Methylphenidate Extended-Release Tablets

Abstract

Each month, subscribers to The Formulary® Monograph Service receive five to six researched monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board called The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical pharmacy are discussed on The F.I.X.

Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The December 2000 Formulary monographs are budesonide inhalation suspension, arsenic trioxide, sodium phosphate, ziprasidone, and unoprostone. The DUE is on budesonide inhalation suspension.

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References

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Approval letter for NDA 21-121. Center for Drug Evaluation and Research. Food and Drug Administration. 1 August 2000.

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Single- and multiple-dose pharmacokinetics of an oral once-a-day osmotic controlled-release OROS7 (methylphenidate HCl) formulation. J Clin Pharmacol. 2000; 40: 379–88.

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Evaluation of different methylphenidate HCl (MPH) delivery patterns for the treatment of children with ADHD [abstract]. American Academy of Neurology Annual Meeting, San Diego, CA; 29 April–6 May, 2000.

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Lack of effect of different breakfast conditions on the pharmacokinetics and efficacy of OROS7 methylphenidate HCl extended-release tablets in children with ADHD [abstract]. Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting, Boston, MA; 12–16 May 2000.

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Approval letter for ANDA 40-306 (Metadate ER Tablets). Center for Drug Evaluation and Research— Food and Drug Administration. 20 October 1999. http://www.fda.gov/cder/foi/appletter/1999/40306LTR.PDF

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Optimizing methylphenidate delivery to improve treatment for ADHD: Results with OROS7 (methylphenidate HCl) [abstract]. Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting, Boston, MA; 12–16 May 2000.

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Anonymous. AACAP: Concerta may provide once-daily treatment for ADD/ADHD. Doctor's Guide to Medical and Other News. http://ww.pslgroup.com/dg/13e452.htm. Accessed 25 October 1999.

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Comparison of the efficacy and safety of OROS methylphenidate HCl with methylphenidate tid and placebo in children with ADHD [abstract]. Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting, Boston, MA; 12–16 May 2000.

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Evaluation of once-a-day OROS methylphenidate HCl (MPH) extended-release tablet versus MPH tid in children with ADHD in natural school settings [abstract]. Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting, Boston, MA; 12–16 May 2000.

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Evaluation of once-a-day OROS methylphenidate HCl (MPH) extended-release tablet versus MPH tid in children with ADHD in a laboratory setting [abstract]. Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting, Boston, MA; 12–16 May 2000.

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Randomized controlled trial of OROS methylphenidate HCl dosed qd in children with attention deficit hyperactivity disorder [abstract]. American Psychiatric Association Annual Meeting, Chicago, IL; 13–18 May 2000.

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Evaluation of efficacy and safety of OROS methylphenidate HCl (MPH) extended-release tablets, methylphenidate tid, and placebo in children with ADHD [abstract]. Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting, Boston, MA; 12–16 May 2000.

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Approval letter for ANDA 75-629 (Methylin ER Tablets). Center for Drug Evaluation and Research— Food and Drug Administration. http://www.fda.gov/cder/foi/appletter/2000/75629ltr.pdf. Accessed 9 May 2000.