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DEXMETHYLPHENIDATE HYDROCHLORIDE
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Effects on QT Interval
- The effect of dexmethylphenidate hydrochloride extended-release capsules on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate hydrochloride extended-release capsules, 40mg in 75 healthy volunteers. ECGs were collected up to 12 hours postdose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was <5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
1
42911
Other ADRs
1085
14116194
Odds Ratio = 0.304
Drug Property Information
ATC Code(s):
- N06BA11 - dexmethylphenidate hydrochloride
- N06BA - Centrally acting sympathomimetics
- N06B - "PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS"
- N06 - PSYCHOANALEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:dexmethylphenidate hydrochloride
Active Ingredient UNII:1678OK0E08
Drugbank ID:DB06701
PubChem Compound:154101
CAS Number:40431-64-9
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 15.0 mg/day N06BA11
Chemical Structure: 
SMILE Code:
COC(=O)[C@@H]([C@H]1CCCCN1)C2=CC=CC=C2
COC(=O)[C@@H]([C@H]1CCCCN1)C2=CC=CC=C2
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
N/ADisclaimer:
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