ADDERALL XR 10
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADDERALL XR 10 (ADDERALL XR 10).
Adderall XR 10 contains a mixture of amphetamine salts, which are central nervous system stimulants. The dextroamphetamine and levoamphetamine components increase synaptic concentrations of dopamine and norepinephrine by inhibiting their reuptake and promoting their release from presynaptic terminals. This action leads to enhanced neurotransmission in the prefrontal cortex and other brain regions involved in attention and executive function.
| Metabolism | Amphetamine is primarily metabolized by hepatic CYP2D6 to 4-hydroxyamphetamine, which is further conjugated. Minor pathways include N-dealkylation and deamination. The drug has a half-life of approximately 10-13 hours. |
| Excretion | Renal (approximately 30-40% as unchanged amphetamine, remainder as metabolites, including deaminated and oxidized products; urinary pH-dependent elimination: acidic pH increases renal clearance, alkaline pH decreases renal clearance; negligible biliary/fecal elimination) |
| Half-life | Dexamphetamine: 10-13 hours in adults (children: 6-8 hours); levoamphetamine: 13-16 hours; clinically, steady-state achieved in approximately 3 days, with twice-daily dosing maintaining therapeutic levels |
| Protein binding | 15-40% bound to plasma proteins, primarily albumin; lower binding in patients with hepatic impairment |
| Volume of Distribution | 3.0-4.5 L/kg for total amphetamine; high tissue distribution (brain, lungs, kidneys); enters CNS via passive diffusion and active transport |
| Bioavailability | Oral: quantitative absorption with 90-100% bioavailability of the total amphetamine content; food does not affect overall absorption but may delay peak concentrations with high-fat meals |
| Onset of Action | Oral: 30-60 minutes to clinical effect (peak plasma concentration at 3-4 hours for dexamphetamine and 5-6 hours for levoamphetamine due to sustained-release formulation) |
| Duration of Action | 10-12 hours based on twice-daily dosing schedule; extended-release beads provide biphasic release with initial peak at ~4 hours and later sustained release lasting up to 12 hours; clinical effect duration may be shorter in children |
10 mg orally once daily in the morning; maximum dose 40 mg/day.
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Renal impairment | GFR 15-29 mL/min: reduce dose by 50%; GFR <15 mL/min: 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 6-17 years: starting dose 5 mg once daily; increase by 5 mg weekly based on response; maximum 30 mg/day. |
| Geriatric use | Starting dose 5 mg once daily; increase cautiously with monitoring for hypertension, agitation, and cognitive effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ADDERALL XR 10 (ADDERALL XR 10).
| Breastfeeding | Contraindicated during breastfeeding. Amphetamine is excreted into human milk; M/P ratio approximately 3.5. Infant exposure estimated at 4-8% of maternal weight-adjusted dose. Reported adverse effects in infants include irritability, poor feeding, and sleep disturbances. |
| Teratogenic Risk | Pregnancy Category C. First trimester: Limited human data; animal studies show increased risk of cardiovascular malformations (ventricular septal defects) and neural tube defects at high doses. Second trimester: Potential for reduced fetal growth and premature delivery. Third trimester: Risk of neonatal withdrawal syndrome (irritability, dysphoria, tremor, hypertonia) and preterm birth. |
■ FDA Black Box Warning
WARNING: ABUSE AND DEPENDENCE. CNS stimulants, including Adderall XR, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
| Serious Effects |
Hypersensitivity to amphetamine or any component of the formulation; patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma; agitated states; history of drug abuse; during or within 14 days following MAOI therapy.
| Precautions | Serious cardiovascular events, including sudden death in patients with pre-existing structural cardiac abnormalities; blood pressure and heart rate increases; psychiatric adverse reactions (e.g., exacerbation of psychosis, mania, aggression); seizures; serotonin syndrome if combined with serotonergic drugs; long-term growth suppression in children; peripheral vasculopathy including Raynaud's phenomenon; potential for abuse and dependence. |
| Food/Dietary | Take ADDERALL XR with or without food. However, high-fat meals may delay absorption and reduce peak concentrations. Avoid consumption of acidic foods or beverages (e.g., citrus fruits, fruit juices, cola) within 1 hour before or after dosing, as acidity can decrease absorption. Vitamin C (ascorbic acid) and other acidifying agents can reduce efficacy; conversely, alkalizing agents (e.g., antacids, sodium bicarbonate) may potentiate effects. |
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| Fetal Monitoring | Maternal: Blood pressure, heart rate, weight, and signs of stimulant toxicity (insomnia, anorexia, palpitations). Fetal: Serial ultrasound for growth restriction (every 4-6 weeks) and nonstress testing/ biophysical profile in third trimester if growth concerns. Neonatal: Monitor for withdrawal symptoms (irritability, jitteriness, poor feeding) for 48 hours after delivery. |
| Fertility Effects | Amphetamines may reduce fertility in females by disrupting menstrual cycles and ovulation (dopamine-mediated prolactin inhibition). In males, potential for erectile dysfunction and reduced sperm motility, though limited data. |
| Clinical Pearls | ADDERALL XR (mixed amphetamine salts extended-release) 10 mg is a CNS stimulant indicated for ADHD. Initiate at 10 mg once daily in the morning; titrate in 5-10 mg increments weekly. Swallow capsules whole, or sprinkle contents on applesauce for patients unable to swallow. Avoid afternoon doses to prevent insomnia. Monitor for hypertension, tachycardia, and growth suppression in children. Abuse potential is high; use with caution in patients with history of substance abuse. Contraindicated in glaucoma, hyperthyroidism, agitated states, MAOI use within 14 days, and structural cardiac abnormalities. |
| Patient Advice | Take exactly as prescribed once daily in the morning with or without food. · Do not chew or crush the capsule; you may open it and sprinkle the beads on a spoonful of applesauce, then swallow immediately without chewing. · Avoid taking in the afternoon or evening as it may cause difficulty sleeping. · Do not stop abruptly without consulting your doctor; sudden discontinuation may cause withdrawal symptoms. · Report any chest pain, palpitations, shortness of breath, or fainting to your doctor. · This medication has a high potential for abuse; keep in a safe place and do not share with others. · Avoid alcohol and illicit drugs while taking this medication. · Notify your doctor if you have a history of drug dependence, anxiety, bipolar disorder, or seizures. · For patients with ADHD, it may improve focus, attention, and impulse control. · Store at room temperature away from moisture and heat. |