Pharmacy & Therapeutics - June 2008 - (Page 313)

DORIBAX™ (doripenem for injection) DRUG INTERACTIONS Valproic Acid: A clinically significant reduction in serum valproic acid concentrations has been reported in patients receiving carbapenem antibiotics and may result in loss of seizure control. Although the mechanism of this interaction is not fully understood, data from in vitro and animal studies suggest that carbapenem antibiotics may inhibit valproic acid glucuronide hydrolysis. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations cannot be maintained in the therapeutic range or a seizure occurs. [see Warnings and Precautions] Probenecid: Probenecid interferes with the active tubular secretion of doripenem, resulting in increased plasma concentrations of doripenem. [see Clinical Pharmacology (12.3) in full Prescribing Information] Coadministration of probenecid with DORIBAXTM is not recommended. USE IN SPECIFIC POPULATIONS Pregnancy: Category B: Doripenem was not teratogenic and did not produce effects on ossification, developmental delays or fetal weight following intravenous administration during organogenesis at doses as high as 1 g/kg/day in rats and 50 mg/kg/day in rabbits (based on AUC, at least 2.4 and 0.8 times the exposure to humans dosed at 500 mg q8h, respectively). There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DORIBAXTM is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Of the total number of subjects in clinical studies of DORIBAXTM, 28% were 65 and over, while 12% were 75 and over. Clinical cure rates in complicated intra-abdominal and complicated urinary tract infections were slightly lower in patients ≥65 years of age and also in the subgroup of patients ≥75 years of age versus patients <65. These results were similar between doripenem and comparator treatment groups. No overall differences in safety were observed between older and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Elderly subjects had greater doripenem exposure relative to nonelderly subjects; however, this increase in exposure was mainly attributed to age-related changes in renal function. [see Clinical Pharmacology (12.3) in full Prescribing Information] This drug is known to be excreted substantially by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function or pre-renal azotemia. Because elderly patients are more likely to have decreased renal function or pre-renal azotemia, care should be taken in dose selection, and it may be useful to monitor renal function. Patients with Renal Impairment: Dosage adjustment is required in patients with moderately or severely impaired renal function. [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) in full Prescribing Information] In such patients, renal function should be monitored. PATIENT COUNSELING INFORMATION • Patients should be advised that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. They should report any previous hypersensitivity reactions to DORIBAXTM, other carbapenems, beta-lactams or other allergens. • Patients should be counseled that anti-bacterial drugs including DORIBAX™ should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When DORIBAX™ is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by DORIBAX™ or other antibacterial drugs in the future. • Keep out of the reach of children. MINI-BAG Plus is a trademark of Baxter International Inc. Manufactured by: Shionogi & Co. Ltd. Osaka 541-0045, Japan January 2008 Distributed by: Ortho-McNeil Pharmaceutical, Inc. Raritan, NJ 08869 10157601B Try Our New Digital Edition The digital edition of P&T is now available. Readers see a complete copy of an issue on their computer screens, with the added ability to search through every single word in the issue. With the digital edition, you can: • click on any URL anywhere in the magazine and go directly to that Web page. • click on the title of any article on the cover or in the table of contents and go directly to that article. • search for any string of characters. • make and save notes with the article that you are reading. • instantly e-mail a link to any article to an associate. • get more information about advertised products by clicking on an ad. • save the magazine file to your desktop for offline reading. • print any or all pages. June 2008 www.PTCommunity.com Volume 33 Number 6 How to Use the Digital Edition To navigate through the issue, use the control bar at the top of the screen. Turn the pages as you would do with the print edition. To access more help click on the red question mark in the bar. Opens the Tools menu. View a list of all articles. Zoom in and out on the current page. Click the word “Zoom” to open the zoom configuration window. Switch to single-page view. Open the magnify window. Navigate to the previous or next page. Navigate to the cover or back page. Search the full text of the issue for a word or phrase. Print pages. Save an offline version to your computer. Save the direct link to an article to bookmark or email A Peer-Reviewed Jour nal for Managed Care and Hospital Formular y Management Challenges in Evaluating and Standardizing Medical Devices In Health Care Facilities C. L. Ventola, MS MEETING HIGHLIGHTS American Psychiatric Association W. Alexander TECHNOLOGY California e-Pedigree Rules Pose Challenges for Pharmacies S. Barlas MEDICATION ERRORS The High Cost of Medications A Bitter Pill to Swallow M. Grissinger, RPh, FASCP MEDICATION ERRORS DRUG FORECAST Etonogestrel (Implanon), Another Treatment Option for Contraception D. D. Maddox, PharmD, and Z. Rahman, PharmD Pharmaceutical Approval Update M. M. Goldenberg, PhD, RPh, MS You can receive P&T’s digital edition every month free by registering here: http://www.ptcommunity.com/digital P&T SNAPSHOT At a Glance: Dermatology Trends In Managed Care N. Scheinfeld, MD, J. Jesitus, MA, and P. Sonnenreich, MA SIGN UP NOW to receive an alert when each new issue is available: http://www.ptcommunity.com/digital http://www.PTCommunity.com http://www.ptcommunity.com/digital http://www.ptcommunity.com/digital

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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