Classes
DEA Class; Rx
Common Brand Names; Dexedrine, ProCentra, Zenzedi
- Stimulants;
- ADHD Agents
dextroamphetamine transdermal (Rx)
- Classes: Stimulants;
- ADHD Agents
Description
Oral and transdermal CNS stimulant; is the dextro-isomer of racemic amphetamine and twice as potent
Used for treatment of attention-deficit hyperactivity disorder (ADD/ADHD) and narcolepsy in adult and pediatric patients; not suitable for chronic use for weight loss or weight management
As with all CNS stimulants, there is a risk for abuse and dependence
Indications
Indicated for the treatment of attention-deficit hyperactivity disorder (ADHD).
Contraindications
Hypersensitivity to drug or components
Hyperthyroidism
Glaucoma
Hypertension, advanced arteriosclerosis, symptomatic CVD
Agitated states, history of drug abuse
Within 14 days of administering MAOIs
Adverse Effects
- Appetite loss (21-22%)
- Insomnia (16-20%)
- Abdominal pain (11-15%)
- Vomiting
- Emotional lability
- Nervousness
- Fatigue
- Fever
- Infection
- Nausea
- Diarrhea
- Dyspepsia
- Dizziness
- Weight loss
- Hyperactivity
- Hypomania
- Palpitations
- Tachycardia
- Hypertension
- Dry mouth
- Constipation
- Tremor
- Headache
- Musculoskeletal: Rhabdomyolysis
- Gastrointestinal: Intestinal ischemia
Warnings
Risk of sudden death in children and adolescents with structural cardiac abnormalities; generally avoid
Risk of adverse psychiatric events; eg, hallucinations and mania
Caution in mild hypertension
Associated with peripheral vasculopathy, including Raynaud phenomenon
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment
Sudden deaths, stroke, and myocardial infarction reported in adults taking stimulants at usual doses
Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation
Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients
Aggressive behavior or hostility is often observed in children and adolescents with ADHD; monitor for the appearance of or worsening of aggressive behavior or hostility
Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected
Stimulants may lower convulsive threshold in patients with prior history of seizure, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures
Use with caution in patients who use other sympathomimetic drugs
Amphetamines may exacerbate motor and phonic tics and Tourette’s syndrome; perform clinical evaluation for tics and Tourette’s syndrome in children and their families prior to treating with stimulant medications
Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections
Pregnancy and Lactation
Pregnancy category: C
Lactation: Enters breast milk; not recommended
Maximum Dosage
40 mg/day PO for ADHD or 60 mg/day PO for narcolepsy; one 18 mg/9 hour transdermal patch applied per 24 hours for ADHD.
40 mg/day PO for ADHD or 60 mg/day PO for narcolepsy; one 18 mg/9 hour transdermal patch applied per 24 hours for ADHD.
40 mg/day PO for ADHD (doses up to 60 mg/day PO have been used off-label for weight more than 50 kg) or 60 mg/day PO for narcolepsy; one 18 mg/9 hour transdermal patch applied per 24 hours for ADHD.
6 years and older: 40 mg/day PO for ADHD (doses up to 60 mg/day PO have been used off-label for weight more than 50 kg) or 60 mg/day PO for narcolepsy; one 18 mg/9 hour transdermal patch applied per 24 hours for ADHD.
3 to 5 years: Maximum dosage information is not provided in the FDA-approved labeling; doses should not exceed 40 mg/day PO for immediate-release formulations. Do not use extended-release or transdermal formulations.
Less than 3 years: Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Dextroamphetamine sulfate
capsule, extended-release (Dexedrine): Schedule II
- 5mg
- 10mg
- 15mg
tablet, immediate-release (Zenzedi): Schedule II
- 2.5mg
- 5mg
- 7.5mg
- 10mg
- 15mg
- 20mg
- 30mg
oral solution (ProCentra): Schedule II
- 5mg/5mL
transdermal system: Schedule II
- 4.5mg/9hr
- 9mg/9hr
- 13.5mg/9hr
- 18mg/9hr