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Clinical Rx Forum Volume 4 Issue 1

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Clinical Rx Forum Volume 4 Issue 1 In This Issue Clevidipine for Hypertensive Urgency and Emergency From the Department of Pharmacy Tramadol: No Longer the Codeine Alternative January/February Issue 2016 Volume 4, Issue 1 FDA Medication Safety Alert: Risk of VTE with TestClevidipine for Hypertensive Urgency and Emergency osterone By: Gretchen D’Arcangelo, Pharm.D. Marcia J. Wyman, Pharm.D., BCPS Introduction: Hypertensive emergen- istration (FDA) for the reduction of BP Drug Information Pharmacist cies are deLined by potentially life- when oral therapy is not feasible Editor threatening elevations in blood pres- or desirable. 3 sure (BP) greater than 180/120 mmHg Mandy C. Leonard, Pharm.D., BCPS Pharmacokinetics: Following IV ad- System Director, Drug Use Policy and and are also paired with organ dysfunc- 1 ministration, clevidipine is rapidly me- Formulary Management tion. Hypertensive urgencies, on the Editor other hand, do not have the characteris- tabolized by blood and tissue esterases tic organ dysfunction present. These giving it a very quick onset of action Meghan K. Lehmann, Pharm.D., BCPS hypertensive crises are said to account and short half-life. 3 Its pharmacologic Drug Information Specialist effect starts within 2 to 4 minutes with Editor for up to 3% of emergency department admissions, with about three-fourths of a duration of action of up to 15 minutes. Marigel Constantiner, MSc, BCPS, CGP, CPh those admissions due to hypertensive EfLicacy and Safety: Patients undergo- Drug Information Specialist emergencies. 2 In patients with either Associate Editor ing cardiac surgery diagnosed with hy- hypertensive urgency or emergency, pertension in the past 6 months were immediate BP reduction should be at- Christopher Snyder, B.S., R.Ph. included in a randomized, double-blind, Drug Information Pharmacist tempted either with oral or intravenous placebo-controlled evaluation of clev- Associate Editor (IV) antihypertensives as appropriate. 1 idipine. 4 Treatment failure, deLined as Intravenous agents utilized for these Kara J. Sink, B.S., R.Ph. failure to decrease systolic BP (SBP) by clinical scenarios could include nicardi- Drug Information Pharmacist ≥15% from baseline or inability to com- pine, sodium nitroprusside, or clev- Associate Editor plete the study, occurred in 82.7% of idipine, with the agent selected based the placebo group compared to only Brian Hoffmaster, Pharm.D., BCPS on appropriate patient-speciLic factors. Student Education Pharmacist 7.5% of the clevidipine-treated group Clevidipine (Cleviprex ®), a dihydro- Associate Editor with a time to target SBP (≤15% base- pyridine calcium channel blocker, is Maya Wai, Pharm.D. approved by the Food and Drug Admin- (Continued on page 2) Drug Information Pharmacist Associate Editor Tramadol: No Longer the Codeine Alternative Scott Knoer, MS, Pharm.D., FASHP Chief Pharmacy OfPicer By: Maria Sellas, Pharm.D. Introduction: Tramadol (Ultram ®) is a ceived tramadol. 3 Those who were giv- centrally-acting, synthetic opioid anal- en tramadol for pain control following a gesic used for moderate to severe pain. 1 tonsillectomy and/or adenoidectomy Although this schedule IV controlled were thought to be at a greater risk for substance is not approved by the Food this adverse effect. and Drug Administration (FDA) for use From the Department of Pharmacy in children under 16 years old, it is used Pharmacogenomics of Tramadol: Drug Information Service off-label in pediatrics at a recommend- Tramadol is extensively metabolized (216) 444-6456, option #1 ed dosage range of 1-2 mg/kg/dose by the Cytochrome P450(CYP)2D6 and every 4 to 6 hours. 2 On September 21, CYP3A4 isoenzymes. Through the Comprehensive information about 2015, the FDA issued a Drug Safety CYP2D6 enzyme system, tramadol is medications, biologics, nutrients, Communication regarding a serious metabolized to an active metabolite, O- and drug therapy risk of slowed or difLicult breathing in desmethyltramadol, which has a 200- children under the age of 17, who re- (Continued on page 3) (Continued from page 1) line SBP) of 6 minutes in the treatment arm. 4 A simi- Availability and Cost: Clevidipine is available as larly designed trial evaluated patients undergoing car- a 0.5 mg/mL, 50 mL vial with a suggested wholesale diac surgery who were randomized to either clev- price (SWP) of $108. 9 Nicardipine, which is available idipine or placebo in the postoperative setting; this as a 20 mg/200 mL IV piggyback, has a SWP of $114. investigation found that treatment failure occurred in Sodium nitroprusside is available as a 25 mg/mL, 79.6% of placebo-treated patients compared to 8.2% 2 mL vial and has a SWP of $1057. of clevidipine-treated patients with a median time to target SBP of 5.3 minutes for clevidipine. 5 Another Formulary Status: Clevidipine, which was FDA- study involving cardiac surgery patients found no sig- approved in 2008, was added to the Cleveland niLicant difference in 30-day safety endpoints including Clinic Health System (CCHS) Formulary in 2015 in re- death, myocardial infarction, stroke, and renal dys- sponse to a signiLicant cost increase to sodium nitro- function in those treated with clevidipine compared prusside. Its use in adults throughout CCHS is unre- with sodium nitroprusside, nitroglycerin, or nicardi- stricted at this time. It remains non-formulary for pe- pine. 6 Finally, in an open-label, single-arm trial evalu- diatric patients. ating the use of clevidipine in patients with severe per- sistent hypertension deLined as SBP >180 mmHg and/ References: 1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, or diastolic BP >115 mmHg, clevidipine use was asso- Izzo JL Jr, Jones DW,Materson BJ, Oparil S, Wright JT Jr, Roccel- ciated with a reduction in BP within the individualized la EJ; Joint National Committee on Prevention, Detection, Eval- patient-speciLic target BP range in 88.9% of patients uation, and Treatment of High Blood Pressure. National Heart, with a median time to achievement of 10.9 minutes. 7 Lung, and Blood Institute; National High Blood Pressure Edu- cation Program Coordinating Committee. Seventh report of Dosing and Administration: The recommended the Joint National Committee on Prevention, Detection, Evalu- ation, and Treatment of High Blood Pressure. Hypertension. starting dose of clevidipine is 1-2 mg/hr which is then 2003 Dec;42(6):1206-52. titrated based on BP response. 3 For titration, the dose 2. Zampaglione B, Pascale C, Marchisio M, Cavallo-Perin P. Hy- can be doubled in short (90 second) intervals initially; pertensive urgencies and emergencies: prevalence and clinical however once the BP is nearing goal, smaller dosage presentation. Hypertension. 1996;27(1):144-7. ® increases should be employed at longer time intervals 3. Cleviprex (clevidipine butyrate) inJectable emulsion for in- travenous use [package inert]. Parsippany, NJ: The Medicines (every 5 to 10 minutes). It is estimated that Company; Dec 2014. a 1-2 mg/hr increase will produce an additional 4. Levy JH, Mancao MY, Gitter R, Kereiakes DJ, Grigore AM, Ar- 2-4 mmHg decrease in SBP. The standard maintenance onson S, et al. Clevidipine effectively and rapidly controls dose that achieves appropriate therapeutic response in blood pressure preoperatively in cardiac surgery patients: the a maJority of patients is between 4-6 mg/hr; however results of the randomized, placebo-controlled efLicacy study of clevidipine assessing its preoperative antihypertensive effect higher doses may be required for severe hypertension. in cardiac surgery-1. Anesth Analg. 2007 Oct;105(4):918-25. Clevidipine is formulated as an oil-in-water, lipid emul- 5. Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Ar- sion. Due to lipid load restrictions, it is recommended onson S, et al. Treatment of acute postoperative hypertension not to exceed 1000 mL/day (2000 kcal/day) of this in cardiac surgery patients: an efLicacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac medication. Patients receiving clevidipine and being surgery-2 (ESCAPE-2), a randomized, double-blind, placebo- transitioned to oral antihypertensive agents should be controlled trial. Anesth Analg. 2008 Jul;107(1):59-67. monitored for at least 8 hours after discontinuation 6. Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, due to the risk of rebound hypertension. et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute Clevidipine Clinical Pearls: hypertension treatment in cardiac surgery patients. Anesth • Analg. 2008 Oct;107(4):1110-21. Once the clevidipine vial is punctured, any product 7. Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Pea- remaining after 12 hours should be discarded and cock WF. Clevidipine, an intravenous dihydropyridine calcium all IV lines used for administration and delivery channel blocker, is safe and effective for the treatment of pa- should be changed. tients with acute severe hypertension. Ann Emerg Med. 2009 • Mar;53(3):329-38. Clevidipine contains 2 kcal/mL of lipids, compared ® 3,8 8. Diprivan (propofol) [prescribing information]. Lake Zurich: to propofol which contains 1.1 kcal/mL. If given Fresenius Kabi USA, LLC; February 2014. together, attention should be paid to the cumula- 9. Lexi-Comp Online, Lexi-Drugs Online, Hudson, Ohio: Lexi- tive amount of kilocalories being administered Comp Inc; 2016 : January 4, 2016. from both products. • Like propofol, clevidipine should not be sent through the pneumatic tube system. 2 (Continued from page 1) fold greater afLinity for the mu -opioid receptor than What’s in Store for Tramadol? The FDA is currently the parent drug. 2,4 Genetic variability in the CYP2D6 investigating the pharmacogenomic impact of tra- isoenzyme can cause differences in the drug’s metabol- madol in the pediatric population. It is encouraging ic rate and consequent serum concentration levels. Pa- medical professionals to report any adverse events tients with increased CYP2D6 activity, classiLied as ul- related to tramadol to the FDA’s MedWatch Safety In- tra-rapid metabolizers, produce more of the active me- formation and Adverse Event Reporting Program.
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