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Lisdexamfetamine is an amide ester conjugate consisting of the amino acid Llysine covalently bound to the amino group of d-amphetamine.
Lisdexamfetamine dimesylate has low lipophilicity (logP-1.76) and high aqueous solubility within a biologically relevant pH range of 1-8. It should be stored at 25°C (77°F) with excursions permitted to 15-30°C (59-86°F).
Lisdexamfetamine should be dispensed in a tight, light-resistant container.
General pharmacology of Vyvanse
Lisdexamfetamine is a prodrug and an inactive molecule until ingestion. After oral administration, enzyme hydrolysis following contact with red blood cells will break lisdexamfetamine into L-lysine, a naturally occurring essential amino acid and active damphetamine which is responsible for the drug’s activity. Gastrointestinal pH does not alter this conversion and the attachment of the L-lysine slows down the relative amount of d-amphetamine available to the blood stream and therefore the CNS.
Routes of administration and dosage
Capsule, Oral: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg.
Lisdexamfetamine PO is rapidly absorbed via the gastrointestinal tract (duodenum, jejunum, and ileum) in animals and attains a maximum plasma concentration -0.25-3 h. Studies in vitro suggest lisdexamfetamine is a substrate for the peptide transport protein PEPT1 and maybe also PEPT2.
Adverse reactions in humans
When tested in subjects with a history of stimulant abuse, doses of 50-150 mg oral lisdexamfetamine dose-ependently increased systolic and diastolic blood pressure, and pulse compared to placebo and the 150 mg dose of lisdexamfetamine produced higher changes than 40 mg d-amphetamine.
The most common adverse effects for lisdexamfetamine are insomnia (13% to 27%), decreased appetite (children and adolescents 34% to 39%; adults 27%), xerostomia (adults 26%; children and adolescents 4% to 5%), and abdominal pain (children 12%). Other adverse effects include increased blood pressure (adults 3%), increased heart rate
(adults 2%), irritability (children 10%), anxiety (adults 6%), dizziness (children 5%), akathisia (adults 4%), agitation (adults 3%), emotional lability (children 3%), restlessness (adults 3%), drowsiness (children 2%), tics (children 2%), hyperhidrosis (adults 3%), skin rash (children 3%).
Dependence potential of vyvanse
No studies were found on tolerance, sensitization, or dependence to lisdexamfetamine. However, abrupt discontinuation following high doses or for prolonged periods may result in symptoms of withdrawal
Current and past national controls
Lisdexamfetamine is controlled as Schedule II (US), S8 (AU), Schedule I (CA), and prescription only medicine (UK, EU).