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  • Lanoxin
    / Perrigo


    Active Ingredient
    Digoxin 0.5 mg / 2 ml, 0.05 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    5 X 0.5 mg/2 ml

    full basket chart 1166 12054

    Elixir

    60 ml X 0.05 mg/ml

    full basket chart 1167 12019

    Related information


    Dosage

    Adults and children over 10 years
    Parenteral loading: Note:
    For use in patients who have not been given cardiac glycosides within the preceding two weeks. The total loading dose of parenteral digoxin is 500 to 1000 micrograms (0.5 to 1.0 mg) depending on age, lean body weight and renal function. The total loading dose should be administered in divided doses with approximately half of the total dose given as the first dose and further fractions of the total dose given at intervals of four to eight hours. An assessment of clinical response should be performed before giving each additional dose. Each dose should be given by i.v. infusion over 10 to 20 mins.
    Maintenance Dose: The maintenance dosage should be based upon the percentage of the peak body stores lost each day through elimination.
    For full details see prescribing information.


    Indications

    Congestional heart failure, myocarditis, atricular fibrillations.


    Contra-Indications

    – Digoxin is contraindicated in intermittent complete heart block or second degree atrioventricular block, especially if there is a history of Stokes-Adams attacks.
    – Digoxin is contraindicated in arrhythmias caused by cardiac glycoside intoxication.
    – Digoxin is contra-indicated in supraventricular arrhythmias associated with an accessory atrioventricular pathway, as in the Wolff-Parkinson-White syndrome, unless the electrophysiological characteristics of the accessory pathway and any possible deleterious effect of digoxin on these characteristics have been evaluated. If an accessory pathway is known or suspected to be present and there is no history of previous supraventricular arrhythmias, digoxin is similarly contraindicated.
    – Digoxin is contra-indicated in ventricular tachycardia or ventricular fibrillation.
    – Digoxin is contra-indicated in hypertrophic obstructive cardiomyopathy, unless there is concomitant atrial fibrillation and heart failure but even then caution should be exercised if digoxin is to be used.
    – Digoxin is contraindicated in patients known to be hypersensitive to digoxin or other digitalis glycosides or to any component of the preparation.


    Special Precautions

    Many of the arrhythmias for which digoxin is indicated closely resemble those reflecting digoxin intoxication. Anorexia, nausea, vomiting and arrhythmias may accompany heart failure or may be indicative of digoxin intoxication. Electrical conversion of arrhythmias may require reduction of dosage of digoxin, to avoid induction of ventricular arrhythmias. However, the consequences of a rapid increase in ventricular response to atrial fibrillation should be considered if digoxin is withheld 1-2 days prior to cardioversion. Patients still experiencing effects from previous digitalis preparations, and in the presence of multiple ventricular extrasystoles or heart block. Patients with incomplete atrioventricular (AV) block, especially those subject to Stokes-Adams attacks, may develop advanced or complete heart block if digoxin is administered. Patients with acute myocardial infarction, severe pulmonary disease, rheumatic carditis, or advanced heart failure. If a therapeutic trial does not result in improvement, the drug should be discontinued. Patients with chronic constrictive pericarditis, patients with Wolff-Parkinson-White syndrome. The presence of acute glomerulonephritis accompanied by CHF requires extreme care in digitalization. Pregnancy and lactation, pediatrics, elderly, hypokalemia. Calcium i.v. should not be administered to patients receiving digoxin. Hypomagnesemia. The plasma half-life of digoxin is inversely related to thyroid status. Atrial arrhythmias associated with hypermetabolic states are particularly resistant to digoxin treatment. Patients with renal impairment.
    For full details see prescribing information.


    Side Effects

    Anorexia, nausea, vomiting and diarrhea are the most common early symptoms of overdose. Uncontrolled heart failure may also produce such symptoms. Visual disturbances, headache, weakness, apathy, drowsiness, mental depression, confusion, disorientation, seizures, EEG abnormalities and delirium, muscular weakness, arrhythmias.
    For full details see prescribing information.


    Drug interactions

    Large I.V. doses of calcium. Thiazide and loop diuretics, potassium-depleting agents, carbenoxolone. Amiodarone, propafenone, quinidine, quinine, hydroxychloroquine, chloroquine, flecainide, verapamil, diltiazem, nifedipine, spironolactone. B-blockers. Antacids, cholestyramine, colestipol, sucralfate. Erythromycin, clarithromycin, azithromycin. Xanthines, corticosteroids, NSAIDs, reserpine. Aminoglutethimide, phenobarbitone, phenytoin, rifampicin, phenylbutazone. Propafenone, esmolol, captopril.
    For full details see prescribing information.


    Pregnancy and Lactation

    Teratogenicity: No data are available on whether or not digoxin has teratogenic effects.
    Fertility: There is no information available on the effect of digoxin on human fertility.
    Pregnancy and lactation: The use of digoxin in pregnancy is not contra-indicated, although the dosage may be less predictable in pregnant than in non-pregnant women, with some requiring an increased dosage of digoxin during pregnancy. As with all drugs, use should be considered only when the expected clinical benefit of treatment to the mother outweighs any possible risk to the developing foetus.Despite extensive antenatal exposure to digitalis preparations, no significant adverse effects have been observed in the foetus or neonate when maternal serum digoxin concentrations are maintained within the normal range. Although it has been speculated that a direct effect of digoxin on the myometrium may result in relative prematurity and low birthweight, a contributing role of the underlying cardiac disease cannot be excluded. administered digoxin has been successfully used to treat foetal tachycardia and congestive heart failure.
    Adverse foetal effects have been reported in mothers with digitalis toxicity. Although digoxin is excreted in breast milk, the quantities are minute and breast feeding is not contraindicated.


    Overdose

    Symptoms and signs: The symptoms and signs of toxicity are generally similar to those described in the Adverse Reactions section but may be more frequent and can be more severe. Signs and symptoms of digoxin toxicity become more frequent with levels above 2.0 nanograms/mL (2.56 nanomol/L) although there is considerable interindividual variation. However, in deciding whether a patient’s symptoms are due to digoxin, the clinical state, together with serum electrolyte levels and thyroid function are important factors.
    Adults: In adults without heart disease clinical observation suggests that an overdose of digoxin of 10-15 mg was the dose resulting in death of half of the patients. If more than 25 mg of digoxin was ingested by an adult without heart disease, death or progressive toxicity responsive only to digoxin-binding Fab antibody fragments resulted.
    For full details please see prescribing information.


    Manufacturer
    Aspen Bad Oldesloe GmbH GlaxoSmithKline Manufacturing S.p.A, Parma, Italy
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