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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]