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PubMed1981

The effects of some organic solvents on the absorption of digoxin by man.

Ten healthy subjects took each of 6 different solutions of 0.5 mg digoxin in a study of the effect of different solvents on absorption. Bioavailability was measured by the urinary recovery of digoxin in the eight days after each dosing. The six liquid preparation were aqueous solution, an organic solvent complex (lanoxicaps fill) for which solvent assisted absorption has been suggested, digoxin elixir, and three different solutions each comprising a single organic solvent in the concentration used in lanoxicaps plus water to make up the balance. Pure aqueous solution and lanoxicaps fill had the highest bioavailability as judged by urinary recovery but there was no significant different at the 5% level between the urinary recovery from the lanoxicap fill, the elixir and the two preparations with water as the preponderant solvent. It is concluded that the greater bioavailability of digoxin from lanoxicaps than from tablet formulations is more likely to ve due at least in part to delivery of digoxin already dissolved than to the identities of the solvents. The rate of intestinal digoxin uptake may possibly influence the degree of urinary recovery.

Adult↗
PubMed1981

Extrarenal clearance, distribution volume, and elimination rate of digoxin and metildigoxin in anuric patients.

The pharmacokinetics of 3H-labeled digoxin and metildigoxin were compared in six anuric patients. The following means +/- s.e.m. were obtained: extrarenal clearance of digoxin, 43.3 +/- 5.4 ml/min, of metildigoxin, 30.3 +/- 2.9 ml/min; distribution volume of digoxin, 315 +/- 29 1, of metildigoxin, 258 +/- 22 1; rate constant for elimination of digoxin, 0.0086 +/- 0.0013 h-1, of metildogixon, 0.0071 +/- 0.0007 h-1. The elimination rates correspond to half-lives of 80 h for digoxin and of 97 h for metildigoxin. From our investigations and published data a weighed mean of 47 ml/min was calculated for the extrarenal clearance of metildigoxin. This is not significantly different from the mean extrarenal clearance of 40 ml/min reported for digoxin. A total body clearance of 40 ml/min and a daily intravenous dose of 0.1 mg correspond to an average steady-state glycoside concentration of 1.74 ng/ml.

Anuria↗
PubMed1979

Four kits for plasma digoxin radioimmunoassay compared.

We evaluated four commercial radioimmunoassay kits for digoxin. We assayed a standard plasma containing digoxin, 2.0 microgram/L, and samples from patients receiving digoxin, with use of the kits and of a bioassay, the 86Rb-uptake inhibition technique. Intra-assay precisions differed significantly. Computer-calculated 95% confidence intervals for the radioimmunoassays averaged 0.4 to 0.6 microgram/L at the proposed toxic threshold of 2.0 microgram/L; the corresponding value of the 86Rb assay was 0.75 microgram/L. Digoxin in the standard plasma was overestimated with three of the kits (means: 2.40, 2.56, and 2.59 microgram/L) but was assayed accurately by the 86Rb technique and by one kit. This same kit gave a significantly lower mean (1.07 microgram/L) for the patients' samples then did the other three kits (1.32, 1.49, and 1.29 microgram/L), two of which also differed significantly in accuracy. The 86Rb assay measured glycoside activity corresponding to a mean digoxin concentration of 1.35 microgram/L. We conclude that the relatively low precision of digoxin assay and the variations in accuracy between kits from various vendors apparently deserve continual attention.

Digoxin↗
PubMed1979

Effect of digoxin on left ventricular contractility in newborns and infants estimated by echocardiography.

In view of the known susceptibility of newborns to digoxin intoxication this study was undertaken in order to evaluate the effect of a relatively low digoxin dose on left ventricular contractility of newborn infants. Left ventricular ejection time, enddiastolic diameter and endsystolic diameter were measured by echocardiography before digitalization as well as between 2 and 4 h after the first digoxin dose (group 1 : 16 patients) or after full digitalization (group 2 : 12 patients). From these data, shortening fraction (SF) and mean velocity of fiber shortening (mean Vcf) were calculated. We found that SF and mean Vcf increased significantly in both groups after the first digoxin dose and after full digitalization. The increase was equal in newborns and infants. The mean plasma digoxin concentration after full digitalization was 2.2 ng/ml (range 0.7--4.4 ng/ml). These results demonstrate clearly the positive inotropic effect of a relatively low digoxin dose in newborns.

Adult↗
PubMed1995

Evaluation of an immunoturbidimetric assay of serum digoxin without sample pretreatment.

We have evaluated a new turbidimetric immunoassay test (On Line, Roche) for the quantification of digoxin in human serum without sample pretreatment. The assay, automated on a Cobas-Mira clinical analyser, is based on the measurement of the changes in absorbance that occur when digoxin-coated microparticles aggregate with digoxin antibody; the aggregation reaction is partially inhibited by digoxin in the sample. The calibration curve extends up to 6.4 nmol/l, with a wide measuring range, and was stable at least for 10 days during the studied period. The intra- and inter-assay coefficients of variation were in all cases lower than 7%. The detection limit of the assay was 0.256 nmol/l and the linearity, assessed by measuring serial dilutions of poisoned patient sera, showed correlation coefficients higher than 0.998. There is no interference from bilirubin (up to 340 mumol/l) or haemoglobin (up to 7900 mg/l), although a positive interference by lipids was found, which can be avoided by previous delipidation of these sera. No digoxin-like factors were identified affecting digoxin values in a concentration higher than that of the sensitivity of the assay in samples of premature infants, pregnant women, or patients with renal or hepatic failure. Correlation coefficients between the turbidimetric assay and two immunoassays (fluorescence polarization and RIA) were 0.983 and 0.955 respectively, calculated from the assay of 102 and 98 samples. Nevertheless the values obtained by the evaluated assay were proportionally 20% higher, a fact probably related to differences in calibrators.

Bilirubin↗
PubMed1979

The relationship of age to the metabolism and protein binding of digoxin in sheep.

The relationship of age to the protein binding and metabolism of digoxin was studied in newborn and adult sheep. Protein binding, studied by equilibrium dialysis, varied directly with albumin concentration. The percentage of digoxin bound to protein did not differ with age: 17.2 +/- 1.2% in newborn lambs and 17.6 +/- 1.7% in ewes. The percentage of drug bound did not change significantly over a concentration range of 0.5 to 5 ng/ml. Metabolic studies were performed by thin-layer chromatography on samples of serum, myocardium and urine obtained after animals had been treated for 4 days with [3H]-digoxin. In both newborns and adults, more than 70% of digoxin remained unmetabolized. The mean metabolic composition of all three tissues for newborns and adults, respectively, was: digoxin--80.3%, 77.0%; digoxigenin bisdigitoxoside--9.6%, 12.5%; digoxigenin monodigitoxoside--6.4%, 7.0%; digoxigenin--3.7%, 3.5%. These studies suggest that age-related differences in the effects of digoxin in sheep are not due to variations in drug binding or drug metabolism.

Aging↗
PubMed1994

[Digoxin is effective in th treatment of patients with heart failure and sinus rhythm].

Due to differences in treatment effect in studies on the effectiveness of digoxin in patients with congestive heart failure in sinus rhythm, a cross-over placebo-controlled, randomized double blind clinical trial was performed. Thirty one patients, without previous treatment with digoxin, in New York Heart Association (NYHA) functional class II to IV, with a dilated left ventricle and/or ventricular systolic dysfunction were included. Patients received digoxin, adjusted for blood levels, or placebo, during an 8 week period, prior to crossing over to the other treatment for another 8 weeks. The order of treatments was randomly allocated. Outcome measurement were performed at the end of each 8 week period. Digoxin, compared with placebo, improved NYHA class, 6.9% vs 41.4% (p = 0.013) and increased the treadmill exercise time, 406 +/- 204 s vs 484 +/- 185 s (p = 0.003). During the digoxin treatment the left ventricular and systolic diameter was reduced from 52.9 +/- 8.9 to 50.1 +/- 9.7 mm (p = 0.016) and the shortening fraction increased from 21.4 +/- 8.3 to 24.8 +/- 8.1% (p = 0.009). No significant difference was observed in the left ventricular end diastolic diameter (LVED) of the left ventricle and in a estimation of quality of life. In conclusion, digoxin treatment produced a significant improvement in functional capacity, exercise time, and left ventricular performance.

Adult↗
PubMed1994

[Potentiation of digoxin by itraconazole].

The case is reported of a 71-year-old woman with clinical signs of digoxin intoxication, presumably developing as a result of the simultaneous use of digoxin for cardiac abnormalities and itraconazole for infection with Candida albicans. Five similar experiences have previously been reported in the literature. Itraconazole may induce a decreased elimination of digoxin, but the mechanism of interaction is still unknown. Comedication and renal function may perhaps contribute to the degree of interaction. When itraconazole is needed in a patient also using digoxin the blood level of the latter drug should be monitored; the daily dose of digoxin may have to be decreased to only one-quarter of the original. Nausea and anorexia may be mistaken for side effects of itraconazole and be overlooked as early signs of digoxin intoxication.

Aged↗
PubMed1993

Digoxin-cyclosporin A interaction: modulation of the multidrug transporter P-glycoprotein in the kidney.

The mechanism of a renal tubular digoxin-cyclosporin A interaction was elucidated using a kidney epithelial cell line and the isolated perfused rat kidney. The cells expressed an excess amount of human P-glycoprotein on the apical membranes by transfection with MDR1 cDNA. Cyclosporin A inhibited the transepithelial transport of digoxin mediated by human P-glycoprotein; net basal-to-apical transport across the cell monolayer was 22.8, 21.2, 6.61 and 0.91 pmol/mg of protein/3 hr in the presence of 0, 1, 5 and 10 microM cyclosporin A, respectively. Cyclosporin A also reduced the renal tubular secretion of digoxin by the kidney. The ratio of fractional excretion/filtration fraction for digoxin was 2.88 +/- 0.71 (mean +/- S.D.) in the control, and this was decreased to 1.21 +/- 0.09 and 1.05 +/- 0.13 in the presence of 1 and 5 microM cyclosporin A, respectively. Because no signs of acute nephrotoxicity were observed, a direct effect of cyclosporin A accounted for the reduced secretion. On the other hand, digoxin did not affect cyclosporin A transport by P-glycoprotein. These findings indicate that serum concentrations of digoxin in patients should be carefully monitored when administered concurrently with cyclosporin A. The present transepithelial transport system using the transfectant cells is a simple and useful screening system for predicting drug interactions that can occur in a clinical situation.

ATP Binding Cassette Transporter, Subfamily B, Mem↗
PubMed1993

Distribution of lidocaine and digoxin in heart tissues and aorta following intrapericardial administration.

The distribution of lidocaine and digoxin in myocardial and aorta tissues of open chest anesthetized dogs was studied, following the administration of 30 ml phosphate buffer solution of the drugs in the pericardial cavity where it was kept for increasing time intervals. Transfer of lidocaine (15 or 30 mg) from the solution to myocardium was almost complete within 60 min, while only 50% of digoxin (2 or 50 micrograms) was removed, and this occurred during the first 30 min. Accordingly, the absorption rate of lidocaine by heart tissues increased with time up to 60 min while that of digoxin decreased with time. Absorption of digoxin by the atria and absorption of both drugs by intrapericardial aorta were higher than that of other heart tissues, between 20 and 60 min. At 30 and 60 min, lidocaine was evenly distributed across the LV wall while digoxin 50 micrograms was mainly concentrated subepicardially. On the contrary, i.v. administration of digoxin resulted in even distribution in the LV wall without preferential concentration in the atria. The uptake of both drugs by aorta was several times lower compared to heart tissues after i.v. administration. Drug concentrations in LV wall almost at therapeutic level, were derived from solution of low concentration of the drug in the pericardial cavity. It is concluded that intrapericardial administration of the drugs may be used when increased concentration of them is desired in specific areas of the heart and the aorta.

Animals↗
PubMed1993

Pharmacokinetics of digoxin administered to horses with congestive heart failure.

Nine horses with (naturally acquired) congestive heart failure were treated with 2.2 micrograms of digoxin/kg of body weight by the IV route, followed by 11 micrograms/kg administered orally every 12 hours thereafter. Furosemide was administered IV concurrently with IV administered digoxin every 12 hours. Serum concentration of digoxin was measured after the first (IV) and seventh (orally administered) dose. After IV administration, digoxin disposition was described by a 2-compartment model, with a rapid distribution phase (t1/2 alpha = 0.17 hour), followed by a slower elimination phase (beta = 0.096 +/- 0.055 h-1, t1/2 beta = 7.2 hours, where beta is the exponential term from the elimination phase of the concentration vs time curve). Bioavailability after oral administration was 21.2 +/- 10.8%. After the seventh orally administered dose, serum concentration of digoxin peaked 1 to 2 hours later, and was 1.9 +/- 0.7 ng/ml (mean +/- SD). In 4 horses, a second increase in serum digoxin concentration was observed 4 to 8 hours after the initial peak, which possibly was evidence of enterohepatic recycling of the drug. Response to treatment included reduction in heart rate, peripheral edema, and pulmonary edema, but these could not be attributed to the digoxin alone because the horses were treated concurrently with furosemide.

Animals↗
PubMed1993

Digoxin-like factors in herbal teas.

Forty-six commercially packaged teas and 78 teas prepared from purchased herbs were assayed for digoxin-like factors (DLF) by their crossreactivity with digoxin antibody (immuno-crossreactive DLF) and by their inhibition of ouabain binding to membrane Na,K-ATPase (NKA inhibitory DLF). Three packaged teas and 3 herbs gave NKA inhibitory DLF values > 30 micrograms digoxin equivalents/cup. Two packaged teas and 3 herbs gave immuno-crossreactive DLF values > .050 micrograms digoxin equivalent/cup. One herb, pleurisy root, had a crossreactive DLF value of 187 micrograms/cup and NKA inhibitory DLF equivalent to 3658 micrograms/cup. Plasma digoxin-like factors were measured after ingestion of the 3 commercially packaged herbal teas with highest values for NKA inhibitory DLF. After ingestion of each of the 3 teas, plasma NKA inhibitory DLF increase, in one case more than 100-fold. Two teas produced a measurable increase in plasma immuno-crossreactive DLF after ingestion. Some digoxin-like factors in human plasma may have a dietary source.

Beverages↗
PubMed1996

Nighttime dosing assures postdistribution sampling for therapeutic drug monitoring of digoxin.

To study the appropriateness of phlebotomy for digoxin therapeutic drug monitoring (TDM) in outpatients, we conducted a retrospective chart review, a computer search of all previous TDM testing, and a questionnaire of all outpatients (n = 86) who had serum digoxin determinations between April 10 and April 28, 1992 (585 tests). In patients who took digoxin at the same time daily (40 patients, 300 tests), 52% of tests were performed on inappropriate samples drawn within 6 h of the last dose. No patient who took digoxin after 1700 had inappropriate tests. Phlebotomy for serum digoxin determinations before distribution of digoxin is complete is a common problem in outpatients, leading to clinically uninterpretable test results. Postdistribution sampling can be assured by nighttime dosing, and this recommendation has been implemented at our hospital.

Adult↗
PubMed1996

A pilot study to investigate the pulmonary effects of digoxin in patients with asthma.

AIM: A number of studies have shown that increased salt intake is associated with worsening asthma. The aim of this study was to investigate the respiratory effects of digoxin (a potent inhibitor of Na+K+ATPase) in patients with asthma. METHODS: Eight asthmatic patients were given digoxin (0.5 mg/daily) or matching placebo for 8 days. Treatments were assigned using a randomised double blind, crossover design. Bronchial hyperresponsiveness to methacholine, forced expiratory volume is one second (FEV1, serum potassium (K), urinary sodium and K, heart rate, blood pressure and the QTc interval of the ECG were measured on each treatment. RESULTS: When compared to placebo, digoxin significantly decreased FEV1 (p<0.03); the QTc interval (p<0.05), and increased serum K (p<0.02). There was a tendency for digoxin to increase bronchial hyperresponsiveness. CONCLUSION: In this small study digoxin resulted in a decline in spirometry. Further studies in a larger group of patients should be performed to assess this potentially adverse effect of digoxin.

Adult↗
PubMed1977

Serum concentration and serum half-life of digoxin in premature and mature newborns.

Serum concentrations and half-life times of digoxin were determined in ten mature and nine premature newborns. Median serum digoxin concentration was 2.3 ng/ml (1.2 to 3.5 ng/ml) in mature newborns and 2.4 ng/ml (1.5 to 4.5 ng/ml) in premature newborns. Median serum digoxin half-life was 35 hours (17 to 52 hours) in mature newborns and 57 hours (38 to 88 hours) in premature newborns. The difference in serum digoxin half-life between the two groups is statistically significant. The relatively long serum digoxin half-life in premature newborns is probably due to immature renal function in this group. The data emphasize the need for cautious digoxin administration, especially in premature infants.

Digoxin↗
PubMed1977

[Clinical study of the biological availability of lanatoside C and digoxin in long-term tests].

The bioavailability of digoxin and lanatoside C from tablets and dragees and from solutions of the two substances has been investigated intraindividually in patients on maintenance therapy. Plasma levels and urinary excretion were analyzed by radioimmunoassay. Both plasma concentrations and urinary excretion were significantly higher after digoxin tablets (1.5+/-0.17 ng/ml; 0.15 mg/24 h) than after lanatoside C dragees (0.98+/-0.15 ng/ml; 0.1 mg/24 h). When equimolar solutions of both drugs, corresponding to 0.5 mg digoxin, were given, plasma concentrations and urinary excretion after digoxin (1.6+/-0.08 ng/ml; 0.14 mg/24 h) were again significantly higher than after lanatoside C (1.18+/-0.09 ng/ml; 0.1 mg/24 h). These results suggest that while the absorption of lanatoside C is lower than that of digoxin, it is better than has been generally assummed. The variability in the absorption of lanatoside C between patients is no greater than with digoxin.

Adolescent↗
PubMed1995

[Comparison between digoxin and atenolol in chronic atrial fibrillation].

The benefits of digoxin in patients with atrial fibrillation may be reduced due to its limited effect on atrioventricular conduction. The aim of this work was to compare digoxin and atenolol on functional class, resting and exercise heart rate and exercise capacity in patients with atrial fibrillation. Thirteen subjects with this condition, normal echocardiographic left ventricular function and size, a resting heart rate less than 80 beats/min and with no contraindication for beta blocker or digoxin use were studied. Patients were randomly assigned to receive initially digoxin 0.25 mg o.d. or atenolol 100 mg o.d. in a double blind fashion. The doses were adjusted to obtain a heart rate between 60 and 80 beats/min at the end of the first week of treatment. After two weeks of treatment, outcomes were assessed, patients were left without treatment for one week and crossed over to the other drug after that. Resting heart rates achieved with digoxin and atenolol were similar (67 +/- 11 and 65 +/- 23 beats/min respectively). However, maximal exercise heart rates and maximal exercise time were higher during digoxin treatment (166 +/- 23 vs 135 +/- 27 beats/min and 9.95 +/- 1.68 vs 8.5 +/- 2 min respectively). NYHA functional class deteriorated in three patients receiving atenolol. We conclude that atenolol achieves a better control of heart rate during exercise but also reduces maximal exercise capacity.

Adult↗
PubMed1995

Pharmacokinetic basis of nifedipine-digoxin interaction: a commentary.

Elevation of plasma digoxin levels following concurrent administration of nifedipine have previously been reported. The mechanism for this interaction has not been fully explained, but may include a reduction in volume of distribution of digoxin and/or reduction in the renal or non-renal clearance of digoxin by nifedipine. The end result is probably an elevation of plasma concentrations of free (pharmacologically active) digoxin, which may lead to manifestation of side effects of digoxin. This communication highlights the possible pharmacokinetic basis of the reported digoxin-nifedipine interaction.

Animals↗