Lanoxin tablet: Difference between revisions

Lanoxin tablet®
Black Box Warning
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration and Monitoring
IV Compatibility
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient information
Precautions with Alcohol
Brand Names
Look-Alike Drug Names
Drug Shortage Status
Price

VisualWikitext

Latest revision as of 17:15, 26 March 2014

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

For information about (Generic Name), click here.

Disclaimer

WikiDoc Drug Project is a constellation of drug information for healthcare providers and patients vigorously vetted on the basis of FDA package insert, MedlinePlus, Practice Guidelines, Scientific Statements, and scholarly medical literature. The information provided is not a medical advice or treatment. WikiDoc does not promote any medication or off-label use of drugs. Please read our full disclaimer here.

Black Box Warning

WARNING

See full prescribing information for complete boxed warning.

Condition Name: (Content)

Overview

Lanoxin tablet is a _______ drug that is FDA approved for the treatment of _______. There is a Black Box Warning for this drug as shown here. Common adverse reactions include _______.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Heart failure

Dosing Information

Loading dose: 10-15 mcg/kg PO half of dose administered initially, and the other two quarters are given every 6-8 hours twice.

Maintenance dose: 3.4-5.1 mcg/kg/day PO once daily.

Atrial fibrillation

Dosing Information

Loading dose: 10-15 mcg/kg PO half of dose administered initially, and the other two quarters are given every 6-8 hours twice.

Maintenance dose: 3.4-5.1 mcg/kg/day PO once daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information

(Dosage)

Condition 2

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information

(Dosage)

Non–Guideline-Supported Use

Condition 1

Dosing Information

(Dosage)

Condition 2

Dosing Information

(Dosage)

Condition 3

Dosing Information

(Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Heart failure

Dosing Information

Loading dose

5-10 years old: 20-45 mcg/kg Administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.

>10 year old: 10-15 mcg/kg Administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.

Maintenence dose:

2-5 years: 10-15 mcg/kg/day.

5-10 years: 7-10 mcg/kg/day.

More than 10 years: 3-5 mcg/kg/day.

Condition 2

Dosing Information

(Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information

(Dosage)

Condition 2

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information

(Dosage)

Non–Guideline-Supported Use

Supraventricular tachycardia, Recurrent; Prophylaxis

0.01 mg/kg orally 3 times daily for the first 2 doses, then 0.0035 mg/kg 3 times daily^[1]^[2]

Fetal tachycardia - Supraventricular tachycardia

Maternal 0.25 to 0.375 mg PO daily alone or with verapamil.^[3]

Condition 1

Dosing Information

(Dosage)

Condition 2

Dosing Information

(Dosage)

Condition 3

Dosing Information

(Dosage)

Contraindications

Ventricular fibrillation
Hypersensitivity to digoxin

Warnings

Sinus Node Disease and AV Block

Because digoxin slows sinoatrial and AV conduction, the drug commonly prolongs the PR interval. The drug may cause severe sinus bradycardia or sinoatrial block in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. In such patients consideration should be given to the insertion of a pacemaker before treatment with digoxin.

Accessory AV Pathway (Wolff-Parkinson-White Syndrome)

After intravenous digoxin therapy, some patients with paroxysmal atrial fibrillation or flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, leading to a very rapid ventricular response or ventricular fibrillation. Unless conduction down the accessory pathway has been blocked (either pharmacologically or by surgery), digoxin should not be used in such patients. The treatment of paroxysmal supraventricular tachycardia in such patients is usually direct-current cardioversion.

Use in Patients With Preserved Left Ventricular Systolic Function

Patients with certain disorders involving heart failure associated with preserved left ventricular ejection fraction may be particularly susceptible to toxicity of the drug. 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. 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.

Adverse Reactions

Clinical Trials Experience

Nervous System

Visual disturbances (blurred or yellow vision), headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).

Cardiovascular

Arrhythmia( 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).

Gastrointestinal

Anorexia, nausea, vomiting, and diarrhea

Miscellaneous

Gynecomastia, thrombocytopenia and maculopapular rash.

Infant and Children

The side effects of digoxin in infants and children differ from those seen in adults in several respects. Although digoxin may produce anorexia, nausea, vomiting, diarrhea, and CNS disturbances in young patients, these are rarely the initial symptoms of overdosage. Rather, the earliest and most frequent manifestation of excessive dosing with digoxin 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 arrhythmia or alteration in cardiac conduction that develops in a child taking digoxin should be assumed to be caused by digoxin, until further evaluation proves otherwise.

Postmarketing Experience

FDA Package Insert for digoxin tablet contains no information regarding 'Postmarketing Experience'.

Drug Interactions

Potassium-depleting diuretics

Potassium-depleting diuretics are a major contributing factor to digitalis toxicity.

Calcium

Calcium, particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients.

Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone

Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone 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.

Erythromycin, clarithromycin, and tetracycline

Erythromycin and clarithromycin (and possibly othermacrolide antibiotics) and tetracycline may increase digoxin absorption in patients who inactivate digoxin by bacterial metabolism in the lower intestine, so that digitalis intoxication may result (see Pharmacology).

Propantheline and diphenoxylate

Decrease gut motility, which may increase digoxin absorption.

Antacids, kaolin-pectin, sulfasalazine, neomycin, cholestyramine, certain anticancer drugs, and metoclopramide

May interfere with intestinal digoxin absorption, resulting in unexpectedly low serum concentrations.

Rifampin

May decrease serum digoxin concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of digoxin.

Thyroxine

Thyroid administration to a digitalized, hypothyroid patient may increase the dose requirement of digoxin.

Sympathomimetics

Concomitant use of digoxin and sympathomimetics increases the risk of cardiac arrhythmias.

Succinylcholine

Succinylcholine may cause a sudden extrusion of potassium from muscle cells, and may thereby cause arrhythmias in digitalized patients.

Calcium Channel Blockers

Use with 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.

Beta blockers

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Digoxin concentrations are increased by about 15% when digoxin and carvedilol are administered concomitantly. Therefore, increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing carvedilol.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):C

Pregnancy Category (AUS): A

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.

Labor and Delivery

(Description)

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 breastfeeding 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 DOSAGE AND ADMINISTRATION).

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Y-Site

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Admixture

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Syringe

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

TPN/TNA

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Lanoxin tablet
Systematic (IUPAC) name
?
Identifiers
CAS number	?
ATC code	?
PubChem	?
Chemical data
Formula	?
Mol. mass	?
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	?
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

National Drug Code (NDC):
Storage:
Manufactured by:
Distributed by:

Images

Drug Images

(PillBox Images)

Package and Label Display Panel

(Package Images)

(Display Panel Images)

Patient Information

Patient Information from FDA

(Patient Counseling Information)

Patient Information from NLM

(Link to patient information page)

Precautions with Alcohol

Alcohol-Lanoxin tablet interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Look-Alike Drug Names

(Paired Confused Name 1a) — (Paired Confused Name 1b)
(Paired Confused Name 2a) — (Paired Confused Name 2b)
(Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Price

References

↑ Pfammatter, JP.; Stocker, FP. (1998). "Re-entrant supraventricular tachycardia in infancy: current role of prophylactic digoxin treatment". Eur J Pediatr. 157 (2): 101–6. PMID 9504781. Unknown parameter |month= ignored (help)
↑ Sanatani, S.; Potts, JE.; Reed, JH.; Saul, JP.; Stephenson, EA.; Gibbs, KA.; Anderson, CC.; Mackie, AS.; Ro, PS. (2012). "The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants". Circ Arrhythm Electrophysiol. 5 (5): 984–91. doi:10.1161/CIRCEP.112.972620. PMID 22962431. Unknown parameter |month= ignored (help)
↑ Lilja, H.; Karlsson, K.; Lindecrantz, K.; Sabel, KG. (1984). "Treatment of intrauterine supraventricular tachycardia with digoxin and verapamil". J Perinat Med. 12 (3): 151–4. PMID 6502442.

[Pfammatter-1998-1] Pfammatter, JP.; Stocker, FP. (1998). "Re-entrant supraventricular tachycardia in infancy: current role of prophylactic digoxin treatment". Eur J Pediatr. 157 (2): 101–6. PMID 9504781. Unknown parameter |month= ignored (help)

[Sanatani-2012-2] Sanatani, S.; Potts, JE.; Reed, JH.; Saul, JP.; Stephenson, EA.; Gibbs, KA.; Anderson, CC.; Mackie, AS.; Ro, PS. (2012). "The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants". Circ Arrhythm Electrophysiol. 5 (5): 984–91. doi:10.1161/CIRCEP.112.972620. PMID 22962431. Unknown parameter |month= ignored (help)

[Lilja-1984-3] Lilja, H.; Karlsson, K.; Lindecrantz, K.; Sabel, KG. (1984). "Treatment of intrauterine supraventricular tachycardia with digoxin and verapamil". J Perinat Med. 12 (3): 151–4. PMID 6502442.

[1]

[2]

[3]

@@ Line 1: / Line 1: @@
-{{Label template
+{{Sandboxrx1}}
-|drugClass=Cardiac glycoside
+<div style="width: 80%">
-|indication=[[heart failure]] and [[atrial fibrillation]]
+__NOTOC__
-|adverseReactions=[[AV block]], [[tachycardia]], GI symptoms and [[visual disturbances]]
+{{CMG}}
-}}
-{{DrugProjectForm
+'''''For information about (Generic Name), click [[(Generic Name)|here]].'''''
-|fdaLIADAdult====Heart failure===
-'''Loading dose"': 10-15 mcg/kg half of dose administered initially, and the other two quarters are given every 6-8 hours twice.
+==Disclaimer==
+'''''WikiDoc Drug Project is a constellation of drug information for healthcare providers and patients vigorously vetted on the basis of FDA package insert, MedlinePlus, Practice Guidelines, Scientific Statements, and scholarly medical literature.  The information provided is not a medical advice or treatment.  WikiDoc does not promote any medication or off-label use of drugs. Please read our full disclaimer [[wikidoc:General_disclaimer|{{fontcolor|#FF0000|here}}]].'''''
+==<span style="color:#FF0000; background:#000000;">Black Box Warning</span>==
+{| style="border: 3px solid #696969;"
+| style="background: #000000; border: 0px; padding: 20px 20px; width: 800px;" |
+<center>
+<font color="#F8F8FF" style="font-weight: bold;">WARNING</font>
+</center>
+<center>
+<font color="#F8F8FF" size="1" style="font-style: italic;">See full prescribing information for complete boxed warning.</font>
+</center>
+<font color="#F8F8FF" style="font-weight: bold;">
+''{{fontcolor|#FF0000|Condition Name:}}'' (Content)
+</font>
+|}
+==Overview==
+{{PAGENAME}} is a _______ drug that is FDA approved for the treatment of _______. There is a Black Box Warning for this drug as shown <span style="background:#000000;">'''[[{{PAGENAME}}#Black Box Warning|{{fontcolor|#FF0000|here}}]]'''</span>. Common adverse reactions include _______.
+==Adult Indications and Dosage==
+===FDA-Labeled Indications and Dosage (Adult)===
+====Heart failure====
+* Dosing Information
+::Loading dose: '''10-15 mcg/kg PO ''' half of dose administered initially, and the other two quarters are given every 6-8 hours twice.
+::Maintenance dose: '''3.4-5.1 mcg/kg/day PO''' once daily.
+====Atrial fibrillation====
+* Dosing Information
+::Loading dose: '''10-15 mcg/kg PO''' half of dose administered initially, and the other two quarters are given every 6-8 hours twice.
+::Maintenance dose: '''3.4-5.1 mcg/kg/day PO''' once daily.
+===Off-Label Use and Dosage (Adult)===
+====Guideline-Supported Use====
+=====Condition 1=====
+* Developed by: (Organisation)
+* Class of Recommendation: (Class) (Link)
+* Strength of Evidence: (Category A/B/C) (Link)
+* Dosing Information
+:: (Dosage)
+=====Condition 2=====
+* Developed by: (Organisation)
+* Class of Recommendation: (Class) (Link)
+* Strength of Evidence: (Category A/B/C) (Link)
+* Dosing Information
+:: (Dosage)
+====Non–Guideline-Supported Use====
+=====Condition 1=====
+* Dosing Information
+:: (Dosage)
+=====Condition 2=====
+* Dosing Information
+:: (Dosage)
+=====Condition 3=====
+* Dosing Information
+:: (Dosage)
+==Pediatric Indications and Dosage==
+===FDA-Labeled Indications and Dosage (Pediatric)===
+=====Heart failure=====
+* Dosing Information
+:*Loading dose
+::* 5-10 years old: '''20-45 mcg/kg''' Administer half the total loading dose initially, then '''¼ the loading dose''' every 6 to 8 hours twice.
+::* >10 year old: '''10-15 mcg/kg''' Administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.
+:*Maintenence dose:
+::*2-5 years: '''10-15 mcg/kg/day'''.
+::*5-10 years: '''7-10 mcg/kg/day'''.
+::*More than 10 years: '''3-5 mcg/kg/day'''.
+=====Condition 2=====
+* Dosing Information
+:: (Dosage)
+===Off-Label Use and Dosage (Pediatric)===
+====Guideline-Supported Use====
+=====Condition 1=====
+* Developed by: (Organisation)
+* Class of Recommendation: (Class) (Link)
+* Strength of Evidence: (Category A/B/C) (Link)
+* Dosing Information
+:: (Dosage)
+=====Condition 2=====
+* Developed by: (Organisation)
+* Class of Recommendation: (Class) (Link)
+* Strength of Evidence: (Category A/B/C) (Link)
+* Dosing Information
+:: (Dosage)
+====Non–Guideline-Supported Use====
+=====Supraventricular tachycardia, Recurrent; Prophylaxis=====
+.01 mg/kg orally 3 times daily for the first 2 doses, then 0.0035 mg/kg 3 times daily<ref name="Pfammatter-1998">{{Cite journal  | last1 = Pfammatter | first1 = JP. | last2 = Stocker | first2 = FP. | title = Re-entrant supraventricular tachycardia in infancy: current role of prophylactic digoxin treatment. | journal = Eur J Pediatr | volume = 157 | issue = 2 | pages = 101-6 | month = Feb | year = 1998 | doi =  | PMID = 9504781 }}</ref><ref name="Sanatani-2012">{{Cite journal  | last1 = Sanatani | first1 = S. | last2 = Potts | first2 = JE. | last3 = Reed | first3 = JH. | last4 = Saul | first4 = JP. | last5 = Stephenson | first5 = EA. | last6 = Gibbs | first6 = KA. | last7 = Anderson | first7 = CC. | last8 = Mackie | first8 = AS. | last9 = Ro | first9 = PS. | title = The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants. | journal = Circ Arrhythm Electrophysiol | volume = 5 | issue = 5 | pages = 984-91 | month = Oct | year = 2012 | doi = 10.1161/CIRCEP.112.972620 | PMID = 22962431 }}</ref>
+=====Fetal tachycardia - Supraventricular tachycardia=====
+Maternal 0.25 to 0.375 mg PO daily alone or with [[verapamil]].<ref name="Lilja-1984">{{Cite journal  | last1 = Lilja | first1 = H. | last2 = Karlsson | first2 = K. | last3 = Lindecrantz | first3 = K. | last4 = Sabel | first4 = KG. | title = Treatment of intrauterine supraventricular tachycardia with digoxin and verapamil. | journal = J Perinat Med | volume = 12 | issue = 3 | pages = 151-4 | month =  | year = 1984 | doi =  | PMID = 6502442 }}</ref>
+=====Condition 1=====
+* Dosing Information
+:: (Dosage)
+=====Condition 2=====
+* Dosing Information
+:: (Dosage)
+=====Condition 3=====
+* Dosing Information
-'''Maintenance dose''': 3.4-5.1 mcg/kg/day once daily.
+:: (Dosage)
-===Atrial fibrillation===
-'''Loading dose"': 10-15 mcg/kg half of dose administered initially, and the other two quarters are given every 6-8 hours twice.
-'''Maintenance dose''': 3.4-5.1 mcg/kg/day once daily.
+==Contraindications==
-|offLabePed=*Supraventricular tachycardia, Recurrent; Prophylaxis<ref name="Pfammatter-1998">{{Cite journal  | last1 = Pfammatter | first1 = JP. | last2 = Stocker | first2 = FP. | title = Re-entrant supraventricular tachycardia in infancy: current role of prophylactic digoxin treatment. | journal = Eur J Pediatr | volume = 157 | issue = 2 | pages = 101-6 | month = Feb | year = 1998 | doi =  | PMID = 9504781 }}</ref>
-*Fetal tachycardia - Supraventricular tachycardia
+*[[Ventricular fibrillation]]
-|contraindications=*Ventricular fibrillation
 *Hypersensitivity to digoxin
-|warnings====Sinus Node Disease and AV Block===
+==Warnings==
+=====Sinus Node Disease and AV Block=====
 Because digoxin slows sinoatrial and AV conduction, the drug commonly prolongs the PR interval. The drug may cause severe sinus bradycardia or sinoatrial block in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. In such patients consideration should be given to the insertion of a pacemaker before treatment with digoxin.
-===Accessory AV Pathway (Wolff-Parkinson-White Syndrome)===
+=====Accessory AV Pathway (Wolff-Parkinson-White Syndrome)=====
 After intravenous digoxin therapy, some patients with paroxysmal atrial fibrillation or flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, leading to a very rapid ventricular response or ventricular fibrillation. Unless conduction down the accessory pathway has been blocked (either pharmacologically or by surgery), digoxin should not be used in such patients. The treatment of paroxysmal supraventricular tachycardia in such patients is usually direct-current cardioversion.
-===Use in Patients With Preserved Left Ventricular Systolic Function===
+=====Use in Patients With Preserved Left Ventricular Systolic Function=====
 Patients with certain disorders involving heart failure associated with preserved left ventricular ejection fraction may be particularly susceptible to toxicity of the drug. 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. 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.
-|hasUsageInfo=In Progress
+==Adverse Reactions==
+===Clinical Trials Experience===
+====== Nervous System======
+: Visual disturbances (blurred or yellow vision), headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).
+======Cardiovascular======
+: '''Arrhythmia'''( 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).
+======Gastrointestinal======
+: [[Anorexia]], [[nausea]], [[vomiting]], and [[diarrhea]]
+======Miscellaneous======
+: [[Gynecomastia]], [[thrombocytopenia ]]and maculopapular rash.
+====Infant and Children====
+The side effects of digoxin in infants and children differ from those seen in adults in several respects. Although digoxin may produce anorexia, nausea, vomiting, diarrhea, and CNS disturbances in young patients, these are rarely the initial symptoms of overdosage. Rather, the earliest and most frequent manifestation of excessive dosing with digoxin 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 arrhythmia or alteration in cardiac conduction that develops in a child taking digoxin should be assumed to be caused by digoxin, until further evaluation proves otherwise.
+===Postmarketing Experience===
+FDA Package Insert for digoxin tablet contains no information regarding ''''Postmarketing Experience''''.
+==Drug Interactions==
+=====Potassium-depleting diuretics=====
+Potassium-depleting diuretics are a major contributing factor to digitalis toxicity.
+=====Calcium=====
+Calcium, particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients.
+=====Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone=====
+Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone 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.
+=====Erythromycin, clarithromycin, and tetracycline=====
+Erythromycin and clarithromycin (and possibly othermacrolide antibiotics) and tetracycline may increase digoxin absorption in patients who inactivate digoxin by bacterial metabolism in the lower intestine, so that digitalis intoxication may result (see ''[[{{PAGENAME}}#Pharmacology|Pharmacology]]'').
+=====Propantheline and diphenoxylate=====
+Decrease gut motility, which may increase digoxin absorption.
+=====Antacids, kaolin-pectin, sulfasalazine, neomycin, cholestyramine, certain anticancer drugs,  and metoclopramide=====
+May interfere with intestinal digoxin absorption, resulting in unexpectedly low serum concentrations.
+===== Rifampin=====
+May decrease serum digoxin concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of digoxin.
+=====Thyroxine=====
+Thyroid administration to a digitalized, [[hypothyroid ]]patient may increase the dose requirement of digoxin.
+=====Sympathomimetics=====
+Concomitant use of digoxin and [[sympathomimetics ]]increases the risk of cardiac arrhythmias.
+=====Succinylcholine=====
+[[Succinylcholine ]]may cause a sudden extrusion of potassium from muscle cells, and may thereby cause [[arrhythmias ]]in digitalized patients.
+=====Calcium Channel Blockers=====
+Use with 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]].
+=====Beta blockers=====
+Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of [[bradycardia]]. Digoxin concentrations are increased by about 15% when digoxin and carvedilol are administered concomitantly. Therefore, increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing [[carvedilol]].
+==Use in Specific Populations==
+====Pregnancy====
+: '''[[Pregnancy category#United States|Pregnancy Category (FDA)]]:C'''
+: '''[[Pregnancy category#Australia|Pregnancy Category (AUS)]]: A'''
+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.
+====Labor and Delivery====
+(Description)
+====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 breastfeeding 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 DOSAGE AND ADMINISTRATION).
+====Gender====
+(Description)
+====Race====
+(Description)
+====Renal Impairment====
+(Description)
+====Hepatic Impairment====
+(Description)
+====Females of Reproductive Potential and Males====
+(Description)
+====Immunocompromised Patients====
+(Description)
+==Administration and Monitoring==
+====Administration====
+(Oral/Intravenous/etc)
+====Monitoring====
+=====Condition 1=====
+(Description regarding monitoring, from ''Warnings'' section)
+=====Condition 2=====
+(Description regarding monitoring, from ''Warnings'' section)
+=====Condition 3=====
+(Description regarding monitoring, from ''Warnings'' section)
+==IV Compatibility==
+===Solution===
+====Compatible====
+* Solution 1
+* Solution 2
+* Solution 3
+====Not Tested====
+* Solution 1
+* Solution 2
+* Solution 3
+====Variable====
+* Solution 1
+* Solution 2
+* Solution 3
+====Incompatible====
+* Solution 1
+* Solution 2
+* Solution 3
+===Y-Site===
+====Compatible====
+* Solution 1
+* Solution 2
+* Solution 3
+====Not Tested====
+* Solution 1
+* Solution 2
+* Solution 3
+====Variable====
+* Solution 1
+* Solution 2
+* Solution 3
+====Incompatible====
+* Solution 1
+* Solution 2
+* Solution 3
+===Admixture===
+====Compatible====
+* Solution 1
+* Solution 2
+* Solution 3
+====Not Tested====
+* Solution 1
+* Solution 2
+* Solution 3
+====Variable====
+* Solution 1
+* Solution 2
+* Solution 3
+====Incompatible====
+* Solution 1
+* Solution 2
+* Solution 3
+===Syringe===
+====Compatible====
+* Solution 1
+* Solution 2
+* Solution 3
+====Not Tested====
+* Solution 1
+* Solution 2
+* Solution 3
+====Variable====
+* Solution 1
+* Solution 2
+* Solution 3
+====Incompatible====
+* Solution 1
+* Solution 2
+* Solution 3
+===TPN/TNA===
+====Compatible====
+* Solution 1
+* Solution 2
+* Solution 3
+====Not Tested====
+* Solution 1
+* Solution 2
+* Solution 3
+====Variable====
+* Solution 1
+* Solution 2
+* Solution 3
+====Incompatible====
+* Solution 1
+* Solution 2
+* Solution 3
+==Overdosage==
+===Acute Overdose===
+====Signs and Symptoms====
+(Description)
+====Management====
+(Description)
+===Chronic Overdose===
+====Signs and Symptoms====
+(Description)
+====Management====
+(Description)
+==Pharmacology==
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+===Mechanism of Action===
+(Description)
+===Structure===
+(Description with picture)
+===Pharmacodynamics===
+(Description)
+===Pharmacokinetics===
+(Description)
+===Nonclinical Toxicology===
+(Description)
+==Clinical Studies==
+=====Condition 1=====
+(Description)
+=====Condition 2=====
+(Description)
+=====Condition 3=====
+(Description)
+==How Supplied==
+(Description)
+* National Drug Code (NDC):
+* Storage:
+* Manufactured by:
+* Distributed by:
+==Images==
+===Drug Images===
+(PillBox Images)
+===Package and Label Display Panel===
+(Package Images)
+(Display Panel Images)
+==Patient Information==
+===Patient Information from FDA===
+(Patient Counseling Information)
+===Patient Information from NLM===
+(Link to patient information page)
+==Precautions with Alcohol==
+Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
+==Look-Alike Drug Names==
+* (Paired Confused Name 1a) — (Paired Confused Name 1b)
+* (Paired Confused Name 2a) — (Paired Confused Name 2b)
+* (Paired Confused Name 3a) — (Paired Confused Name 3b)
+==[http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm Drug Shortage Status]==
+==[http://www.goodrx.com/{{urlencode:{{#if:{{{1|}}}|{{{1}}}|{{PAGENAME}}}}}}/price Price]==
+==References==
+{{reflist}}
+</div>