Lisdexamfetamine

Vyvanse capsules and chewable tablets treat ADHD in adults and children aged 6 years or older, and moderate to severe binge eating disorder in adults. Pediatric BED safety/effectiveness are not established below age 18 years.

Use below age 6 years is not approved or recommended: younger children had higher dextroamphetamine exposure and more adverse reactions, including weight loss, at the same dose. Vyvanse is not indicated or recommended for weight loss; safety and efficacy for obesity are unestablished. Do not infer a BED diagnosis from appetite reduction.

Take in the morning with or without food; avoid afternoon doses because of insomnia. Reassess benefit and adverse effects rather than automatically titrate to the maximum. Lower renal caps take priority.

These limits apply to the reviewed product across its labeled indications. Preserve the label’s indexed GFR units; dialysis does not remove the active drug or justify an extra post-dialysis dose.

Swallow capsules whole, or open and mix the entire contents thoroughly with yogurt, water, or orange juice. Break up compacted powder if needed, consume the entire mixture immediately, and do not store it. An inactive-ingredient film may remain after consumption. Chewable tablets must be chewed thoroughly before swallowing. The label permits Vyvanse capsules and chewables to substitute mg-for-mg at the same dose; a single dose must not be divided, and partial capsule contents or tablets are not a dose-measuring method.

Before treatment, assess cardiac history, family history of sudden death or ventricular arrhythmia, and physical examination; evaluate tics and family history of Tourette’s syndrome. Screen psychiatric risk. When a serotonergic drug or CYP2D6 inhibitor must be combined, use lower starting doses and monitor during initiation and titration. Urinary pH modifiers can alter active amphetamine exposure; dose decisions remain with the prescriber.

Known hypersensitivity to amphetamine products or Vyvanse ingredients; and MAOI treatment or use within 14 days after stopping an MAOI, including linezolid or IV methylene blue, because of hypertensive-crisis risk. Serious cardiac disease is an avoid-use warning in this current label, rather than an additional item in its formal contraindication list.

Vyvanse has high potential for abuse and misuse, which can lead to substance-use disorder and addiction. Overdose and death can occur, especially with higher doses or unapproved administration such as snorting or injection. Assess risk, educate patients and families, store securely, dispose appropriately, and repeatedly monitor for misuse.

ADHD trials commonly report decreased appetite, weight loss, insomnia, dry mouth, GI symptoms, anxiety, irritability, and dizziness. Adult BED trials commonly report dry mouth, insomnia, decreased appetite, increased heart rate, constipation, jitteriness, and anxiety. Serious postmarketing reports include cardiomyopathy, seizures, severe hypersensitivity or skin reactions, and rhabdomyolysis; reported frequencies and causality are uncertain.

MAOIs are contraindicated during treatment and for 14 days after their last dose. SSRIs, SNRIs, triptans, tramadol, fentanyl, lithium, buspirone, St. John’s wort, and other serotonergic agents raise serotonin-syndrome risk. CYP2D6 inhibitors can increase dextroamphetamine exposure. Consider alternatives; if combination is warranted, initiate lower and monitor closely during dose changes.

Urinary alkalinizing agents such as sodium bicarbonate can increase amphetamine exposure; the interaction table advises avoiding coadministration. Acidifying agents such as ascorbic acid can lower exposure and efficacy; adjust only according to clinical response and within dose limits. Tricyclic antidepressants may potentiate sympathomimetic and cardiovascular effects; monitor and consider adjustment or alternative treatment.

Vyvanse can interfere with ioflupane I-123 dopamine-transporter imaging and produce false-positive diagnostic findings. Inform the imaging team and allow an adequate clinician-directed washout; the label does not provide a universal number of days.

Human pregnancy data are insufficient to determine drug-associated major-birth-defect or miscarriage risk. Amphetamines may impair placental perfusion; adverse outcomes in amphetamine-dependent mothers do not establish an exact risk from therapeutic Vyvanse. Discuss potential fetal effects and the National Pregnancy Registry for Psychostimulants. Monitor exposed newborns for withdrawal or feeding symptoms. Amphetamine enters milk and long-term infant effects are unknown; the current label advises against breastfeeding during Vyvanse treatment.

ADHD safety and efficacy are established at ages 6–17 years; pediatric BED below 18 years is unestablished. Below 6 years, use is not approved or recommended because of higher exposure and more adverse reactions. Monitor growth and appetite, not weight alone. Trials included too few adults aged 65 years or older to determine differences; start cautiously at the low end and consider organ function and comorbid disease.

Severe renal impairment and ESRD require the 50 mg/day and 30 mg/day caps above, respectively; neither the prodrug nor active dextroamphetamine is dialyzable. The selected label supplies no validated numeric hepatic-impairment regimen. Red-cell conversion of lisdexamfetamine does not establish safety in every hepatic disorder or remove active-metabolite drug interactions.

Lisdexamfetamine is converted to dextroamphetamine and L-lysine, primarily through red-cell hydrolysis. Amphetamines increase extracellular norepinephrine and dopamine through reduced reuptake and increased release. The exact therapeutic mechanism in ADHD and BED is unknown; lisdexamfetamine itself does not bind the relevant reuptake sites in vitro.

Food can delay the active-drug peak; the label permits administration with or without food. Active dextroamphetamine exposure is similar for matched Vyvanse capsule and chewable doses. These PK results do not authorize conversion mg-for-mg to mixed amphetamine salts or other stimulants.

Conversion

Primarily in blood; lisdexamfetamine is not CYP-metabolized

Active-drug peak

About 3.5 hours after capsules in fasted 6–12 year-olds;4.4 hours after 60 mg chewable in fasted healthy subjects

Active half-life

About 8.6–9.5 hours in 6–12 year-olds;10–11.3 hours in healthy adults

Renal considerations

Urinary pH affects active-drug elimination; neither drug is dialyzable

Physical dependence and tolerance can develop. Abrupt discontinuation or substantial dose reduction after prolonged use can produce depressed or dysphoric mood, fatigue, unpleasant dreams, sleep changes, increased appetite, or psychomotor changes. Arrange discontinuation and reassessment with the prescriber; the label does not specify a universal taper.

Monitor BP and pulse, weight and pediatric height, appetite, sleep, mood or psychotic/manic symptoms, tics, digital circulation, and misuse risk. Reassess ADHD function or binge-eating response and tolerability. Review renal function when impaired or changing and the complete medication list; do not use weight loss as a marker of BED treatment success.

• Read the Medication Guide; take the morning dose as prescribed, and never share this Schedule II medicine.
• Tell the prescriber about MAOIs, antidepressants, serotonin-risk medicines, supplements, and urinary pH modifiers. Tell imaging clinicians before dopamine-transporter scans.
• Use the entire capsule mixture immediately, or chew the selected tablet thoroughly; do not portion a dose or save a mixture.
• Report chest pain, fainting, new hallucinations/mania, painful or discolored digits, wounds, or worsening tics. Discuss pregnancy and breastfeeding before or during treatment.

Overdose can cause dangerous arrhythmias, vascular events, extreme agitation, serotonin syndrome, seizures, hyperthermia, or rhabdomyolysis. Seek immediate medical advice for suspected excess exposure; delayed prodrug conversion matters during observation. Call U.S. Poison Control at 1-800-222-1222; call 911 for collapse, seizure, impaired breathing, or inability to awaken. There is no home antidote and dialysis does not remove lisdexamfetamine or dextroamphetamine.

These are brand-product identifiers; generic capsules can look different. A photograph or color match alone cannot verify identity.

Strength / form

30 mg lisdexamfetamine dimesylate capsule

Appearance

White body; orange cap

Imprint

S489 and 30 mg

Package example

Takeda bottle of 100 · NDC 59417-103-10

Vyvanse capsules: 10, 20, 30, 40, 50, 60, and 70 mg. Vyvanse chewables: 10, 20, 30, 40, 50, and 60 mg; no 70 mg chewable is listed. Both are oral products. Doses refer to lisdexamfetamine dimesylate, not an equivalent mg amount of dextroamphetamine or mixed amphetamine salts. Other manufacturers require their own product-identification and dispensing checks.

Dispense in a tight, light-resistant container. Store at 20–25°C(68–77°F), with excursions 15–30°C(59–86°F). Keep securely, preferably locked, away from children. Prefer a medicine take-back program or DEA-authorized collector for unused medicine; follow the Medication Guide’s disposal directions when unavailable. Do not store opened-capsule mixtures.