Multicenter Clinical Trial of Cefoperazone Sodium in the United States

Cohen, Myron S.; Washton, Harriet E.; Barranco, Stephen F.

doi:10.1016/s0002-9343(84)80094-7

Cited by 37 publications

(11 citation statements)

References 14 publications

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“…It is interesting that the incidence of loose stools (less than or equal to three a day) associated with cefoperazone given alone or in combination in this normal volunteer study was higher than the 4.5% incidence reported in a study involving 659 patients (4). Diarrhea (greater than or equal to four stools a day) was found in 3% of patients in this large-scale study.…”

Section: Discussioncontrasting

confidence: 52%

Multiple-dose pharmacokinetics and toleration of intravenously administered cefoperazone and sulbactam when given as single agents or in combination

Reitberg

Whall

Chung

et al. 1988

Antimicrob Agents Chemother

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every 12 h) were studied when these antimicrobial agents were administered continuously over 7 days as a 15-min infusion of individual agents and as a 3/1.5-g cefoperazone-sulbactam combination. Fourteen (CL). The area under the curve, apparent volume of distribution by the area method (V), t112, and Cmax were not significantly altered. Although cefoperazone pharmacokinetic parameters were not significantly altered when comparing single-agent to combination drug administration, the area under the curve was slightly lower and CL, nonrenal 6earance, and V were modestly higher from day 1 to day 7. Because Cmax and tl2 were unaffected, these minor day effects would not be of clinical significance. Intravenous administration of cefoperazone and sulbactam given as individual agents compared with the combination did not show pharmacokinetic differences that are likely to produce clinically relevant effects. The combination of cefoperazone and sulbactam was well tolerated, and the safety profile of the combination was similar to that of either drug given alone under the conditions of this study.

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Section: Discussioncontrasting

confidence: 52%

Multiple-dose pharmacokinetics and toleration of intravenously administered cefoperazone and sulbactam when given as single agents or in combination

Reitberg

Whall

Chung

et al. 1988

Antimicrob Agents Chemother

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“…Prolonged prothrombin time was observed in 4% of patients receiving cefoperazone in a large multicentre trial (Cohen et al' 1984). This occurred primarily in patients over 65 years of age.…”

Section: Nomentioning

confidence: 97%

“…These effects are more common in older adults, those with associated impaired vitamin K status, and those with renal failure facilitating subsequent increased biliary excretion with destruction of intestinal bacteria, an important source of vitamin K. These effects are rapidly reversible, easily treatable and usually preventable with administration of vitamin K (phytomenadione) [Cohen et al 1984;Meyers 1985;Mueller et a1. 1987;Sattler et a1.…”

Section: Nomentioning

confidence: 99%

Adverse Effects of Newer Cephalosporins

Thompson

Jacobs

1993

Drug Safety

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While classifications into generations according to antimicrobial activity has helped clinicians incorporate the increasing number of cephalosporins into their pharmacological repertoire, adverse effects among the different agents fail to follow similar categories. In general, cephalosporins are fairly well tolerated antibiotics, and toxicity has been limited to specific agents. Subtle differences in chemical structure and pharmacokinetics can influence the potential for adverse effects. The route of administration may result in minor adverse reactions, including thrombophlebitis and pain. The most common adverse effects of cephalosporins are allergic reactions, occurring in 0.9 to 3.2% of patients. Cephalosporins have very rarely been associated with haematological toxicity (less than 1% of patients), but specific agents have been associated with neutropenia, hypoprothrombinaemia, haemolytic anaemia, and problems with platelet production and function. Other reactions include localised gastrointestinal disturbances, hepatotoxicity (e.g. biliary sludging), nephrotoxicity and mild central nervous system effects. The cephalosporins are generally well tolerated in the paediatric population. Very few interactions have been observed between cephalosporins and other drugs, largely because cephalosporins do not affect the microsomal P450 hepatic enzyme system. While cephalosporins are considered to be relatively 'safe' drugs, the introduction of newer members warrants continued careful observation for reporting of adverse drug reactions.

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“…As active pharmaceutical ingredient (API), it is one kind of third generation semisynthetic cephalosporin drugs and it is widely used to treat a variety of bacterial infections at human body. [4] During the manufacturing process of cefoperazone, crystallization is the key step which will directly determine the quality of final product. To make sure a reliable and robust crystallization process of cefoperazone is designed, it is crucial to know the thermodynamic data, such as solubility and dissolution enthalpy.…”

Section: Introductionmentioning

confidence: 99%

Determination and correlation of cefoperazone solubility in different pure solvents and binary mixture

Wang

et al. 2014

Fluid Phase Equilibria

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Multicenter Clinical Trial of Cefoperazone Sodium in the United States

Cited by 37 publications

References 14 publications

Multiple-dose pharmacokinetics and toleration of intravenously administered cefoperazone and sulbactam when given as single agents or in combination

Multiple-dose pharmacokinetics and toleration of intravenously administered cefoperazone and sulbactam when given as single agents or in combination

Adverse Effects of Newer Cephalosporins

Determination and correlation of cefoperazone solubility in different pure solvents and binary mixture

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