Stability of cefepime hydrochloride injection in polypropylene syringes at -20 °C, 4 °C, and 22–24 °C

Stewart, James T.; Warren, Flynn W.; Maddox, Frances C.

doi:10.1093/ajhp/56.5.457

Cited by 13 publications

(11 citation statements)

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“…21 This instability is potentially enhanced by an increase in drug concentration (combination of both intra-and intermolecular attack), and has been studied in detail for ceftazidime (see references 22 and 23 for recent publications), but only limited public data are available for cefepime. 17,24 Moreover, only a few studies 23,[25][26][27] have used conditions strictly relevant to those that will be encountered in the clinics if using cefepime by continuous infusion (while the present contribution was being reviewed, one study quite similar to ours was presented as a poster). 28 Finally, no systematic comparison between Table 1.…”

Section: Discussionmentioning

confidence: 98%

Stability and compatibility study of cefepime in comparison with ceftazidime for potential administration by continuous infusion under conditions pertinent to ambulatory treatment of cystic fibrosis patients and to administration in intensive care units

Baririan

Chanteux

Viaene

et al. 2003

Journal of Antimicrobial Chemotherapy

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Cefepime has been examined for stability, potential liberation of degradation products and compatibility with other drugs under conditions mimicking its potential use by continuous infusion in cystic fibrosis and intensive care patients (5-12% w/v solutions; temperatures from 20 to 37 degrees C; 1 h contact at 25 degrees C with other drugs frequently co-administered by intravenous route to these types of patients). Ceftazidime was used as a comparator based on a previous normative study with this antibiotic for the same indications. Based on a limit of max. 10% degradation, cefepime can be considered stable for a maximum of 24 h at 25 degrees C, but for only approximately 14 h at 30 degrees C, and for <10 h at 37 degrees C. Cefepime released so far unidentified degradation products if maintained at >30 degrees C for >12 h as shown from a marked increase in pH and from the development of a strong red-purple colour. Incompatibilities were observed with erythromycin, propofol, midazolam, phenytoin, piritramide, theophylline, nicardipine, N-acetylcysteine and a concentrated solution of dobutamine. We conclude that: (i) cefepime cannot be used safely by continuous infusion if containers are kept for more than a few hours at 37 degrees C (as will be the case for cystic fibrosis patients if using portable pumps carried under clothes); (ii) caution must be exercised in intensive care patients if the temperature and co-administration of other drugs is not kept under tight control. The nature and safety of the cefepime degradation products need to be studied further.

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Section: Discussionmentioning

confidence: 98%

Stability and compatibility study of cefepime in comparison with ceftazidime for potential administration by continuous infusion under conditions pertinent to ambulatory treatment of cystic fibrosis patients and to administration in intensive care units

Baririan

Chanteux

Viaene

et al. 2003

Journal of Antimicrobial Chemotherapy

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“…Forced decomposition of cefepime was carried out and samples were analyzed. Cefepime solutions were degraded for 30 min at 80°C in 1 N nitric acid, 1 min at 23°C in 0.2 N sodium hydroxide and/or 1 h at ambient temperature in 30% hydrogen peroxide 38. After dilution or neutralization of the solutions, samples were analyzed by the developed HPLC method.…”

Section: Resultsmentioning

confidence: 99%

“…After dilution or neutralization of the solutions, samples were analyzed by the developed HPLC method. It was reported that exposure of cefepime to these degradation conditions resulted in up to 48% decrease of cefepime concentration 38.…”

Section: Resultsmentioning

confidence: 99%

High‐performance liquid chromatographic determination and pharmacokinetic study of cefepime in goat plasma and milk after pre‐column derivatization with Hg(I)

El-Rabbat

Abdel-Wadood

Sayed

et al. 2010

J of Separation Science

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A highly sensitive and selective HPLC method with UV detection was developed for the determination of cefepime in goat plasma and milk. The proposed method was based on the complexation of cefepime with Hg(I) ions that imparts the high selectivity of the proposed method with enhancement of the sensitivity which enabled the analysis of cefepime in complex matrices such as plasma and milk. Detection was performed at 263 nm, using cefuroxime sodium as an internal standard. Chromatographic separation of cefepime and the internal standard was achieved with Aqua RP-C(18) column using methanol/triethylamine-acetate buffer, pH 3.5 (18:82, v/v) as mobile phase at a flow rate of 1 mL/min. Linear detector responses were observed spanning the range of 1.3-20 μg/mL. The LOD for standard cefepime was 0.43 μg/mL, whereas the LOD for cefepime in goat plasma was 0.84 μg/mL and the corresponding value in goat milk was 1.1 μg/mL. No interference from endogenous substances in plasma and milk was observed. The developed HPLC method has been successfully applied for the pharmacokinetic study of cefepime in goat plasma and milk, for the first time, after a single intramuscular injection of 50 mg cefepime/kg body weight.

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“…No studies on cefepime met all three of our nominated criteria for testing stability in warmer climates. Sequential data for cefepime showed stability after 7 days refrigeration and 24 hours at room temperature of 22°C–24°C18 and up to 29°C 19. However, there were no data showing stability in warmer climates, and only non-sequential data demonstrating stability up to 13 hours at 37°C 20.…”

Section: Discussionmentioning

confidence: 97%

Systematic review of stability data pertaining to selected antibiotics used for extended infusions in outpatient parenteral antimicrobial therapy (OPAT) at standard room temperature and in warmer climates

et al. 2019

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AimTo determine if there are sufficient stability data to confirm appropriate prescribing of antibiotics commonly used in outpatient parenteral antimicrobial therapy (OPAT) in warmer climates.Data sourcesFour databases were systematically searched using the terms ‘beta-lactams’, or ‘antibiotics’, or ‘anti-bacterial agents’ and ‘drug stability’ or drug storage’ for studies specific to drug stability published between 1966 and February 2018.Study selectionThe search strategy initially identified 2879 potential articles. After title and abstract review, the full-texts of 137 potential articles were assessed, with 46 articles matching the inclusion and exclusion criteria included in this review.ResultsA large volume of stability data is available for the selected drugs. Stability data at temperatures higher than 25°C were available for several of the medications, however few drugs demonstrated stability in warmer climates of 34°C or higher. Only buffered benzylpenicillin, cefoxitin and buffered flucloxacillin were found to have stability data supporting OPAT in warmer climates. Sequential data, profiling the drug for an extended period in solution under refrigeration prior to the run-out period at the higher temperatures, are also lacking.LimitationsThis study was limited by including only peer reviewed articles. There may be further grey literature supporting the stability of some of the drugs mentioned.ConclusionThere are insufficient stability data of antibiotic use in warmer climates. Studies to verify the stability and appropriate use of many antibiotics used in OPAT at standard room temperature and in warmer climates are urgently required. Several drugs in current use in the OPAT settings are lacking stability data.ImplicationsFurther research in this field is needed to develop structured evidence-based guidelines. Results of this review should be further compared with observed patient outcomes in current clinical practice.

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Stability of cefepime hydrochloride injection in polypropylene syringes at -20 °C, 4 °C, and 22–24 °C

Cited by 13 publications

References 0 publications

Stability and compatibility study of cefepime in comparison with ceftazidime for potential administration by continuous infusion under conditions pertinent to ambulatory treatment of cystic fibrosis patients and to administration in intensive care units

Stability and compatibility study of cefepime in comparison with ceftazidime for potential administration by continuous infusion under conditions pertinent to ambulatory treatment of cystic fibrosis patients and to administration in intensive care units

High‐performance liquid chromatographic determination and pharmacokinetic study of cefepime in goat plasma and milk after pre‐column derivatization with Hg(I)

Systematic review of stability data pertaining to selected antibiotics used for extended infusions in outpatient parenteral antimicrobial therapy (OPAT) at standard room temperature and in warmer climates

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