Lanoxin tablet
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
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Black Box Warning
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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
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- Strength of Evidence: (Category A/B/C) (Link)
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Condition 2
- Developed by: (Organisation)
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- Strength of Evidence: (Category A/B/C) (Link)
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Non–Guideline-Supported Use
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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
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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)
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Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information
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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
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Condition 2
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Condition 3
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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
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 Lanoxin tablet contains no information regarding 'Postmarketing Experience'.
Drug Interactions
- Potassium-depleting diuretics
- Calcium
- Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone
- Erythromycin, clarithromycin, and tetracycline
- Drug 5
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).
Drug 5
(Description)
Use in Specific Populations
Pregnancy
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
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Race
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Renal Impairment
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Hepatic Impairment
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Females of Reproductive Potential and Males
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Immunocompromised Patients
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Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
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Condition 2
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Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
Solution
Compatible
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Not Tested
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Variable
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Incompatible
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Y-Site
Compatible
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Not Tested
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Variable
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Incompatible
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Admixture
Compatible
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Not Tested
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Variable
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Incompatible
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Syringe
Compatible
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Not Tested
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Variable
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Incompatible
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TPN/TNA
Compatible
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Not Tested
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Variable
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Incompatible
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Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
Lanoxin tablet
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Mechanism of Action
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Structure
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Pharmacodynamics
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Pharmacokinetics
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Nonclinical Toxicology
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Clinical Studies
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How Supplied
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- National Drug Code (NDC):
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Images
Drug Images
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Package and Label Display Panel
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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.