Relative bioavailability in healthy volunteers of ciprofloxacin administered through a nasogastric tube with and without enteral feeding

Yuk, Jae H.; Nightingale, Charles H.; Sweeney, Kevin; Quintiliani, Richard; Lettieri, John; Frost, R. Wayne

doi:10.1128/aac.33.7.1118

Cited by 55 publications

(18 citation statements)

References 10 publications

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“…The absorption characteristics (Cm., Tm., AUCG,) of both fluoroquinolones when administered with water were similar to those reported by other investigators (34,48). Ensure significantly decreased the Cm,, and AUCOO,, while it lengthened the Tm.…”

Section: Resultssupporting

confidence: 78%

Effect of enteral feeding with ensure on oral bioavailabilities of ofloxacin and ciprofloxacin

Mueller

Brierton

Abel

et al. 1994

Antimicrob Agents Chemother

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The relative oral bioavailabilities of ciprofloxacin and ofloxacin when they were coadministered with water or an enteral feeding product (Ensure) were assessed in 13 healthy volunteers. The area under the concentration time curve from time zero to infinity and the maximum concentration of drug in serum for both drugs were reduced by Ensure in comparison with those by water (P < 0.01). However, Ensure reduced the percent relative bioavailability of ciprofloxacin (72% ± 14%; range, 52 to 96%) significantly more than ofloxacin (90% ± 8.3%; range, 74 to 105%) (P < 0.005). Coadministration of Ensure significantly diminished ciprofloxacin and ofloxacin absorption, but ciprofloxacin absorption was reduced significantly more than ofloxacin absorption.Fluoroquinolone antibiotics represent an important therapeutic advance in the treatment of bacterial infections. The beneficial characteristics of these agents include unique spectra of antimicrobial activity, favorable side effect profiles, and the advantages of both oral and parenteral routes of administration. Many serious infections which previously could be treated only with parenteral drugs can now be treated with an oral fluoroquinolone. The availability of oral fluoroquinolones has allowed more patients to be treated as outpatients and has expanded the use of oral antibiotics to the nursing home and critical care setting (49) to reduce drug costs (12,31,37).The oral bioavailabilities of fluoroquinolone antibiotics may be affected adversely by interactions with divalent cations (1,22,35,39,41). Divalent cations contribute to the clinically important interactions of fluoroquinolone antibiotics with food (9,15,16,18,19,27,42,43,45), vitamins with iron (4, 17, 36), antacids (8,14,21,28,40,41), and sucralfate (10,32,44). Of the two most studied fluoroquinolones, ciprofloxacin absorption appears to be affected more than ofloxacin absorption (6,15,26).The reduced bioavailabilities of oral fluoroquinolone antibiotics because of drug interactions may be important, particularly in the critical care setting, because therapeutic failures have been reported (30,38). The practice of using the enteral rather than the parenteral route to provide nutrition is becoming more common in intensive care units (ICUs) Because of the increasingly common practices of using oral fluoroquinolones and enteral feedings in ICU and nursing home settings, many patients may receive both of these therapies concurrently (23). We conducted a study to assess the influence that concomitant enteral feeding with an enteral feeding product (Ensure) has on the absorption of oral ciprofloxacin and ofloxacin. MATERIALS AND METHODSProtocol. Thirteen healthy adults gave informed consent and were enrolled in the study. Subjects were excluded if they were pregnant or were intending to become pregnant within 30 days of the conclusion of the study. Other exclusion criteria included breastfeeding at the time of the study and use of any medications during the 24 h prior to the study periods. Any known allergies to t...

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Section: Resultssupporting

confidence: 78%

Effect of enteral feeding with ensure on oral bioavailabilities of ofloxacin and ciprofloxacin

Mueller

Brierton

Abel

et al. 1994

Antimicrob Agents Chemother

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“…10 Thus, the fact that a tablet may be crushed and administered orally mixed in food or provided as a water suspension via a nasogastric (NG) tube provides an important alternative method of drug administration for these patients. 11,12 However, crushing a tablet and administering it as a suspension might alter the pharmacokinetics of the compound. Additionally, administering a suspension via an NG tube may alter the amount of drug delivered to the GI tract due to drug adsorption onto the luminal surface of the tube.…”

mentioning

confidence: 99%

Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube

Moore

Krook

Vaidyanathan

et al. 2014

Clinical Pharm in Drug Dev

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Purpose: Because some patients have difficulty swallowing a whole tablet, we investigated the relative bioavailability of a crushed 20 mg rivaroxaban tablet and of 2 alternative crushed tablet dosing strategies. Methods: Stability and nasogastric (NG) tube adsorption characteristics of a crushed rivaroxaban tablet were assessed. Then, in 55 healthy adults, relative bioavailability of rivaroxaban administered orally as a whole tablet (Reference [WholeOral]), crushed tablet in applesauce suspension (Crushed-Oral), or crushed tablet in water suspension via NG tube (Crushed-NG) were determined. Results: There were no significant changes in mean percent of non-degraded rivaroxaban recovered over 4 hours from crushed tablet suspensions (>98.4% recovery across all suspensions and time points) or after NG tube exposure (recovery: 99.1% for silicone and 98.9% for polyvinyl chloride NG tubes). Relative bioavailability was similar between Crushed-Oral and Reference dosing (C max and AUC 1 were within the 80-125% bioequivalence limits). Relative bioavailability was also similar between the Crushed-NG and Reference dosing (AUC 1 was within bioequivalence limits; C max [90% CI range: 78.5-85.8%] was only slightly below the 80% lower bioequivalence limit). Conclusions: A crushed rivaroxaban tablet was stable and when administered orally or via NG tube, displayed similar relative bioavailability compared to a whole tablet administered orally.Keywords rivaroxaban, factor Xa inhibitor, nasogastric tube, bioavailability, pharmacokinetics Rivaroxaban is a novel oral anticoagulant that selectively inhibits factor Xa (FXa) at the beginning of the final common pathway of the coagulation cascade; thus, blocking the downstream burst of thrombin generation. [1][2][3][4] Rivaroxaban is readily absorbed after oral tablet administration, with maximum plasma concentrations (C max ) occurring approximately 2-4 hours after dosing. 5,6The 20 mg tablet displays an absolute bioavailability of approximately 66% in a fasted state, increasing by approximately 39% when administered with food.7 A similar absorption profile and food effect may be expected for the 15 mg tablet. Therefore, both dose strengths should be administered with food. Both doses are approved for DVT or PE treatment, reducing the risk of DVT and PE recurrence and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 8 The 10 mg dose is approved for DVT prophylaxis in patients undergoing hip or knee replacement surgery and has near complete absorption (80-100% absolute bioavailability) that is not affected by food.9 The half-life of rivaroxaban ranges from 5 to 13 hours in healthy subjects. 8 Dysphagia (difficulty swallowing food or liquids) is associated with many health conditions and complications may include aspiration pneumonia, dehydration, or malnutrition. In the United States, dysphagia is estimated to affect more than 18 million adults. More than 40% of

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“…The absorption of temafloxacin and ciprofloxacin is not significantly altered in the presence of Osmolite ® enteral feedings [105,106]. However, other studies have found significant interaction potential between the quinolones and enteral feedings.…”

Section: Absorption Interactionsmentioning

confidence: 96%

Quinolones

Guay¹

2011

Drug Interactions in Infectious Diseases

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Fluoroquinolone (FQ) antimicrobials are among the most commonly used agents in the outpatient and institutional patient care environments. Due to this high frequency of utilization, the potential for deleterious drug-drug interactions with nonantimicrobials is also high. The majority of interactions with the FQs involve deleterious effects on the FQ component. These are also the most clinically-important interactions with these agents. Multivalent cations such as Mg , and other minerals as well as drugs such as sucralfate, lanthanum, sevelamer, and didanosine (the cation-supplemented version of the latter) can substantially reduce FQ bioavailability, leading the subtherapeutic drug concentrations at the infection site and clinical failure. Separation of dose administrations may or may not reduce the magnitude of these interactions. Ciprofloxacin, norfloxacin, and two experimental FQs in clinical trials (pazufloxacin and prulifloxacin) act as moderate cytochrome P450 enzyme inhibitors and may increase serum concentrations of theophylline and caffeine. Warfarin pharmacodynamics are variably affected by the FQs. The pharmacodynamic interactions between NSAIDs and FQs are only relevant if fenbufen is used concurrently with enoxacin or, possibly, prulifloxacin. Caution is warranted if sparfloxacin or moxifloxacin is used concurrently with other medications prolonging the QTc interval or if patients have other risk factors for prolongation of the QTc interval (e.g. abnormal QTc interval pre-treatment, electrolyte abnormalities, use of starvation-liquid diets, or history of heart disease). Fluoroquinolone antimicrobials can be used effectively and safely in the vast majority of patients if the clinician remembers those few drug-drug interactions that are clinically-important.

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Relative bioavailability in healthy volunteers of ciprofloxacin administered through a nasogastric tube with and without enteral feeding

Cited by 55 publications

References 10 publications

Effect of enteral feeding with ensure on oral bioavailabilities of ofloxacin and ciprofloxacin

Effect of enteral feeding with ensure on oral bioavailabilities of ofloxacin and ciprofloxacin

Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube

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