transfer | Amphetamines cross the placenta; evidence from studies shows transfer and accumulation in fetal tissues. |
| Breastfeeding | Amphetamine salts are excreted into breast milk in concentrations higher than maternal plasma. Irritability and poor feeding have been reported in infants. Avoid breastfeeding due to potential for adverse effects on infant CNS. |
■ FDA Black Box Warning
Adderall has a high potential for abuse and dependence. Misuse may cause sudden death or serious cardiovascular events.
| Serious Effects |
Hypersensitivity to amphetamines or any componentConcurrent use of MAOIs or within 14 days of MAOI discontinuationGlaucomaHyperthyroidismSevere hypertension or advanced arteriosclerosisSymptomatic cardiovascular diseaseAgitated statesHistory of drug abuse
| Precautions | Serious cardiovascular events including sudden death in patients with pre-existing structural cardiac abnormalities, Blood pressure and heart rate increases, Psychiatric adverse events such as psychosis or mania, Growth suppression in pediatric patients, Seizures, Peripheral vasculopathy including Raynaud's phenomenon, Serotonin syndrome when co-administered with serotonergic drugs |
| Food/Dietary | Avoid acidic foods or vitamin C supplements within 1 hour of dosing as they decrease absorption. Grapefruit may increase drug levels. Caffeine and other stimulants should be limited. Avoid alcohol. High-fat meals may delay onset but not overall absorption. |
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| Lactation Rating | L5 - Contraindicated |
| Teratogenic Risk | Pregnancy Category C (pre-2015) / Not assigned under current FDA labeling. First trimester: Studies suggest a possible small increased risk of congenital malformations, particularly cardiovascular defects and oral clefts, but absolute risk is low. Second and third trimesters: Exposure may increase risk of preterm delivery, low birth weight, and neonatal withdrawal symptoms including irritability, dysphoria, and feeding difficulties. Chronic use may lead to fetal growth restriction. |
| Fetal Monitoring | Maternal: Monitor blood pressure, heart rate, weight gain, and signs of toxicity or abuse. Assess for symptoms of anxiety, insomnia, or cardiovascular complications. Fetal: Serial ultrasound for fetal growth (growth restriction) and anatomy (if first-trimester exposure). Neonatal: Monitor for withdrawal symptoms (irritability, poor feeding, jitteriness) after delivery. |
| Fertility Effects | Amphetamines may impair fertility in both males and females due to effects on hormonal regulation; however, conclusive human data are lacking. In females, altered menstrual cycles and possible ovulation suppression have been reported. In males, erectile dysfunction, reduced libido, and impaired spermatogenesis may occur. Effects are generally reversible upon discontinuation. |
| Clinical Pearls | ADDERALL 5 (amphetamine/dextroamphetamine) is a CNS stimulant. Note that 5 mg is a low starting dose; titrate based on response and tolerability. Avoid use in patients with structural cardiac abnormalities, glaucoma, hyperthyroidism, or history of drug abuse. Monitor for hypertension, tachycardia, and psychiatric symptoms. Can worsen tics or Tourette syndrome. Use with caution with MAOIs (risk of hypertensive crisis). |
| Patient Advice | Take exactly as prescribed; do not increase dose without consulting doctor. · Swallow tablet whole; do not crush or chew. · Avoid taking late in the day to prevent insomnia. · May cause dizziness; avoid driving if affected. · Report chest pain, shortness of breath, or fainting. · May be habit-forming; do not share with others. · Store at room temperature away from moisture and heat. |