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Amphetamine

    Brands

    DEA Class;  Rx

    Common Brand Names; Adzenys XR-ODT, Dyanavel XR, Evekeo, Adzenys ER, Evekeo ODT

    • Stimulants; 
    • ADHD Agents

    Sympathomimetic amine; a racemic mixture of L-amphetamine and D-amphetamine
    Used for attention-deficit hyperactivity disorder (ADHD) and narcolepsy
    Used as an anorectic agent in the short-term (8 to 12 weeks) exogenous treatment of obesity; abuse and addiction potential; not generally recommended by guidelines due to lack of longer-term health benefits

    For the treatment of narcolepsy.
    For the treatment of attention-deficit hyperactivity disorder (ADHD).
    For the short-term (i.e., 8 to 12 weeks) treatment of exogenous obesity.

    Advanced arteriosclerosis, symptomatic cardiovascular disease, or moderate-to-severe hypertension

    In patients known to be hypersensitive to amphetamine, or other components

    Patients with a history of drug abuse

    During or within 14 days following the administration of MAOIs (hypertensive crises may result)

    • Decreased appetite (28%)
    • Infections (22%)
    • Abdominal pain (15%)
    • Irritability (14%)
    • Headache (13%)
    • Appetite loss (22-36%)
    • Dry mouth (1.6-35%)
    • Headache (1.6-26%)
    • Insomnia (5.2-17%)
    • Abdominal pain (11-14%)
    • Insomnia (10%)
    • Fatigue (10%)
    • Affect lability, includes mood swings (9%)
    • Tachycardia (9%)
    • Nausea (6%)
    • Vomiting (6%)
    • Dry mouth (6%)
    • Decreased appetite (4%)
    • Insomnia (4%)
    • Abdominal pain (3%)
    • Affect lability (3%)
    • Injury (3%)
    • Epistaxis (3.8%)
    • Rhinitis allergic (3.8%)
    • Upper abdominal pain (3.8%

    Sudden death reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems

    May cause a modest increase in average blood pressure (~2-4 mmHg) and heart rate (~3-6 bpm); caution with hypertension and other cardiovascular conditions

    May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder CNS stimulants may induce a mixed or manic episode in patients with bipolar disorder; before initiating treatment, screen for risk factors for developing a manic episode (eg, comorbid or has a history of depressive symptoms or a family history of suicide, bipolar disorder, and depression)

    Treatment emergent psychotic or manic symptoms (eg, hallucinations, delusional thinking, mania) in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses

    Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD; monitor for the worsening of aggressive behavior or hostility

    Monitor childhood growth during treatment; patients who are not growing or gaining height or weight as expected may need to interrupt their treatment

    May lower seizure threshold in patients with prior history of seizures

    Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon

    Pregnancy exposure registry monitors pregnancy outcomes in women exposed to amphetamines during pregnancy

    Based on limited published case reports, amphetamine (d- or d1) is present in human milk at relative infant doses of 2-13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9and 7.5

    Adults

    12.5 mg/day PO (Adzenys XR products); 20 mg/day PO (Dyanavel XR); 60 mg/day PO (immediate-release products).

    Geriatric

    12.5 mg/day PO (Adzenys XR products); 60 mg/day PO (immediate-release products).

    Adolescents

    12.5 mg/day PO (Adzenys XR products); 20 mg/day PO (Dyanavel XR); 40 mg/day PO (immediate-release products).

    Children

    6 to 12 years: 18.8 mg/day PO (Adzenys XR products); 20 mg/day PO (Dyanavel XR); 40 mg/day PO (immediate-release products).
    3 to 5 years: 40 mg/day PO for immediate-release products; safety and efficacy have not been established for extended-release formulations.
    1 to 2 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Amphetamine sulfate

    tablet (Evekeo): Schedule II

    • 5mg
    • 10mg

    extended-release oral tablets (Dyanavel XR): Schedule II

    • 5mg
    • 10mg
    • 15mg
    • 20mg

    extended-release oral suspension (Dyanavel XR): Schedule II

    • 2.5mg/mL

    extended-release oral disintegrating tablet (Adzenys XR-ODT): Schedule II

    • 3.1mg
    • 6.3mg
    • 9.4mg
    • 12.5mg
    • 15.7mg
    • 18.8mg

    extended-release oral suspension (Adzenys ER): Schedule II

    • 1.25 mg/mL