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Digoxin information from DrugsUpdate  

See Available Brands of Digoxin in India

P - Caution when used during pregnancy

Digoxin, also known as digitalis, is a purified cardiac glycoside extracted from the foxglove plant, Digitalis lanata.[2] Its corresponding aglycone is digoxigenin, and its acetyl derivative is acetyldigoxin. Digoxin is widely used in the treatment of various heart conditions, namely atrial fibrillation, atrial flutter and sometimes heart failure that cannot be controlled by other medication. Digoxin preparations are commonly marketed under the trade names Lanoxin, Digitek, and Lanoxicaps. It is also available as a 0.05mg/mL oral solution and 0.25mg/mL or 0.5mg/mL injectable solution.

Pharmacodynamics

Pharmacokinetics

Digoxin is a cardiac glycoside which has positive inotropic activity characterized by an increase in the force of myocardial contraction. It also reduces the conductivity of the heart through the atrioventricular (AV) node. Digoxin also exerts direct action on vascular smooth muscle and indirect effects mediated primarily by the autonomic nervous system and an increase in vagal activity.
Absorption: Absorption from the GI tract is variable.
Distribution: Widely distributed in tissues, including the heart, brain, erythrocytes, and skeletal muscle. 20-30% bound to plasma proteins.
Excretion: Excreted mainly unchanged.

Digoxin Indications / Digoxin Uses

Information Not Available

Digoxin Adverse Reactions / Digoxin Side Effects

Extra beats, anorexia, nausea and vomiting. Diarrhoea in elderly, confusion, dizziness, drowsiness, restlessness, nervousness, agitation and amnesia, visual disturbances, gynaecomastia, local irritation (IM/SC inj), rapid IV admin may lead to vasocostriction and transient hypertension.
Potentially Fatal: Cardiac arrhythmias in combination with heart block.

Precautions

Use in Patients with Impaired Renal Function
Digoxin is primarily excreted by the kidneys; therefore, patients with impaired renal function require smaller than usual maintenance doses of digoxin (see DOSAGE AND ADMINISTRATION). Because of the prolonged elimination half-life, a longer period of time is required to achieve an initial or new steady-state serum concentration in patients with renal impairment than in patients with normal renal function. If appropriate care is not taken to reduce the dose of digoxin, such patients are at high risk for toxicity, and toxic effects will last longer in such patients than in patients with normal renal function.

Use in Patients with Electrolyte Disorders
In patients with hypokalemia or hypomagnesemia, toxicity may occur despite serum digoxin concentrations below 2.0 ng/mL, because potassium or magnesium depletion sensitizes the myocardium to digoxin. Therefore, it is desirable to maintain normal serum potassium and magnesium concentrations in patients being treated with digoxin. Deficiencies of these electrolytes may result from malnutrition, diarrhea, or prolonged vomiting, as well as the use of the following drugs or procedures: diuretics, amphotericin B, corticosteroids, antacids, dialysis, and mechanical suction of gastrointestinal secretions.
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
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. Care must be taken to avoid toxicity if digoxin is used.

Use in Patients with Acute Myocardial Infarction
Digoxin should be used with caution in patients with acute myocardial infarction. The use of inotropic drugs in some patients in this setting may result in undesirable increases in myocardial oxygen demand and ischemia.

Use during Electrical Cardioversion
It may be desirable to reduce the dose of 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 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.

Overdosage
Symptoms: Hyperkalaemia, cardiac arrhythmias and heart block. Management: Treatment is symptomatic and supportive. Reduce absorption by gastric lavage if present within 30 min of ingestion. Do not induce vomiting or attempt passage of a gastric tube if presented >2 hr after ingestion or already has toxic manifestations, as this may induce an acute vagal episode and worsen digitalis-related arrhythmias. Activated charcoal is helpful in reducing drug absorption. Monitor serum potassium levels and keep potassium levels between 4.0-5.5 mmol/l. Digoxin-specific antibody fragments (FAB) is a specific antidote for digoxin and may be used to reverse potentially life-threatening ventricular arrhythmias due to digoxin overdosage. Haemodialysis is unlikely to be useful.

Special Precautions

Cardiac dysrhythmias, hypokalaemia, hypertension, IHD, hypercalcaemia, hypomagnesaemia, electroconversion, chronic cor pulmonale, aortic valve disease, acute myocarditis, congestive cardiomyopathies, constrictive pericarditis, heart block, elderly, renal impairment, abnormalities in thyroid function; pregnancy. IV digoxin can only be given to patients who have not received cardiac glycosides in the preceding 2 wk.

Other Drug Interactions

Effectiveness reduced by phenytoin, neomycin, sulphasalazine, kaolin, pectin, antacids and in patients receiving radiotherapy. Metoclopramide may alter the absorption of solid dosage forms of digoxin. Blood levels increased by calcium channel blockers, spironolactone, quinidine and calcium salts.
Potentially Fatal: Electrolyte imbalances such as hypokalaemia and hypomagnesemia (e.g. admin of potassium-losing diuretics, corticosteroids) can increase the risk of cardiac toxicity.

Other Interactions

Food Interactions: Absorption delayed

Dosage

Oral
Heart failure
Adult: Rapid digitalisation: Loading dose of 0.75-1.5 mg during the first 24-hr period as a single dose or in divided doses every 6 hr for less urgent or greater risk cases. For mild heart failure: Loading dose may not be required, 250 mcg 1-2 times daily. For patients with normal renal function, steady-state plasma concentrations are usually achieved in about 7 days. Usual maintenance: 125-250 mcg daily but may range from 62.5-500 mcg daily.
Child: Neonate <1.5 kg: Initial: 25 mcg/kg/day in 3 divided doses for 24 hr, then 4-6 mcg/kg/day in 1-2 divided doses; neonate 1.5-2.5 kg: Initial: 30 mcg/kg/day in 3 divided doses for 24 hr, then 4-6 mcg/kg/day in 1-2 divided doses; Neonate >2.5 kg and child 1 mth-2 yr: Initial: 45 mcg/kg/day in 3 divided doses for 24 hr, then 10 mcg/kg/day in 1-2 divided doses. 2-5 yr: Initial: 35 mcg/kg/day in 3 divided doses for 24 hr, then 10 mcg/kg/day in 1-2 divided doses. 5-10 yr: Initial: 25 mcg/kg/day (max: 750 mcg/day) in 3 divided doses for 24 hr, then 6 mcg/kg/day (max: 250 mcg/day) in 1-2 divided doses. 10-18 yr: Initial: 0.75-1.5 mg/day in 3 divided doses for 24 hr, then 62.5-750 mcg/day in 1-2 divided doses. Reduce doses if patient has been given cardiac glycoside in the preceding 2 wk.
Elderly: Lower doses are given.
Renal impairment: Dosage reductions may be needed.
Oral
Supraventricular arrhythmias
Adult: Rapid digitalisation: Loading dose of 0.75-1.5 mg during the first 24-hr period as a single dose or in divided doses every 6 hr for less urgent or greater risk cases. For mild heart failure: Loading dose may not be required, 250 mcg 1-2 times daily. For patients with normal renal function, steady-state plasma concentrations are usually achieved in about 7 days. Usual maintenance: 125-250 mcg daily but may range from 62.5-500 mcg daily.
Child: Neonate <1.5 kg: Initial: 25 mcg/kg/day in 3 divided doses for 24 hr, then 4-6 mcg/kg/day in 1-2 divided doses; neonate 1.5-2.5 kg: Initial: 30 mcg/kg/day in 3 divided doses for 24 hr, then 4-6 mcg/kg/day in 1-2 divided doses; Neonate >2.5 kg and child 1 mth-2 yr: Initial: 45 mcg/kg/day in 3 divided doses for 24 hr, then 10 mcg/kg/day in 1-2 divided doses. 2-5 yr: Initial: 35 mcg/kg/day in 3 divided doses for 24 hr, then 10 mcg/kg/day in 1-2 divided doses. 5-10 yr: Initial: 25 mcg/kg/day (max: 750 mcg/day) in 3 divided doses for 24 hr, then 6 mcg/kg/day (max: 250 mcg/day) in 1-2 divided doses. 10-18 yr: Initial: 0.75-1.5 mg/day in 3 divided doses for 24 hr, then 62.5-750 mcg/day in 1-2 divided doses. Reduce doses if patient has been given cardiac glycoside in the preceding 2 wk.
Elderly: Lower doses are given.
Renal impairment: Dosage reductions may be needed.
Intravenous
Emergency heart failure
Adult: For patients who have not received cardiac glycosides in the previous 2 wk. 0.5-1 mg by IV infusion as a single dose over at least 2 hr or in divided doses with each dose given over 10-20 minutes. Maintenance dose is usually given orally.
Renal impairment: Dosage reductions may be needed.
Reconstitution: Admin undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection.
Incompatibility: Using less than a 4-fold volume of diluent could lead to precipitation of the digoxin.

Food(before/after)

May be taken with or without food.

List of Contraindications

Digoxin and Pregnancy

Caution when used during pregnancy.
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Digoxin and Lactation

Information Not Available

Digoxin and Geriatic

Information Not Available

Digoxin and Other Contraindications

Digitalis toxicity, ventricular tachycardia/fibrillation, obstructive cardiomyopathy. Arrhythmias due to accessory pathways (e.g. Wolff-Parkinson-White syndrome).

Storage

Intravenous: Store at 25°C.
Oral: Store at 25°C.

Lab interference

Intravenous: Store at 25°C.
Oral: Store at 25°C.

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