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PubMed1982

Pharmacokinetics of theophylline in patients following short-term intravenous infusion.

Serum theophylline concentrations after intravenous administration of a new short-term infusion (Euphyllin Kurzzeitinfusion) were measured in 50 out-patients with chronic obstructive airways disease (COAD). An intravenous infusion of theophylline ethylenediamine 480 mg (corresponding to approximately 350 mg anhydrous theophylline) in 50 ml isotonic solution was given in 20 min. Blood samples were taken beforehand and 25 to 30 min and 1, 3 and 6 h after starting the infusion. 86% of the patients had a one-hour serum level in he therapeutic range of 8.20 mg/l, and 2 h later, this was true of 64% of the patients. The short-term infusion was well tolerated, even in cases with unknown high pre-infusion serum levels. Pertinent pharmacokinetic parameters were determined, such as total body clearance, apparent volume of distribution, and half-life of elimination. Geometric mean an 95%-confidence limits, derived from the log-normal distribution of these parameters, were: Cl = 0.044 (0.018-0.190) l/h/kg ideal body weight, Vd = 0.451 (0.258-0.789) l/kg ideal body weight, and t 1/2(el) = 7.1 (2.6-19.1) h.

Adolescent↗

PubMed1990

Effect of intravenous omeprazole on intragastric pH during intravenous infusion of amino acids.

Intravenous amino acids stimulate gastric acid secretion by an unknown mechanism. In patients on parenteral nutrition, this amino acid-induced gastric acid secretion might contribute to the failure of H2-receptor antagonists to raise intragastric pH above 4.0, a level thought to be needed to prevent stress ulceration. Therefore we studied the effect of single and repeated doses of the H+/K(+)-ATPase blocker omeprazole on the intragastric pH during a 3-hr infusion of amino acids in 10 healthy volunteers; 5% glucose was used as a control infusion. Amino acids significantly decreased intragastric pH when compared to glucose infusion (P less than 0.05). After intravenous administration of 40 mg, 80 mg and 2 X 40 mg omeprazole, this amino acid-induced fall in pH was significantly inhibited (P less than 0.01). No advantage of the 80-mg dose over the 40-mg dose could be demonstrated. The repeated dose of 40 mg showed a tendency to higher pH values compared to the single-dose experiments, which reached significance in the amino acid experiments only (P less than 0.05). Neither during the infusion of amino acids nor the glucose infusion omeprazole was able to continuously raise intragastric pH above 4.0. In conclusion, this study shows that intravenous omeprazole prevents gastric acid stimulation by intravenous amino acids but fails to continuously raise intragastric pH above 4.

Adult↗

PubMed1993

Pharmacokinetics and applications of ampicillin sodium as an intravenous infusion in the horse.

A regime for administration of ampicillin sodium by continuous intravenous infusions to horses was designed. The aim was to achieve plasma ampicillin concentrations between 5 and 10 micrograms/ml over a 4-h period. A 2 mg/kg bodyweight loading dose of ampicillin sodium was administered intravenously at the beginning of the infusion in order to achieve steady-state plasma concentrations rapidly. The infusion system subsequently administered ampicillin at a rate of approximately 19.2 micrograms/min/kg bodyweight. The plasma concentrations obtained over the infusion period correlated very well with predicted calculations based on pharmacokinetic parameters. A mean +/- SEM steady-state plasma concentration (Cpss) of 5.94 +/- 0.33 was obtained and ampicillin was shown to have an apparent steady-state volume of distribution (Vdss) of 175.43 +/- 13.63 ml/kg. When the pump was disconnected the concentrations declined over the following 4 h in an exponential way with an elimination half-life (t1/2 beta) of 0.62 h. In addition, three different infusion dose rates (13.78, 19.34 and 24.48 micrograms/min/kg) were administered to a single animal showing that a good correlation (correlation coefficient > 0.99) existed between the dose administered the steady-state plasma concentrations and the corresponding areas under the plasma concentration versus time curve.

Ampicillin↗

PubMed1995

Effect of isradipine on renal haemodynamics and systemic blood pressure changes induced by intravenous infusion of endothelin in healthy humans.

BACKGROUND: In some vascular beds calcium-channel-blocking agents have been shown to possess some antagonism to endothelin-1 (ET-1)-induced vasoconstriction. This issue has not been well investigated in humans, however. METHODS: The study had a double-blind cross-over design. In 12 healthy human volunteers we investigated the effect of pretreatment with either isradipine 10 mg daily for 1 week or placebo on changes in (i) systemic and renal haemodynamics and (ii) renal handling of sodium and water induced by intravenous infusion of ET-1 at a rate of 1 pmol/min/kg for 60 min. RESULTS: Infusion of ET-1 affected systemic haemodynamics. The increase in diastolic blood pressure was similar after pretreatment with placebo (+6.8%) or isradipine (+5.3%). The changes in renal haemodynamics in response to ET-1 infusion were also familiar, e.g. renal plasma flow (-32.1% versus -31.2%), glomerular filtration rate (-8.8% versus -10.9%) and renal vascular resistance (+55.1% versus +52.7%). Likewise the changes in renal handling of sodium and water in response to ET-1 infusion were unaffected by pretreatment with placebo or isradipine, e.g. sodium excretion (-44.6% versus -40.8%), urine flow rate (-49.8% versus -38.9%) and clearance of lithium (-32.0% versus -29.1%). CONCLUSIONS: Intravenous infusion of ET-1 in healthy humans discretely increases diastolic blood pressure and profoundly decreases renal haemodynamics and excretion of sodium and water. Pretreatment with the calcium-channel blocking agent isradipine for 1 week in a clinically relevant dose does not interfere with the action of ET-1.

Adult↗

PubMed1988

Circadian rhythm in theophylline disposition during a constant-rate intravenous infusion of aminophylline in the dog.

The disposition of theophylline in three dogs was determined during a 48-h constant-rate intravenous infusion of aminophylline. A systematic fluctuation in serum theophylline concentrations was observed over a 24-h period, which appeared to be characteristic of a circadian rhythm. Neither assay variability nor fluctuations in the infusion pump rate could account for the observed variations in the serum concentrations. It was concluded that the changes in the theophylline concentrations were the result of a circadian rhythm in theophylline disposition.

Aminophylline↗

PubMed1998

A clinical pharmacokinetics study of carzelesin given by short-term intravenous infusion in a phase I study.

We investigated the pharmacokinetic behavior of carzelesin in 31 patients receiving this drug by 10-min intravenous infusion in a Phase I clinical trial, which was conducted at institutions in Nijmegen (institution 1) and Brussels (institution 2). The dose steps were 24, 48, 96, 130, 150, 170, 210, 250, and 300 microg/m2. Carzelesin is a cyclopropylpyrroloindole prodrug that requires metabolic activation via U-76,073 to U-76,074. The lower limit of quantitation (LLQ) of the high-performance liquid chromatography (HPLC) method used in this study was 1 ng/ml for the parent drug and its metabolic products. Carzelesin was rapidly eliminated from plasma (elimination half-life 23 +/- 9 min; mean value +/- SD). At all dose levels, U-76,073 was found as early as in the first samples taken after the start of the infusion. However, the concentration of U-76,074 exceeded the LLQ for only short periods and only at the higher dose levels. Although the plasma levels of all three compounds were well above the respective IC50 values obtained by in vitro clonogenic assays, they were much lower than those observed in a preclinical study in mice. There was a substantial discrepancy in the mean plasma clearance observed between patients from institution 1 (7.9 +/- 2.1 l h[-1] m[-2]) and those from institution 2 (18.4 +/- 13.6 l h[-1] m[-2]; P = 0.038), probably reflecting problems with drug administration in the latter institution. The results recorded for patients in institution 1 indicated that the AUC increased proportionately with increasing doses. There was a good correlation between the maximal plasma concentration and the AUC, enabling future monitoring of drug exposure from one timed blood sample. Urinary excretion of carzelesin was below 1% of the delivered dose.

Antineoplastic Agents↗

PubMedDate not supplied

Comparative studies on the effect of continuous intravenous infusion of some sulphonamides on blood and urine glucose levels in buffaloes.

Three groups of five clinically healthy buffaloes each were injected intravenously with sulphadiazine, sulphadimidine and sulphamerazine in a dose of 100 mg/kg b. wt. (as a singly initial dose of 40 mg/kg b. wt. an subsequently the plasma level kept constant by a continuous intravenous infusion of a maintenance dose of 20 mg/kg per hour over a period of 3 hours). It was found that, 1) sulphadiazine, sulphadimidine and sulphamerazine increase the plasma glucose levels at 1, 2, 2.5 and 3.5 hours from the start of i.v. infusion. 2) The glucose concentration in urine increased in the buffaloes infused i.v. with sulphadiazine. 3) The glucose level in urine of buffaloes infused i.v. with sulphadimidine and sulphamerazine was slightly increased. 4) The concentrations of sulphadiazine, sulphadimidine and sulphamerazine in plasma reached its highest level, 2.5, 2 and 2.5 hours during the i.v. infusion, respectively, then declined rapidly. 5) The concentrations of sulphadiazine, sulphadimidine and sulphamerazine in urine reached their highest concentrations 3.5 hours after i.v. infusion.

Animals↗

PubMedDate not supplied

The reliability of blood sampling from peripheral intravenous infusion lines. Complete blood cell counts, electrolyte panels, and survey panels.

To assess the accuracy of venous blood sampling obtained from peripheral intravenous infusion lines, peripheral saline locks, and by peripheral venipuncture, dual blood samples from 55 hospitalized patients were compared for test reliability. Tests included complete blood cell counts, electrolyte studies, and general survey panels. Results showed that within certain limitations, blood sampling from a wide range of peripheral indwelling devices is reliable for many routine blood tests.

Adult↗

PubMed1983

High serum colony-stimulating activity of leukocytopenic patients after intravenous infusions of human urinary colony-stimulating factor.

Eight adult patients suffering from leukocytopenia have been injected by droplet intravenous infusions with partially purified human urinary colony-stimulating factor (CSFHU), which stimulated human monocytes to produce colony-stimulating activity (CSA) in vitro. Three of eight patients were injected with low-dose CSFHU and five with high-dose CSFHU. The infusion of high-dose CSFHU led to a slightly earlier rise in absolute neutrophil counts and a higher CSA level in the serum, as compared to noninjected leukocytopenic patients. There was little toxicity associated with it. Human urinary colony-stimulating factor used in the clinical studies did not have any CSA in vitro in the presence or absence of the patients' sera. These data may suggest that the intravenous infusion of CSFHU increased the serum CSA level, probably through the stimulation of CSA-producing cells in vivo.

Clinical Trials as Topic↗

PubMed1982

The stability of amoxycillin sodium in intravenous infusion fluids.

The stability of amoxycillin sodium has been determined at 25 degrees C in water and in ten intravenous infusion fluids at concentrations of 1, 2 and 5% w/v. Little difference in stability was found between 1% and 2% amoxycillin solutions in the various vehicles, but the antibiotic was significantly less stable at 5%. Stabilities in sodium and potassium chloride solutions were similar to those in water and were markedly superior to those in dextrose or dextran fluids. Solutions in lactate or bicarbonate had intermediate stability. The antibiotic was, for practical purposes, unstable in 30% sorbitol solution. Guidelines are provided for intravenous infusion of amoxycillin in the solutions studied.

Amoxicillin↗

PubMed1994

The utilization of intravenously infused pyridoxine in humans.

The utilization of a usual dose of intravenously infused pyridoxine (100 mg pyridoxine hydrochloride) was investigated in ten healthy males. Blood plasma and erythrocytes were investigated by means of high-performance liquid chromatography. Detectable metabolites in blood plasma were pyridoxine, pyridoxal 5'-phosphate, pyridoxal and 4-pyridoxic acid. In erythrocytes pyridoxine, pyridoxal 5'-phosphate, pyridoxal, and pyridoxamine 5'-phosphate were found. From their concentration-time curves rate constants of elimination and invasion, volume of distribution (pyridoxine) and the areas under the curves were calculated. Values for concmax and tmax are reported. A comparison with earlier results of oral pyridoxine administration revealed a better utilization after intravenous than after oral application, i.e. a greater build-up of coenzyme forms. A regulatory phenomenon in erythrocytes caused by high doses of pyridoxine is described. In view of the potential toxicity of pyridoxine the doses used in parenteral nutrition are called into question.

Adult↗

PubMed1982

Potential life-threatening variations of drug concentrations in intravenous infusion systems: potassium chloride, insulin, and heparin.

The investigation of concentrations of active agents in common carrier media for intravenous infusion revealed that potassium chloride tends to form a pool when it is added without mixing to carrier media in glass or polyvinyl chloride (PVC) containers which are already suspended in their functional position with ports pointing downwards. Heparin behaves in a similar fashion when added without mixing to carrier media in PVC containers. Such uneven distribution may expose a patient to potentially dangerous, possibly lethal, concentrations of a drug even when a relatively small amount of it is used. Insulin floats to the top of a Haemaccel container if its contents are not adequately mixed after addition of insulin. The resultant irregularity of insulin dosage may make the management of diabetic ketoacidosis more difficult. It is recommended that the instructions for the adequate mixing of contents should appear on all containers of carrier media for intravenous infusions.

Drug Packaging↗

PubMed1994

Phase I trial of recombinant human macrophage colony-stimulating factor administered by continuous intravenous infusion in patients with metastatic cancer.

BACKGROUND: Macrophage colony-stimulating factor is a bone marrow-derived glycoprotein that can stimulate monocytes and macrophages, resulting in production of factors involved in immune response. In vitro and in vivo preclinical studies in animals have demonstrated that recombinant human macrophage colony-stimulating factor (rHuM-CSF) can have antitumor activity. PURPOSE: A phase I clinical trial was undertaken to evaluate the toxicity, pharmacokinetics, and immunologic effects of rHuM-CSF given by continuous intravenous infusion in patients with cancer. METHODS: Eighteen patients with metastatic solid tumors refractory to conventional therapy were treated with rHuM-CSF. Twelve patients received two 14-day cycles of rHuM-CSF by continuous infusion, with a 2-week interval. Dose escalation levels were 50, 100, and 150 micrograms/kg over 24 hours. Consecutive cohorts of three to six patients were planned at each dose level. Six patients received a modified regimen of four 7-day periods of infusion at 100 micrograms/kg over 24 hours, with 1-week intervals. RESULTS: Dose-limiting toxicity was grade 4 thrombocytopenia at a dose of 150 micrograms/kg over 24 hours in two patients receiving the 2-week regimen. Platelet count nadirs and concomitant monocytosis were seen on days 7-9, but recovery occurred during the treatment period. Macrophage colony-stimulating factor serum levels were maximal on day 1 and returned to near baseline on day 7 of infusion. Patients treated with four 7-day infusions had no treatment-limiting thrombocytopenia. There were no cumulative effects on platelet or monocyte counts or significant constitutional symptoms. Subclinical conjunctival injection was noted in five of 10 patients receiving screening ophthalmologic evaluation. Grade 2 episcleritis was diagnosed in one patient, and asymptomatic perilimbal and retinal hemorrhages were seen in two. Two patients developed sepsis caused by the intravenous line, which required cessation of therapy. No objective responses were documented. CONCLUSION: The maximum tolerated dose of rHuM-CSF given by continuous intravenous infusion for 14 days was 100 micrograms/kg over 24 hours, with rapidly reversible, dose-limiting thrombocytopenia at 150 micrograms/kg over 24 hours. A regimen alternating weekly cycles of infusion avoids dose-limiting toxicity and allows long-term treatment. IMPLICATIONS: The regimen of repeated 7-day infusions may be useful for future studies evaluating rHuM-CSF-activated monocytes in therapy for long-term infectious diseases or in investigation of new modes of cancer therapy using rHuM-CSF in conjunction with a tumor-specific antibody.

Adult↗

PubMed1988

Pharmacokinetics of chloroquine in Thais: plasma and red-cell concentrations following an intravenous infusion to healthy subjects and patients with Plasmodium vivax malaria.

1. Chloroquine diphosphate (15 mg base kg-1) was given by constant rate intravenous infusion to two groups of Thai subjects. Eleven were patients with malaria (10 with Plasmodium vivax and one case with Plasmodium malariae) and 10 were healthy normal volunteers. 2. Plasma and packed red-cell concentrations of chloroquine, electrocardiographic intervals, arterial blood pressure and pulse were measured at frequent intervals. 3. Peak plasma concentrations at the end of the infusion ranged from 979 to 2,900 ng ml-1 in the malaria patients. In the group of healthy subjects the range was 550-2,200 ng ml-1. Values for terminal elimination rate constant, (lambda z) plasma clearance (CL), initial volume of distribution (V1) and volume of distribution at steady state (Vss) were calculated. For the healthy subjects, mean estimates of these parameters were lambda z = 0.062 +/- 0.030 day-1, CL = 597 +/- 238 ml min-1, V1 = 0.66 +/- 0.71 l kg-1 and Vss = 132 +/- 50 l.kg-1 For the group of malaria patients, the corresponding values were lambda z = 0.055 +/- 0.032 day-1, CL = 535 +/- 246 ml min-1, V1 = 0.74 +/- 0.75 l kg-1 and Vss = 136 +/- 64 l kg-1 There was no statistically significant difference in the estimates for any parameter between groups (P less than or equal to 0.05). 4. Chloroquine concentrations in packed red blood cells consistently exceeded those in plasma and showed no consistent change with time throughout the period of study in either group. The median value for the red cell to plasma ratio was between 3 and 4 in each group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1998

[A 2-week toxicity study of magnesium sulfate administered by 24-hr intravenous infusion in beagle dogs followed by 2-week recovery period].

A 2-week toxicity study of magnesium sulfate administered by a 24-hr intravenous infusion at the dosage levels of 0, 12.5, 50, 100 and 200 mg/kg/hr in female beagle dogs was conducted, with 2-week follow-up observation after drug withdrawal. One of 2 animals in the 200 mg/kg/hr group died approx. 32 hr after the start of infusion. At the same time, the remaining 1 animal of the same group was sacrificed in a moribund state. Changes attributable to the treatment of magnesium sulfate were decreased food consumption and body weight gain, anemia, mild prolongation of conduction time in electrocardiogram and tubular basophilia in the kidneys in the animals treated with 100 mg/kg/hr. Furthermore, decreased calcium level was recorded in the animals treated with 50 mg/kg/hr or more. However, these changes disappeared after drug withdrawal, and reversibility was suggested. Judging from the mode of occurrence, since the change in calcium level observed in the group treated with 50 mg/kg/hr was slight, it was considered to be toxicologically insignificant. In conclusion, the nontoxic dosage level of magnesium sulfate was judged to be 50 mg/kg/hr under the condition of the present study.

Anemia↗

PubMed1991

Clearance and disposition of ritodrine in the fluid compartments of the fetal lamb during and after constant rate fetal intravenous infusion.

The disposition of the beta-2 adrenoreceptor agonist, ritodrine, has been examined in the fetal lamb during and after constant rate fetal intravenous infusion (8-24 h). Samples were collected from the fetal femoral artery, umbilical vein, maternal femoral artery, uterine vein, fetal trachea and the amniotic activity for ritodrine quantitation. The amniotic fluid was also analyzed for conjugated metabolites of ritodrine. Ritodrine appears to be cleared across the sheep placenta only to a limited extent (placental clearance 9.2 +/- 2 ml/min/kg; mean +/- S.E.M.). There is, however, significant fetal nonplacental clearance of ritodrine (fetal nonplacental clearance 52.8 +/- 8.0 ml/min/kg). At least part of this clearance appears to be due to fetal drug metabolism, as evidenced by the accumulation of glucuronide conjugates of ritodrine in the amniotic fluid. Ritodrine was also shown to accumulate in the amniotic and fetal tracheal fluids and persist after fetal arterial plasma ritodrine concentrations became undetectable. The accumulation of ritodrine in the tracheal fluid may be of pharmacologic significance, given the well documented, potent effects of beta-2 agonists on fetal lung function and development.

Animals↗

PubMed1986

Evidence of somatostatin as a humoral modulator of motilin release in man. A study of plasma motilin and somatostatin during intravenous infusion of somatostatin, secretin, cholecystokinin, and gastric inhibitory polypeptide.

In six healthy persons receiving graded intravenous infusions of synthetic somatostatin the plasma motilin concentrations decreased significantly (p less than 0.05) already with doses giving physiological plasma somatostatin levels, and a rebound of plasma motilin was observed after cessation of infusion of pharmacological somatostatin doses. After an intravenous secretin infusion (280 pmol/kg-h) producing pharmacological plasma secretin concentrations, a comparable plasma somatostatin increase was observed together with a substantial decrease in plasma motilin (p less than 0.05). Infusion of cholecystokinin in a pharmacological dose and of gastric inhibitory polypeptide (GIP) in doses giving plasma GIP levels in the physiological range had no effect on plasma somatostatin or motilin. Circulating plasma somatostatin may be a physiological modulator of the motilin release, and the plasma motilin fall seen during infusion of pharmacological doses of secretin may possibly be explained by the secretin-induced somatostatin release occurring simultaneously.

Adult↗

PubMed1993

Comparison of intra-arterial and intravenous infusion of cisplatin for head and neck squamous cell carcinoma in a modified rat model.

To study intra-arterial infusion of chemotherapeutic agents, human squamous carcinoma cells were obtained from the FaDu cell line and were implanted in athymic rats (rnu/rnu). The xenografts were grown and then were reimplanted on a vascular pedicle and were completely isolated from the surrounding tissue. The vascular isolation of these pedicles was confirmed radiographically and histologically. After 26 days of growth, an osmotic pump was implanted to deliver either saline, intra-arterial cisplatin, or intravenous cisplatin to the vascular pedicle. Platinum levels were identified in the tumors following intra-arterial and intravenous infusions, demonstrating the usefulness of this model for delivery of antineoplastic agents. We were unable to detect differences between tumor groups for final tumor volume, tumor platinum levels, and tumor histology with the one-dose schedule used. We were able to show a remarkable uniformity of the tumor platinum levels with varying serum platinum levels with intra-arterial and intravenous infusion of cisplatin. The toxicity of each drug administration method was assessed by levels of renal platinum and rat serum creatinine and blood urea nitrogen. No differences in toxicity with the dose administrated. We believe the immunodeficient rat with a xenografted isolated vascular pedicle is an excellent model to study the effect of intra-arterial therapeutic modalities on head and neck squamous cell carcinoma.

Animals↗