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DIGOXIN - digoxin tablet West-ward Pharmaceutical Corp. ---------- DIGOXIN TABLETS, USP Revised 05/08 Rx Only | DIGOXIN [DEPT HEALTH CENTRAL PHARMACY] | BioPortfolio

11:57 EST 27th January 2019 | BioPortfolio

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Mechanism of Action: 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 neu-rohormonal 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.

Table 1: Comparisons of the Systemic Availability and Equivalent Doses for Oral Preparations of Digoxin
Product
Absolute
Bioavailability
Equivalent Doses (mcg)*
Amoung Dosage Forms



Digoxin Tablets
60-80%
62.5             125         250        500
Digoxin Elixir Pediatric
70-85%
62.5             125         250        500
Digoxin Solution in Capsules
90-100%
50                100         200        400
Digoxin Injection/IV
100%
50                100         200        400
Table 2: Times to Onset of Pharmacologic Effect and to Peak Effect of Preparations of Digoxin
Product
Time to
Onset of Effect*
Time to
Peak Effect



Digoxin Tablets
0.5 - 2 hours
2 - 6 hours
Digoxin Elixir Pediatric
0.5 - 2 hours
2 - 6 hours
Digoxin Soultion in Capsules
0.5 - 2 hours
2 - 6 hours
Digoxin Injection/IV
5-30 minutes
1 - 4 hours

WARNINGS:Sinus Node Disease and AV Block: Because digoxin slows sinoatrial and AV conduction, the drug commonly prolongs the PRinterval. The drug may cause severe sinus bradycardia or sinoatrial block in patients with preexisting sinus node disease and maycause advanced or complete heart block in patients with preexisting incomplete AV block. In such patients consideration should begiven to the insertion of a pacemaker before treatment with digoxin.Accessory AV Pathway (Wolff-Parkinson-White Syndrome): After intravenous digoxin therapy, some patients with paroxysmalatrial fibrillation or flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across theaccessory pathway bypassing the AV node, leading to a very rapid ventricular response or ventricular fibrillation. Unless conductiondown 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 failureassociated with preserved left ventricular ejection fraction may be particularly susceptible to toxicity of the drug. Such disordersinclude restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, and acute cor pulmonale. Patients with idiopathichypertrophic subaortic stenosis may have worsening of the outflow obstruction due to the inotropic effects of digoxin.

Table 4: Adverse Experience in Two Parallel, Double-Blind, Placebo-Controlled Withdrawal Trials (number of Patients Reporting)
Adverse Experience
Digoxin Patients
(n=123)
Placebo Patients
(n=125)



Cardiac
   Palpitation
   Ventricular Extrasystole
   Tachycardia
   Heart Arrest
1
1
2
1
4
1
1
1
Gastrointestional
   Anorexia
   Nausea
   Vomiting
   Diarrhea
   Abdominal pain
1
4
2
4
0
4
2
1
1
6
CNS
   Headache
   Dizziness
   Mental Disturbances
4
6
5
4
5
1
Other
   Rash
   Death
2
4
1
3

Manufacturer

DEPT HEALTH CENTRAL PHARMACY

Active Ingredients

Source

Clinical Trials [66 Associated Clinical Trials listed on BioPortfolio]

A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital

Digoxin is the primary cardiac glycoside in clinical use. Because of the narrow therapeutic index and risk of toxicity, therapeutic drug monitoring is highly recommended. In Egypt, most ca...

Bexagliflozin Drug/Drug Interaction Study With Digoxin

The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with the heart failure medication digoxin. The study will evaluate ...

Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia

This is a randomized, double-blind, multi-centered study to compare 6 months of medical treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common sustain...

Safety and Activity of Digoxin With Decitabine in Adult AML and MDS

The primary hypothesis is that digoxin can be safely added to decitabine and will increase the response rates in medically unfit patients with newly diagnosed AML/MDS or those with relapse...

to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers

The aim of this trial is to investigate the effect of multiple doses of flibanserin on the single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a narro...

PubMed Articles [27 Associated PubMed Articles listed on BioPortfolio]

Characterization of bilirubin interference in three commonly used digoxin assays.

Due to the narrow therapeutic range of digoxin, determining serum/plasma digoxin concentrations is critical for assessing patients with congestive heart failure, atrial fibrillation, and certain types...

Digoxin and Platelet Activation in Patients With Atrial Fibrillation: In Vivo and In Vitro Study.

Background Digoxin use was shown to be associated with an increased risk of cardiovascular events in atrial fibrillation ( AF ). We hypothesized that digoxin may affect cardiovascular risk by increasi...

The Effect of Autoantibody against M2-Muscarinic Acetylcholine Receptor in Heart Failure Patients on Digoxin Treatment.

Autoantibody against M2-muscarinic acetylcholine receptor (anti-M2AChR) has a biological effect similar to a vagus agonist. Digoxin has a function of vagus nervous system stimulation. We hypothesized ...

Intra-amniotic digoxin for feticide between 21 and 30 weeks of gestation: a prospective study.

Intra-amniotic injection of digoxin is a well-known method for feticide before inducing termination of pregnancy (TOP) at 17-24 weeks of gestation. Information on its effectiveness when administered a...

Digoxin sensitizes gemcitabine-resistant pancreatic cancer cells to gemcitabine via inhibiting Nrf2 signaling pathway.

Chemoresistance is a major therapeutic obstacle in the treatment of human pancreatic ductal adenocarcinoma (PDAC). As an oxidative stress responsive transcription factor, nuclear factor erythroid 2-re...

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