Miscellaneous Antibacterial Drugs

C H A P T E R

26 Miscellaneous Antibacterial Drugs Lucy Burr§,¶,1, Jordan Cunninghamǁ, David Serisier*,¶ *Mater Research, Translational Research Institute, Brisbane, Australia; §University of Queensland, Brisbane, Australia; ¶Mater Health Services, Brisbane, Australia; ǁGreenslopes Private Hospital, Brisbane, Australia 1Corresponding author: E-mail: [email protected]

AMINOGLYCOSIDES [SED-15, 118; SEDA-32, 461; SEDA-33, 509; SEDA-34, 399, SEDA 35, 463] High-intensity aminoglycoside therapeutic drug monitoring in the ICU did not lead to a significant reduction of aminoglycoside-induced nephrotoxicity in patients with septic shock. These patients clearly have abnormal haemodynamics and pharmacodynamics. Alternative drug-level monitoring for these patients will need to be investigated [1R]. Animal models suggest that aminoglycoside-induced hearing loss in neonates may be potentiated by loud noise. Administration of aminoglycosides to neonates, who are in the final stages of auditory development, may also result in increased rates of hearing loss due to the sensitivity of the cochlea to damage in this developmental stage. The mechanisms of ototoxicity are multifactorial, but include direct toxicity to the eighth cranial nerve and accumulation of aminoglycosides in the endolymph of the inner ear [2R].

Amikacin [SED-15, 111; SEDA-32, 461; SEDA-33, 510; SEDA-34, 400; SEDA-35, 463] Sensory Systems The effect of serum ferritin on promoting amikacin ototoxicity was investigated in 181 subjects undergoing amikacin treatment at 10 mg/kg for skin wounds and burns. Hearing was measured before treatment and 6 weeks after treatment. There was an increase in hearing threshold with treatment regardless of baseline ferritin level, however in those with a higher ferritin level, there was a significantly greater increase in hearing thresholds, particularly at the higher frequencies. Serum ferritin is a marker of iron stores, however it is also a marker of inflammation and may represent a greater degree of inflammation in these subjects rather than iron excess [3E]. No other inflammatory markers were published in this study, however the mean corpuscular volume (MCV) was lower in the group with low ferritin. This study supports ototoxicity of amikacin, however whether iron deficiency is protective of this effect remains unclear. Urinary Tract A multicenter, nonrandomised trial investigating the effect of ceftazadime/levofloxacin vs ceftazadime/amikacin for the treatment of febrile neutropenia did not demonstrate a significant difference in nephrotoxicity with amikacin treatment. A total number of 137 febrile neutropenic patients received amikacin at a dose of 15/mg/kg per day for an average of 5 days. Only one patient developed nephrotoxicity during the observation period [4c]. Respiratory Aerosolised amikacin was used to treat pulmonary nontuberculous mycobacterial infection at a dose of 300 mg twice per day via a nebuliser. A cumulative dose of 35,000 mg was administered over the trial period. No significant effects on nephro- or ototoxicity were seen. A hoarse voice and a bitter taste reported by one subject required a dose reduction to 100 mg [5E]. Although a small cohort, this study supports the safety of nebulised amikacin in these patients. Side Effects of Drugs Annual, Volume 36 ISSN: 0378-6080 http://dx.doi.org/10.1016/B978-0-444-63407-8.00026-5

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Immunologic One case report of a drug reaction with eosinophilia and systemic symptoms (DRESS) was attributed to amikacin treatment of a septic arthritis. Patch testing and the presence of circulating amikacin sensitive T-cells confirmed the diagnosis [6A]. Delayed-type hypersensitivity reactions are possible with all medications given and should be considered in a subject with prominent eosinophilia and systemic symptoms who are not responding as expected to treatment.

Gentamicin [SED-15, 1500; SEDA-32, 461; SEDA-33, 510; SEDA-34, 400; SEDA-35, 463] Nervous System Drug-induced multifocal myoclonus was reported in a 59-year-old female 1 h after receiving a supra-therapeutic dose of gentamicin (300 mg) and a renal-appropriate dose of vancomycin. This patient had end stage renal failure and was on haemodialysis [7A]. It is likely that the supra-therapeutic dose of gentamicin caused the myoclonus, however as vancomycin was co-administered it is difficult to exclude the possibility that vancomycin was the causative agent. Sensory Systems A retrospective case series assessed the effect of gentamicin on the vestibulocochlear system in a cohort of patients presenting to a balance disorders clinic. A total of 103 patients were diagnosed with gentamicin vestibular toxicity. Seventy-three patients had audiometry available but results were not considered different to age matched accepted means. Forty-three patients developed nephrotoxicity whilst receiving gentamicin in hospital [8c]. Two cases of toxic anterior segment syndrome in a single centre were reported. This occurred due to a presumed spillover of 20 mg gentamicin into the anterior chamber, following postoperative subconjunctival injection [9A]. Care to prevent spillover into the anterior chamber following eye surgery is recommended to prevent this complication. Urinary Tract A multicenter, nonrandomised, observational, cohort study examined the effectiveness of ampicillin/ceftriaxone (n = 159) versus ampicillin/gentamicin (n = 87) for the treatment of Enterococcus fecalis infective endocarditis. There was an increased rate of adverse events in the gentamicin group requiring withdrawal of treatment. The adverse events included both new renal impairment (n = 20 (23%)) and vestibular toxicity (n = 2 (2%)). Overall new renal impairment was detected in 43% of patients in the gentamicin group [10c]. Conversely, a historical control cohort study, which investigated the effect of a single dose of gentamicin (240 mg) on acute kidney injury prior to surgery from a fractured neck of femur, did not find a difference between the two groups [11c]. Chronic exposure to systemic gentamicin has been reported to be linked to a single case of acquired Bartter syndrome. Profound hypokalaemia occurred during the course of chronic gentamicin treatment without an associated rise in creatinine. Gene testing for congenital Bartter syndrome was not performed [12A]. The role of gentamicin in this case remains theoretical. Paediatric A total number of 255 neonates were enrolled in a prospective study assessing the safety of once daily intramuscular gentamicin dosing. Of the 255 neonates, 4.4% had a high trough level suggesting impaired clearance. Hearing data were available for 142 babies, three of whom were diagnosed with moderate to severe hearing impairment. Of those with hearing impairment, one was hypoxic and suffered neonatal seizures, one had a chromosomal defect and the last was very premature (25 weeks) and was on prolonged ventilation [13c]. There are several confounders in this group, however both nephrotoxicity and ototoxicity were a concern. Skin A total number of 375 patients were randomly assigned to topical treatment with 15% paromomycin, paromomycin-0.5% gentamicin or vehicle control, for the treatment of cutaneous leishmaniasis. There was no clinically significant effect on nephrotoxicity or ototoxicity. There was an increased incidence of vesicle formation in both treatment groups compared with the vehicle control [14c]. Drug Induction of Antimicrobial Resistance Prevention of cutaneous infection around the site of peritoneal dialysis catheter exit site with long-term topical gentamicin was associated with nine cases of rapidly growing nontuberculous mycobacterial infections. Six cases

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involved Mycobacterium abscessus, two were Mycobacterium fortuitum and one Mycobacterium chelonae. All but two cases involved exit-site infections, however the remaining two cases developed peritonitis with M. abscessus as the causative organism [15c]. As with all long-term antimicrobial use, overgrowth with resistant organisms is a consideration. Nontuberculous mycobacterial infections are increasingly a concern in patients requiring long-term or repeated antimicrobials.

Tobramycin [SED-15, 3437; SEDA-32, 463; SEDA-33, 513; SEDA-35, 464] Respiratory Tobramycin nebuliser solution was used in an open-label, randomised, crossover trial investigating the effects of different nebulisers on the pharmacokinetics and safety. Twenty-seven patients with cystic fibrosis were recruited. The most commonly reported adverse events were bronchitis, nasal congestion, oropharyngeal pain (7.4% each) and viral infection (11.3%). Respiratory tract infection, elevated CRP and pyrexia occurred in one patient and one other patient developed a severe pulmonary exacerbation of their cystic fibrosis and discontinued the study [16C]. Inhaled fosfomycin/tobramycin at doses of 80/20 mg and 160/40 mg administered via a nebuliser for 28 days most commonly caused cough, dyspnoea and wheezing in the cystic fibrosis patients treated. There appeared to be a dosedependent relationship, with more adverse events occurring in the higher-dose group [17C]. These events are typical of a subject with cystic fibrosis (CF) using inhaled treatment. While these events are possibly drug related, they could also be attributed to daily changes in the underlying clinical course of the patient. Nervous System A prospective, single-centre study assessing once daily intravenous tobramycin dosing to treat pulmonary exacerbations of CF noted two cases (8%) of transient vestibular disturbance, without any significant nephrotoxicity. Vestibular disturbance appeared to be an early indicator of tobramycin toxicity [18c]. Cessation of therapy or dose reduction with careful monitoring should be considered in patients experiencing vestibular symptoms. Topical Treatment A total number of 109 paediatric patients were randomised to receive topical loteprednol etabonate 0.5% and tobramycin 0.3% for 2 weeks to treat eyelid inflammation or blepharoconjunctivitis. The most frequent side effects included conjunctivitis (2.8%), pyrexia (4.2%) and rash (2.8%). There were no significant differences in side effects between each treatment [19C]. Whether these effects can be directly attributed to tobramycin therapy cannot be deduced from this study as the drug was given in combination.

FLUOROQUINOLONES [SEDA-15, 1396; SEDA-32, 464; SEDA- 33, 514; SEDA-34, 401; SEDA-36, 464] The incidence of serious cardiac arrhythmia with the use of fluoroquinolones was investigated in a retrospective, nested case–controlled study. Fluoroquinolones were associated with an increased risk of serious cardiac arrhythmia (RR 1.76) with gatifloxacin giving the highest risk (RR7.38), followed by moxifloxacin (RR 3.30) and ciprofloxacin (RR 2.15) [20c]. Hypersensitivity reactions to fluoroquinolones are more likely in subjects who have had a previous reaction to beta-lactam antibiotics (OR 4.57) [21c]. Retinal detachment, thought secondary to fluoroquinolone therapy, was recorded in 3.3% of patients reviewed in a nested case–control study (ARR 4.5) [22c].

Ciprofloxacin [SED-15, 783; SEDA-32, 465; SEDA-33, 514; SEDA-34, 402; SEDA-35, 465] Drug Studies A randomised, placebo-controlled trial using 500 mg ciprofloxacin twice daily for the prevention of postoperative recurrence of Crohn’s disease did not show a benefit of the treatment over the disease. The following adverse events were listed: diarrhoea, headache, sun sensitivity, yeast infection, oral candidiasis, difficulty breathing, pharyngeal paraesthesia and tendonitis. Twenty-four percent of subjects (four cases) withdrew due to adverse events [23C]. These are all expected side effects of ciprofloxacin. Similarly, use of ciprofloxacin 300 mg twice daily in febrile

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neutropenic patients was assessed in a randomised controlled open-label trial comparing the efficacy of cefepime (n = 26) with ciprofloxacin (n = 24). The most common adverse events in the ciprofloxacin patient group were liver enzyme and electrolyte abnormalities. One serious adverse event in one patient involved both liver enzyme derangement and a cutaneous reaction. No subjects ceased the medication due to adverse events [24C]. Finally, a multicenter, randomised, controlled trial investigating the efficacy and safety of intravenous ciprofloxacin (300 mg twice daily) vs intravenous meropenem (500 mg twice daily) was carried out. One hundred patients were enrolled in the ciprofloxacin arm. Eight patients suffered from an adverse event, requiring withdrawal in three cases. All were mild and involved liver dysfunction, diarrhoea and a rash [25C]. Nervous System A single case report of choreoathetosis temporally related to ciprofloxacin use in a haemodialysis patient highlights the need to carefully monitor drug dosing, particularly in renal patients [26A]. In this case, the symptoms resolved within a week of ceasing the medication. Ciprofloxacin was also associated with posterior reversible encephalopathy syndrome in an adolescent male treated for a respiratory tract infection [27A]. Skin Using a questionnaire-based assessment, 99 CF patients were assessed for photosensitivity to ciprofloxacin. Fortyeight patients reported phototoxicity, with the majority reporting a rash on sun-exposed areas. Predominant symptoms were burning, itching and a rash consistent with sunburn [28c]. Conversely, oral ciprofloxacin (20 mg/kg) was used to prevent fever in children undergoing chemotherapy for acute leukaemia. Forty-five patients were in the treatment arm and 50 in the placebo. One episode of a skin rash occurred and was reported to be related to the drug treatment [29c]. An erythema multiforme reaction was reported in one 40-year-old female 4 days after taking ciprofloxacin for a urinary tract infection [30A]. Cardiovascular One case report of an episode of torsades de pointes was reported in association with the use of oral ciprofloxacin in a patient with cardiovascular (CV) risk factors [31A]. Gastrointestinal A 95-year-old female developed oesophageal ulceration, with associated haematemesis and malena, following administration of oral ciprofloxacin (500 mg twice daily) for 2 days [32A]. This drug was administered to the patient in the supine position. This side effect is most likely due to ineffective oesophageal peristalsis, worsened by the supine position, rather than a direct effect of ciprofloxacin itself. Musculoskeletal Rhabdomyolysis leading to biopsy-proven acute myoglobin kidney injury was reported in a bilateral lung transplant patient receiving ciprofloxacin 500 mg twice daily for the treatment of posttransplant bronchiectasis with Pseudomonas aeruginosa. Rhabdomyolysis developed following a 2-week course in association with ceftazadime. Myalgia was reported after 2 days of use during previous ciprofloxacin use [33A]. Drug–Drug Interaction During high-dose methotrexate (3 g/m2) administration for the treatment of non-Hodgkin lymphoma in a 24-yearold female, concomitant standard-dose ciprofloxacin was given (500 mg twice daily for 5 days) for a febrile illness with no identifiable bacteria. Seven days following the methotrexate dose, the patient developed fever, pancytopenia and mucositis in the context of an inappropriately high methotrexate level. The co-administration of ciprofloxacin was thought to be the cause [34A]. Ciprofloxacin inhibits the activity of the cytochrome P450 system, therefore co-administration with medications metabolised by this pathway must be done with careful monitoring for drug toxicity.

Levofloxacin [SED-15, 2047; SEDA-32, 467; SEDA-33, 516; SEDA-34, 403; SEDA-35, 465] Drug Studies A randomised, double-blind, placebo-controlled trial comparing solithromycin (800 mg day 1 followed by 400 mg daily PO for the remaining 5 days) with levofloxacin (750 mg daily for 5 days) was carried out. Sixty-four patients were randomised to receive solithromycin and 68 levofloxacin. Adverse events were more prevalent in the levofloxacin

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group and consisted of bradycardia (1.5%), palpitations (1.5%), gastrointestinal disorders (10.3%), elevated liver enzymes (4.5%), hyponatraemia (1.5%), convulsions, headache, hypoaesthesia, hallucinations, insomnia and nightmares (all 1.5%) [35C]. Dizziness, nausea and digestive tract symptoms were the most commonly reported adverse events noted in 209 patients treated with levofloxacin 500 mg daily in a randomised trial investigating the efficacy of levofloxacin in treating bacterial prostatitis [36C]. Finally once daily levofloxacin was used to treat acute exacerbations of COPD. Side effects were minimal but included dyspepsia, insomnia and headache [37C]. Psychiatric Three cases of insomnia and anxiety were reported in young adults (age 30–32) in direct association with levofloxacin use (500–750 mg orally (PO) daily) [38A]Disturbingly, levofloxacin was implicated in an episode of acute psychosis in a 38-year-old man with known schizoaffective disorder [39A]. Nervous System A 49-year-old male suffered from optic neuritis within minutes of taking 500 mg levofloxacin for the treatment of maxillary sinusitis [40A]. Skin A 68-year-old woman developed a palmar macular rash and uveitis 4 days after starting oral levofloxacin therapy for a dog bite. These symptoms resolved after discontinuation of therapy and the introduction of corticosteroids [41A]. One case of bullous pemphigoid was described in an elderly Chinese woman being treated with levofloxacin for a pulmonary condition [42A]. Musculoskeletal Several cases of tendinopathy were reported. Four consecutive cases of levofloxacin-induced tendonitis were reported in haemodialysis patients. Doses ranged between 200 mg daily and 500 mg twice daily orally. All cases occurred within a week of starting the treatment and resolved within a few months [43A]. A 63-year-old female presented with shoulder tendonitis 2 weeks following a 10-day course of levofloxacin 500 mg twice daily [44A] and tendonopathy of the hip was reported 10 days following a 5-day course of levofloxacin (750 mg daily) in a 58-year-old male [45A]. One case of levofloxacin-induced rhabdomyolysis was reported in a haemodialysis patient [46A]. Sensory Systems Postmarketing surveillance of levofloxacin 0.5% ophthalmic solution revealed only 42 adverse events in over 6000 cases reviewed. The main adverse events were blepharitis, eye irritation and punctate keratitis [47c]. Haematologic One case of severe coagulopathy leading to hypovolemic renal failure was caused by the interaction of levofloxacin and warfarin in a 30-year-old man [48A]. Addition of any medication whilst on warfarin must be carefully monitored. Endocrine A 72-year-old, end-stage renal failure patient developed hypoglycaemia in association with toxic levels of levofloxacin [49A]. This is further supported in three patients with type II diabetes, on oral hypoglycaemic agents developing hypoglycaemia in association with levofloxacin use [50A].

Moxifloxacin [SED-15, 2392; SEDA-32, 468; SEDA-33, 518; SEDA-34, 404; SEDA-35, 466] Drug Studies Moxifloxacin 400 mg was administered for an average of 6.4 days (+/−1.9) in acute exacerbations of COPD. A total number of 2536 patients were enrolled in this prospective observational study. Serious adverse events related to the study drug included atrial fibrillation (n = 2) and one each of acute myocardial infarction, cardiac flutter, diplopia, vomiting, allergic oedema, amnesia, dizziness, dyspnoea and skin reaction. Mild adverse events included diarrhoea, nausea, dizziness, dyspepsia, fatigue and headache [51C]. A similar trial comparing moxifloxacin (400 mg) with amoxicillin/clavurinic acid in COPD reported adverse events in 220/538 moxifloxacin with 1.8% withdrawing due to side effects. Four serious adverse events were reported with moxifloxacin use in one patient each: anaphylaxis, bronchitis, gastroenteritis and tachyarrhythmia [52C]. A further trial comparing moxifloxacin (400 mg IV 5–14 days) with ertapenem in the treatment of complicated

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intra-abdominal infections noted that 58.6% of subjects treated with moxifloxacin had an adverse event. The most common adverse events were: gastrointestinal disorders (4.7%), elevated gamma-glutamyl transpeptidase (GGT) (3.2%) and elevated lipase (3.4%). Death occurred in 5.4% of subjects treated with moxifloxacin and in 3.1% of subjects treated with ertapenem [53C]. Low-risk neutropenic patients with cancer were randomised to receive 400 mg moxifloxacin to treat fever. The most common adverse events were: diarrhoea, abdominal pain, dizziness, vertigo and sleep disorders [54c]. A meta-analysis of the cardiac effects of moxiflocaxin was carried out. Moxifloxacin-received 14981 subjects were included in the analysis. The most common adverse events were those commonly described with moxifloxacin use and included diarrhoea, dizziness, vomiting, increased lipase, increased GGT and rash. Prolonged QTc (corrected QT) occurred in 72 patients and cardiac arrest in 18. No events were significantly greater than a standard comparator in this study [55M]. Haematologic A 37-year-old woman being treated for breast cancer with tamoxifen and goserelin was treated with moxifloxacin for left lower lobe pneumonia. Four days into treatment, she developed neutropenia (0.48 × 103/ul). Moxifloxacin was ceased and the neutrophil count recovered rapidly, normalising by day 4 [56A]. One case of immune thrombocytopenia was reported in a 39-year-old female following a 10-day course of oral moxifloxacin [57A]. Musculoskeletal A case of Achilles tendonopathy was reported in a 56-year-old man following a 14-day course of topical ophthalmic moxifloxacin [58A]. Moxifloxacin-induced rhabdomyolysis was reported in an elderly female admitted to ICU following a left cerebellar stroke. A urinary tract infection was treated for 4 days with intravenous moxifloxacin (400 mg). She subsequently developed typical rhabdomyolysis symptoms including myalgia and dark-coloured urine. A serum creatinine phosphokinase measured 61,000 U/L. Cessation of the antibiotic and alkaline diuresis resolves the problem [59A]. Cardiovascular Asymptomatic prolongation of the QT interval occurred in two patients receiving oral moxifloxacin to treat a diabetic foot infection [60A]. Nervous System A 58-year-old woman with no known renal or liver dysfunction developed orofacial dyskinesia following treatment with oral moxifloxacin for acute bronchitis. The symptoms settled after withdrawal of the medication and 12 weeks of clonidine [61A]. Electrolyte Imbalance One case report of SIADH was noted on day 2 of treatment with moxifloxacin for an acute exacerbation of chronic obstructive pulmonary disease (COPD). SIADH has many causes, some of which were potentially present in this patient; however, careful monitoring for adverse events is recommended in all [62A].

Ofloxacin [SED-15, 2597; SEDA-34, 405; SEDA-35, 466] Ofloxacin 200 mg twice daily to treat typhoid fever was well tolerated. Ten percent of treated subjects developed nausea and vomiting and one patient developed a skin rash [63A]. Whether this was related to the underlying disease or the treatment is unclear.

GLYCOPEPTIDES [SEDA-32, 469; SEDA-33, 519; SEDA-34, 405; SEDA-35, 466] Teicoplanin [SED-15, 3305; SEDA-32, 469; SEDA-33, 519; SEDA-34, 405; SEDA-35, 467] Cardiovascular One case of teicoplanin-induced complete atrioventricular heart block was reported in a 31-month-old boy undergoing treatment for acute lymphoblastic leukaemia. The patient presented to the hospital for maintenance chemotherapy (consisting of 6-mercaptopurine and methotrexate) however was noted to be febrile. Further investigations

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revealed febrile neutropenia. Teicoplanin at a dose of 10 mg/kg twice per day was started. After 15 h, he developed complete heart block, which ultimately required the insertion of a permanent pacemaker [64A]. Urinary Tract A study designed to determine the effectiveness and toxicity of a teicoplanin regimen targeting an elevated trough concentration of >20 mg/L was carried out. In the group achieving a trough concentration greater than 20 mg/L, nephrotoxicity occurred at a rate of 7.1% and hepatotoxicity at a rate of 14.3% [65c]. Haematologic A 66-year-old woman was treated with 400 mg intravenous teicoplanin for suspected postoperative endocarditis. Eighteen days into treatment she developed fever and neutropenia. The fevers spiked 40 min following administration of teicoplanin. The neutropenia and fever resolved within a few days following cessation of the treatment [66A]. This case highlights the potential for drug-induced fever as well as neutropenia and must be considered in patients on long-term antibiotics.

Telavancin [SEDA-33, 520; SEDA-34, 405; SEDA-35, 467] Drug Studies The ATTAIN study investigated the effect of telavancin for the treatment of hospital-acquired pneumonia. Adult subjects were randomised to receive either 10 mg/kg intravenously once per day of telavancin or 1 g of vancomycin intravenously twice per day for 2–21 days. A total number of 751 patients received telavancin. Most subjects were older than 65 years of age and 58% had treatment initiated in the ICU. Twenty percent died in the telavancin group, which was similar to the vancomycin group and reflected the severity of the disease rather than the treatment. The most common adverse events included diarrhoea, renal impairment, anaemia, constipation, hypokalaemia and hypotension. Serious adverse events included septic shock, respiratory failure and multiorgan failure and again most likely reflected the underlying disease process. Telavancin was more likely to induce an increase in serum creatinine >50% from baseline [67C]. In support of this, a meta-analysis of six randomised controlled trials investigating the efficacy and tolerability of telavancin vs vancomycin found that clinically significant increases in serum creatinine were more common in the telavancin group (10% vs 5%). Data were taken from patients receiving the drug for the treatment of skin and soft-tissue infections as well as hospital-acquired pneumonia [68M]. Urinary Tract A retrospective cohort study observed an increased risk of renal impairment with the use of telavancin (33%). Predictors of renal impairment in this cohort of 21 patients included: a high body mass index, previously recorded high trough levels of vancomycin and receipt of intravenous contrast dye prior to administration of telavancin [69c].

Vancomycin [SED-15, 3593; SEDA-32, 470; SEDA-33, 520; SEDA-34, 406; SEDA-35, 467] Drug Studies A meta-analysis of the use of local vancomycin prophylaxis (powdered/cement) in the prevention of deep and superficial infection in orthopaedic surgery did not report any significant adverse events with its use [70M]. Urinary Tract A multicenter, retrospective, cohort study found nephrotoxicity at a rate of 23% whilst receiving vancomycin either empirically or weight based for the treatment of methicillin resistant S. aureus (MRSA) bacteraemia. A total number of 337 patients were included in the cohort with an average age of 55 years (76% male). After a multivariate analysis, risk factors for nephrotoxicity included: vancomycin duration greater than 15 days (OR 3.36), weight greater than 100 kg (OR 2.74), vancomycin trough greater than 20 mcg/ml (OR 2.36), age greater than 52 years (OR 2.10) and a Pitt bacteraemia score of 4 or greater (OR 2.73) [71c]. A similar rate was also seen in a retrospective analysis of the IMPACT-HAP (Improving Medicine through Pathway Assessment of Critical Therapy in Hospital Acquired Pneumonia) database. Nephrotoxicity with vancomycin use was noted in 29/188 (15.4%) with initial trough levels >15 mg/L (OR 5.2), concomitant aminoglycocide use (OR 2.67) and duration of vancomycin therapy (OR 1.12 per day) as independent predictors of nephrotoxicity in multivariate analysis [72c].

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A systematic review and meta-analysis of vancomycin-induced nephrotoxicity associated with strict dosing schedules aimed at maintaining troughs between 15 and 20 mg/L noted that nephrotoxicity was more likely to occur with higher trough levels (>15 mg/L OR 2.67) and longer duration of treatment [73M]. Similarly, a study designed to determine the effectiveness and toxicity of a vancomycin regimen targeting an elevated trough concentration of >20 mg/L was carried out. In the group achieving a trough concentration greater than 20 mg/L, nephrotoxicity occurred at a rate of 11.8% and hepatotoxicity at a rate of 20.6% [65C]. Interestingly, when using a continuous infusion of vancomycin (60 mg/h) in an intensive care setting, renal replacement therapy had to be started less frequently than those treated with standard intermittent dose vancomycin (7/94 vs 12/52) [74c]. The indication for renal replacement therapy was not noted in this study and the data were gathered retrospectively, limiting the significance of these findings. This was supported however by a meta-analysis stating that continuously infused vancomycin resulted in a lower risk of nephrotoxicity than intermittent dose vancomycin (RR 0.6) [75M]. Biopsy-proven acute tubular necrosis was reported in a 45-year-old poorly controlled diabetic patient admitted for a right hallux amputation. He was treated with 1500 mg of vancomycin, 6 h for 4 days prior to a recorded increase in his serum creatinine [76A]. A similar case was also reported in a 79-year-old female patient receiving vancomycin (1 g intravenously twice per day) for Staphylococcus bacteraemia. This patient developed classical acute interstitial nephritis as well as acute tubular necrosis [77A]. Haematologic There was a single case report of thrombocytopenia occurring in a 41-year-old male receiving vancomycin 500 mg twice a day for the treatment of MRSA pneumonia. Following a decline in platelet count, the vancomycin was ceased. Complete resolution of platelets occurred within 6 days. Re-challenge with vancomycin 2 weeks later caused the same effect [78A]. Thrombocytopenia is a reasonably common side effect, as demonstrated by a cohort study investigating the incidence of thrombocytopenia in subjects receiving vancomycin. This study reported a rate of critical thrombocytopenia (<20,000 cells/mm) of 3%. A >50% decline in platelets was seen in 31.8% of patients. High trough concentrations were associated with an increased risk of low platelets [79c]. A case of agranulocytosis was reported in a 78-year-old woman 3 weeks after completing an 8-week course of vancomycin 750 mg twice daily [80A]. Immunologic An anaphylactic reaction was reported following 500 mg of oral vancomycin to treat severe Clostridium difficile infection. The patient was a 35-year-old posttransplant cystic fibrosis man who had several documented IgE reactions to antibiotics including cefepime, piperacillin as well as latex [81A]. Five patients over a period of 4 years at the Massachusetts General Hospital were reported to have developed DRESS syndrome in association with vancomycin use. Onset of symptoms varied from 12 days to 4 weeks after starting treatment and should be considered in subjects presenting late with typical findings [82c]. Nervous System A single case of severe tremor was reported in a 69-year-old female during an infusion of 1 g of intravenous vancomycin. She had been on vancomycin for 2 weeks prior to this occurring. The high-amplitude tremor affecting all four limbs recurred during subsequent infusions and subsided within 30 min of cessation of the infusion [83A]. Skin A single case report of cutaneous vasculitis in association with oral vancomycin use for the treatment of C. difficile infection in an 86-year-old man [84A]. One report of a localised bullous eruption resembling linear IgA bullous dermatosis was documented following extravasation of vancomycin [85A].

KETOLIDES [SED-15, 1976; SEDA-32, 471; SEDA-33, 521; SEDA- 34, 407; SEDA-35, 469] Solithromycin [SEDA-35, 469] A randomised, double-blind, placebo-controlled trial comparing solithromycin (800 mg intravenously day 1 followed by 400 mg PO daily for the remaining 5 days) with levofloxacin (750 mg daily for 5 days) was carried out. Sixtyfour patients were randomised to receive solithromycin and 68 levofloxacin. Adverse events were more prevalent in

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the levofloxacin group. Adverse effects in the solithromycin group consisted of diarrhoea (4.7%), elevated creatine phosphokinase (CPK) (1.5%) and hyponatraemia (1.5%) [35C].

Telithromycin [SEDA-35, 469] A meta-analysis comparing telithromycin with clarithromycin reviewed data from five randomised controlled trials. Adverse events were similar in both groups. Common adverse events included diarrhoea, nausea, vomiting, flatulence, dyspepsia and abdominal pain. Other events included headache, oral candidiasis, dizziness, dysgeusia, abnormal liver function tests and fatigue. Serious adverse events included allergic reactions, abnormal liver function tests as well as death (in three cases) [86M].

LINCOSAMIDES [SED-15, 2063; SEDA-32, 472; SEDA-33, 522; SEDA-34, 407; SEDA-35, 469] Clindamycin Drug Studies In a meta-analysis of the effectiveness of clindamycin plus quinine for the treatment of falciparum malaria, two patients reported watery diarrhoea secondary to C. difficile [87M]. Immunologic A single case of DRESS syndrome was reported in a 63-year-old lady treated for an methicillin sensitive S. aureus infection with clindamycin for 4 days. This unfortunately progressed rapidly and led to death [88A]. A 34-year-old female developed a hypersensitivity syndrome following 23 days of treatment with clindamycin (900 mg per day). The reaction consisted of a skin rash, fever, facial erythema and oedema [89A]. Reproductive System Clindamycin cream (2%) for the treatment of bacterial vaginosis caused vaginal discharge in 4.6% of patients and vulvovavginal pruritus in 8.5%. No serious adverse events were reported [90A].

MACROLIDES [SED-15, 2183; SEDA-32, 472; SEDA-33, 522; SEDA-34, 408; SEDA-35, 469] Azithromycin [SED-15, 389; SEDA-33, 522; SEDA-34, 408; SEDA-35, 469] Drug Studies Multiple studies assessed azithromycin in chronic lung disease, including non-CF bronchiectasis [91C,92C], asthma [93C] and chronic lung allograft rejection. Existing evidence was extensively reviewed for postlung transplant chronic rejection [94R]. Cardiovascular A retrospective case matching study among Tennessee Medicaid recipients aged 30–74 years found an increase in sudden cardiac death with 5 days of azithromycin when compared to amoxycillin or no antibiotics, equivalent to 47 excess cardiac deaths per million courses overall, and 245 excess cardiac deaths in the decile with highest CV risk [95c]. The U.S. FDA responded by issuing a statement in May 2012, and strengthened the warnings and precautions regarding azithromycin and cardiac risk – specifically advising caution in groups with known QT prolongation, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or decompensated heart failure. They also cautioned that elderly and those with cardiac disease may be more susceptible (FDA statements 2012, 2013[96S]). A further Danish population study comparing over a million episodes of azithromycin use in patients aged 18–64 years with matched episodes of no antibiotics and penicillin V, found higher cardiac death compared to no antibiotics, but did not find a significant difference in risk between azithromycin and penicillin V (RR 0.93, confidence interval (CI) 0.56–1.55). The lower rates may reflect the younger population with less CV risk, and suggests excess death is heavily dependent on premorbid CV risk [97R,98R,99R].

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A case study of pulseless electrical activity (PEA) arrest with postresuscitation prolonged QT in a 47-year-old American man on chronic methadone after 3 days of azithromycin highlights potential interactions with other arrhythmogenic drugs [100A]. Gastrointestinal Gastrointestinal symptoms such as nausea, diarrhoea and abdominal pain were the most frequently reported side effects in multiple randomized controlled trials (RCTs) and reviews [92CR,101–104CR], although a meta-analysis did not find a significant difference from placebo in six RCTs of azithromycin in chronic lung disease – potentially due to the generally lower doses used [105M]. Induction of Resistance A meta-analysis of azithromycin for greater than 6 months in chronic lung disease was associated with a 2.7fold increase in resistant pathogens (95% CI 1.249–5.211) [105M]. High rates of macrolide-resistant pathogens were also seen in controlled trials of Tanzanian children treated with Mass Distribution of Azithromycin for endemic Chlamydia trachomatis [106c] and in paediatric cystic fibrosis patients [107c]. A French case–control study did not find an association between long-term Azithromycin use and M. abscessus in adult and paediatric cystic fibrosis patients [108c]. Nervous System In a meta-analysis of controlled trials comparing oral azithromycin with intramuscular penicillin G benzathine for primary, secondary and latent syphilis, ageusia, dizziness and headache were more common in the azithromycin groups [102M]. Sensory Systems Mild burning was common in one retrospective review of topical azithromycin for adults with ocular rosacea [109c]. While one RCT reported no adverse events post keratoplasty [110C]. Another reported ocular adverse events in 40% contact lens-related dry eye patients, including conjunctival hyperaemia, conjunctival oedema, punctate keratitis, irritation, pain and foreign body sensation [111C].

Clarithromycin [SED-15, 799; SEDA- 32, 473; SEDA-33, 523; SEDA-34, 408; SEDA-35, 470] Psychiatric A 51-year-old woman, with no previous psychiatric history, developed acute psychosis, including dissociative thinking 2 h following oral administration of clarithromycin (500 mg) with rabeprazole (10 mg) for gastritis. The symptoms resolved 48 h after cessation of the medication [112A]. Cardiovascular A post hoc analysis of two prospectively collected data sets on acute exacerbations of COPD and communityacquired pneumonia, investigated the effect of clarithromycin on CV events. There was an increased risk of CV events (HR 1.5) and acute coronary syndrome (HR 1.67) in those treated with clarithromycin for an acute exacerbation of COPD. There was an increased risk of CV events only (HR 1.68) in those treated for community-acquired pneumonia. There was also an increased risk of CV mortality (HR 1.52) in those treated for an acute exacerbation of COPD, but not for community-acquired pneumonia [113C]. Reproductive System A register-based nationwide study on the effect of clarithromycin in early pregnancy identified an increased risk of miscarriage (10% HR 1.56) but no increased risk of congenital malformations (3.6% HR 1.03) [114c]. Liver Fulminant hepatitis was reported in a 23-year-old patient with a background of schizoaffective psychosis. He was treated with clarithromycin 500 mg twice per day for 5 days, presenting within 8 days of the initial dose [115A].

Oxazolidinones [SED-15, 2645; SEDA-32, 474; SEDA-33, 525; SEDA-34, 409; SEDA-35, 471]

373

Erythromycin [SED-15, 1237; SEDA- 32, 474; SEDA-33, 523; SEDA-34, 409; SEDA-35, 470] Paediatric A 5-day-old infant was given a 4-day course of erythromycin. Two weeks later, the patient developed pyloric stenosis, which was managed surgically [116A]. Cardiovascular A randomised, placebo-controlled trial of erythromycin succinate (400 mg twice daily) in noncystic fibrosis subjects recorded few adverse events. One subject with a baseline QTc of 470 ms was withdrawn from the trial at week 24 due to an increase in the QTc to 480 ms [117C].

OXAZOLIDINONES [SED-15, 2645; SEDA-32, 474; SEDA-33, 525; SEDA-34, 409; SEDA-35, 471] Linezolid [SEDA-35, 469] Drug Studies A randomised trial of the addition of linezolid (600 mg twice daily for 4 months) to baseline extensively drugresistant TB treatment, reported an adverse event rate of 82% (31/38). The most common adverse events included peripheral neuropathy (21 cases), myelosuppression (seven cases), optic neuropathy (seven cases), hepatic dysfunction (four cases), hyperglycaemia (three cases), pneumonia (three cases), uric acid elevation (two cases) and rhabdomyolysis (two cases) [118C]. Similar side effects were seen in a prospective, observational study which was carried out to examine the effectiveness of linezolid in the treatment of late chronic prosthetic joint infection. Six hundred milligrammes twice per day was used for a total of 42 days. The most common adverse events were: thrombocytopenia (76%), anaemia (36%), nausea (40%), abdominal pain (32%), vomiting (28%), taste disturbance (24%), insomnia and anxiety (both 20%), dizziness (24%) and mood disorder (24%). No neuropathy was recorded, but paraesthesia occurred in 4% [119c]. Interestingly, a meta-analysis of 13 trials including 3863 patients noted a higher rate of haematological (OR 2.23) and gastrointestinal (OR 2.34) adverse events with linezolid when compared with glycopeptide use. The rate of nephrotoxicity (OR 0.25) and skin reactions (OR 0.27) was significantly lower [120M]. Haematologic A cohort study investigating the incidence of thrombocytopenia in subjects receiving linezolid reported a rate of critical thrombocytopenia (<20,000 cells/mm) of 0.8%. A >50% decline in platelets was seen in 17.1% of patients. High trough concentrations were associated with an increased risk of low platelets [79c]. This is supported somewhat by a retrospective case study which noted a rate of thrombocytopenia of (27.2%) in adult Chinese patients. Multivariate analysis noted that a daily dose of linezolid of >18.75 mg/kg, a baseline platelet count of <181 × 109/L, therapy >10 days and concomitant use of caspofungin and levofloxacin as predictors for low platelets with linezolid treatment [121c]. One case reported pure red cell aplasia 2 weeks following linezolid treatment of a post stem cell transplant Staphylococcus epidermidis bacteraemia [122A]. Metabolic A single case of lactic acidosis was reported in a Japanese male receiving 600 mg twice daily of linezolid for 72 days for an MRSA spinal infection [123A]. Urinary Tract Acute tubulointerstitial nephritis with associated pruritic skin rash and eosinophilia was reported in a 54-year-old diabetic patient receiving linezolid (600 mg twice daily) for enterococcal urosepsis [124A]. Paediatric Linezolid use in 16 infants was assessed prospectively. Two patients experienced adverse events. One had elevated liver enzymes and one developed low platelets [125A].

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26. MISCELLANEOUS ANTIBACTERIAL DRUGS

Nervous System Painful polyneuropathy was reported in a 24-year-old female receiving linezolid (1200 mg per day) in addition to clarithromycin and ethambutol for the treatment of M. chelonae [126A]. Drug–Drug Interactions Serotonin syndrome was reported at a frequency of 0.24–4% in a meta-analysis of seven studies and 24 case reports when linezolid was administered with drugs such as selective serotonin reuptake inhibitors [127A].

POLYMYXINS [SED-15, 2891; SEDA-32, 476; SEDA-33, 527; SEDA-34, 412; SEDA-35, 473] Colistin [SEDA-35, 473] Drug Studies Colistin was used to treat bone and joint infections in 19 patients across eight centres in Europe. Four patients developed acute renal failure leading to cessation of treatment. One patient developed a serum creatinine level three times above baseline in association with a high colistin dose. Two patients developed an increase in blood eosinophil count and a transient distal dysaesthesia developed in one subject [128C]. A meta-analysis investigating the efficacy and safety of colistin compared with other standard antimicrobials found a similar safety and efficacy profile. As with other antimicrobials tested, colistin use led to an increase in nephrotoxicity (OR 1.14) and neurotoxicity (OR 1.39). Respiratory toxicity occurred in 4 of 51 subjects reviewed [129M]. Urinary Tract In a retrospective study examining the effectiveness and toxicity of colistin, nephrotoxicity occurred in 3 of 14 adult patients receiving between 3 and 6 million units intravenously [130c]. Predictors of nephrotoxicity in obese adults were investigated in a retrospective nested case–control study. Forty-two cases were reviewed. High BMI (OR 3.1), diabetes (OR 2.11), age (OR 1.08) and length of stay (OR 1.04) were associated with an increased risk of nephrotoxicity. Dosing based on actual body weight, rather than ideal body weight, was thought responsible [131c]. An acquired Bartter syndrome was reported in a preterm infant (28 weeks) receiving 5 mg/kg per day of colistin intravenously. Cessation of colistin led to rapid resolution of her symptoms [132A]. Nervous System A 75-year-old man developed flaccid paralysis, dyspnoea, tachypnoea and hypokalaemia 36 h after being treated with 6 mg/kg per day of intravenous colistin. Twelve hours following his final dose he became apnoeic necessitating endotracheal intubation. The recommended dose for colistin is 5 mg/kg per day. The proposed mechanism for neurotoxicity is presynaptic blockade of acetylcholine release [133A]. Paediatric A multicenter, observational study investigated the effectiveness and toxicity of colistin in a paediatric intensive care setting. Seventy-nine patients were followed with a median age of 30 months. Four serious adverse events were recorded, including two of each of renal failure and seizures [134c]. A survey study of 229 paediatric infectious disease specialists gathered data on 92 cases of colistin use in children. Twenty-two percent of children developed nephrotoxicity and four children developed reversible neurotoxicity. Concerningly development of resistance to colistin was noted in 20.5% [135c]. Musculoskeletal A case report of rhabdomyolysis in association with colistin (3 × 150 mg) was reported in a 49-year-old intensive care patient who had been admitted with Hantavirus [136A]. Respiratory A retrospective matched case–control study was carried out to determine the effect of inhaled colistin (160 mg twice daily) in patients with multidrug resistant Acinetobacter baumannii infection. The majority of patients reviewed were intensive care patients with baseline renal impairment. After 28 days of treatment, 17.9% developed haemodynamic instability, 30.6% developed acute renal failure and 20.8% required intubation. These results were not different to the control group and highlight the poor clinical state of the patient rather than the antibiotic used [137c].

Other Antimicrobial Drugs

375

STREPTOGRAMINS [SED-15, 3182; SEDA-32, 528; SEDA-34, 413; SEDA-35, 473] Pristinamycin [SEDA-34, 413; SEDA-35, 469] A single case of a 56-year-old woman developing acute generalised exanthematous pustulosis following 1 g three times per day of pristinamycin was reported [138A].

TRIMETHOPRIM, AND CO-TRIMOXAZOLE [SED-15, 3216, 3510; SEDA-32, 477; SEDA-33, 528; SEDA-34, 414; SEDA-35, 474] Trimethoprim-sulphamethoxazole [SEDA-35, 474] Haematologic A 41-year-old woman with systemic lupus erythematosis developed methemoglobinemia 2 days following administration of trimethoprim-sulphamethoxazole (40/400 mg) for prophylaxis of pneumocystis pneumonia [139A]. Urinary Tract A retrospective chart review conducted over 3 years revelled an acute kidney injury rate of 11.2% in those receiving treatment with TMP-SMZ for six or more days [140c]. A comparison of adverse events between standard dose and high dose TMP-SMX (four double strength tablets per day) revealed an increased risk of hyperkalaemia (3.46% vs 0.81%), acute renal injury (3.67% vs 1.63%) and rash (1.83% vs 0.20%) [141c]. A 61-year-old female developed severe hyperkalaemia following a 4-day course of TMP-SMX for an upper respiratory tract infection. She had a background of type II diabetes and was treated with lisinopril for hypertension. Her renal function was otherwise normal. The combination of an ACE inhibitor with TMP-SMX was determined as the cause [142A]. Musculoskeletal A single case of TMP-SMX-induced rhabdomyolysis was reported in a 40-year-old immunocompetent female [143A]. Paediatric Over a 9-year review period, 109 children had an adverse reaction to TMP-SMX. Of which, 40 required hospitalisation, with common adverse events in the hospitalised group including, rash, fever, mental status change, mucous membrane involvement, vomiting, diarrhoea, cytopenia and elevated alanine aminotransferase [144c]. Skin A case of Stevens–Johnson syndrome was reported in an HIV patient receiving TMP-SMX treatment (two doublestrength tablets three times per day) for presumed pneumocystic pneumonia. Ten days following treatment, the patient developed typical symptoms of the Stevens–Johnson syndrome and the TMP-SMX was withdrawn. Treatment with dexamethasone led to improvement of the symptoms within 8 days [145A]. Psychiatric A retrospective chart review of 135 patients receiving TMP-SMX for Pneumocystis jiroveci pneumonia was identified, where 11.9% developed acute psychosis. A higher dose of TMP-SMX (OR 1.4 per 1 mg increase in trimethoprim) and concomitant steroid use (OR 4.43) were associated with this risk [146c].

OTHER ANTIMICROBIAL DRUGS Daptomycin [SED-15, 1053; SED-32, 478; SEDA-33, 529; SEDA-34, 416; SEDA-35, 474] Haematologic A single case of immune thrombocytopenia was reported following 4 days of intravenous daptomycin (6 mg/kg per day) [147A].

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Musculoskeletal A randomised, open-label, controlled trial of daptomycin to treat osteomyelitis associated with prosthetic devices revealed increases in CPK levels in 16% of those treated with 6 mg/kg, and 21.7% of those treated with 8 mg/kg. Daptomycin was given for between 6 and 8 weeks [148c]. Similarly, a retrospective analysis of the use of daptomycin (4–6 mg/kg) for complicated skin and soft-tissue infections with or without associated bacteraemia revealed a favourable safety profile. The most common adverse event reported was elevation of blood CPK [149c]. A similar retrospective analysis investigating the safety of prolonged (>14 days) daptomycin in 2263 patients reported: increased blood CPK, nausea, diarrhoea, vomiting, thrombocytopenia, rash, pyrexia and increased blood creatinine at a rate of between 0.1% and 2.2% [150c]. In contrast to this, a retrospective study assessed the safety of co-administration of daptomycin with statins. There was no significant increase in rhabdomyolysis with the combination [151c]. Immunologic A search of the U.S. FDA adverse event reporting system noted 7 definite, 13 probable and 38 possible cases of daptomycin-induced eosinophilic pneumonia. Doses ranged from 4.4 from 8 mg/kg per day [152c].

Fosfomycin [SED-15, 1448; SEDA-34, 417; SEDA-35, 476] Fosfomycin/tobramycin (80/20 and 160/40 mg) solution for inhalation was studied in a randomised, controlled trial in patients with cystic fibrosis. A total number of 119 patients were randomised. Adverse events were reported in 29% of the low-dose group and 51% of the high-dose group. The most common adverse events were cough, dyspnoea, fever, wheeze, nasal congestion, fatigue, rhinorrhoea and haemoptysis [17C].

Fusidic Acid [SED-15, 1460; SEDA-32, 479; SEDA-33, 530; SEDA-34, 417; SEDA-35, 475] A case report of severe rhabdomyolysis leading to death highlighted the risks of combining statins with fusidic acid. In this case, rifampicin was administered with fusidic acid in an elderly man following total hip revision surgery [153A].

References









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