-- Back to Table of ContentsAs pharmacists, we have made great progress as clinicians. We have successfully converted our educational endeavors to the all-Doctor of Pharmacy curriculum. We have a well-defined postgraduate program consisting of residencies, specialty residencies, and fellowship training. We are likely to achieve success with drug therapy management under the Medicare Modernization Act. Pharmacy practitioners continue to develop and expand their roles as clinicians. We play an increased role in the training of those in the medical and nursing professions. To continue our growth as practitioners in a learned profession, however, we must attend to the imperative of leadership development. There is a need for us to make leadership training an integral aspect of our professional endeavors. Symphony orchestras are composed of a number of musician specialists who are part of an age-old hierarchy -- first chair, second chair, and so on. Parallels exist in pharmacy with levels of faculty and of clinical practitioners. However, one cannot have an orchestra that plays brilliantly without a conductor.
Key Words: clinical pharmacists, leadership, management, training.
(Pharmacotherapy 2006;26(1):1-2)
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Bacillus anthracis (anthrax), Yersinia pestis (plague), Francisella tularensis (tularemia), Coxiella burnetti (Q fever), and Brucella sp (brucellosis) are all potential bioterrorism agents. Their known virulence, potential lethality, and ability to develop resistance to known antibiotic treatments make these pathogens particularly dangerous. We reviewed the scientific literature by searching MEDLINE databases and published abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America from 1989-2005 for studies of each of these biologic agents with the specific aim of examining whether doxycycline or a fluoroquinolone should be stockpiled for mass-scale postexposure prophylaxis. An evidence-based approach was used to determine whether doxycycline or fluoroquinolones were efficacious (both in vitro and in vivo) against these biologic agents and to examine these drugs’ respective susceptibility patterns and differences in cost, based on available data. Little published data are available on these pathogens, and much of the data are from studies that used older strains obtained from patient or animal sources in outbreaks decades ago. Doxycycline appears to show comparable minimum inhibitory concentrations to those of the fluoroquinolone class in most clinical and in vitro studies, perhaps with the exception of inhalation plague. Studies also suggest that development of antibiotic resistance is less likely to occur with doxycycline. Doxycycline is several-fold less expensive than most fluoroquinolones and appears to have similar efficacy in most scenarios based on clinical case studies and established Clinical and Laboratory Standards Institute (formerly known as the National Committee for Clinical Laboratory Standards) breakpoints for staphylococci. Therefore, doxycycline should be considered as a first-line antibiotic in the management of bioterrorism agents.
Key Words: bioterrorism agents, antibiotic selection, antibiotic resistance, doxycycline, fluoroquinolones, postexposure prophylaxis.
(Pharmacotherapy 2006;26(1):3-14)
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Study Objectives. To compare the disposition of cyclosporine after the administration of two oral formulations to children undergoing hematopoietic stem cell transplantation, and to evaluate the relationship between whole blood cyclosporine concentrations during the dosing interval and the area under the whole blood concentration-time curve.
Design. Prospective, descriptive, crossover study.
Setting. Hematopoietic stem cell transplantation unit in a tertiary-quaternary university-affiliated pediatric hospital.
Patients. Twenty-four pediatric patients aged 0.5-16.9 years undergoing allogeneic hematopoietic stem cell transplantation.
Intervention. The modified oral formulation of cyclosporine was given on the first day (divided as two doses), and a single identical dose of the original oral formulation was given on the morning of the second day.
Measurements and Main Results. Blood samples were obtained at 0, 0.5, 1.25, 2, 4, 6, 9, and 12 hours after the morning dose from the lumen of the central venous catheter not previously used for intravenous cyclosporine administration. Cyclosporine concentration-time data were analyzed by using noncompartmental methods. Mean ± SD maximum concentrations were significantly higher after administration of the modified form than after administration of the original form (594.9 ± 349.7 vs 483.0 ± 363.0 µg/L, p=0.003), as was the area under the concentration-time curve from 0-12 hours (AUC0-12; 3432 ± 1563 vs 3144 ± 1780 µg/L•hr, p=0.022). For both formulations, cyclosporine concentrations at 4 hours after administration were most strongly correlated with the AUC0-12. Unlike that of the original formulation, the trough cyclosporine concentration of the modified form had the weakest relationship with AUC (Spearman r coefficient 0.584, p=0.003).
Conclusion. Cyclosporine absorption is lower in children undergoing hematopoietic stem cell transplantation than in children receiving solid organ transplants. Dosage adjustment for the modified formulation based on trough concentration may not be appropriate because its relationship with the AUC was weak. The link between pharmacokinetic parameters and clinical outcomes, such as graft-versus-host disease, must be further studied.
Key Words: cyclosporine, pharmacokinetics, bone marrow transplant, hematopoietic stem cell transplantation, HSCT, pediatrics.
(Pharmacotherapy 2006;26(1):15-22)
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Study Objectives. To correlate serum propylene glycol concentration with osmol gap, serum lactate concentration, and amount of propylene glycol administered to mechanically ventilated patients receiving continuous infusions of lorazepam (80% propylene glycol by weight), and to characterize the prevalence of hyperosmolality and range of serum propylene glycol concentrations in this patient population.
Design. Prospective, controlled, observational study.
Setting. Adult surgical and cardiothoracic intensive care units (ICUs) of a 1200-bed, urban, tertiary care, teaching hospital.
Patients. Sixty-four consecutively enrolled intensive care patients requiring mechanical ventilation and pharmacologic sedation.
Intervention. Thirteen patients received continuous infusions of high-dose lorazepam (> 6 mg/hr) for a minimum of 36 hours, and 26 received continuous infusions of low-dose lorazepam (2-5.99 mg/hr) for 36 hours. Twenty-five control patients received sedatives that did not contain propylene glycol.
Measurements and Main Results. Serum propylene glycol and lactate concentrations, osmolality, and basic metabolic profiles were obtained 72-108 hours after ICU admission. Clinical data, drug administration, and severity of illness scores were recorded. Osmol gap and the amount of propylene glycol administered before serum sampling predicted propylene glycol concentrations (r2=0.692, p<0.05). Osmol gap alone also predicted serum propylene glycol concentrations (r2=0.532, p<0.05). Serum lactate concentrations did not correlate with serum propylene glycol concentrations. Unlike the low-dose and control patients, eight (62%) of 13 high-dose patients had osmol gaps above 10. All 13 high-dose patients had serum propylene glycol concentrations previously associated with toxicity.
Conclusion. Osmol gap can be used as a surrogate marker for serum propylene glycol concentration. In critically ill patients receiving lorazepam for sedation, an osmol gap above 10 was associated with concentrations previously reported to cause toxicity.
Key Words: propylene glycol, hyperosmolality, osmol gap, lorazepam, lactate, toxicology.
(Pharmacotherapy 2006;26(1):23-33)
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Study Objective. To model the cost-effectiveness of nesiritide compared with dobutamine in patients with decompensated heart failure.
Design. Cost-effectiveness analysis.
Measurements and Main Results. A decision tree model was derived from randomized clinical trial data and data from a previously published economic study. Four cost-effectiveness analyses were performed: analysis 1 -- full probabilistic analysis, repeatedly sampled probabilities for 6-month mortality and hospital readmission from distributions based on 95% confidence intervals (CIs); analysis 2 -- best-case nesiritide analysis, used the limiting values of the 95% CI favorable to nesiritide; analysis 3 -- best-case dobutamine analysis, used the limiting values of the 95% CI favorable to dobutamine; and analysis 4 -- replicated the previously published cost-effectiveness study and served as a methodologic control. Fifty-one consecutive Monte Carlo simulations for cohorts of 1000 hypothetical patients were performed for each analysis. Incremental cost, incremental effectiveness, and incremental cost-effectiveness ratios (ICERs) were calculated for nesiritide versus dobutamine. Analysis 1 showed a mean ICER of $767/life-year gained for nesiritide versus dobutamine (incremental cost $251 ± $290, incremental effectiveness 0.33 ± 0.22 yr). The 95% confidence region surrounding this point estimate spanned all four quadrants of the incremental cost-effectiveness scatterplot, suggesting inconclusive results. Nesiritide was the dominant treatment strategy in analysis 2 (incremental cost -$734 ± $106, incremental effectiveness 1.19 ± 0.07 yrs), whereas dobutamine was dominant in analysis 3 (incremental cost $1242 ± $73, incremental effectiveness -0.57 ± 0.05 yr). Analysis 4 was comparable to the previously published cost-effectiveness analysis (incremental cost -$77 ± $87, incremental effectiveness 0.48 ± 0.05 yr).
Conclusions. Based on available randomized clinical trial data, nesiritide did not exhibit robust economic superiority over dobutamine. When incorporating the uncertainty (i.e., 95% CIs) in clinical effectiveness as reported in available clinical trial data into the economic analysis, either nesiritide or dobutamine may be the dominant treatment (i.e., more effective at lower cost) for the studied population. Economic analyses of nesiritide and any comparator must account for uncertainty in estimates of cost as well as in clinical effectiveness.
Key Words: nesiritide, dobutamine, heart failure, cost-effectiveness, pharmacoeconomics, outcomes.
(Pharmacotherapy 2006;26(1):34-43)
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Study Objective. To determine whether a sex-based difference in digoxin pharmacokinetics exists in patients receiving long-term digoxin therapy for chronic heart failure or atrial fibrillation.
Design. Single-center, retrospective review of medical records.
Setting. University-based teaching hospital and outpatient clinic.
Patients. Sixty-seven adults (32 men, 35 women) with chronic heart failure or atrial fibrillation who were receiving digoxin therapy.
Measurements and Main Results. Serum digoxin concentrations and daily digoxin doses were obtained from patients’ medical records. Daily doses were adjusted for patients’ actual and ideal body weight and body mass index (BMI). The ratio between the serum digoxin concentration and each of the adjusted daily doses of digoxin was compared between men and women. The mean ± SD serum digoxin concentration was 0.85 ± 0.51 ng/ml for men compared with 1.02 ± 0.51 ng/ml for women. Mean ± SD unadjusted doses of digoxin were 0.180 ± 0.063 and 0.164 ± 0.059 mg/day for men and women, respectively; the difference was not statistically significant. Ratios of serum digoxin concentration to daily digoxin doses did not differ by sex when doses were estimated with actual or ideal weight. Only the ratio of the digoxin concentration to the BMI-adjusted dose was significantly different between men and women (0.14 ± 0.09 and 0.19 ± 0.11, respectively, p<0.05).
Conclusion. Sex-based differences in digoxin pharmacokinetics were absent when actual or ideal body weight was used. However, the ratio of serum digoxin concentration to daily digoxin dose adjusted for BMI differed by sex. Because digoxin is distributed to lean body mass, use of the BMI could have overadjusted body weight, leading to inaccurate pharmacokinetic assumptions and calculations. The pharmacokinetics of digoxin do not appear to differ by sex.
Key Words: digoxin, sex-based difference, pharmacokinetics, body mass index, P-glycoprotein, body weight.
(Pharmacotherapy 2006;26(1):44-50)
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Study Objective. To evaluate differences in the efficacy and safety of recombinant tissue plasminogen activator (rt-PA) and urokinase in the treatment of peripheral arterial occlusion.
Design. Systematic review and meta-analysis of prospective comparative trials.
Data Source. PubMed/MEDLINE database from 1966-October 2004.
Measurements and Main Results. The literature was systematically searched to identify prospective comparative trials of urokinase and rt-PA for the treatment of peripheral arterial occlusion. The primary outcome measure was successful complete lysis of the occlusion. Other outcome measures were hemorrhage (major, minor, or combined), intracranial hemorrhage, limb loss, and mortality. Six trials were identified, five of which were randomized. On meta-analysis, the rate of clot lysis was higher with rt-PA than with urokinase (odds ratio [OR] 1.54, 95% confidence interval [CI] 1.12-2.10, p=0.007). However, urokinase was associated with lower rates of minor (OR 0.52, 95% CI 0.28-0.97, p=0.04) and total (OR 0.51, 95% CI 0.29-0.91, p=0.02) bleeding. Rates of major hemorrhage, intracranial hemorrhage, limb loss, and mortality were similar between agents.
Conclusion. Urokinase was less effective than rt-PA in successfully lysing acute peripheral arterial occlusion, but it was associated with lower rates of total and minor bleeding. Overall, rt-PA was a reasonable substitute for urokinase, now that urokinase has been removed from the market in the United States. However, judicious monitoring for minor bleeding is necessary.
Key Words: peripheral arterial occlusion, recombinant tissue plasminogen activator, urokinase.
(Pharmacotherapy 2006;26(1):51-60)
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Study Objective. To evaluate the impact of a shortage of piperacillin-tazobactam in the United States in 2002 on antimicrobial prescribing and associated rates of vancomycin-resistant enterococci (VRE) and Clostridium difficile infections.
Design. Retrospective chart review.
Setting. University-affiliated medical center.
Measurements and Main Results. Microbiologic reports, patient demographics, and antimicrobial utilization were evaluated for patients admitted 6 months before the shortage (March 1-August 31, 2001) and for 6 months during the shortage (March 1-August 31, 2002). Significant increases in usage of alternative b-lactamase inhibitor combinations, cefepime, levofloxacin, vancomycin, clindamycin, and metronidazole were observed during the shortage; in contrast, a significant decrease in the use of ceftriaxone took place. No change in the rate of VRE infection was observed from before to during the piperacillin-tazobactam shortage. However, a paradoxical 47% decrease in the rate of C. difficile colitis was documented during the shortage. Subsequent multivariate analyses suggested the reduced use of ceftriaxone and increased use of levofloxacin, but not the reduced use of piperacillin-tazobactam, correlated with the decreased rate of C. difficile infections.
Conclusion. The piperacillin-tazobactam shortage was associated with significant changes in antimicrobial prescribing, which resulted in a significant reduction in the rate of C. difficile but not VRE infections.
Key Words: piperacillin-tazobactam, Clostridium difficile, vancomycin-resistant enterococci, drug shortages, antimicrobial prescribing.
(Pharmacotherapy 2006;26(1):61-67)
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Objective. To review the current pharmacotherapy for idiopathic pulmonary arterial hypertension (IPAH).
Methods. A search of the primary literature was conducted by using MEDLINE, the National Institutes of Health medical research Web site (www.clinicaltrials.gov), and the United States Food and Drug Administration’s Center for Drug Evaluation and Research Web site (www.fda.gov/cder).
Results. Until the early 1980s, conventional therapy for IPAH consisted of anticoagulation, diuretics, digitalis extracts, and supplemental oxygen, yet the 5-year mortality rate remained at 66%. Calcium channel blocker therapy was introduced with the hope that it would improve survival in patients with IPAH, but it was found to be effective in only approximately 25% of patients. In 1996, intravenous epoprostenol was the first drug to show long-term benefit on hemodynamics, exercise capacity, and survival. However, administration of epoprostenol requires a permanently indwelling central venous catheter, and tachyphylaxis is common, necessitating continuous dosage escalations. Subsequently, treprostinil, a prostacyclin analog of epoprostenol that can be administered by continuous subcutaneous infusion, was introduced, followed by aerosolized iloprost, a prostacyclin analog for inhalation. An increasing understanding of the multiple pathogeneses of IPAH led to the discovery of another target for drug therapy, and bosentan, an orally administered agent, became the first endothelin-receptor antagonist approved for treatment of IPAH. Most recently, the phosphodiesterase inhibitor, sildenafil, has received approval from the United States Food and Drug Administration for the treatment of IPAH.
Conclusion. Recently developed pharmacotherapies offer greater effectiveness and safety than traditional agents for the treatment of IPAH.
Key Words: pulmonary arterial hypertension, IPAH, prostacyclins, endothelin-receptor antagonists, phosphodiesterase inhibitors.
(Pharmacotherapy 2006;26(1):68-94)
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Influenza viruses are accountable for annual epidemics worldwide that result in significant morbidity and mortality. In preschool and school-aged children, prospective surveillance of influenza demonstrates yearly infection rates of 15-42%. Children can easily transmit the virus to other children, to employees in day-care and school settings, and to family members. Two classes of antiviral drugs, the adamantine derivatives (amantadine, rimantadine) and neuraminidase inhibitors (zanamivir and oseltamivir), have been approved for treatment and prophylaxis of influenza in the pediatric population. Duration of clinical symptoms decreases and daily activities are resumed sooner when therapy is begun within 48 hours of the onset of influenza symptoms. Mechanism of action, adverse effects, and development of resistant variants differ between the two drug classes. To our knowledge, head-to-head clinical trials between the classes and involving the neuraminidase inhibitors are nonexistent. Antiviral agents do not replace the annual influenza vaccine, and clinical trials indicate that amantadine, rimantadine, zanamivir, and oseltamivir are safe and effective for administration in the pediatric population.
Key Words: influenza, antiviral, pediatric, amantadine, rimantadine, zanamivir, oseltamivir.
(Pharmacotherapy 2006;26(1):95-103)
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Osteoporosis is a skeletal disorder characterized by compromised bone strength that predisposes the patient to an increased risk for fracture. Elements of bone strength include bone mineralization, architecture, turnover, size, and bone mineral density (BMD). Measurement of BMD is the most readily available, noninvasive method for assessing osteoporotic fracture risk and is used by the World Health Organization for diagnostic purposes. Because low BMD is predictive of increased fracture risk, it was believed that changes in BMD during pharmacologic therapy for osteoporosis would strongly predict observed fracture risk reductions. We examined the relationship between changes in BMD and reduction in fracture risk during pharmacologic therapy in postmenopausal women with osteoporosis. The correlation between BMD increases and fracture risk reduction during treatment is not consistent; larger increases in BMD do not necessarily correlate with greater reductions in fracture risk. Multiple factors, in addition to BMD, appear to contribute to the increased bone strength and decreased fracture risk achieved with approved drug therapies for osteoporosis. Until the exact relationship of these factors is fully understood, clinicians should continue to evaluate drug efficacy for osteoporosis based on the fracture risk reductions from well-designed clinical trials.
Key Words: fracture, bone mineral density, BMD, bone quality, osteoporosis.
(Pharmacotherapy 2006;26(1):104-114)
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Eletriptan is a new selective serotonin agonist approved for the treatment of acute migraine headaches. To review the pharmacologic, pharmacodynamic, pharmacokinetic, safety, and clinical efficacy data for eletriptan, we searched the literature in PubMed/MEDLINE, EMBASE, International Pharmaceutical Abstracts, and Science Direct databases to gather all published reports from January 1996-October 2004. All English-language reports (abstract or full trial reports) about the pharmacology, pharmacokinetics, clinical efficacy, and safety of eletriptan were reviewed. Eletriptan’s pharmacokinetic and pharmacodynamic parameters translate into a favorable safety and efficacy profile. The drug is rapidly absorbed when administered orally, has good bioavailability and central nervous system penetration due to its lipophilicity, and has a long half-life, which contributes to its ability to prevent recurrent headaches. Compared with other serotonin agonists, eletriptan has a longer duration of action and greater lipophilicity. Eletriptan is metabolized through the cytochrome P450 3A4 system; therefore, it does have the potential for clinically significant drug interactions. In clinical trials, eletriptan demonstrated efficacy superior to that of placebo and similar or superior efficacy to that of other serotonin agonists, with limited adverse effects. With clinical use, headache and pain-free responses and headache recurrence rates were similar to those of other serotonin agonists, but the agent is superior to ergotamine tartrate-caffeine. Based on pharmacoeconomic data, eletriptan is more cost-effective than other agents in its class. Eletriptan is a safe and cost-effective option for the treatment of migraine headaches.
Key Words: eletriptan, serotonin agonist, 5-HT agonist, migraine headache, triptan.
(Pharmacotherapy 2006;26(1):115-128)
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Appropriate treatment with antimicrobials involves factors we cannot control. Factors such as interpatient variability in drug exposure, the minimum inhibitory concentration (MIC) of the infecting pathogen, and the patient’s clinical status clearly affect the therapeutic response. Despite these uncertainties, we can estimate the probability of attaining a successful therapeutic outcome in the context of factors that are within our control. Chief among these are drug, dose, and the dosing interval. One way to predict the probability of a positive therapeutic outcome is through the use of an integrated pharmacokinetic-pharmacodynamic stochastic model. Pharmacokinetic-pharmacodynamic target attainment analyses using Monte Carlo simulation to integrate interpatient variability in drug exposure, drug potency, and in vivo exposure targets predictive of positive therapeutic outcomes are influencing antibacterial susceptibility breakpoints at home and abroad. The consequences of this paradigm shift are far reaching, affecting the commercial concerns of drug and susceptibility testing device manufacturers, perceptions about antimicrobial resistance, and ultimately patient care decisions.
Key Words: susceptibility breakpoints, antibiotics, Monte Carlo simulation.
(Pharmacotherapy 2006;26(1):129-134)
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One of the first signs of ischemic heart disease may manifest as chronic stable angina, a mismatch between oxygen supply and demand. With more than approximately 16.5 million people each year having stable angina, development of new therapies to help control this disease state are warranted. Ranolazine, a novel agent exerting its effect through a partial fatty oxidase inhibitor, is one of the first new drugs in more than 20 years to be developed for chronic stable angina. Working through enzymatic modulation, instead of altering myocardial hemodynamics, ranolazine appears to be effective. An overview of chronic stable angina is provided, the American College of Cardiology-American Heart Association (ACC-AHA) current pharmacologic treatment guidelines are reviewed, and the mechanism of action of ranolazine is explored. Finally, the major clinical trials supporting its place in medical therapy are discussed. Additional clinical trials are under way to further elucidate ranolazine’s exact role in the treatment of chronic stable angina. From results of the existing phase III clinical trials, however, the most beneficial potential role of ranolazine in the treatment algorithm of chronic stable angina appears to be as adjunctive therapy to the recommended ACC-AHA treatment modalities.
Key Words: ranolazine, chronic stable angina, pharmacologic treatment guidelines, pharmacokinetics.
(Pharmacotherapy 2006;26(1):135-142)
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An 84-year-old Asian woman with hypertension and chronic renal failure was evaluated for incoherent speech, followed by intermittent interruptions of consciousness, and then status epilepticus after ingesting one star fruit (Averrhoa carambola) each day for 3 days. Conventional first-line anticonvulsants and hemodialysis were administered without significant control of the patient’s seizures. Treatment was started with propofol, an intravenous agent that induces anesthesia with rapid onset and elimination from the central nervous system; this resulted in complete control of the seizures. Propofol may be an effective alternative when dialysis and conventional first-line anticonvulsants are unsuccessful in treating the symptoms of neurotoxicity.
Key Words: star fruit toxicity, status epilepticus, propofol, dialysis.
(Pharmacotherapy 2006;26(1):143-146)
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A 9-month-old infant was inadvertently administered azithromycin 50 mg/kg, taken from floor stock, instead of the prescribed ceftriaxone. Shortly thereafter, she became unresponsive and pulseless. The initial heart rhythm observed when cardiopulmonary resuscitation was started was a wide-complex bradycardia, with a prolonged rate-corrected QT interval and complete heart block. The baby was resuscitated with epinephrine and atropine, but she suffered severe anoxic encephalopathy. Torsade de pointes and QT-interval prolongation have been reported after administration of macrolide antibiotics, including azithromycin, both intravenously and orally. This has occurred especially in the context of coadministered drugs that inhibit the cytochrome P450 (CYP) 3A4 isoenzyme, such as ketoconazole and astemizole. However, bradycardia with complete heart block has not, to our knowledge, been reported specifically with intravenous administration of azithromycin alone, either with therapeutic doses or overdose. Clinicians should be alerted about the potential of azithromycin to cause life-threatening bradycardia, and pharmacy systems should be implemented to ensure special care in the safe administration of this drug, especially when dispensed from a point-of-care source.
Key Words: bradyarrhythmia, azithromycin, macrolide antibiotics, QT-interval prolongation, QTc, torsade de pointes.
(Pharmacotherapy 2006;26(1):147-150)
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