Dosing and uses of Evekeo, Dyanavel XR (amphetamine)
Adult dosage forms and strengths
tablet (Evekeo): Schedule II
- 5mg
- 10mg
extended-release oral disintegrating tablet (Adzenys XR-ODT): Schedule II
- 3.1mg
- 6.3mg
- 9.4mg
- 12.5mg
- 15.7mg
- 18.8mg
Narcolepsy
5-60 mg/day PO in divided doses depending on the individual patient response
Administer at the lowest effective dose; individually adjust dosage
Obesity
Indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy (eg, repeated diets, group programs, and other drugs)
Usual dosage is up to 30 mg daily, taken in divided doses of 5-10 mg, 30-60 minutes before meals
Administer at the lowest effective dose; individually adjust dosage
Attention Deficit Hyperactivity Disorder
CNS stimulant indicated for ADHd
Adzenys XR-ODT: 12.5 mg PO qDay in Am
Pediatric dosage forms and strengths
tablet (Evekeo): Schedule II
- 5mg
- 10mg
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
Attention Deficit Hyperactivity Disorder
Evekeo
- <3 years: Safety and efficacy not established
- 3-5 years: 2.5 mg PO qDay initially; may increase daily dose by 2.5-mg increments at weekly intervals until optimal response is obtained
- ≥6 years: 5 mg PO qDay initially; may increase daily dose by 5-mg increments at weekly intervals until optimal response is obtained; only in rare cases will it be necessary to exceed 40 mg/day
- Administer first dose on awakening; give additional doses (1 to 2) at intervals of 4-6 hr
Dyanavel Xr
- <6 years: Safety and efficacy not established
- ≥6 years: Initial: 2.5-5 mg qDay in AM
- May increase dose in increments of 2.5-10 mg/day q4-7 days; not to exceed dose of 20 mg/day
- Shake suspension well before measuring dose with a calibrated measuring device
- Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine base compositions and differing pharmacokinetic profiles
Adzenys XR-ODt
- <6 years: Safety and efficacy not established
- 6-17 years (initial dose): 6.3 mg PO qDay in AM
Maximum dose
- 6-12 years: 18.8 mg qDay
- 13-17 years: 12.5 mg qDay
Narcolepsy
Seldom occurs in children younger than 12 yr; however, when it does, amphetamine may be prescribed
6-12 years: 5 mg/day PO initially; daily dose may be increased by 5-mg increments at weekly intervals until optimal response obtained
≥12 years: 10 mg/day PO initially; daily dose may increase by 10-mg increments at weekly intervals until optimal response is obtained
Administer in divided doses according to individual response
Administer first dose on awakening; give additional doses (5-10 mg) at intervals of 4-6 hr
Obesity
Indicated as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy (eg, repeated diets, group programs, and other drugs)
<12 years: Safety and efficacy not established
≥12 years: Usual dosage is up to 30 mg daily, taken in divided doses of 5-10 mg, 30-60 minutes before meals
Evekeo, Dyanavel XR (amphetamine) adverse (side) effects
Frequency not defined
Cardiovascular: Palpitations, tachycardia, elevation of blood pressure; isolated reports of cardiomyopathy associated with chronic use
Central nervous system: Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette’s syndrome
Gastrointestinal: Dry mouth, unpleasant taste, diarrhea, constipation; anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect
Allergic: Urticaria
Endocrine: Impotence, changes in libido, and frequent or prolonged erections
Postmarketing reports
Musculoskeletal: Rhabdomyolysis
Warnings
Black box warnings
Amphetamines have a high potential for abuse
Administration for prolonged periods of time may lead to drug dependence and must be avoided
Pay attention to the possibility of subjects obtaining amphetamines for nontherapeutic use or distribution to others
Prescribe/dispense sparingly according to law
Misuse may cause sudden death and serious cardiovascular adverse events
Contraindications
Advanced arteriosclerosis, symptomatic cardiovascular disease, or moderate-to-severe hypertension
Hyperthyroidism
Known hypersensitivity or idiosyncrasy to the sympathomimetic amines
Agitated states
Patients with a history of drug abuse
During or within 14 days following the administration of MAOIs (hypertensive crises may result)
Cautions
Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems
Causes a modest increase in average blood pressure (~2-4 mmHg) and average heart rate (~3-6 bpm); caution with hypertension and other cardiovascular conditions
Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease
May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder
Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients
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; although there is no systematic evidence that stimulants cause aggressive behavior or hostility, monitor for the appearance of or worsening of aggressive behavior or hostility
Childhood growth should be monitored during treatment; patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted
May lower seizure threshold in patients with prior history of seizures
Stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon
Visual disturbances reported (eg, difficulties with accommodation, blurred vision)
Pregnancy and lactation
Pregnancy category: C; no adequate and well-controlled studies in pregnant women
Another stimulant (ie, dextroamphetamine sulfate) has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose
Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose
Lactation: Distributed in human breast milk; do not breastfeed
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Evekeo, Dyanavel XR (amphetamine)
Mechanism of action
Noncatecholamine, sympathomimetic amine that elicits CNS stimulant activity
Peripheral actions include increased systolic and diastolic blood pressures, and weak bronchodilator and respiratory stimulant action
Administration
Oral Administration
To avoid substitution errors and overdosage, do not substitute Adzenys XR-ODT for other amphetamine products on a mg-per-mg basis because of different amphetamine base compositions and differing pharmacokinetic profiles
Avoid late evening doses because of insomnia
tablet
- Take 30-60 minutes before meals
Oral suspension
- Shake suspension well before measuring dose with a calibrated measuring device
- May take with or without meals
Oral disintegrating tablet
- May be taken with or without food
- Allow tablet to disintegrate in saliva then swallow
