Classes
DEA Class; Rx
Common Brand Names; Adzenys XR-ODT, Dyanavel XR, Evekeo, Adzenys ER, Evekeo ODT
- Stimulants;
- ADHD Agents
Description
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
Indications
Contraindications
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)
Adverse Effects
- 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%
Warnings
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 and Lactation
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
Maximum Dosage
12.5 mg/day PO (Adzenys XR products); 20 mg/day PO (Dyanavel XR); 60 mg/day PO (immediate-release products).
12.5 mg/day PO (Adzenys XR products); 60 mg/day PO (immediate-release products).
12.5 mg/day PO (Adzenys XR products); 20 mg/day PO (Dyanavel XR); 40 mg/day PO (immediate-release products).
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
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