Mixed amphetamine salts (triple-bead)

FDA label

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Titration May adjust in 12.5 mg increments no sooner than weekly

Renal Severe impairment (GFR 15–<30): adults max 25 mg/day, peds max 12.5 mg/day; not recommended in ESRD (<15)

Hepatic Undefined (not studied; hepatic dysfunction may prolong exposure)

Instructions

• Administer once daily in the morning upon awakening (effects may last up to 16 h)
• Take consistently with or without food
• Swallow whole or open capsule and sprinkle contents on applesauce, taken immediately without chewing
• Do not substitute for other amphetamine products on a mg-per-mg basis
• Allow 14 days after an MAOI

Contraindications

• Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis

Cautions

• Risks to patients with serious cardiac disease — avoid in structural cardiac abnormalities
• Increased blood pressure and heart rate — monitor
• Psychiatric adverse reactions (mania, new psychotic/manic symptoms)
• Long-term growth suppression in pediatric patients
• Peripheral vasculopathy, including Raynaud's phenomenon
• Seizures — lowers convulsive threshold
• Serotonin syndrome with serotonergic drugs
• Motor and verbal tics, worsening of Tourette's syndrome

Adverse reactions

• Insomnia
• Decreased appetite
• Decreased weight
• Dry mouth
• Increased heart rate
• Anxiety
• Nausea (adolescents)
• Irritability (adolescents)

Pregnancy Limited data insufficient for risk; amphetamines cause vasoconstriction/decreased placental perfusion and may increase premature delivery/low birth weight; monitor neonate for withdrawal; registry available

Lactation Amphetamine present in human milk (relative infant dose 2–13.8%); breastfeeding not recommended during treatment