lisdexamfetamine dimesylate
Pharmacologic class: Amphetamine prodrug
Therapeutic class: CNS stimulant
Controlled substance schedule II
Pregnancy risk category C
FDA Box Warning
• Drug has high abuse potential. Prolonged use may lead to drug dependence. Stay alert for possibility of persons obtaining it for nontherapeutic use or distribution. Drug should be prescribed or dispensed sparingly.
• Drug misuse may cause sudden death and serious cardiovascular adverse events.
Action
Rapidly absorbed and converted to dextroamphetamine, which is responsible for CNS activity. Therapeutic action in attention deficit hyperactivity disorder (ADHD) is unknown.
Availability
Capsules: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg
Indications and dosages
➣ ADHD
Adults and Children ages 6 to 12: Individualize dosage based on therapeutic needs and response. For child starting treatment for first time or switching from another drug, recommended dosage is 30 mg P.O. once daily in morning. If daily dosage will be increased above 30 mg, adjust in increments of 10 to 20 mg/day at approximately weekly intervals. Maximum recommended dosage is 70 mg/day.
Contraindications
• Hypersensitivity or idiosyncratic reaction to sympathomimetic amines
• Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma, agitated state
• History of drug abuse
• During or within 14 days of MAO inhibitor therapy
Precautions
Use cautiously in:
• concurrent use of other sympathomimetics
• tics, Tourette syndrome, hypertension or other cardiovascular conditions, preexisting psychosis (such as bipolar disorder)
• electroencephalogram (EEG) abnormalities or seizures
• pregnant and breastfeeding patients
• adults
• children younger than age 6 or older than age 12 (safety and efficacy not established).
Administration
• Administer with or without food.
• Give in morning to avoid insomnia.
• Give capsules whole, or open and dissolve entire contents in glass of water. When using solution method, don't divide single-capsule dose; make sure patient consumes solution immediately.
☞ Don't give within 14 days of MAO inhibitors.
Adverse reactions
CNS: dizziness, headache, somnolence, insomnia, irritability, labile affect, manic symptoms, dysphoria, euphoria, aggression, restlessness, tics, dyskinesia, psychomotor hyperactivity, psychotic episodes, depression, tremor, seizure, stroke
CV: palpitations, tachycardia, hypertension, ventricular hypertrophy, myocardial infarction, cardiomyopathy, sudden death
EENT: visual disturbances
GI: abdominal pain, nausea, vomiting, diarrhea, constipation, dry mouth, unpleasant taste
GU: libido changes, erectile dysfunction
Skin: rash, toxic epidermal necrolysis, urticaria, Stevens-Johnson syndrome
Other: decreased appetite, weight loss, growth suppression, fever, amphetamine tolerance and dependency, hypersensitivity reactions including angioedema and anaphylaxis
Interactions
Drug-drug. Adrenergic blockers: inhibited adrenergic blocker action
Antihistamines: decreased sedative effect of antihistamine
Antihypertensives: antagonism of anti-hypertensive effect
Chlorpromazine: inhibited stimulant effect
Desipramine, protriptyline (and possibly other tricyclic antidepressants): enhanced antidepressant activity, causing sustained rise in d-amphetamine concentration in brain
Ethosuximide: delayed intestinal absorption of this drug
Haloperidol: inhibited central stimulant effects
Lithium carbonate: inhibited anorectic and stimulatory effects of lisdexamfetamine
MAO inhibitors: slowed lisdexamfetamine metabolism, possibly leading to hypertensive crises
Meperidine: potentiated analgesic effect of meperidine
Methenamine therapy: increased amphetamine urinary excretion, causing reduced lisdexamfetamine blood level and efficacy
Norepinephrine: enhanced norepinephrine adrenergic effect
Phenobarbital, phenytoin: possible delayed intestinal absorption of these drugs, possible synergistic anticonvulsant action
Propoxyphene: increased risk of potentiated CNS stimulation (leading to life-threatening seizures in propoxyphene overdosage)
Drug-diagnostic tests. Plasma corticosteroids: increased levels
Urinary steroids: interference with results
Drug-herbs. Veratrum alkaloids, such as Veratrum album (white hellebore), V. eschsholtzii (American hellebore), and V. luteum (false unicorn): inhibited hypotensive effect of these herbs
Patient monitoring
• Before initiating therapy, evaluate patient and family for history of cardiovascular abnormalities, tics or Tourette syndrome (or exacerbation of these), EEG abnormalities, and seizures. Drug may lower seizure threshold.
• During early treatment phase, stay alert for worsening of aggressive behavior or hostility.
• Monitor blood pressure and pulse.
• Know that when possible, drug therapy should be interrupted occasionally to determine if behavioral symptoms recur to extent that necessitates continued therapy.
• Monitor patient for appropriate growth and weight gain.
• Watch for signs and symptoms of drug tolerance, dependence, and abuse.
Patient teaching
• Inform patient or caregiver that drug can be taken with or without food. Advise them that it should be taken in morning to help avoid insomnia.
• Instruct patient to take capsule whole, or to open it and dissolve entire contents in glass of water, and consume solution immediately.
• Advise patient or caregiver to watch for and report seizures, worsening of aggressive behavior, tics, or inappropriate growth or weight gain.
• Instruct patient to avoid using herbs unless prescriber approves.
• Caution patient to avoid hazardous activities until drug's effects on concentration, coordination, and vision are known.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.