A review of the Food and Drug Administration's spontaneous reporting system identified 48 reports of adverse events in patients who received concomitant therapy with ciprofloxacin (n = 39) or norfloxacin (n = 9) and theophylline. The mean (SD) age of these cases...
Population pharmacokinetic analysis of didanosine (2′,3′-dideoxyinosine) plasma concentrations obtained in phase I clinical trials in patients with AIDS or AIDS related complex
Plasma didanosine concentration data from 36 patients receiving once-a-day therapy and from 33 patients receiving twice-a-day therapy were subject to population pharmacokinetic analysis with the computer program NONMEM. Once- or twice-a-day regimens of...
A nationwide investigation of a possible protamine drug product defect
To follow-up a report submitted to FDA Spontaneous Reporting System, we investigated the hypothesis that there was not a striking increase in unexpected deaths within four hours after elective coronary artery bypass surgery associated with protamine sulfate use.
Prospective evaluation of risk factors for antibiotic associated bleeding in critically ill patients
A prospective surveillance program was initiated to determine the relative role of antibiotics containing N-methylthiotetrazole (NMTT) versus patient risk factors in producing antibiotic-associated bleeding. Five hundred forty-six critically ill patients with serum albumin 30...
A nationwide survey of clinical laboratory methodologies for fungal infections
Many hospitalized patients are at risk for fungal infections. In order to characterize present clinical laboratory experience and facilities for diagnosis and management...
Clinical and Economic Impact of Oral Ciprofloxacin as Follow-Up to Parenteral Antibiotics
This study assessed the effects of switching to ciprofloxacin hydrochloride in patients initially treated with parenteral antibiotics for respiratory tract (RTI), skin or skin structure (SSS), bone or joint…
Adverse Reaction Reporting of Interaction Between Warfarin and Fluoroquinolones
Reports to the Food and Drug Administration's Adverse Drug Reaction Reporting System of prolonged prothrombin time due to a suspected interaction between warfarin sodium and a fluoroquinolone were…
An Evaluation of Point and Interval Estimates in Population Pharmacokinetics Using NONMEM Analysis
In a simulation study of the estimation of population pharmacokinetic parameters, including fixed and random effects, the estimates and confidence intervals produced by NONMEM were evaluated.
A Nationwide Survey of Antibiotic Prescribing Patterns and Clinical Outcomes in Patients with Bacterial Pneumonia
Antibiotic prescribing information was prospectively collected on 1822 hospitalized patients treated for suspected or documented bacterial pneumonia. Antibacterial therapy with a single antibiotic...
Prospective Surveillance of Intravenous Amphotericin B Use Patterns
Information on amphotericin B use patterns and infusion-related adverse events were prospectively collected from 397 hospitalized adults. The methods of initiating amphotericin B varied greatly, with the…
A Nationwide Survey of Prescribing Patterns for Thrombolytic Drugs in Acute Myocardial Infarction
In November 1988, 164 hospitals enrolled in the Drug Surveillance Network participated in a nationwide survey of prescribing patterns for thrombolytic drugs for patients with an acute myocardial infarction.
An Evaluation of Population Pharmacokinetics in Therapeutic Trials. Part III. Prospective Data Collection Versus Retrospective Data Assembly
The ability to estimate population pharmacokinetic parameters of alprazolam from fragmentary clinical data collected during clinical efficacy trials was evaluated in this series of studies. In the...
The Influence of Intravenous Cimetidine Dosage Regimens on the Disposition of Theophylline
The influence of the method of cimetidine administration on theophylline disposition was studied in nine healthy, cigarette smoking male volunteers. The treatment phases consisted of: A) theophylline...
Comparison of N-methylthiotetrazole dispositions in healthy volunteers following single intravenous doses of moxalactam, cefoperazone, and cefotetan
he N-methylthiotetrazole side chain (NMTT) that is present on several cephalosporins has been implicated in the development of antibiotic-associated hypoprothrombinemia.
Prospective Surveillance of Antibiotic-Associated Coagulopathy in 970 Patients
N-methyl-thio-tetrazole (NMTT) has been proposed as a causative factor in antibiotic-associated coagulopathy. To evaluate this hypothesis, a nationwide surveillance program was initiated to determine...
Inhibition of Enoxacin Absorption By Antacids or Ranitidine
Ten normal volunteers participated in a randomized, five-way crossover study to determine the effect of concurrent enoxacin and antacid or ranitidine administration on enoxacin absorption...
A Clinical Pharmacy-Oriented Drug Surveillance Network: Results of a Nationwide Antibiotic Utilization Review of Bacterial Pneumonia 1987
One hundred eighteen pharmacists enrolled in the Drug Surveillance Network completed a survey of antibiotic prescribing patterns for bacterial infections. A total of 319 hospitalized patients being...
The Population Pharmacokinetics of Theophylline in Neonates and Young Infants
The population pharmacokinetics of theophylline were evaluated using 391 theophylline serum concentration measurements from 108 neonates and young infants (postnatal age 0-26 weeks), who received...
Kinetics and Action of N-Methylthiotetrazole in Volunteers and Patients. Population-Based Clinical Comparisons of Antibiotics With and Without This Moiety
Normal volunteers and patients were studied to determine the relative importance of NMTT and patient risk factors in the production of hypoprothrombinemia. The normal volunteers demonstrated in vivo NMTT…