-
The Medical Letter on Drugs and... Jan 2020
Review
Topics: Adrenergic alpha-2 Receptor Agonists; Amphetamines; Attention Deficit Disorder with Hyperactivity; Behavior Therapy; Central Nervous System Stimulants; Child; Child, Preschool; Delayed-Action Preparations; Humans; Methylphenidate; Transcutaneous Electric Nerve Stimulation
PubMed: 31999670
DOI: No ID Found -
Journal of Child and Adolescent... Dec 2022To evaluate the short-term effect of dexmethylphenidate (D-MPH) on visual acuity (VA), pupil size, anterior chamber depth, and accommodation-convergence reflex in... (Clinical Trial)
Clinical Trial
To evaluate the short-term effect of dexmethylphenidate (D-MPH) on visual acuity (VA), pupil size, anterior chamber depth, and accommodation-convergence reflex in children treated with D-MPH for attention-deficit/hyperactivity disorder (ADHD). Prospective cohort study including 15 patients aged 8-16 (11.58 ± 2.39) treated with D-MPH for ADHD. Patients were questioned for subjective complaints such as blurred vision and photosensitivity. An ophthalmic evaluation was performed twice; before and 1.5 hours after D-MPH administration. The examination included evaluation of best corrected visual acuity at distance and near, accommodation range, convergence range, 3D vision test (stereopsis), and anterior segment optical coherence tomography. A significant association between change in pupil diameter and D-MPH treatment dose was demonstrated ( = 0.01). In addition, a positive correlation between complaints about blurred vision and pupil's size change was found ( < 0.05). There were no significant changes in VA, convergence range, stereopsis, accommodation range, or anterior chamber measures. Our findings provide support for the effect of stimulants on pupil diameter in a dose-dependent manner. No clinically significant differences in visual functions were found 1.5 hours after consumption of D-MPH. Institutional review board clinical trial refference no. 0122-17-TLV.
Topics: Child; Humans; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Delayed-Action Preparations; Dexmethylphenidate Hydrochloride; Double-Blind Method; Methylphenidate; Prospective Studies
PubMed: 36548361
DOI: 10.1089/cap.2022.0074 -
Clinical Case Reports Mar 2020Dexmethylphenidate, and potentially other methylphenidates used in the treatment of attention deficit hyperactivity disorder (ADHD), may cause severe muscle pain and...
Dexmethylphenidate, and potentially other methylphenidates used in the treatment of attention deficit hyperactivity disorder (ADHD), may cause severe muscle pain and stiffness. Medication side effects should be considered as the possible cause if a patient with ADHD develops severe symptoms.
PubMed: 32185027
DOI: 10.1002/ccr3.2628 -
Drug Metabolism and Disposition: the... Mar 2016The postulate that twice the milligram/kilogram dose of dl-methylphenidate (dl-MPH) would result in equal exposure to d-MPH compared with half that milligram/kilogram... (Randomized Controlled Trial)
Randomized Controlled Trial
The postulate that twice the milligram/kilogram dose of dl-methylphenidate (dl-MPH) would result in equal exposure to d-MPH compared with half that milligram/kilogram dose of the chiral switch product dexmethylphenidate (d-MPH) was tested. Using a randomized, crossover study design, 12 men and 12 women received either immediate-release (IR) dl-MPH (0.3 mg/kg) or IR d-MPH (0.15 mg/kg). Relative bioavailability comparisons included partial area under the plasma concentration-time curves (pAUC0-3 h) for d-MPH. The pAUC0-3 h is a new regulatory metric presently only required for bioequivalence testing of a specific dl-MPH modified-release product. The geometric mean ratios for both the Cmax and area under the plasma concentration-time curve (AUC0-∞) were within the 90% confidence interval (CI) regulatory range of 0.8-1.25, indicating that these two drugs were bioequivalent in terms of d-MPH. However, the pAUC0-3 h geometric mean ratio for d-MPH after IR dl-MPH versus IR d-MPH was 0.76 (P < 0.001; 90% CI, 0.67-0.87), showing significantly less early exposure to the d-isomer than IR d-MPH. The 1-hour d-MPH concentration after dl-MPH was 56% of that after the enantiopure drug. The maximum d-MPH plasma concentration (Cmax) for dl-MPH was also significantly lower for dl-MPH (P < 0.05; CI, 1.02-1.19), whereas the AUC0-∞ ratio of 0.89 was not significantly different (P = 0.21; CI, 0.98-1.13). The AUC0-3 h difference reported here points to the potential limitations of using bioequivalence for sound predictions of dose-response relationships. Knowledge of the greater early exposure to d-MPH after the pure d-isomer drug compared with the racemate may contribute to drug individualization/optimization in the treatment of attention deficit hyperactivity disorder.
Topics: Adult; Area Under Curve; Biological Availability; Cross-Over Studies; Delayed-Action Preparations; Dexmethylphenidate Hydrochloride; Female; Humans; Male; Methylphenidate; Young Adult
PubMed: 26729760
DOI: 10.1124/dmd.115.067975 -
Journal of the American Academy of... Feb 2008This study compared once-daily dexmethylphenidate extended release (D-MPH-ER) 20 mg/day and placebo over 12 hours in children ages 6 to 12 with... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
This study compared once-daily dexmethylphenidate extended release (D-MPH-ER) 20 mg/day and placebo over 12 hours in children ages 6 to 12 with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting.
METHOD
All of the children were stabilized for > or =2 weeks on a total dose (nearest equivalent) MPH 40 mg/day or immediate-release D-MPH 20 mg/day before screening. After a practice day, they received 6 days of D-MPH-ER 20 mg/day or placebo at home, returning on day 7 for one dose. Subjects were evaluated at predose and postdose hours 0.5, 1, 3, 4, 5, 7, 9, 10, 11, and 12 and then crossed over to the other treatment arm using the identical protocol. The primary efficacy variable was the change from predose in Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP) combined score from 1 to 12 hours. Secondary efficacy variables included SKAMP combined score at 0.5 hours, SKAMP subscale scores, and math test results over 12 hours.
RESULTS
Sixty-eight children were randomized, with 67 completing the study. Onset of action was indicated by a significant difference between D-MPH-ER and placebo at 0.5 hour on the SKAMP combined score (p = .001). For efficacy measures, differences from placebo were significant at all points between 0.5 and 12 hours (p < .001 top = .013).
CONCLUSIONS
D-MPH-ER provided sustained improvement in attention, deportment, and academic productivity throughout the 12-hour laboratory day.
Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Cross-Over Studies; Delayed-Action Preparations; Dexmethylphenidate Hydrochloride; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Methylphenidate; Personality Assessment; Social Environment; Stereoisomerism; Treatment Outcome
PubMed: 18176337
DOI: 10.1097/chi.0b013e31815cd9a4 -
Journal of Child and Adolescent... Jun 2022The study was designed to determine (1) the pharmacokinetic (PK) profile of dexmethylphenidate (d-MPH) after oral administration of three dosage strengths of a new...
Dose Proportionality and Steady-State Pharmacokinetics of Serdexmethylphenidate/Dexmethylphenidate, a Novel Prodrug Combination to Treat Attention-Deficit/Hyperactivity Disorder.
The study was designed to determine (1) the pharmacokinetic (PK) profile of dexmethylphenidate (d-MPH) after oral administration of three dosage strengths of a new treatment containing d-MPH and a novel prodrug, serdexmethylphenidate (SDX); (2) the dose proportionality of the different SDX/d-MPH dosages; and (3) the steady-state PK profile of d-MPH and SDX after multiple dosing of SDX/d-MPH. Twenty-three healthy volunteers (aged 18-55 years) under fasted conditions received in a crossover design SDX/d-MPH 26.1/5.2 mg (Treatment A), 39.2/7.8 mg (Treatment B), and 52.3/10.4 mg (Treatment C) for a total d-MPH hydrochloride equivalent dose of 20, 30, and 40 mg, respectively. After a 96-hour washout period, all participants received four consecutive daily doses of SDX/d-MPH 52.3/10.4 mg. Blood samples were collected for measurement of plasma d-MPH and SDX and for PK analysis. Administration of all three doses of SDX/d-MPH resulted in a rapid rise and slow decline in the plasma concentration of d-MPH. For Treatments A, B, and C, mean (± standard deviation) maximum concentrations () were 7.1 ± 2.1, 9.8 ± 2.8, and 13.8 ± 3.8 ng/mL, and overall exposures (AUC) were 97.2 ± 28.8, 142.5 ± 41.2, and 199.8 ± 57.2 h*ng/mL, respectively. Dose-normalized , AUC, and AUC for d-MPH were similar when comparing the high and low doses versus the middle dose. Power model regression analysis revealed that and AUC proportionally increased with an increase in SDX/d-MPH dose. In the multiple-dose study, d-MPH reached steady state before the third dose, and SDX after the first dose. The PK profile of SDX/d-MPH is characterized by a rapid rise and a gradual decline in d-MPH concentration, with proportional and AUC across doses. The PK attributes of SDX/d-MPH may optimize symptom control from early morning to early evening, while the demonstrated dose proportionality may facilitate initial dose titration and ongoing dose adjustment.
Topics: Area Under Curve; Attention Deficit Disorder with Hyperactivity; Biological Availability; Central Nervous System Stimulants; Cross-Over Studies; Delayed-Action Preparations; Dexmethylphenidate Hydrochloride; Humans; Methylphenidate; Prodrugs
PubMed: 35666231
DOI: 10.1089/cap.2022.0015 -
Journal of Child and Adolescent... 2018
Topics: Adolescent; Autism Spectrum Disorder; Central Nervous System Stimulants; Delayed-Action Preparations; Dexmethylphenidate Hydrochloride; Dyskinesias; Female; Humans
PubMed: 29781724
DOI: 10.1089/cap.2018.0034 -
Neuropsychiatric Disease and Treatment Dec 2006Attention-deficit/hyperactivity disorder (ADHD) affects a large number of children. For decades, the stimulants have been the mainstay of pharmacological treatment for...
Attention-deficit/hyperactivity disorder (ADHD) affects a large number of children. For decades, the stimulants have been the mainstay of pharmacological treatment for ADHD. Dexmethylphenidate (d-MPH), the d-isomer of the traditional racemic mixtures of d,l-threo-(R,R)-MPH, was recently introduced as another potential option in the stimulant class of medications. This paper reviews and summarizes the available research literature on d-MPH regarding pharmacodynamic, pharmacokinetic, chemical structure, receptor binding, toxicology, and clinical perspectives. d-MPH potentially may offer some advantages in the realms of absorption and duration of action compared with its racemic counterpart. The differences in pharmacokinetics and clinical implications of the immediate-release and extended-release forms of d-MPH are also compared and contrasted.
PubMed: 19412495
DOI: 10.2147/nedt.2006.2.4.467 -
Developmental Neurorehabilitation Nov 2019This study evaluated the effects of dexmethylphenidate on problem behavior during functional analyses conducted across dexmethylphenidate and placebo conditions for a...
This study evaluated the effects of dexmethylphenidate on problem behavior during functional analyses conducted across dexmethylphenidate and placebo conditions for a child with multiple disabilities. We conducted functional analyses in a multielement format embedded in a withdrawal design and collected data on the frequency of disruptive behavior and duration of crying. Results suggest disruptive behaviour was maintained by attention when DMPH was absent, but not when it was present. Results also suggest DMPH may have had collateral effects on the probability of non-targeted behaviour (crying). Consistent with previous research, functional analyses exhibited a change in disruptive behaviour's function between medication and placebo conditions. These findings provide further support that stimulant medication may change the function of disruptive behavior and highlight the need to investigate the effects of stimulants on non-targeted behaviors.
Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Dexmethylphenidate Hydrochloride; Humans; Male; Problem Behavior
PubMed: 30632865
DOI: 10.1080/17518423.2019.1566279 -
Pediatric Pulmonology Sep 2022
Topics: Chlorides; Cystic Fibrosis Transmembrane Conductance Regulator; Dexmethylphenidate Hydrochloride; Guanfacine; Humans; Metabolic Syndrome; Mutation; Sweat
PubMed: 35570399
DOI: 10.1002/ppul.25975