Skip to main content
Erschienen in: CNS Drugs 6/2001

01.06.2001 | Adis New Drug Profile

Methylphenidate (OROS® Formulation)

verfasst von: Gillian M. Keating, Karen McClellan, Blair Jarvis

Erschienen in: CNS Drugs | Ausgabe 6/2001

Einloggen, um Zugang zu erhalten

Abstract

  • ▲ Methylphenidate is a CNS stimulant that is thought to block the reuptake of dopamine and noradrenaline (norepinephrine) into the presynaptic neuron. A sustained release (OROS®) formulation of the drug has been developed for use in children with attention deficit/hyperactivity disorder (ADHD).
  • ▲ In children aged 6 to 12 years with ADHD, the maximum plasma concentration of OROS® methylphenidate 18 to 54mg was reached after approximately 7 to 8 hours. In adults, the plasma concentration-time profile of OROS® methylphenidate differed markedly from that of the sustained release and immediate release (IR) methylphenidate formulations.
  • ▲ In a clinical trial involving 282 children with ADHD, once daily OROS® methylphenidate 18 to 54mg was significantly more effective than placebo and demonstrated an effect similar to IR methylphenidate 5 to 15mg 3 times daily in reducing the symptoms of ADHD.
  • ▲ OROS® methylphenidate demonstrated sustained efficacy in a 1-year noncomparative study involving children with ADHD.
  • ▲ In clinical trials, the OROS® formulation of methylphenidate had a tolerability profile similar to that of IR methylphenidate.
Fußnoten
1
1SKAMP = Swanson,Kotkin,Atkins,M-Flynn andPelham.
 
Literatur
1.
Zurück zum Zitat Kimko HC, Cross JT, Abernethy DR. Pharmacokinetics and clinical effectiveness of methylphenidate. Clin Pharmacokinet 1999 Dec; 37: 457–70PubMedCrossRef Kimko HC, Cross JT, Abernethy DR. Pharmacokinetics and clinical effectiveness of methylphenidate. Clin Pharmacokinet 1999 Dec; 37: 457–70PubMedCrossRef
2.
Zurück zum Zitat Findling RL, Dogin JW. Psychophannacology of ADHD: children and adolescents. J Clin Psychiatry 1998; 59Suppl. 7: 42–9PubMed Findling RL, Dogin JW. Psychophannacology of ADHD: children and adolescents. J Clin Psychiatry 1998; 59Suppl. 7: 42–9PubMed
3.
Zurück zum Zitat ALZA Corporation. CONCERTA™ (methylphenidate HCl) prescribing information [online]. ALZA Corporation. Available from: URL: http://www.concerta.net [Accessed 2001 Feb 21] ALZA Corporation. CONCERTA™ (methylphenidate HCl) prescribing information [online]. ALZA Corporation. Available from: URL: http://​www.​concerta.​net [Accessed 2001 Feb 21]
4.
Zurück zum Zitat Wolraich ML. Long-term safety and effectiveness of CONCERTA™ (methylphenidate HCl) in children with ADHD [poster]. 12th Annual International CHADD Conference on Attention-Deficit/Hyperactivity Disorder; 2000 Nov 1–4; Chicago (IL) Wolraich ML. Long-term safety and effectiveness of CONCERTA™ (methylphenidate HCl) in children with ADHD [poster]. 12th Annual International CHADD Conference on Attention-Deficit/Hyperactivity Disorder; 2000 Nov 1–4; Chicago (IL)
5.
Zurück zum Zitat Modi NB, Wang B, Noveck RJ, et al. Dose-proportional and stereospecific pharmacokinetics of methylphenidate delivered using an osmotic, controlled-release oral delivery system. J Clin Pharmacol 2000 Oct; 40: 1141–9PubMed Modi NB, Wang B, Noveck RJ, et al. Dose-proportional and stereospecific pharmacokinetics of methylphenidate delivered using an osmotic, controlled-release oral delivery system. J Clin Pharmacol 2000 Oct; 40: 1141–9PubMed
6.
Zurück zum Zitat Modi NB, Lindemulder B, Gupta SK. Single-and multiple-dose pharmacokinetics of an oral once-a-day osmotic controlledrelease OROS (methylphenidate HCl) formulation. J Clin Pharmacol 2000 Apr; 40: 379–88PubMedCrossRef Modi NB, Lindemulder B, Gupta SK. Single-and multiple-dose pharmacokinetics of an oral once-a-day osmotic controlledrelease OROS (methylphenidate HCl) formulation. J Clin Pharmacol 2000 Apr; 40: 379–88PubMedCrossRef
7.
Zurück zum Zitat Baren M, Swanson JM, Wigal SB, et al. Lack of effect of breakfast conditions on the pharmacokinetics and efficacy of OROS® methylphenidate HCl extended-release tablets in children with ADHD [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA) Baren M, Swanson JM, Wigal SB, et al. Lack of effect of breakfast conditions on the pharmacokinetics and efficacy of OROS® methylphenidate HCl extended-release tablets in children with ADHD [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA)
8.
Zurück zum Zitat Wolraich W, on behalf of the CONCERTA™ Study Group. Evaluation of efficacy and safety of OROS® methylphenidate HCl (MPH) extended-release tablets, methylphenidate tid, and placebo in children with ADHD [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA) Wolraich W, on behalf of the CONCERTA™ Study Group. Evaluation of efficacy and safety of OROS® methylphenidate HCl (MPH) extended-release tablets, methylphenidate tid, and placebo in children with ADHD [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA)
9.
Zurück zum Zitat Pelham WE, Hoffman MT, Lock T, et al. Evaluation of once-a-day OROS® methylphenidate HCl (MPH) extended-release tablet versus MPH tid in children with ADHD in natural school settings [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA) Pelham WE, Hoffman MT, Lock T, et al. Evaluation of once-a-day OROS® methylphenidate HCl (MPH) extended-release tablet versus MPH tid in children with ADHD in natural school settings [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA)
10.
Zurück zum Zitat Pelham WE, Hoffman MT, Lock T, et al. Evaluation of once-a-day OROS® methylphenidate HCl (MPH) extended-release tablets vs MPH tid in children with ADHD in a laboratory setting [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA) Pelham WE, Hoffman MT, Lock T, et al. Evaluation of once-a-day OROS® methylphenidate HCl (MPH) extended-release tablets vs MPH tid in children with ADHD in a laboratory setting [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA)
11.
Zurück zum Zitat Swanson JM, Wigal SB, Lerner MA, et al. Comparison of the efficacy and safety of OROS® methylphenidate HCl with methylphenidate tid and placebo in children with ADHD [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA) Swanson JM, Wigal SB, Lerner MA, et al. Comparison of the efficacy and safety of OROS® methylphenidate HCl with methylphenidate tid and placebo in children with ADHD [poster]. The Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting; 2000 May 12–16; Boston (MA)
12.
Zurück zum Zitat Williams L, Steinhoff K. Treatment preference comparison of CONCERTA™ (methylphenidate HCl) extended-release tablets, MPH tid, and placebo in children with ADHD [poster]. 12th Annual International CHADD Conference on Attention-Deficit/Hyperactivity Disorder; 2000 Nov 1–4; Chicago (IL) Williams L, Steinhoff K. Treatment preference comparison of CONCERTA™ (methylphenidate HCl) extended-release tablets, MPH tid, and placebo in children with ADHD [poster]. 12th Annual International CHADD Conference on Attention-Deficit/Hyperactivity Disorder; 2000 Nov 1–4; Chicago (IL)
13.
Zurück zum Zitat McDaniel D, Schnipper E, Madrid A. Consistency of measures for assessing ADHD symptoms [poster]. American Academy of Child and Adolescent Psychiatry Annual Meeting; 2000 Oct 24–29; New York (NY) McDaniel D, Schnipper E, Madrid A. Consistency of measures for assessing ADHD symptoms [poster]. American Academy of Child and Adolescent Psychiatry Annual Meeting; 2000 Oct 24–29; New York (NY)
14.
Zurück zum Zitat Schnipper E, McDaniel D, Evashenk M. Open-label study to evaluate participant use and safety of CONCERTA™ (methylphenidate HCl) in subjects with ADHD in a community setting [other]. 12th Annual International CHADD Conference on Attention-Deficit/Hyperactivity Disorder; 2000 Nov 1–4; Chicago (IL) Schnipper E, McDaniel D, Evashenk M. Open-label study to evaluate participant use and safety of CONCERTA™ (methylphenidate HCl) in subjects with ADHD in a community setting [other]. 12th Annual International CHADD Conference on Attention-Deficit/Hyperactivity Disorder; 2000 Nov 1–4; Chicago (IL)
15.
Zurück zum Zitat Swanson J, Greenhill L, Pelham W, et al. Dose-ranging initiation of Concerta™ (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder. J Clin Res 2000; 3: 59–76 Swanson J, Greenhill L, Pelham W, et al. Dose-ranging initiation of Concerta™ (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder. J Clin Res 2000; 3: 59–76
16.
Zurück zum Zitat Swanson J, Sadeh A, Lerner MA, et al. Comparison of the impact of OROS methylphenidate HCl with methylphenidate tid and placebo on the sleep of children with ADHD. ALZA Corporation (Mountain View, CA, US), 2000. (Data on file) Swanson J, Sadeh A, Lerner MA, et al. Comparison of the impact of OROS methylphenidate HCl with methylphenidate tid and placebo on the sleep of children with ADHD. ALZA Corporation (Mountain View, CA, US), 2000. (Data on file)
Metadaten
Titel
Methylphenidate (OROS® Formulation)
verfasst von
Gillian M. Keating
Karen McClellan
Blair Jarvis
Publikationsdatum
01.06.2001
Verlag
Springer International Publishing
Erschienen in
CNS Drugs / Ausgabe 6/2001
Print ISSN: 1172-7047
Elektronische ISSN: 1179-1934
DOI
https://doi.org/10.2165/00023210-200115060-00006

Weitere Artikel der Ausgabe 6/2001

CNS Drugs 6/2001 Zur Ausgabe

Leitlinien kompakt für die Neurologie

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Sozialer Aufstieg verringert Demenzgefahr

24.05.2024 Demenz Nachrichten

Ein hohes soziales Niveau ist mit die beste Versicherung gegen eine Demenz. Noch geringer ist das Demenzrisiko für Menschen, die sozial aufsteigen: Sie gewinnen fast zwei demenzfreie Lebensjahre. Umgekehrt steigt die Demenzgefahr beim sozialen Abstieg.

Hirnblutung unter DOAK und VKA ähnlich bedrohlich

17.05.2024 Direkte orale Antikoagulanzien Nachrichten

Kommt es zu einer nichttraumatischen Hirnblutung, spielt es keine große Rolle, ob die Betroffenen zuvor direkt wirksame orale Antikoagulanzien oder Marcumar bekommen haben: Die Prognose ist ähnlich schlecht.

Was nützt die Kraniektomie bei schwerer tiefer Hirnblutung?

17.05.2024 Hirnblutung Nachrichten

Eine Studie zum Nutzen der druckentlastenden Kraniektomie nach schwerer tiefer supratentorieller Hirnblutung deutet einen Nutzen der Operation an. Für überlebende Patienten ist das dennoch nur eine bedingt gute Nachricht.

Thrombektomie auch bei großen Infarkten von Vorteil

16.05.2024 Ischämischer Schlaganfall Nachrichten

Auch ein sehr ausgedehnter ischämischer Schlaganfall scheint an sich kein Grund zu sein, von einer mechanischen Thrombektomie abzusehen. Dafür spricht die LASTE-Studie, an der Patienten und Patientinnen mit einem ASPECTS von maximal 5 beteiligt waren.

Update Neurologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.