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Kasr Alainy Drug Information Center Newsletter Volume 1 Issue 2, Novamber 2010 We opened since 1/3/2010, one of the activities of clinical Pharmacology and Pharmacy committee. Our mission is to provide a better drug information service for hospital patients by providing the advice for the best use of drug. The Service provided by the Centre in the first place is answering inquiries from medical workers to optimize the use of medication available in Kasr Alainy hospitals and solving problems related to the use of medicines and what is new in the world of medicine. Center In this issue: Once-daily dosing of the aminoglycoside Gentamicin. (P.1.2) Market withdrawal of Meridia. (P.3) Risk of Cardiovascular Events of Avandia. (P.3) From our questions (Switching from atorvastatin to simvastatin). (P.4) A Drug Overview Once-daily dosing of the aminoglycoside Gentamicin… ? The traditional approach to Gentamicin dosing involves the administration of 1 to 3 mg/kg intravenously (IV) every eight hours in adults; the dose is reduced and/or the dosing interval extended in patients with decreased renal functions.(1) Gentamicin is potentially nephrotoxic and neurotoxic where neurotoxicity is manifested by ototoxicity both vestibular and auditory. The risk of nephrotoxicity and ototoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged therapy, therefore patients treated with Gentamicin should be under close clinical observation .(2) The consolidated aminoglycoside therapy of Gentamicin which is also known as once-daily aminoglycosides, single daily aminoglycoside dosing, or high-dose aminoglycoside therapy, uses doses of 7 mg/kg every 24 hours or longer in patients with renal dysfunction, taking in consideration that the consolidated Gentamicin therapy should not be confused with an every 24hour regimen used with "traditional" dosing (i.e., 1 to 3 mg/kg) whose frequency of administration has been adjusted because of renal dysfunction. [1] KASR ALAINY DRUG INFORMATION CENTER The consolidated Gentamicin therapy is most frequently employed in the treatment of gram-negative pathogens and data on this use of aminoglycoside therapy as part of combination therapy treatment of gram-positive pathogens are limited. The once-daily dosage, in the suitable patients, appears to be as safe and effective as conventional regimens, and is more convenient. However, it is not suitable for all patients, especially those with endocarditis, extensive burns, or renal impairment (creatinine clearance less than 20 mL/minute). (3) The once daily aminoglycoside administration has three potential advantages over traditional administration with comparable efficacy: Possibility of decreased nephrotoxicity, based primarily on data from animal models. Ease of administration and serum concentration monitoring. Reductions in cost.(3) A clinical study in the Kasr Alainy hospital on the efficacy of the consolidated Aminoglycoside therapy: Multiple clinical trials worldwide have compared the efficacy of consolidated aminoglycoside dosing and divided daily dosing in both adults and children. One of these studies was carried out in the Kasr Alainy hospital. The study done on the two aminoglycosides Gentamicin and Amikacin proved that the once daily dosing regimen is preferred in critically ill patients to individualized multiple daily dosing. The study proved that the efficacy of both regimens is the same, no difference was noticed regarding the incidence of nephrotoxicity and there was no need for dose adjustments in the once daily dosing regimen since the serum levels measured at the steady state (i.e. before the forth dose) have never been above the toxic levels in both the two Aminoglycosides. (4) References: 1-Martindale 36th edition, 2-FDA professional Gentamicin sulphate injection monograph 3-Uptodate.com 4-Clinical Pharmacokinetics of Single versus Multiple Daily Dosing of Aminoglycosides in Critically Ill Patients . Practical application in achieving optimum drug Efficacy and avoiding toxicity”, a thesis submitted by Pharmacist Naglaa Bazan, critical care medicine departments, Cairo university hospitals; under supervision of prof. Dr. Ahmed Abd El Bary, PHD; Prof. Dr. Sherif Mokhtar, MD and Asst. Prof. Dr. Nagwa Saber, PHD. [2] KASR ALAINY DRUG INFORMATION CENTER FDA News and Alerts 1. Market withdrawal of MERIDIA (Sibutramine) [October 8, 2010] (Also available in the Egyptian market as Sibotrim, Regitrim, Slimax, Diet-Max and Smartan) (1) Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (Sibutramine), an obesity drug, from the market because of clinical trial data indicating an increased risk of heart attack and stroke, after reviewing the data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given Sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received Sibutramine. Recommendations: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. (2) References: 1- Drugs> Drug Safety and Availability on FDA 2- 2- Master on therapeutic drugs 2011. 2. Avandia (Rosiglitazone)…Risk of Cardiovascular Events [09/23/2010] (Also available in the Egyptian market as Rosizone, Rosidexx, Diazan, Rosilon, Rosiglit, Rosandia and Avalgit.Rosiglitazone also found combined with other drugs in Avandaryl, Avandamet, and Rosiplus) (2) Audience: Endocrinology, Cardiology The use of the diabetic drug Avandia (Rosiglitazone) by patients with Type 2 diabetes will be significantly restricted. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia. The manufacturer is required by the FDA to develop a restricted access program for Avandia under a risk evaluation and mitigation strategy (REMS). Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Pioglitazone. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. (1) References: 1-Med Watch the FDA Safety Information and Adverse Event Reporting Program>Safety Information 2010. 2-Master on therapeutic drugs [3] KASR ALAINY DRUG INFORMAION CENTER From our answered questions Advisory Board: How to switch from Atorvastatin to Simvastatin The most significant difference between Atorvastatin and Simvastatin when switching patients is that simvastatin but not atorvastatin requires caution at doses above 10mg in renal impairment and so lower doses may be appropriate in patients with chronic renal failure. Also special dosing considerations are required when used with a number of drugs, including some antiarrhymics and calcium channel-blockers. A comparative study of the efficacy of some statins showed that, 10 mg of atorvastatin is approximately equivalent to 30 mg simvastatin. (2,3) Dr.Magda Zaki Professor of Pharmacology, Head of Pharmacology department, Faculty of medicine, Cairo University. Dr. Samia Rashid Ex Head of Pharmacy department, Technical director of KDIC, Cairo University Hospitals. Editorial Board: Chief Editor: Dr.Rania Ramzi Director of KDIC, Drug information specialist, Cairo University Hospitals. Editors: Dr. Samar Samy Drug information pharmacist, Cairo university Hospitals. Dr. Maha Ollaek Drug information pharmacist, Cairo university Hospitals. Note: Following the Heart Protection Study there is a growing consensus, as highlighted in a recent article in the British Medical Journal, that all patients taking both 10 and 20 mg atorvastatin should be switched to 40 mg simvastatin. (4, 5) Dr.Doaa Bazan Drug information pharmacist, Cairo university Hospitals. To contact us Internal line: 1260 External line & Fax: 23687397 Email: [email protected] References: 1-Medscape CME 2-Jones P, Kafonek S, Laurora I et al. Comparative dose efficacy study of atorvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES Study). Am J Cardiol 1998; 81: 582-7. 3-Jones P, Davidson M, Stein E et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). Am J Cardiol 2003; 92: 152-60. 4-Heart Protection Study Collaborative Group. MCR/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 20,536 high-risk individuals: a randomized placebo-controlled trial. Lancet 2002; 360: 7-22. 5- Moon JC. Switching statins. BMJ 2006; 332: 1344-5. [4]