DEXEDRINE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DEXEDRINE (DEXEDRINE).
Dextroamphetamine is a central nervous system stimulant that enhances the activity of dopamine and norepinephrine in the brain by blocking their reuptake and increasing their release from presynaptic terminals.
| Metabolism | Primarily metabolized by CYP2D6 to 4-hydroxydextroamphetamine, which is further metabolized to various metabolites. Also undergoes deamination and oxidation. |
| Excretion | Renal: 30-45% unchanged, 50-60% as deaminated metabolites; fecal: minor (<5%) |
| Half-life | Terminal elimination half-life is 4-6 hours for dextroamphetamine; clinical effects last longer due to CNS accumulation |
| Protein binding | Approximately 16-20% bound; primarily to albumin |
| Volume of Distribution | 3.5-4.5 L/kg; indicates extensive tissue distribution, particularly CNS |
| Bioavailability | Oral: 75-100% (immediate-release), 70-90% (extended-release); rectal and parenteral routes are not clinically utilized |
| Onset of Action | Oral: 30-60 minutes (immediate-release), 1-2 hours (extended-release) |
| Duration of Action | Immediate-release: 4-6 hours; extended-release: 8-12 hours; tolerance may shorten effective duration |
5–60 mg/day orally in divided doses, typically 5–20 mg 1–3 times daily; use immediate-release or extended-release formulations per indication.
| Dosage form | TABLET |
| Renal impairment | GFR 15–30 mL/min: use with caution, consider dose reduction by 50%. GFR <15 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: not recommended. |
| Pediatric use | Age 3–5 years: 2.5 mg orally once daily, increase by 2.5 mg weekly as needed (max 40 mg/day). Age ≥6 years: 5 mg orally once or twice daily, increase by 5 mg weekly (max 40 mg/day). |
| Geriatric use | Start at lowest dose (2.5–5 mg orally once daily), titrate slowly; monitor for cardiovascular effects, agitation, and weight loss. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DEXEDRINE (DEXEDRINE).
| Breastfeeding | Dextroamphetamine is excreted into breast milk; M/P ratio not established but concentration about 2-7 times maternal plasma. potential for infant stimulation, insomnia, and growth impairment. American Academy of Pediatrics recommends use during breastfeeding only if benefits outweigh risks; monitor infant for agitation and poor weight gain. |
| Teratogenic Risk | First trimester: Limited human data; animal studies show increased risk of cardiovascular malformations and cleft palate at high doses. Second/third trimester: Increased risk of preterm delivery, low birth weight, and neonatal withdrawal symptoms (hyperactivity, irritability, feeding difficulties). Dextroamphetamine is a sympathomimetic amine with potential for vasoconstriction reducing uteroplacental perfusion. |
■ FDA Black Box Warning
WARNING: ABUSE AND DEPENDENCE. CNS stimulants, including DEXEDRINE, 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 |
["Known hypersensitivity to amphetamine products or other components of DEXEDRINE","Concurrent use or within 14 days of MAO inhibitor therapy (risk of hypertensive crisis)","Advanced arteriosclerosis","Symptomatic cardiovascular disease","Moderate to severe hypertension","Hyperthyroidism","Glaucoma","Agitated states","History of drug abuse"]
| 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 increases","Psychiatric adverse events including exacerbation of pre-existing psychosis, manic episodes, and aggression","Seizures in patients with prior seizure history","Long-term suppression of growth in children","Peripheral vasculopathy including Raynaud's phenomenon","Serotonin syndrome risk when co-administered with serotonergic drugs"] |
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| Fetal Monitoring | Maternal: Blood pressure, heart rate, weight, and psychiatric status (anxiety, agitation). Fetal: Serial growth ultrasounds to detect intrauterine growth restriction (IUGR); nonstress testing and biophysical profile in third trimester if signs of insufficiency. Neonatal: Observe for withdrawal symptoms (hyperactivity, poor feeding) for 48 hours after delivery. |
| Fertility Effects | Animal studies: High doses may impair male fertility (reduced spermatogenesis) and female fertility (disrupted estrous cycle). Human data insufficient; theoretical risk due to vasoconstrictive effects on reproductive organs. |