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Dexmethylphenidate MICROMEDEX® Healthcare Series : Document Page 1 of 31 Case 3:09-cv-00080-TMB Document 78-23 Filed 03/24/2010 Page 1 of 105 DRUGDEX® Evaluations DEXMETHYLPHENIDATE 0.0 Overview 1) Class a) This drug is a member of the following class(es): Amphetamine Related CNS Stimulant 2) Dosing Information a) Dexmethylphenidate Hydrochloride 1) Adult a) Attention deficit hyperactivity disorder 1) extended-release: methylphenidate-naive patients, initial 10 mg ORALLY daily in the morning; adjust dose weekly in 10 mg increments; MAX 20 mg/day 2) extended-release: patients currently using methylphenidate, one-half the total daily dose of racemic methylphenidate; patients currently using dexmethylphenidate immediate-release may be switched to the same daily dose of dexmethylphenidate extended-release; MAX 20 mg/day 2) Pediatric a) safety and efficacy not established in patients under 6 years of age 1) Attention deficit hyperactivity disorder a) immediate-release (ages 6 years and older): methylphenidate-naive patients, initial 2.5 mg ORALLY twice daily; adjust dose weekly in 2.5 to 5 mg increments; MAX 20 mg/day (10 mg twice a day) b) immediate-release (ages 6 years and older): patients currently using methylphenidate, one-half the dose of racemic methylphenidate; MAX 20 mg/day (10 mg twice a day) c) extended-release (ages 6 years and older): methylphenidate-naive patients, initial 5 mg ORALLY in the morning; adjust dose weekly in 5 mg increments; MAX 20 mg/day(Prod Info FOCALIN XR(R) extended-release oral capsules, 2008) d) extended-release (ages 6 years and older): patients currently using methylphenidate, one-half the total daily dose of racemic methylphenidate; patients currently using immediate release dexmethylphenidate may be switched to the same daily dose of dexmethylphenidate extended release (Prod Info FOCALIN XR(R) extended-release oral capsules, 2008) 3) Contraindications a) Dexmethylphenidate Hydrochloride 1) agitation, severe; anxiety; or tension; may aggravate symptoms (Prod Info FOCALIN(TM) XR extended- release oral capsules, 2006) 2) glaucoma (Prod Info FOCALIN(TM) XR extended-release oral capsules, 2006) 3) hypersensitivity to methylphenidate or other components of the product (Prod Info FOCALIN(TM) XR extended-release oral capsules, 2006) 4) MAOI use within 14 days; hypertensive crisis may result (Prod Info FOCALIN(TM) XR extended-release oral capsules, 2006) 5) motor tics (Prod Info FOCALIN(TM) XR extended-release oral capsules, 2006) 6) Tourette's syndrome, family history or diagnosis of (Prod Info FOCALIN(TM) XR extended-release oral capsules, 2006) 4) Serious Adverse Effects a) Dexmethylphenidate Hydrochloride 1) Mania 2) Psychotic disorder 3) Seizure 5) Clinical Applications a) Dexmethylphenidate Hydrochloride 1) FDA Approved Indications a) Attention deficit hyperactivity disorder 1.0 Dosing Information Drug Properties Storage and Stability Adult Dosage Exhibit E.11, page 1 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/7/2009 MICROMEDEX® Healthcare Series : Document Page 2 of 31 Case 3:09-cv-00080-TMB Document 78-23 Filed 03/24/2010 Page 2 of 105 Pediatric Dosage 1.1 Drug Properties A) Information on specific products and dosage forms can be obtained by referring to the Tradename List (Product Index) B) Synonyms Dexmethylphenidate Dexmethylphenidate HCl Dexmethylphenidate Hydrochloride C) Physicochemical Properties 1) Molecular Weight a) 269.77(Prod Info Focalin™, 2001a) 2) Solubility a) Systemic: Freely soluble in water and in methanol; soluble in alcohol; slightly soluble in chloroform and in acetone (Prod Info Focalin™, 2001a) 1.2 Storage and Stability A) Oral route 1) The US manufacturer recommends storage of dexmethylphenidate tablets and capsules at 25 degrees C (77 degrees F), with excursions permitted to 15 to 30 degrees C (59 to 86 degrees F). Tablets should be protected from moisture (Prod Info FOCALIN(TM) XR, 2005; Prod Info Focalin(TM), 2001d). 1.3 Adult Dosage Normal Dosage Dosage in Renal Failure Dosage in Hepatic Insufficiency 1.3.1 Normal Dosage 1.3.1.A Dexmethylphenidate Hydrochloride 1.3.1.A.1 Oral route 1.3.1.A.1.a Attention deficit hyperactivity disorder 1) Extended-Release a) The recommended starting dose for patients not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 10 milligrams (mg)/day in the morning. The dose may be adjusted weekly in 10 mg increments to a maximum of 20 mg/day for adult patients. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered (Prod Info FOCALIN(TM) XR, 2005). b) For patients currently using methylphenidate, the recommended starting dose is half the total daily dose of racemic methylphenidate. Patients using immediate-release dexmethylphenidate may be switched to the same daily dose of extended-release dexmethylphenidate. Maximum recommended dose is 20 milligrams/day (Prod Info FOCALIN (TM) XR, 2005). c) The treatment duration is unclear, however, it is generally agreed that pharmacological treatment of ADHD may be needed for extended periods. The patient should be periodically reevaluated with periods off medication to assess patient's functioning without pharmacotherapy (Prod Info FOCALIN(TM) XR, 2005). d) If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced or, if necessary, the drug should be discontinued (Prod Info FOCALIN(TM) XR, 2005). e) If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued (Prod Info FOCALIN(TM) XR, 2005). 1.3.2 Dosage in Renal Failure A) Dexmethylphenidate Hydrochloride 1) Pharmacokinetic data for dexmethylphenidate in renal impairment are unavailable. However, data for racemic methylphenidate indicate that only small amounts are excreted unchanged in the urine (about 1%) Exhibit E.11, page 2 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/7/2009 MICROMEDEX® Healthcare Series : Document Page 3 of 31 Case 3:09-cv-00080-TMB Document 78-23 Filed 03/24/2010 Page 3 of 105 (USPDI, 2001; Prod Info Focalin(TM), 2001); thus, dose adjustments of dexmethylphenidate do not appear to be necessary in this population. 1.3.3 Dosage in Hepatic Insufficiency A) Dexmethylphenidate Hydrochloride 1) Similar to methylphenidate, dexmethylphenidate undergoes hepatic metabolism (USPDI, 2001); (Prod Info Focalin(TM), 2001). Dose adjustment should be considered in patients with moderate or greater hepatic dysfunction. Specific guidelines for dexmethylphenidate or the racemic compound are unavailable. 1.4 Pediatric Dosage Normal Dosage Dosage in Renal Failure Dosage in Hepatic Insufficiency 1.4.1 Normal Dosage 1.4.1.A Dexmethylphenidate Hydrochloride 1.4.1.A.1 Oral route 1.4.1.A.1.a Attention deficit hyperactivity disorder 1) Immediate-Release a) The efficacy of dexmethylphenidate has been demonstrated only in patients 6 to 17 years of age. The drug should be given twice daily, at least 4 hours apart; it can be given with or without food (Prod Info Focalin(TM), 2001). b) In patients not currently receiving racemic methylphenidate, or for those who are on stimulants other than methylphenidate, the manufacturer recommends an initial dose of 2.5 milligrams (mg) twice daily, with dose adjustments in 2.5- to 5-mg increments to a maximum of 10 mg twice daily; dose adjustments may be undertaken at approximately weekly intervals (Prod Info Focalin(TM), 2001). An extended-release methylphenidate formulation (duration, 8 hours) may be preferable, as administration of doses during school can be eliminated; generic formulations are available. c) For patients who are currently receiving racemic methylphenidate, the initial dose recommended by manufacturer is half the dose of methylphenidate, with a maximum daily dose of 20 mg (10 mg twice daily) (Prod Info Focalin(TM), 2001). However, available data suggest no clinical advantage in switching to the d-enantiomer. d) The longest duration of effective treatment in clinical studies with dexmethylphenidate has been 6 weeks (Prod Info Focalin(TM), 2001). However, prolonged use may be indicated. Racemic methylphenidate has maintained improvement for up to 2 years. 2) Extended-Release a) The recommended starting dose for patients not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 milligrams (mg)/day in the morning. The dose may be adjusted weekly in 5 mg increments to a maximum of 20 mg/day for pediatric patients. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered (Prod Info FOCALIN XR(R) extended-release oral capsules, 2008). b) For patients currently using methylphenidate, the recommended starting dose is half the total daily dose of racemic methylphenidate. Patients using immediate-release dexmethylphenidate may be switched to the same daily dose of extended-release dexmethylphenidate. Maximum recommended dose is 20 milligrams/day (Prod Info FOCALIN XR(R) extended-release oral capsules, 2008). c) The treatment duration is unclear, however, it is generally agreed that pharmacological treatment of ADHD may be needed for extended periods. The patient should be periodically reevaluated with periods off medication to assess patient's functioning without pharmacotherapy (Prod Info FOCALIN XR(R)
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