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PubMed1986

Acute pediatric digoxin ingestion. A ten-year experience.

A retrospective study conducted in three major pediatric teaching hospitals revealed only 41 cases of acute digoxin ingestion with well-documented serum concentrations. All patients who were symptomatic at presentation (27%) had digoxin concentrations greater than 2 ng/mL (2.6 nmol/L). Only one patient had a transient elevation of the serum potassium concentration. Electrocardiographic (ECG) abnormalities (bradycardia, 1 degree or 2 degrees atrioventricular block, and ST depression) were present in 11 patients. Seven of the 11 patients had ECG abnormalities delayed more than five hours after ingestion. None of these ECG abnormalities were life-threatening. Serum digoxin concentrations ranged from 0.2 to 11.6 ng/mL (0.3 to 14.9 nmol/L). Serum half-lives were rapid (approximately three hours) in an initial phase and longer (approximately 20 hours) in a second phase. Our findings were as follows: acute pediatric digoxin ingestions are not common and are usually not severe; signs and symptoms on presentation predict a digoxin concentration greater than 2 ng/mL (2.6 nmol/L); a correlation between serum potassium and digoxin concentrations was not observed; non-life-threatening bradycardia and conduction disturbances were noted; and a serum digoxin concentration greater than 2 ng/mL (2.6 nmol/L) in the absence of signs or symptoms or ECG abnormalities soon after ingestion does not accurately predict their occurrence later in the course.

Adolescent↗
PubMed2000

Digoxin for preventing or treating neonatal respiratory distress syndrome.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To assess the effect of digoxin on clinical outcome in infants at risk of, or with, respiratory distress syndrome (RDS). SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: digoxin; limits: age groups, newborn infants; publication type, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. SELECTION CRITERIA: Randomized controlled trials of digoxin in either the prevention or treatment of respiratory distress syndrome are included in this overview. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes were excerpted from the trial reports by the reviewer. Data were analyzed according to the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Two randomized controlled trials have studied the effects of digoxin in the prevention and treatment of respiratory distress syndrome. No improvement in respiratory status or mortality was noted. Meta-analysis of the effect of digoxin given to infants at risk of or with RDS on mortality does not suggest any benefit of digoxin treatment (typical relative risk 1.27 95% CI 0.78, 2.07; typical risk difference 0.06, 95% CI -0.06, 0.17). REVIEWER'S CONCLUSIONS: Although hemodynamic disturbances play a role in the overall pathogenesis of respiratory distress syndrome, the specific contribution of early congestive heart failure (unrelated to hemodynamically significant patent ductus arteriosus) does not appear to be a significant factor in RDS. Treatment with digoxin has no proven value in infants solely affected with respiratory distress syndrome.

Cardiotonic Agents↗
PubMed1987

Transplacental passage of digoxin in the case of nonimmune hydrops fetalis.

Successful treatment of intrauterine fetal tachyarrhythmia was reported in several cases recently. It was also pointed out that placental transfer of digoxin is unsatisfactory under certain conditions. However, it has not been clearly shown in which cases fetal digoxin level does not reach the maternal level. We present a case of nonimmune hydrops fetalis due to congenital atrial flutter in which digoxin concentration in the sera of the mother and the neonate showed significant dissociation, and discuss perinatological matters about the digoxin treatment and the factor that obstructs the transplacental passage of digoxin. Conclusively, we recommend that maternal digoxin concentration should be raised to near toxic level if the resolution of fetal and placental hydrops is not attained in the initial digoxin loading.

Adult↗
PubMed1988

Relation between serum digoxin concentration and the electrocardiogram.

The relation between serum digoxin concentration and the electrocardiogram was assessed by correlating computerized measurements of electrocardiographic parameters (PR, QRS, QT and QTc intervals, ST segment, and T-wave amplitude) with the serum digoxin concentration in 97 patients on digoxin maintenance therapy and in 40 nondigitalized control subjects. None of the patients had unstable ischemic heart disease, electrolyte disorders, medication known to influence the ST segment, and/or the presence of a bundle-branch block or ventricular hypertrophy. We found a trend toward lengthened PR interval and shortened QT and QTc intervals in digitalized versus nondigitalized patients. Increasing serum digoxin concentrations were associated with progressive depression of the ST segment and decreased T-wave amplitude (p less than 0.001). A normal ST segment in four leads (I, aVF, V5, V6) excluded the presence of a serum digoxin concentration greater than 1.3 ng/ml in our patients, whereas severe ST-segment depression with a J point of greater than or equal to 100 microV was a strong indicator for the presence of a serum digoxin concentration greater than 2.0 ng/ml in our selected patient population (specificity 99%, sensitivity 30%, predictive accuracy 85%). We conclude that computerized electrocardiographic analysis of the ST segment may provide clinically useful information for the management of selected patients on digitalis therapy and may therefore increase the diagnostic yield of the electrocardiogram in predicting the presence of higher serum digoxin concentrations in a small but significant percentage of patients.

Adult↗
PubMed1989

Digoxin-like immunoreactive substances in chronic liver disease.

Digoxin-like immunoreactive substances, which cross-react with digoxin antibody, have been found to have natriuretic effect and Na+,K+-ATPase inhibitory effect. The role of digoxin-like immunoreactive substances in chronic liver disease was studied by radioimmunoassay in 63 serum and 60 urine samples from 58 patients with chronic liver disease and compared with 16 controls. Although the mean serum digoxin-like immunoreactive substances level of compensated chronic liver disease patients (0.06 +/- 0.05 ng per ml, p less than 0.01) was higher than that of controls (0.02 +/- 0.03 ng per ml), only four patients had serum digoxin-like immunoreactive substances higher than 0.10 ng per ml. Mean serum digoxin-like immunoreactive substances level was much higher in patients with decompensated chronic liver disease who had ascites (0.32 +/- 0.17 ng per ml, p less than 0.001), hepatorenal syndrome (0.57 +/- 0.20 ng per ml, p less than 0.001) and hepatic encephalopathy (0.43 +/- 0.20 ng per ml, p less than 0.001). Five patients with recent variceal hemorrhage requiring transfusions and saline infusion had significantly increased serum digoxin-like immunoreactive substances (mean: 0.16 +/- 0.06 ng per ml, p less than 0.001) before the development of clinically detectable ascites.(ABSTRACT TRUNCATED AT 250 WORDS)

Chronic Disease↗
PubMed1990

Exacerbation of doxorubicin cardiotoxicity by digoxin administration in an experimental rabbit model.

The relationship between digoxin administration and the development of doxorubicin cardiomyopathy was evaluated in a chronic experimental rabbit model. We graded the myocardial pathology by conventional light microscopic histologic techniques. Additionally, myocardial fibrosis was quantified by hydroxyproline determinations and myocardial cellular damage by technetium-99m pyrophosphate uptake. Twenty-four rabbits were studied: 6 control, 6 doxorubicin-treated, and 12 digoxin-doxorubicin-treated. Mortality in the digoxin-doxorubicin group was 50%. All other rabbits lived throughout the entire experiment. The severest grades of histologic lesions were seen only in the digoxin-doxorubicin group. Myocardial hydroxyproline content was greater (p less than 0.05) in the digoxin-doxorubicin group than in the doxorubicin or control groups. Myocardial technetium-99m pyrophosphate content was also significantly greater (p less than 0.05) in the digoxin-doxorubicin group than in controls. In conclusion, the pretreatment and continued administration of digoxin, together with doxorubicin, increased the severity of myocardial damage and reduced longevity in this experimental model of doxorubicin cardiotoxicity.

Animals↗
PubMedDate not supplied

Effect of intravenous furosemide on the renal excretion of digoxin.

The effect of an 80-mg intravenous dose of furosemide on the urinary excretion of digoxin was determined in three adult men with normal renal function, each of whom was taking 0.25 mg digoxin daily on a chronic basis. On two separate days, serum samples were taken and urine was collected every 2 hours over an 8-hour period for determination of digoxin, creatinine, calcium, and sodium concentrations. On the first day of study, a saline bolus was given intravenously, and on the second day, furosemide was given. In all subjects, urinary digoxin excretion increased after furosemide in direct proportion to the increase in urine volume. No consistent correlation was seen between digoxin excretion and creatinine, calcium, or sodium output. No significant changes in serum digoxin were found in this active study. These results are consistent with the hypothesis that increasing glomerular filtration rate or total urine volume increases the renal excretion of digoxin and may result in increased total urinary output of this glycoside.

Calcium↗
PubMed1981

Influence of kaolin-pectin suspension on steady-state plasma digoxin levels.

The effect of a kaolin-pectin antidiarrheal mixture on steady-state plasma levels of orally administered digoxin in subjects receiving chronic digoxin therapy was evaluated when the antidiarrheal and the cardiac glycoside were given concomitantly and when two doses of antidiarrheal were given, one 2 hours before and the other 2 hours after digoxin. Although simultaneous administration of both products decreased peak digoxin levels by 36 per cent, 24-hour areas under the curve were reduced by only 15 per cent, indicative of a slight decrease in digoxin bioavailability. In contrast, when their times of administration were separated by 2 hours, no evidence of a drug interaction was noted. Hence, the effect of one or two doses of kaolin-pectin suspension on steady-state plasma levels of digoxin appears inconsequential in patients on chronic digoxin therapy. Saliva levels were poorly correlated with plasma levels, presumably because of complexation in the oral cavity.

Absorption↗
PubMedDate not supplied

Evaluation of various methods of digoxin dosing.

The ability to precisely predict serum digoxin concentrations using 12 published methods in a group of 85 patients was undertaken. Two methods of estimating creatinine clearance and two estimates of ideal body weight were employed as input variables using the 12 dosing methods. This resulted in 40 relationships from which correlation coefficients and linear regression constants were derived for predicted versus measured serum digoxin concentrations. The correlation coefficients between predicted and measured serum digoxin ranged from -0.393 to 0.389. Possible explanations for the low correlation coefficients are interpatient variability in the kinetics of digoxin, the small number of subjects used to generate some of the digoxin dosing methods, undetected patient noncompliance in the present study, the use of empirically derived dosing methods, and/or the use of rather homogeneous patient populations to develop a given method while this study is comprised of a heterogeneous group of patients. The methods studied tend to overpredict serum digoxin concentrations and therefore generally allow safe, first approximations for digoxin dosing.

Adult↗
PubMed1986

The effect of flecainide acetate, a new antiarrhythmic, on plasma digoxin levels.

The possible effect of oral flecainide acetate on steady-state digoxin levels was assessed in 15 healthy men. Each volunteer received digoxin 0.25 mg daily (8 AM) for 22 consecutive days and flecainide 200 mg bid (8 AM and 8 PM) on days 11 through 15. Plasma digoxin and flecainide levels were measured by radioimmunoassay and gas-liquid chromatography methods, respectively. Flecainide levels were within the range associated with suppression of premature ventricular contractions in patients. Mean plasma digoxin levels just before the 8 AM dose were 0.46 ng/mL on days 9 and 10 (baseline), 0.57 ng/mL (P less than .05) on day 13, and 0.49 ng/mL (not significant [NS]) on day 15. Compared with a mean six-hour postdose baseline digoxin level of 0.58 ng/mL, postdose levels were 0.62 ng/mL (NS) and 0.65 ng/mL (P less than .05) on days 13 and 15, respectively. On an average for each subject, predose and six-hour postdose digoxin levels increased by 24 +/- 35% and 13 +/- 19%, respectively, during coadministration. The changes in electrocardiographic intervals and vital signs that occurred during concomitant drug administration were not clinically significant although a slight prolongation of the PR interval was noted in some subjects. Unless plasma digoxin levels are in the upper end of the therapeutic range, changes in magnitude as observed in this study should be clinically inconsequential for most patients.

Adult↗
PubMed1988

Effect of oral cibenzoline on steady-state digoxin concentrations in healthy volunteers.

The effect of oral cibenzoline on steady-state digoxin concentrations was studied in 12 healthy subjects ranging from 41 to 55 years of age. Each subject received an oral dose of 0.25 mg or 0.375 mg digoxin once daily for 27 days. On days 14 to 21, 160 mg of oral cibenzoline were administered concomitantly every 12 hours for a total of 15 doses. Plasma digoxin concentration-time profiles obtained before, during, and after cibenzoline coadministration were compared to determine the effect of oral cibenzoline on steady-state digoxin concentrations. The maximum plasma concentration, time of maximum concentration, area under the curve during a dosing interval and steady-state trough plasma concentration for digoxin, during and after concomitant doses of cibenzoline were similar to those before administration, indicating that cibenzoline did not affect the pharmacokinetics of digoxin. In addition, plasma cibenzoline concentration-time profiles after the first and last dose of cibenzoline were similar to those observed in previous studies in which multiple doses of cibenzoline alone were administered. The results of this study indicate that there is no pharmacokinetic interaction between digoxin and cibenzoline when the two drugs are coadministered to healthy subjects in multiple doses.

Adult↗
PubMed1992

The effects of cardiac transplantation and cyclosporine therapy on digoxin pharmacokinetics.

Most patients needing cardiac transplantation are treated with digoxin for heart failure. Because of its narrow therapeutic range, even recommended doses of digoxin may cause severe toxicity. Several drugs, including quinidine, amiodarone, verapamil, and propafenone can interact with digoxin, leading to toxic accumulation of the glycoside. The authors have recently reported two cases of severe digitalis toxicity after the initiation of cyclosporine treatment in patients awaiting cardiac transplantation. A preliminary study on two additional patients suggested that cyclosporine reduced the plasma clearance and volume of distribution of digoxin. To assess the mechanism of this interaction, the authors studied digoxin pharmacokinetics in patients awaiting cardiac transplantation and again after the surgery, during chronic cyclosporine therapy. To separate the effects of transplantation and cyclosporine on digoxin pharmacokinetics, pharmacokinetic studies were subsequently performed in dogs to allow controlled experimental conditions for evaluation of the digoxin-cyclosporine interaction.

Administration, Oral↗
PubMed1998

Effect of troglitazone on steady-state pharmacokinetics of digoxin.

Twelve healthy subjects participated in a study to determine the effect of multiple doses of troglitazone on the steady-state pharmacokinetics of digoxin. Subjects received digoxin 0.25 mg orally once daily on days 1 through 20 and 400 mg of troglitazone orally once daily on days 11 through 20. Serial plasma samples and 24-hour urine samples collected before and after the doses on days 10 and 20 were analyzed for digoxin using a radioimmunoassay method. Eleven subjects completed the study. Administration of multiple oral doses of digoxin and troglitazone was well tolerated. Mean values for maximum concentration (Cmax), time to Cmax (tmax), and area under the concentration-time curve from 0 to 24 hours (AUC0-24) of digoxin on day 10 were similar to those on day 20. Mean day 10 digoxin values for minimum concentration (Cmin), apparent oral clearance (Cl/F), total urinary excretion from 0 to 24 hours (Ae0-24), and renal clearance (Clr) were also similar to corresponding values on day 20. Thus, concomitant administration of multiple-dose troglitazone does not alter the steady-state pharmacokinetics of digoxin.

Administration, Oral↗
PubMed2006

Effects of citronellal, a monoterpenoid in Zanthoxyli Fructus, on the intestinal absorption of digoxin in vitro and in vivo.

Complementary and alternative medicines can be applied concomitantly with conventional medicines; however, little drug information is available on these interactions. Previously, we reported on the inhibitory effects of an extract and monoterpenoids (e.g., (R)-(+)-citronellal) contained in citrus herbs on P-glycoprotein (P-gp) using P-gp-overexpressed LLC-PK1 cells. The objective of the present study was to investigate the effects of (R)-(+)-citronellal on P-gp-mediated transport in the intestinal absorption process in vitro and in vivo. Transcellular transport of [(3)H]digoxin across Caco-2 cell monolayers was measured in the presence or absence of (R)-(+)-citronellal. (R)-(+)-citronellal reduced the basolateral-to-apical transport and efflux ratio for [(3)H]digoxin significantly. Serum concentration-time profiles and pharmacokinetic parameters of digoxin after intravenous and oral administration were analyzed in rats pretreated with oral (R)-(+)-citronellal. The bioavailability of digoxin after oral administration decreased significantly to 75.8% of that after intravenous administration at the same dose. (R)-(+)-citronellal increased the bioavailability of oral digoxin to 99.9% but had no effects on total body clearance, volume of distribution, or elimination rate. These findings suggest that (R)-(+)-citronellal can increase the bioavailability of oral digoxin based on the blockade of P-gp-mediated efflux of digoxin from intestinal epithelia to the lumen in the absorption process.

ATP Binding Cassette Transporter, Subfamily B, Mem↗
PubMed1986

Color vision tests to identify elevated digoxin levels.

The purpose of this study was to determine the usefulness of color vision screening in identifying patients with elevated digoxin levels (greater than or equal to 2.0 ng/ml). Test-retest color vision measurements were obtained on 56 subjects with elevated digoxin levels and 93 non-digoxin subjects. Two tests, the Ishihara and Sahlgren's Saturation Test (SST), identified digoxin levels of 2.9 ng/ml or more. These tests also yielded a high percentage of improved retest scores among subjects with elevated digoxin levels (greater than or equal to 2.7 ng/ml) of more than 4-days duration and a low percentage of improved retest scores among the non-digoxin group. The Ishihara, SST, and other bedside color vision tests may prove useful in the routine monitoring of patients on digoxin therapy, especially those with a high risk for toxicity.

Adult↗
PubMed1982

Kinetics of the translactal passage of digoxin from breast feeding mothers to their infants.

In order to find out whether digoxin therapy of nursing mothers might produce discomfort in suckling infants we have investigated the kinetics of the transfer of digoxin from plasma to milk in 11 nursing mothers. After intravenous or oral application of a single dose of 0.5 mg or 0.75 mg digoxin simultaneous serum, fore- and hindmilk samples were taken. Obviously, a rapid equilibrium occurred between the serum and the milk compartments and there was no difference between fore- and hindmilk. All three digoxin concentration profiles ran parallel with a milk to serum ratio of 0.6 to 0.7. The curves could best be fitted by the sum of two exponential functions. For predicting the digoxin intake into the suckling infant, simulations were carried out on the basis of two coupled compartment models. When the kinetic milk data as well as the kinetic data obtained in infants were fitted by this model it could be shown that even in the case of long half-lives only about 3% of the therapeutic drug levels were reached in the baby. Thus, one can conclude that digoxin accumulation to toxic concentrations should not occur in infants of women treated with appropriate doses of digoxin.

Adult↗
PubMed1987

A simple aid to digoxin prescribing.

We have designed a simple nomogram for predicting digoxin dosage and have tested it prospectively in two consecutive studies. These were both conducted in hospital inpatients who were not already taking digoxin but who required drug therapy for atrial tachyarrhythmias and/or cardiac failure. Study I. Sixty-seven patients received digoxin according to the nomogram and 50 completed the ten day course of the study. Forty-one of these patients were eligible for the final analysis. On the tenth day of treatment, 28 patients were within the therapeutic range for plasma digoxin (0.8 to 2.0 ng.ml-1), 12 were subtherapeutic (less than 0.8 ng.ml) and one was potentially toxic (greater than 2.0 ng.ml-1). Study II. Thirty patients completed the second study. Digoxin was prescribed according to the nomogram with the addition of a dosage correction based on the plasma digoxin level on Day 3. On the tenth day of treatment, 24 patients were within the therapeutic range, one in the subtherapeutic and 5 in the potentially toxic. This simple digoxin nomogram, with or without the Day 3 dosage correction, should prove to be a useful aid to prescribing in patients who do not require rapid digitalisation. It is particularly relevant to elderly inpatients with atrial tachyarrhythmias and/or cardiac failure.

Adult↗
PubMed1977

Overall pharmacokinetics during prolonged treatment of healthy volunteers with digoxin and beta-methyldigoxin.

Five healthy volunteers received digoxin 0.4 mg or beta-methyldigoxin 0.4 mg i.v., daily for 14 days, in a randomized cross-over arrangement. By monitoring minimal plasma concentrations during multiple dosing, it was found that the steady state pharmacokinetics of digoxin and beta-methyldigoxin could be estimated even better by a one-compartment than by a two-compartment model. The following mean parameters were calculated: the half life of digoxin of 1.54 +/- 0.31 days was significantly shorter than the half life of 2.29 +/- 0.34 days for beta-methyldigoxin. The distribution volume of 807 +/- 187 liters for digoxin was not significantly larger than the 735 +/- 227 liters for beta-methyldigoxin. Renal digoxin clearance of 191 +/- 25 ml/min was significantly higher than both the renal clearance of beta-methyldigoxin of 111 +/- 23 ml/min and also the creatinine clearance, which indicates tubular secretion of digoxin. There was a 2.8-fold accumulation of beta-methyldigoxin injected once a day, which was significantly higher than the 1.80-fold accumulation of digoxin.

Adult↗