ADDERALL 30
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADDERALL 30 (ADDERALL 30).
Adderall contains mixed amphetamine salts that increase synaptic levels of dopamine and norepinephrine by inhibiting their reuptake and promoting release from presynaptic terminals.
| Metabolism | Primarily hepatic via CYP2D6, with minor contributions from CYP1A2, CYP2B6, and CYP3A4. |
| Excretion | Approximately 30-40% of a dose is excreted unchanged in urine; the remainder is metabolized primarily by oxidative deamination and aromatic hydroxylation. Biliary/fecal elimination accounts for less than 5%. |
| Half-life | Terminal elimination half-life: d-amphetamine 10-13 hours, l-amphetamine 13-15 hours; in adults (children: 6-8 hours). The longer half-life allows for once-daily dosing. |
| Protein binding | Approximately 20-25% bound to plasma proteins, mainly albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd: 3-4 L/kg (approximately 210-280 L for a 70 kg adult). This indicates extensive tissue distribution and penetration into the central nervous system. |
| Bioavailability | Oral immediate-release: approximately 75-100%; oral extended-release: approximately 94% relative to immediate-release. Food does not significantly affect absorption but may delay peak concentration. |
| Onset of Action | Oral immediate-release: 30-60 minutes; oral extended-release (Mydayis): 2-3 hours. Onset is due to rapid absorption and peak plasma concentrations at 3 hours (IR) or 8 hours (ER). |
| Duration of Action | Immediate-release: 4-6 hours; extended-release: 8-12 hours (Adderall XR) or up to 16 hours (Mydayis). Clinical duration correlates with therapeutic window for ADHD symptoms. |
| Molecular Weight | 135.21 |
Initial: 5 mg orally once or twice daily; increase by 5 mg increments weekly; usual maintenance: 20-30 mg daily in divided doses; maximum: 40 mg/day
| Dosage form | TABLET |
| Renal impairment | GFR 30-89 mL/min: no adjustment; GFR 15-29 mL/min: reduce dose by 50%; GFR <15 mL/min: avoid use |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use |
| Pediatric use | Children 3-5 years: initial 2.5 mg orally once daily; increase by 2.5 mg weekly; usual range 2.5-20 mg/day. Children ≥6 years: initial 5 mg once or twice daily; increase by 5 mg weekly; usual range 5-40 mg/day in divided doses |
| Geriatric use | Initiate at 2.5 mg orally once or twice daily; titrate slowly; monitor for cardiovascular effects, insomnia, and weight loss |
| 1st trimester | Contraindicated due to risk of fetal cardiovascular anomalies and low birth weight. |
| 2nd trimester | Contraindicated; associated with increased risk of preterm delivery and low birth weight. |
| 3rd trimester | Contraindicated; can cause neonatal withdrawal syndrome, including irritability and poor feeding. |
Clinical note
Comprehensive clinical and safety monograph for ADDERALL 30 (ADDERALL 30).
| Placental transfer | Crosses placenta extensively; amphetamine concentrations in fetal blood can approach maternal levels. |
| Breastfeeding | Contraindicated during breastfeeding due to excretion into breast milk and potential for adverse effects on infant development. If unavoidable, monitor infant for agitation, insomnia, and growth suppression. |
■ FDA Black Box Warning
Amphetamines have a high potential for abuse and dependence. Misuse may cause sudden death or serious cardiovascular events.
| Serious Effects |
Hypersensitivity to amphetamines or other sympathomimeticsCurrent or recent use of MAOIs (within 14 days)GlaucomaHyperthyroidismSymptomatic cardiovascular disease (including structural abnormalities, hypertension, arrhythmias)Agitated statesHistory of drug abuseConcurrent use of other stimulantsPregnancy (especially first trimester)
| Precautions | Risk of serious cardiovascular events including sudden death in patients with pre-existing structural cardiac abnormalities, Increased blood pressure and heart rate, Psychiatric adverse events including exacerbation of pre-existing psychosis, mania, or aggressive behavior, Serotonin syndrome risk when co-administered with serotonergic drugs, Long-term suppression of growth in children, Seizure risk in patients with history of seizures, Peripheral vasculopathy including Raynaud's phenomenon, Visual disturbances due to mydriasis |
| Food/Dietary | Avoid high-fat meals as they delay absorption; avoid acidic foods (e.g., citrus) and vitamin C supplements within 1 hour of dosing as they decrease absorption; limit caffeine and other stimulants to avoid additive cardiovascular effects. |
Loading safety data…
| Lactation Rating |
| L5 (Contraindicated) |
| Teratogenic Risk | Pregnancy category C. First trimester: No well-controlled studies, but potential for congenital malformations not definitively established. Second and third trimesters: Increased risk of premature delivery, low birth weight, and neonatal withdrawal symptoms (e.g., dysphoria, agitation, lassitude). Chronic use may lead to neonatal toxicity. |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and weight. Assess for signs of preeclampsia, placental insufficiency, and intrauterine growth restriction. Fetal monitoring: ultrasound surveillance for fetal growth and well-being. |
| Fertility Effects | May impair fertility in males and females through effects on hormone regulation and gamete quality. Clinical data limited. |
| Clinical Pearls | For ADHD: start low, go slow; monitor weight and height in children; avoid late doses to prevent insomnia; check for abuse/diversion; screen for bipolar disorder and hypertension; consider urine drug screen before prescribing; avoid MAOIs within 14 days; use with caution in seizure disorders and glaucoma. |
| Patient Advice | Take exactly as prescribed; do not crush or chew capsules. · Take the first dose upon waking; avoid afternoon/evening doses. · May cause insomnia, loss of appetite, or nervousness. · Do not drink alcohol while taking this medication. · Report chest pain, palpitations, shortness of breath, or mood changes. · Store securely; do not share medication with others. · Regular blood pressure and heart rate monitoring is necessary. |