- Side Effects
- Drug Interactions
- Warnings and Precautions
Brand Name: Vyvanse
Generic Name: Lisdexamfetamine
Drug Class: Stimulants; ADHD Agents
What Is Lisdexamfetamine and How Does It Work?
- Lisdexamfetamine is available under the following different brand names: Vyvanse
What Are Dosages of Lisdexamfetamine?
Adult and pediatric dosage
Capsules: Schedule II
Chewable tablet: Schedule II
- Starting/Switching treatment: 30 mg orally taken once daily in the morning
- Dose adjustment: Increase by 10 to 20 mg/day increments approximately once weekly
- Not to exceed 70 mg per day
- Children younger than 6 years of age: Safety and efficacy not established
- Children 6 years of age or older: 30 mg orally taken once daily in the morning; may increase by 10 to 20 mg/day increments approximately once weekly; not to exceed 70 mg per day
Binge Eating Disorder
- Starting dose: 30 mg/day orally then
- Target dose: Titrate in increments of 20 mg at approximately 1-week intervals to achieve the recommended target dose of 50-70 mg/day
- Not to exceed 70 mg/day
- Discontinue if symptoms do not improve
Dosage Considerations – Should be Given as Follows:
- See “Dosages”.
What Are Side Effects Associated with Using Lisdexamfetamine?
Common side effects of Lisdexamfetamine include:
- dry mouth,
- loss of appetite,
- weight loss,
- sleep problems (insomnia),
- fast heart rate,
- feeling jittery,
- stomach pain,
- diarrhea, and
Serious side effects of Lisdexamfetamine include:
- difficult breathing,
- swelling in the face or throat,
- chest pain,
- pounding heartbeats,
- fluttering in the chest,
- new behavior problems,
- cold feeling,
- unexplained wounds,
- skin color changes (pale, red, or blue appearance) in the fingers or toes,
- fast heart rate,
- muscle stiffness,
- loss of coordination,
- vomiting, and
Rare side effects of Lisdexamfetamine include:
What Other Drugs Interact with Lisdexamfetamine?
If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first
- Lisdexamfetamine has severe interactions with the following drugs:
- Lisdexamfetamine has serious interactions with at least 30 other drugs.
- Lisdexamfetamine has moderate interactions with at least 200 other drugs.
- Lisdexamfetamine has minor interactions with at least 15 other drugs.
This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.
What Are Warnings and Precautions for Lisdexamfetamine?
- Patient taking MAOIs or within 14 days of stopping MAOIs (including linezolid or IV methylene blue) owing to increased risk of hypertensive crisis
Effects of drug abuse
- See “What Are Side Effects Associated with Using Lisdexamfetamine?”
- See “What Are Side Effects Associated with Using Lisdexamfetamine?”
- Use with caution in hyperthyroidism, glaucoma, mild to severe hypertension, advanced arteriosclerosis, symptomatic CVD, agitated states, history of psychosis or drug abuse
- May cause psychotic or manic symptoms in patients with no prior history or exacerbation of symptoms in patients with pre-existing psychosis; evaluate for bipolar disorder before stimulant use
- Misuse of dextroamphetamine may cause sudden death and serious cardiovascular adverse events
- Monitor blood pressure and pulse; consider benefits and risks before use in patients for whom blood pressure increases may be problematic
- Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems; in adults, sudden death, stroke, and myocardial infarction have been reported; avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, or coronary artery disease
- 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; screen for risk factors for developing a manic episode before initiating
- 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 the 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 a clinical evaluation for tics and Tourette’s syndrome in children and their families before treating with stimulant medications
- Interrupt drug administration occasionally to assess if recurrence of behavioral symptoms sufficient to require continued treatment
- Associated with peripheral vasculopathy, including Raynaud phenomenon
- Difficulties with accommodation and blurring of vision have been reported with stimulant treatment
- The use of stimulants may suppress appetite, especially in children, which may cause weight loss and slow the rate of growth
- Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often after an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections
- Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems (eg, MAOIs, SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, St John’s Wort)
- Coadministration with MAOI drugs is contraindicated (see Contraindications)
- Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by CYP2D6 and display minor CYP2D6 inhibition
- Discontinue therapy with any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment; concomitant use with other serotonergic drugs or CYP2D6 inhibitors should be used only if the potential benefit justifies the potential risk
- If clinically warranted, consider initiating therapy with lower doses, monitoring patients for the emergence of serotonin syndrome during drug initiation or titration, and informing patients of increased risk for serotonin syndrome
- There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and research programs/pregnancy registry/adhdmedications/
- The limited available data from published literature and postmarketing reports on use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; adverse pregnancy outcomes, including premature delivery and low birth weight, seen in infants born to mothers dependent on amphetamines.
- Lisdexamfetamine is a prodrug of dextroamphetamine; based on limited case reports in published literature, amphetamine (or d, l-) is present in human milk, at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5; there are no reports of adverse effects on the breastfed infant;
- Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown; large doses of dextroamphetamine might interfere with milk production, especially in women whose lactation is not well established
- Because of the potential for serious adverse reactions in nursing infants, including serious cardiovascular reactions, blood pressure and heart rate increase, suppression of growth, and peripheral vasculopathy, advise patients that breastfeeding is not recommended during treatment