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Digoxin
Overview
What is DIGOX?
Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of . The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”).
Digoxin is described chemically as (3β,5β,12β)-3-[(-2,6-dideoxy-β--hexopyranosyl-(1→4)--2,6-dideoxy-β--hexopyranosyl-(1→4)-2,6-dideoxy-β--hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is CHO, its molecular weight is 780.95, and its structural formula is:
Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.
Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: 0.250 mg - colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid.
0.125 mg - colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid.
What does DIGOX look like?
What are the available doses of DIGOX?
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What should I talk to my health care provider before I take DIGOX?
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How should I use DIGOX?
Heart Failure:
Atrial Fibrillation:
General:
Serum Digoxin Concentrations:
To allow adequate time for equilibration of digoxin between serum and tissue, sampling of serum concentrations should be done just before the next scheduled dose of the drug. If this is not possible, sampling should be done at least 6 to 8 hours after the last dose, regardless of the route of administration or the formulation used. On a once-daily dosing schedule, the concentration of digoxin will be 10% to 25% lower when sampled at 24 versus 8 hours, depending upon the patient’s renal function. On a twice-daily dosing schedule, there will be only minor differences in serum digoxin concentrations whether sampling is done at 8 or 12 hours after a dose.
If a discrepancy exists between the reported serum concentration and the observed clinical response, the clinician should consider the following possibilities:
Heart Failure:
Rapid Digitalization with a Loading Dose:
The loading dose should be administered in several portions, with roughly half the total given as the first dose. Additional fractions of this planned total dose may be given at 6 to 8-hour intervals,
If the patient’s clinical response necessitates a change from the calculated loading dose of digoxin, then calculation of the maintenance dose should be based upon the amount actually given.
A single initial dose of 500 to 750 mcg (0.5 to 0.75 mg) of digoxin tablets usually produces a detectable effect in 0.5 to 2 hours that becomes maximal in 2 to 6 hours. Additional doses of 125 to 375 mcg (0.125 to 0.375 mg) may be given cautiously at 6 to 8-hour intervals until clinical evidence of an adequate effect is noted. The usual amount of digoxin tablets that a 70 kg patient requires to achieve 8 to 12 mcg/kg peak body stores is 750 to 1250 mcg (0.75 to 1.25 mg).
Digoxin Injection is frequently used to achieve rapid digitalization, with conversion to digoxin tablets or digoxin solution in capsules for maintenance therapy. If patients are switched from intravenous to oral digoxin formulations, allowances must be made for differences in bioavailability when calculating maintenance dosages (see Table 1, ).
Maintenance Dosing:
In a subset of approximately 1800 patients enrolled in the DIG trial (wherein dosing was based on an algorithm similar to that in Table 5) the mean (± SD) serum digoxin concentrations at 1 month and 12 months were 1.01 ± 0.47 ng/mL and 0.97 ± 0.43 ng/mL, respectively.
The maintenance dose should be based upon the percentage of the peak body stores lost each day through elimination. The following formula has had wide clinical use:
(Ccr is creatinine clearance, corrected to 70 kg body weight or 1.73 m body surface area.)
Table 5 provides average daily maintenance dose requirements of digoxin tablets for patients with heart failure based upon lean body weight and renal function:
Example:
Infants and Children:
Daily maintenance doses for each age group are given in Table 6 and should provide therapeutic effects with minimum risk of toxicity in most patients with heart failure and normal sinus rhythm. These recommendations assume the presence of normal renal function:
In children with renal disease, digoxin must be carefully titrated based upon clinical response.
It cannot be overemphasized that both adult and pediatric dosage guidelines provided are based upon average patient response and substantial individual variation can be expected. Accordingly, ultimate dosage selection must be based upon clinical assessment of the patient.
Atrial Fibrillation:
Dosage Adjustment When Changing Preparations:
What interacts with DIGOX?
Digitalis glycosides are contraindicated in patients with ventricular fibrillation or in patients with a known hypersensitivity to digoxin. A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.
What are the warnings of DIGOX?
The American Heart Association has made the following recommendations regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: "Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used." (Kaplan, EL. editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association).
Sinus Node Disease and AV Block:
Accessory AV Pathway (Wolff-Parkinson-White Syndrome):
Use in Patients with Preserved Left Ventricular Systolic Function:
What are the precautions of DIGOX?
Use in Patients with Impaired Renal Function:
Use in Patients with Electrolyte Disorders:
Hypercalcemia from any cause predisposes the patient to digitalis toxicity. Calcium, particularly when administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients. On the other hand, hypocalcemia can nullify the effects of digoxin in humans; thus, digoxin may be ineffective until serum calcium is restored to normal. These interactions are related to the fact that digoxin affects contractility and excitability of the heart in a manner similar to that of calcium.
Use in Thyroid Disorders and Hypermetabolic States:
Use in Patients with Acute Myocardial Infarction:
Use During Electrical Cardioversion:
Laboratory Test Monitoring
Patients receiving digoxin should have their serum electrolytes and renal function (serum creatinine concentrations) assessed periodically; the frequency of assessments will depend on the clinical setting. For discussion of serum digoxin concentrations, see section.
Drug Interactions
Potassium-depleting are a major contributing factor to digitalis toxicity. particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients. and raise the serum digoxin concentration due to a reduction in clearance and/or in volume of distribution of the drug, with the implication that digitalis intoxication may result. and (and possibly other ) and may increase digoxin absorption in patients who inactivate digoxin by bacterial metabolism in the lower intestine, so that digitalis intoxication may result (see ). and by decreasing gut motility, may increase digoxin absorption. certain and may interfere with intestinal digoxin absorption, resulting in unexpectedly low serum concentrations. may decrease serum digoxin concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of digoxin. There have been inconsistent reports regarding the effects of other drugs [e.g., ] on serum digoxin concentration. administration to a digitalized, hypothyroid patient may increase the dose requirement of digoxin. Concomitant use of digoxin and increases the risk of cardiac arrhythmias. may cause a sudden extrusion of potassium from muscle cells, and may thereby cause arrhythmias in digitalized patients. Although beta-adrenergic blockers or calcium channel blockers and digoxin may be useful in combination to control atrial fibrillation, their additive effects on AV node conduction can result in advanced or complete heart block.
Due to the considerable variability of these interactions, the dosage of digoxin should be individualized when patients receive these medications concurrently. Furthermore, caution should be exercised when combining digoxin with any drug that may cause a significant deterioration in renal function, since a decline in glomerular filtration or tubular secretion may impair the excretion of digoxin.
Drug/Laboratory Test Interactions
The use of therapeutic doses of digoxin may cause prolongation of the PR interval and depression of the ST segment on the electrocardiogram. Digoxin may produce false positive ST-T changes on the electrocardiogram during exercise testing. These electrophysiologic effects reflect an expected effect of the drug and are not indicative of toxicity.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There have been no long-term studies performed in animals to evaluate carcinogenic potential, nor have studies been conducted to assess the mutagenic potential of digoxin or its potential to affect fertility.
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with digoxin. It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Digoxin should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Studies have shown that digoxin concentrations in the mother’s serum and milk are similar. However, the estimated exposure of a nursing infant to digoxin via breast feeding will be far below the usual infant maintenance dose. Therefore, this amount should have no pharmacologic effect upon the infant. Nevertheless, caution should be exercised when digoxin is administered to a nursing woman.
Pediatric Use
Newborn infants display considerable variability in their tolerance to digoxin. Premature and immature infants are particularly sensitive to the effects of digoxin, and the dosage of the drug must not only be reduced but must be individualized according to their degree of maturity. Digitalis glycosides can cause poisoning in children due to accidental ingestion.
Geriatric Use
The majority of clinical experience gained with digoxin has been in the elderly population. This experience has not identified differences in response or adverse effects between the elderly and younger patients. However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, which should be based on renal function, and it may be useful to monitor renal function (see ).
What are the side effects of DIGOX?
In general, the adverse reactions of digoxin are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when digoxin is used within the recommended dose range or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.
Because some patients may be particularly susceptible to side effects with digoxin, the dosage of the drug should always be selected carefully and adjusted as the clinical condition of the patient warrants. In the past, when high doses of digoxin were used and little attention was paid to clinical status or concurrent medications, adverse reactions to digoxin were more frequent and severe. Cardiac adverse reactions accounted for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse reactions. However, available evidence suggests that the incidence and severity of digoxin toxicity has decreased substantially in recent years. In recent controlled clinical trials, in patients with predominantly mild to moderate heart failure, the incidence of adverse experiences was comparable in patients taking digoxin and in those taking placebo. In a large mortality trial, the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking digoxin compared to 0.9% in patients taking placebo. In this trial, the most common manifestations of digoxin toxicity included gastrointestinal and cardiac disturbances; CNS manifestations were less common.
Adults:
Gastrointestinal:
CNS:
Other:
Table 4 summarizes the incidence of those adverse experiences listed above for patients treated with digoxin tablets or placebo from two randomized, double-blind, placebo-controlled withdrawal trials. Patients in these trials were also receiving diuretics with or without angiotensin-converting enzyme inhibitors. These patients had been stable on digoxin, and were randomized to digoxin or placebo. The results shown in Table 4 reflect the experience in patients following dosage titration with the use of serum digoxin concentrations and careful follow-up. These adverse experiences are consistent with results from a large, placebo-controlled mortality trial (DIG trial) wherein over half the patients were not receiving digoxin prior to enrollment.
Infants and Children:
| Cardiac Palpitation Ventricular extrasystole Tachycardia Heart arrest | 1121 | 4111 |
| Gastrointestinal Anorexia Nausea Vomiting Diarrhea Abdominal pain | 14240 | 42116 |
| CNS Headache Dizziness Mental disturbances | 465 | 451 |
| Other Rash Death | 24 | 13 |
What should I look out for while using DIGOX?
Digitalis glycosides are contraindicated in patients with ventricular fibrillation or in patients with a known hypersensitivity to digoxin. A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.
Sinus Node Disease and AV Block:
Accessory AV Pathway (Wolff-Parkinson-White Syndrome):
Use in Patients with Preserved Left Ventricular Systolic Function:
What might happen if I take too much DIGOX?
Treatment of Adverse Reactions Produced by Overdosage:
Withdrawal of digoxin may be all that is required to treat the adverse reaction. However, when the primary manifestation of digoxin overdosage is a cardiac arrhythmia, additional therapy may be needed.
If the rhythm disturbance is a symptomatic bradyarrhythmia or heart block, consideration should be given to the reversal of toxicity with DIGIBIND® [Digoxin Immune Fab (Ovine)] (see Massive Digitalis Overdosage subsection), the use of atropine, or the insertion of a temporary cardiac pacemaker. However, asymptomatic bradycardia or heart block related to digoxin may require only temporary withdrawal of the drug and cardiac monitoring of the patient.
If the rhythm disturbance is a ventricular arrhythmia, consideration should be given to the correction of electrolyte disorders, particularly if hypokalemia (see Administration of Potassium subsection) or hypomagnesemia is present. DIGIBIND is a specific antidote for digoxin and may be used to reverse potentially life-threatening ventricular arrhythmias due to digoxin overdosage.
Administration of Potassium:
Massive Digitalis Overdosage:
DIGIBIND should be used to reverse the toxic effects of ingestion of a massive overdose. The decision to administer DIGIBIND to a patient who has ingested a massive dose of digoxin but who has not yet manifested life-threatening toxicity should depend on the likelihood that life-threatening toxicity will occur (see above).
Patients with massive digitalis ingestion should receive large doses of activated charcoal to prevent absorption and bind digoxin in the gut during enteroenteric recirculation. Emesis or gastric lavage may be indicated especially if ingestion has occurred withing 30 minutes of the patient’s presentation at the hospital. Emesis should not be induced in patients who are obtunded. If a patient presents more than 2 hours after ingestion or already has toxic manifestations, it may be unsafe to induce vomiting or attempt passage of a gastric tube, because such maneuvers may induce an acute vagal episode that can worsen digitalis-related arrhythmias.
Severe digitalis intoxication can cause a massive shift of potassium from inside to outside the cell, leading to life-threatening hyperkalemia. The administration of potassium supplements in the setting of massive intoxication may be hazardous and should be avoided. Hyperkalemia caused be massive digitalis toxicity is best treated with DIGIBIND; initial treatment with glucose and insulin may also be required if hyperkalemia itself is acutely life-threatening.
How should I store and handle DIGOX?
Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 10,30 63187-740-30), 60 (63187-740-60) and 90 (NDC 63187-740-90).Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light.Dispense in a tight, light-resistant container as defined in the USP.Rx ONLYManufactured by:Jerome Stevens Pharmaceuticals, Inc.Bohemia, NY 11716Repackaged by:Proficient Rx, LP.Thousand Oaks, CA 91320Rev. 11/09MG #28531Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 10,30 63187-740-30), 60 (63187-740-60) and 90 (NDC 63187-740-90).Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light.Dispense in a tight, light-resistant container as defined in the USP.Rx ONLYManufactured by:Jerome Stevens Pharmaceuticals, Inc.Bohemia, NY 11716Repackaged by:Proficient Rx, LP.Thousand Oaks, CA 91320Rev. 11/09MG #28531Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 10,30 63187-740-30), 60 (63187-740-60) and 90 (NDC 63187-740-90).Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light.Dispense in a tight, light-resistant container as defined in the USP.Rx ONLYManufactured by:Jerome Stevens Pharmaceuticals, Inc.Bohemia, NY 11716Repackaged by:Proficient Rx, LP.Thousand Oaks, CA 91320Rev. 11/09MG #28531Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 10,30 63187-740-30), 60 (63187-740-60) and 90 (NDC 63187-740-90).Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light.Dispense in a tight, light-resistant container as defined in the USP.Rx ONLYManufactured by:Jerome Stevens Pharmaceuticals, Inc.Bohemia, NY 11716Repackaged by:Proficient Rx, LP.Thousand Oaks, CA 91320Rev. 11/09MG #28531Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 10,30 63187-740-30), 60 (63187-740-60) and 90 (NDC 63187-740-90).Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light.Dispense in a tight, light-resistant container as defined in the USP.Rx ONLYManufactured by:Jerome Stevens Pharmaceuticals, Inc.Bohemia, NY 11716Repackaged by:Proficient Rx, LP.Thousand Oaks, CA 91320Rev. 11/09MG #28531Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 10,30 63187-740-30), 60 (63187-740-60) and 90 (NDC 63187-740-90).Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light.Dispense in a tight, light-resistant container as defined in the USP.Rx ONLYManufactured by:Jerome Stevens Pharmaceuticals, Inc.Bohemia, NY 11716Repackaged by:Proficient Rx, LP.Thousand Oaks, CA 91320Rev. 11/09MG #28531Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 10,30 63187-740-30), 60 (63187-740-60) and 90 (NDC 63187-740-90).Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light.Dispense in a tight, light-resistant container as defined in the USP.Rx ONLYManufactured by:Jerome Stevens Pharmaceuticals, Inc.Bohemia, NY 11716Repackaged by:Proficient Rx, LP.Thousand Oaks, CA 91320Rev. 11/09MG #28531Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 10,30 63187-740-30), 60 (63187-740-60) and 90 (NDC 63187-740-90).Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light.Dispense in a tight, light-resistant container as defined in the USP.Rx ONLYManufactured by:Jerome Stevens Pharmaceuticals, Inc.Bohemia, NY 11716Repackaged by:Proficient Rx, LP.Thousand Oaks, CA 91320Rev. 11/09MG #28531
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Digoxin inhibits sodium-potassium ATPase, an enzyme that regulates the quantity of sodium and potassium inside cells. Inhibition of the enzyme leads to an increase in the intracellular concentration of sodium and thus (by stimulation of sodium-calcium exchange) an increase in the intracellular concentration of calcium. The beneficial effects of digoxin result from direct actions on cardiac muscle, as well as indirect actions on the cardiovascular system mediated by effects on the autonomic nervous system. The autonomic effects include: (1) a vagomimetic action, which is responsible for the effects of digoxin on the sinoatrial and atrioventricular (AV) nodes; and (2) baroreceptor sensitization, which results in increased afferent inhibitory activity and reduced activity of the sympathetic nervous system and renin-angiotensin system for any given increment in mean arterial pressure. The pharmacologic consequences of these direct and indirect effects are: (1) an increase in the force and velocity of myocardial systolic contraction (positive inotropic action); (2) a decrease in the degree of activation of the sympathetic nervous system and renin-angiotensin system (neurohormonal deactivating effect); and (3) slowing of the heart rate and decreased conduction velocity through the AV node (vagomimetic effect). The effects of digoxin in heart failure are mediated by its positive inotropic and neurohormonal deactivating effects, whereas the effects of the drug in atrial arrhythmias are related to its vagomimetic actions. In high doses, digoxin increases sympathetic outflow from the central nervous system (CNS). This increase in sympathetic activity may be an important factor in digitalis toxicity.
Non-Clinical Toxicology
Digitalis glycosides are contraindicated in patients with ventricular fibrillation or in patients with a known hypersensitivity to digoxin. A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.Sinus Node Disease and AV Block:
Accessory AV Pathway (Wolff-Parkinson-White Syndrome):
Use in Patients with Preserved Left Ventricular Systolic Function:
Potassium-depleting are a major contributing factor to digitalis toxicity. particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients. and raise the serum digoxin concentration due to a reduction in clearance and/or in volume of distribution of the drug, with the implication that digitalis intoxication may result. and (and possibly other ) and may increase digoxin absorption in patients who inactivate digoxin by bacterial metabolism in the lower intestine, so that digitalis intoxication may result (see ). and by decreasing gut motility, may increase digoxin absorption. certain and may interfere with intestinal digoxin absorption, resulting in unexpectedly low serum concentrations. may decrease serum digoxin concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of digoxin. There have been inconsistent reports regarding the effects of other drugs [e.g., ] on serum digoxin concentration. administration to a digitalized, hypothyroid patient may increase the dose requirement of digoxin. Concomitant use of digoxin and increases the risk of cardiac arrhythmias. may cause a sudden extrusion of potassium from muscle cells, and may thereby cause arrhythmias in digitalized patients. Although beta-adrenergic blockers or calcium channel blockers and digoxin may be useful in combination to control atrial fibrillation, their additive effects on AV node conduction can result in advanced or complete heart block.
Due to the considerable variability of these interactions, the dosage of digoxin should be individualized when patients receive these medications concurrently. Furthermore, caution should be exercised when combining digoxin with any drug that may cause a significant deterioration in renal function, since a decline in glomerular filtration or tubular secretion may impair the excretion of digoxin.
Use in Patients with Impaired Renal Function:
Use in Patients with Electrolyte Disorders:
Hypercalcemia from any cause predisposes the patient to digitalis toxicity. Calcium, particularly when administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients. On the other hand, hypocalcemia can nullify the effects of digoxin in humans; thus, digoxin may be ineffective until serum calcium is restored to normal. These interactions are related to the fact that digoxin affects contractility and excitability of the heart in a manner similar to that of calcium.
Use in Thyroid Disorders and Hypermetabolic States:
Use in Patients with Acute Myocardial Infarction:
Use During Electrical Cardioversion:
In general, the adverse reactions of digoxin are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when digoxin is used within the recommended dose range or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.
Because some patients may be particularly susceptible to side effects with digoxin, the dosage of the drug should always be selected carefully and adjusted as the clinical condition of the patient warrants. In the past, when high doses of digoxin were used and little attention was paid to clinical status or concurrent medications, adverse reactions to digoxin were more frequent and severe. Cardiac adverse reactions accounted for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse reactions. However, available evidence suggests that the incidence and severity of digoxin toxicity has decreased substantially in recent years. In recent controlled clinical trials, in patients with predominantly mild to moderate heart failure, the incidence of adverse experiences was comparable in patients taking digoxin and in those taking placebo. In a large mortality trial, the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking digoxin compared to 0.9% in patients taking placebo. In this trial, the most common manifestations of digoxin toxicity included gastrointestinal and cardiac disturbances; CNS manifestations were less common.
Adults:
Gastrointestinal:
CNS:
Other:
Table 4 summarizes the incidence of those adverse experiences listed above for patients treated with digoxin tablets or placebo from two randomized, double-blind, placebo-controlled withdrawal trials. Patients in these trials were also receiving diuretics with or without angiotensin-converting enzyme inhibitors. These patients had been stable on digoxin, and were randomized to digoxin or placebo. The results shown in Table 4 reflect the experience in patients following dosage titration with the use of serum digoxin concentrations and careful follow-up. These adverse experiences are consistent with results from a large, placebo-controlled mortality trial (DIG trial) wherein over half the patients were not receiving digoxin prior to enrollment.
Infants and Children:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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