DIGOXIN tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)
Available from:
REMEDYREPACK INC.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin increases myocardial contractility in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin is contraindicated in patients with: - Ventricular fibrillation [see Warnings and Precautions (5.1)]. - Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication
Product summary:
Digoxin Tablets USP, 250 micrograms (0.25 mg): Bottles of 100 with child-resistant cap Round, biconvex, white tablets, debossed with "441" on one side and scored on other side. NDC: 70518-2959-00 PACKAGING: 30 in 1 BLISTER PACK Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] in a dry place and protect from light. Keep out of reach of children. Dispense in tight, light-resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Authorization status:
Abbreviated New Drug Application
Authorization number:
70518-2959-0

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DIGOXIN- digoxin tablet

REMEDYREPACK INC.

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively.

See full prescribing information for DIGOXIN TABLETS.

DIGOXIN tablets, for oral use

Initial U.S. Approval: 1954

INDICATIONS AND USAGE

Digoxin is a cardiac glycoside indicated for:

Treatment of mild to moderate heart failure in adults (1.1).

Increasing myocardial contractility in pediatric patients with heart failure (1.2).

Control of resting ventricular rate in patients with chronic atrial fibrillation in adults (1.3).

DOSAGE AND ADMINISTRATION

Digoxin dose is based on patient-specific factors (age, lean body weight, renal function, etc.). See full prescribing

information. Monitor for toxicity and therapeutic effect (2).

DOSAGE FORMS AND STRENGTHS

Tablets: 125 microgram and 250 microgram scored (3).

CONTRAINDICATIONS

Ventricular fibrillation (4).

Known hypersensitivity to digoxin or other forms of digitalis (4).

WARNINGS AND PRECAUTIONS

Risk of rapid ventricular response leading to ventricular fibrillation in patients with AV accessory pathway (5.1).

Risk of advanced or complete heart block in patients with sinus node disease and AV block. (5.2).

Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances, and cardiac arrhythmias. Advanced age, low body

weight, impaired renal function and electrolyte abnormalities predispose to toxicity. (5.3).

Risk of ventricular arrhythmias during electrical cardioversion (5.4).

Not recommended in patients with acute myocardial infarction (5.5).

Avoid Digoxin in patients with myocarditis (5.6.)

ADVERSE REACTIONS

The overall incidence of adverse reactions with digoxin has been reported as 5 to 20%, with 15 to 20% of adverse events

considered serious. Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and

CNS and other toxicity for about one-fourth of these adverse events (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-

7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

PGP Inducers/Inhibitors: Drugs that induce or inhibit PGP have the potential to alter digoxin pharmacokinetics (7.1).

The potential for drug-drug interactions must be considered prior to and during drug therapy. See full prescribing

information (7.2, 7.3, 12.3).

USE IN SPECIFIC POPULATIONS

Pregnant patients: It is unknown whether use during pregnancy can cause fetal harm (8.1).

Pediatric patients: Newborn infants display variability in tolerance to digoxin (8.4).

Geriatric patients: Consider renal function in dosage selection, and carefully monitor for side effects (8.5).

Renal impairment: Digoxin is excreted by the kidneys. Consider renal function during dosage selection (8.6).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Heart Failure in Adults

1.2 Heart Failure in Pediatric Patients

1.3 Atrial Fibrillation in Adults

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing and Administration Information

2.2 Loading Dosing Regimen in Adults and Pediatric Patients

2.3 Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old

2.4 Maintenance Dosing in Pediatric Patients Less Than 10 Years Old

2.5 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels

2.6 Switching from Intravenous Digoxin to Oral Digoxin

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Ventricular Fibrillation in Patients With Accessory AV Pathway (Wolff-Parkinson-White

Syndrome)

5.2 Sinus Bradycardia and Sino-atrial Block

5.3 Digoxin Toxicity

5.4 Risk of Ventricular Arrhythmias During Electrical Cardioversion

5.5 Risk of Ischemia in Patients With Acute Myocardial Infarction

5.6 Vasoconstriction in Patients With Myocarditis

5.7 Decreased Cardiac Output in Patients With Preserved Left Ventricular Systolic Function

5.8 Reduced Efficacy In Patients With Hypocalcemia

5.9 Altered Response in Thyroid Disorders and Hypermetabolic States

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

7.1 P-Glycoprotein (PGP) Inducers/Inhibitors

7.2 Pharmacokinetic Drug Interactions

7.3 Potentially Significant Pharmacodynamic Drug Interactions

7.4 Drug/Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Malabsorption

10 OVERDOSAGE

10.1 Signs and Symptoms in Adults and Children

10.2 Treatment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Chronic Heart Failure

14.2 Chronic Atrial Fibrillation

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Heart Failure in Adults

Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left

ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise

capacity and decreased heart failure-related hospitalizations and emergency care, while having no

effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an

angiotensin-converting enzyme (ACE) inhibitor.

1.2 Heart Failure in Pediatric Patients

Digoxin increases myocardial contractility in pediatric patients with heart failure.

1.3 Atrial Fibrillation in Adults

Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial

fibrillation.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing and Administration Information

In selecting a digoxin dosing regimen, it is important to consider factors that affect digoxin blood levels

(e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only

slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by

maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading

dose.

Consider interruption or reduction in digoxin dose prior to electrical cardioversion [see Warnings and

Precautions (5.4)].

Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with

very low body weight.

2.2 Loading Dosing Regimen in Adults and Pediatric Patients

For adults and pediatric patients if a loading dosage is to be given, administer half the total loading

dose initially, then ¼ the loading dose every 6 to 8 hours twice, with careful assessment of clinical

response and toxicity before each dose. The recommended loading dose is displayed in Table 1.

Table 1. Recommended Digoxin Oral Loading Dose

Total Oral Loading Dose (mcg/kg)

Administer half the total loading dose initially, then 1/4 the loading

Sections or subsections omitted from the full prescribing information are not listed.

dose every 6 to 8 hours twice

5 to 10 years

20-45

Adult and pediatric patients over

10 years

10-15

mcg= microgram

2.3 Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old

The maintenance dose is based on lean body weight, renal function, age, and concomitant products [see

Clinical Pharmacology (12.3)].

The recommended starting maintenance dose in adults and pediatric patients over 10 years old with

normal renal function is given in Table 2. Doses may be increased every 2 weeks according to clinical

response, serum drug levels, and toxicity.

Table 2. Recommended Starting Digoxin Maintenance Dosage in Adults and Pediatric Patients

Over 10 Years Old

Age

Total Oral Maintenance Dose, mcg/kg/day

(given once daily)

Adults and pediatric patients over 10 years

3.4 to 5.1

mcg=microgram

Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over

10 years old (to be given once daily) according to lean body weight and renal function. The doses are

based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be

estimated by the following formula (peak body stores lost each day through elimination):

Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100

(% Daily Loss = 14 + Creatinine clearance/5)

Reduce the dose of digoxin in patients whose lean weight is an abnormally small fraction of their total

body mass because of obesity or edema.

Table 3. Recommended Maintenance Dose (in micrograms given once daily) of Digoxin in

Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Functionª

Corrected

Creatinine

Clearance

Lean Body Weight

Number of days

Before Steady

State Achieved

Kg

40

50

60

70

80

90

100

10 mL/min

62.5*

187.5 187.5 187.5

20 mL/min

187.5 187.5

30 mL/min

187.5 187.5

312.5

40 mL/min

187.5

187.5

312.5 312.5

50 mL/min

187.5

187.5

312.5 312.5

60 mL/min

187.5

312.5 312.5

70 mL/min

187.5

187.5

312.5

80 mL/min

187.5

187.5

312.5 312.5

437.5

90 mL/min

187.5

312.5

437.5 437.5

100 mL/min

187.5

312.5 312.5

437.5 500

Doses are rounded to the nearest dose possible using whole digoxin tablets. Recommended doses

approximately 30 percent lower than the calculated dose are designated with an *. Monitor digoxin

b

d

levels in patients receiving these initial doses and increase dose if needed.

For adults, creatinine clearance was corrected to 70-kg body weight or 1.73 m

body surface area. If

only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as

(140 – Age)/Scr. For women, this result should be multiplied by 0.85.

For pediatric patients, the modified Schwartz equation may be used. The formula is based on height in

cm and Scr in mg/dL where k is a constant. Ccr is corrected to 1.73 m

body surface area. During the

first year of life, the value of k is 0.33 for pre-term babies and 0.45 for term infants. The k is 0.55 for

pediatric patients and adolescent girls and 0.7 for adolescent boys.

GFR (mL/min/1.73 m2) = (k x Height)/Scr

If no loading dose administered.

The doses listed assume average body composition.

2.4 Maintenance Dosing in Pediatric Patients Less Than 10 Years Old

The starting maintenance dose for heart failure in pediatric patients less than 10 years old is based on

lean body weight, renal function, age, and concomitant products [ see Clinical Pharmacology (12.3)]. The

recommended starting maintenance dose for pediatric patients between 5 years and 10 years old is

given in Table 4. These recommendations assume the presence of normal renal function.

Table 4. Recommended Starting Digoxin Oral Maintenance Dosage in Pediatric Patients Between

5 years and 10 Years Old

Age

Oral Maintenance Dose,

mcg/kg/day

5 years to 10 years

3.2 to 6.4 Twice daily

Table 5 provides average daily maintenance dose requirements for pediatric patients between 5 and 10

years old (to be given twice daily) with heart failure based on age, lean body weight, and renal function.

Table 5. Recommended Maintenance Dose (in micrograms given TWICE daily) of Digoxin in

Pediatric Patients between 5 and 10 Years of Age

Based upon Lean Body Weight and Renal

Function

Corrected

Creatinine

Clearance

Lean Body Weight

Number of Days

Before Steady

State Achieved

Kg

20

30

40

50

60

10 mL/min

62.5

62.5*

20 mL/min

62.5

62.5

30 mL/min

62.5

62.5*

187.5

40 mL/min

62.5

62.5*

187.5

187.5

50 mL/min

62.5

187.5

187.5

60 mL/min

62.5

187.5

70 mL/min

62.5

187.5

187.5

80 mL/min

62.5*

187.5

187.5

90 mL/min

62.5*

187.5

100 mL/min

62.5*

187.5

312.5

Recommended are doses to be given twice daily.

The doses are rounded to the nearest dose possible using whole and/or half digoxin tablets.

Recommended doses approximately 30 percent lower than the calculated dose are designated with an *.

Monitor digoxin levels in patients receiving these initial doses and increase dose if needed.

a

a,b

c

d

The modified Schwartz equation may be used to estimate creatinine clearance. See footnote b under

Table 3.

If no loading dose administered.

2.5 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels

Monitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on

toxicity, efficacy, and blood levels.

Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels

above 2 ng/mL have been associated with increased toxicity without increased benefit.

Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated

measurement of serum digoxin concentration as the basis for increasing or decreasing the digoxin dose.

Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [ see

Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline

digoxin level before starting digoxin and correct post-treatment values by the reported baseline level.

Obtain serum digoxin concentrations just before the next scheduled digoxin dose or at least 6 hours

after the last dose. The digoxin concentration is likely to be 10% to 25% lower when sampled right

before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-

daily dosing). However, there will be only minor differences in digoxin concentrations using twice

daily dosing whether sampling is done at 8 or 12 hours after a dose.

2.6 Switching from Intravenous Digoxin to Oral Digoxin

When switching from intravenous to oral digoxin formulations, make allowances for differences in

bioavailability when calculating maintenance dosages (see Table 6).

Table 6. Comparison of the Systemic Availability and Equivalent Doses of Oral and Intravenous

Digoxin

Absolute Bioavailability

Equivalent Doses (mcg)

Digoxin Tablets

60-80%

62.5

Digoxin Intravenous Injection

100%

3 DOSAGE FORMS AND STRENGTHS

Tablets, USP: 125 micrograms (0.125 mg) are round, biconvex, yellow tablets, debossed with "437" on

one side and scored on other side.

Tablets, USP: 250 micrograms (0.25 mg) are round, biconvex, white tablets, debossed with "441" on

one side and scored on other side.

4 CONTRAINDICATIONS

Digoxin is contraindicated in patients with:

Ventricular fibrillation [see Warnings and Precautions (5.1)].

Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth,

lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations

usually constitutes a contraindication to digoxin.

5 WARNINGS AND PRECAUTIONS

5.1 Ventricular Fibrillation in Patients With Accessory AV Pathway (Wolff-Parkinson-White

Syndrome)

Patients with Wolff-Parkinson-White syndrome who develop atrial fibrillation are at high risk of

ventricular fibrillation. Treatment of these patients with digoxin leads to greater slowing of conduction

in the atrioventricular node than in accessory pathways, and the risks of rapid ventricular response

leading to ventricular fibrillation are thereby increased.

5.2 Sinus Bradycardia and Sino-atrial Block

Digoxin may cause severe sinus bradycardia or sinoatrial block particularly in patients with pre-existing

sinus node disease and may cause advanced or complete heart block in patients with pre-existing

incomplete AV block. Consider insertion of a pacemaker before treatment with digoxin.

5.3 Digoxin Toxicity

Signs and symptoms of digoxin toxicity include anorexia, nausea, vomiting, visual changes and cardiac

arrhythmias [first-degree, second-degree (Wenckebach), or third-degree heart block (including

asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal

or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular

tachycardia; and ventricular fibrillation]. Toxicity is usually associated with digoxin levels greater than

2ng/ml although symptoms may also occur at lower levels. Low body weight, advanced age or impaired

renal function, hypokalemia, hypercalcemia, or hypomagnesemia may predispose to digoxin toxicity.

Obtain serum digoxin levels in patients with signs or symptoms of digoxin therapy and interrupt or adjust

dose if necessary [see Adverse Reactions (6)and Overdosage (10)]. Assess serum electrolytes and renal

function periodically.

The earliest and most frequent manifestation of digoxin toxicity in infants and children is the appearance

of cardiac arrhythmias, including sinus bradycardia. In children, the use of digoxin may produce any

arrhythmia. The most common are conduction disturbances or supraventricular tachyarrhythmias, such

as atrial tachycardia (with or without block) and junctional (nodal) tachycardia. Ventricular arrhythmias

are less common. Sinus bradycardia may be a sign of impending digoxin intoxication, especially in

infants, even in the absence of first-degree heart block. Any arrhythmias or alteration in cardiac

conduction that develops in a child taking digoxin should initially be assumed to be a consequence of

digoxin intoxication.

Given that adult patients with heart failure have some symptoms in common with digoxin toxicity, it may

be difficult to distinguish digoxin toxicity from heart failure. Misidentification of their etiology might

lead the clinician to continue or increase digoxin dosing, when dosing should actually be suspended.

When the etiology of these signs and symptoms is not clear, measure serum digoxin levels.

5.4 Risk of Ventricular Arrhythmias During Electrical Cardioversion

It may be desirable to reduce the dose of or discontinue digoxin for 1 to 2 days prior to electrical

cardioversion of atrial fibrillation to avoid the induction of ventricular arrhythmias, but physicians must

consider the consequences of increasing the ventricular response if digoxin is decreased or withdrawn.

If digitalis toxicity is suspected, elective cardioversion should be delayed. If it is not prudent to delay

cardioversion, the lowest possible energy level should be selected to avoid provoking ventricular

arrhythmias.

5.5 Risk of Ischemia in Patients With Acute Myocardial Infarction

Digoxin is not recommended in patients with acute myocardial infarction because digoxin may increase

myocardial oxygen demand and lead to ischemia.

5.6 Vasoconstriction in Patients With Myocarditis

Digoxin can precipitate vasoconstriction and may promote production of pro-inflammatory cytokines;

therefore, avoid use in patients with myocarditis.

5.7 Decreased Cardiac Output in Patients With Preserved Left Ventricular Systolic Function

Patients with heart failure associated with preserved left ventricular ejection fraction may experience

decreased cardiac output with use of digoxin. Such disorders include restrictive cardiomyopathy,

constrictive pericarditis, amyloid heart disease, and acute cor pulmonale. Patients with idiopathic

hypertrophic subaortic stenosis may have worsening of the outflow obstruction due to the inotropic

effects of digoxin. Patients with amyloid heart disease may be more susceptible to digoxin toxicity at

therapeutic levels because of an increased binding of digoxin to extracellular amyloid fibrils. Digoxin

should generally be avoided in these patients, although it has been used for ventricular rate control in

the subgroup of patients with atrial fibrillation.

5.8 Reduced Efficacy In Patients With Hypocalcemia

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.

5.9 Altered Response in Thyroid Disorders and Hypermetabolic States

Hypothyroidism may reduce the requirements for digoxin. Heart failure and/or atrial arrhythmias

resulting from hypermetabolic or hyperdynamic states (e.g., hyperthyroidism, hypoxia, or arteriovenous

shunt) are best treated by addressing the underlying condition. Atrial arrhythmias associated with

hypermetabolic states are particularly resistant to digoxin treatment.

Patients with beri beri heart disease may fail to respond adequately to digoxin if the underlying thiamine

deficiency is not treated concomitantly.

6 ADVERSE REACTIONS

The following adverse reactions are included in more detail in the Warnings and Precautions section of

the label:

Cardiac arrhythmias [see Warnings and Precautions (5.1, 5.2)]

Digoxin Toxicity [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug

and may not reflect the rates observed in clinical practice.

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, is maintained within the therapeutic serum concentration range, and

when there is careful attention to concurrent medications and conditions.

In the DIG trial (a trial investigating the effect of digoxin on mortality and morbidity in patients with

heart failure), the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking

digoxin compared to 0.9% in patients taking placebo [see Clinical Studies (14.1)].

The overall incidence of adverse reactions with digoxin has been reported as 5 to 20%, with 15 to 20%

of adverse events considered serious. Cardiac toxicity accounts for about one-half, gastrointestinal

disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse

events.

Gastrointestinal: In addition to nausea and vomiting, the use of digoxin has been associated with

abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.

CNS: Digoxin can cause headache, weakness, dizziness, apathy, confusion, and mental disturbances

(such as anxiety, depression, delirium, and hallucination).

Other: Gynecomastia has been occasionally observed following the prolonged use of digoxin.

Thrombocytopenia and maculopapular rash and other skin reactions have been rarely observed.

7 DRUG INTERACTIONS

Digoxin has a narrow therapeutic index, increased monitoring of serum digoxin concentrations and for

potential signs and symptoms of clinical toxicity is necessary when initiating, adjusting, or discontinuing

drugs that may interact with digoxin. Prescribers should consult the prescribing information of any drug

which is co-prescribed with digoxin for potential drug interaction information.

7.1 P-Glycoprotein (PGP) Inducers/Inhibitors

Digoxin is a substrate of P-glycoprotein, at the level of intestinal absorption, renal tubular section and

biliary-intestinal secretion. Therefore, drugs that induce/inhibit P-glycoprotein have the potential to

alter digoxin pharmacokinetics.

7.2 Pharmacokinetic Drug Interactions

Digoxin concentrations increased greater than 50%

Digoxin Serum

Concentration Increase

Digoxin AUC

Increas e

Recommendations

Amiodarone

Measure serum digoxin concentrations

before initiating concomitant drugs.

Reduce digoxin concentrations by

decreasing dose by approximately

30% - 50% or by modifying the dosing

frequency and continue monitoring.

Captopril

Clarithromycin

Dronedarone

150%

Gentamicin

129 - 212%

Erythromycin

100%

Itraconazole

Lapatinib

180%

Propafenone

60 - 270 %

Quinidine

100%

Ranolazine

Ritonavir

Telaprevir

Tetracycline

100%

Verapamil

50 - 75%

Digoxin concentrations increased less than 50%

Atorvastatin

Measure serum digoxin concentrations

before initiating concomitant drugs.

Reduce digoxin concentrations by

decreasing the dose by approximately

15% - 30% or by modifying the dosing

frequency and continue monitoring.

Carvedilol

Conivaptan

Diltiazem

Indomethacin

Mirabegron

Nefazodone

Nifedipine

Propantheline

Quinine

Rabeprazole

Saquinavir

Spironolactone

Telmisartan

20 - 49%

Ticagrelor

Tolvaptan

Trimethoprim

22 - 28%

Digoxin concentrations increased, but magnitude is unclear

Alprazolam, azithromycin, cyclosporine, diclofenac,

diphenoxylate, epoprostenol, esomeprazole, ibuprofen,

ketoconazole, lansoprazole, metformin, omeprazole

Measure serum digoxin concentrations

before initiating concomitant drugs.

Continue monitoring and reduce

digoxin dose as necessary.

Digoxin concentrations decreased

Acarbose, activated charcoal, albuterol, antacids, certain cancer

chemotherapy or radiation therapy, cholestyramine, colestipol,

extenatide, kaolin-pectin, meals high in bran, metoclopramide,

miglitol, neomycin, penicillamine, phenytoin, rifampin, St.

John’s Wort, sucralfate, and sulfasalazine

Measure serum digoxin concentrations

before initiating concomitant drugs.

Continue monitoring and increase

digoxin dose by approximately 20 %

to 40 % as necessary.

NA- Not available/reported

7.3 Potentially Significant Pharmacodynamic Drug Interactions

Because of considerable variability of pharmacodynamic interactions, the dosage of digoxin should be

individualized when patients receive these medications concurrently.

Drugs that Affect Renal

Function

A decline in GFR or tubular secretion, as from ACE inhibitors, angiotensin

receptor blockers, nonsteroidal anti-inflammatory drugs [NSAIDS], COX-2

inhibitors may impair the excretion of digoxin.

Antiarrthymics

Dofetilide

Concomitant administration with digoxin was associated with

a higher rate of torsades de pointes

Sotalol

Proarrhythmic events were more common in patients

receiving sotalol and digoxin than on either alone; it is not

clear whether this represents an interaction or is related to the

presence of CHF, a known risk factor for proarrhythmia, in

patients receiving digoxin.

Dronedarone

Sudden death was more common in patients receiving digoxin

with dronedarone than on either alone; it is not clear whether

this represents an interaction or is related to the presence of

advanced heart disease, a known risk factor for sudden death

in patients receiving digoxin.

Parathyroid Hormone

Analog

Teriparatide

Sporadic case reports have suggested that hypercalcemia may

predispose patients to digitalis toxicity. Teriparatide

transiently increases serum calcium.

Thyroid supplement

Thyroid

Treatment of hypothyroidism in patients taking digoxin may

increase the dose requirements of digoxin.

Sympathomimetics

Epinephrine

Norepinephrine

Dopamine

Can increase the risk of cardiac arrhythmias.

Neuromuscular Blocking

Agents

SuccinylcholineMay cause sudden extrusion of potassium from muscle cells

causing arrhythmias in patients taking digoxin.

Supplements

Calcium

If administered rapidly by intravenous route, can produce

serious arrhythmias in digitalized patients.

Beta-adrenergic blockers

and calcium channel

Additive effects on AV node conduction can result in

bradycardia and advanced or complete heart block.

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