Lisdexamfetamine Mesilate

What it is and how it works

Mechanism of Action Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known.

Indications

Lisdexamfetamine Dimesylate Capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older . Moderate to severe binge eating disorder (BED) in adults . Lisdexamfetamine dimesylate capsules are a central nervous system (CNS) stimulant indicated for the treatment of : Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use: The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. ( 5.5 , 8.4 ) Lisdexamfetamine dimesylate capsules are not indicated for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events.

Dosage and administration (summary)

Indicated Population Initial Dose Titration Schedule Recommended Dose Maximum Dose ADHD (Adults and pediatric patients 6 years and older) 30 mg every morning 10 mg or 20 mg weekly 30 mg to 70 mg per day 70 mg per day BED (Adults) 30 mg every morning 20 mg weekly 50 mg to 70 mg per day 70 mg per day Prior to treatment, assess for presence of cardiac disease. Severe renal impairment: Maximum dose is 50 mg/day. End stage renal disease (ESRD): Maximum dose is 30 mg/day.

Contraindications

Lisdexamfetamine dimesylate capsules are contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports .

Warnings and precautions

Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. Psychiatric Adverse Reactions: Prior to initiating lisdexamfetamine dimesylate capsules, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing lisdexamfetamine dimesylate capsules.

Pregnancy

Pregnancy Risk Summary The limited available data from published literature and postmarketing reports on use of lisdexamfetamine dimesylate capsules in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.

Storage and supply

How Supplied Lisdexamfetamine Dimesylate Capsules: 50 mg: blue opaque cap/white opaque body (imprinted with "RP" on cap and "50mg" on body). NDC: 72162-2456-1: 100 Capsules in a Bottle NDC: 72162-2456-3: 30 Capsules in a Bottle NDC: 72162-2456-9: 90 Capsules in a Bottle Storage and Handling Dispense in a tight, light-resistant container as defined …

Source: Lisdexamfetamine Dimesylate (Lisdexamfetamine Dimesylate) — US FDA prescribing information, 2026-03-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.