DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

LISDEXAMFETAMINE DIMESYLATE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIR concern

Severity Score:2

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

ADVERSE REACTIONS
Postmarketing Experience
The following adverse reactions have been identified during post approval use of VYVANSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events are as follows: cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, tics, bruxism, depression, dermatillomania, alopecia, aggression, Stevens-Johnson Syndrome, chest pain, angioedema, urticaria, seizures, libido changes, frequent or prolonged erections, constipation, and rhabdomyolysis.
OVERDOSAGE
Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.
Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has been reported with amphetamine use, including VYVANSE. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
Lisdexamfetamine and d-amphetamine are not dialyzable.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42894

Other ADRs

8628

14108651

Odds Ratio = 0.687

Drug Property Information

ATC Code(s):

N06BA12 - lisdexamfetamine dimesylate

N06BA - Centrally acting sympathomimetics
N06B - "PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS"
N06 - PSYCHOANALEPTICS
N - NERVOUS SYSTEM

Active Ingredient:lisdexamfetamine dimesylate

Active Ingredient UNII:SJT761GEGS

Drugbank ID:DB01255

PubChem Compound:11597698

CAS Number:608137-32-2

Dosage Form(s):capsule; tablet, chewable

Route(s) Of Administrator:oral

Daily Dose:

30.0 mg/day N06BA12

Chemical Structure:

SMILE Code:
C[C@@H](CC1=CC=CC=C1)NC(=O)[C@H](CCCCN)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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