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AURO-DIGOXIN is a brand name for Digoxin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Auro-Digoxin (digoxin tablets) are indicated for: • Congestive Heart Failure: Auro-Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related…
Verbatim from this product's HC label. Tap a section to expand.
3 Pharmacokinetics, Pediatrics. 2 Geriatrics Geriatrics (over 70 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 3 Pharmacokinetics, Geriatrics.
2 CONTRAINDICATIONS • Digitalis glycosides are contraindicated in ventricular fibrillation. Auro-Digoxin Product Monograph Page 5 of 45 • In a given patient, an untoward effect requiring permanent discontinuation of other digitalis preparations usually constitutes a contraindication to Auro-Digoxin.
• Allergy to digoxin, though rare, does occur. It may not extend to all such preparations, and another digitalis glycoside may be tried with caution. Auro-Digoxin is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
1 Adverse Reaction Overview Adults In general, the adverse reactions of digoxin are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when digoxin is used within the recommended dose range or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.
Auro-Digoxin Product Monograph Page 16 of 45 Because some patients may be particularly susceptible to side effects with digoxin, the dosage of the drug should always be selected carefully and adjusted as the clinical condition of the patient warrants.
In the past, when high doses of digoxin were used and little attention was paid to clinical status or concurrent medications, adverse reactions to digoxin were more frequent and severe. Cardiac adverse reactions accounted for about one -half, gastrointestinal disturbances for about one-fourth, and central nervous system (CNS) and other toxicity for about one-fourth of these adverse reactions.
However, available evidence suggests that the incidence and severity of digoxin toxicity has decreased substantially in recent years. In recent controlled clinical trials in patients with predominantly mild to moderate heart failure, the incidence of adverse experiences was comparable in patients taking digoxin and in those taking placebo.
9% in patients taking placebo. In this trial, the most common manifestations of digoxin toxicity included gastrointestinal and cardiac disturbances; CNS manifestations were less common. Cardiac Unifocal or multiform ventricular premature contractions, especially in bigeminal or trigeminal patterns, are the most common arrhythmias associated with digoxin toxicity in adults with heart disease.
Persistent bigeminy at rest but not on exercise when the sinus rate increases has traditionally been acceptable in the management of some arrhythmias. Ventricular tachycardia and ventricular fibrillation may result from digitalis toxicity.
3 Pharmacokinetics, Pediatrics. 2 Geriatrics Geriatrics (over 70 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 3 Pharmacokinetics, Geriatrics.
2 CONTRAINDICATIONS • Digitalis glycosides are contraindicated in ventricular fibrillation. Auro-Digoxin Product Monograph Page 5 of 45 • In a given patient, an untoward effect requiring permanent discontinuation of other digitalis preparations usually constitutes a contraindication to Auro-Digoxin.
• Allergy to digoxin, though rare, does occur. It may not extend to all such preparations, and another digitalis glycoside may be tried with caution. Auro-Digoxin is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Do not take other prescription, non-prescription and herbal medications without advice from your doctor.
1 Dosing Considerations Recommended dosages of digoxin may require considerable modification because of individual sensitivity of the patient to the drug, the presence of associated conditions, or the use of concurrent medications.
In selecting the dose of digoxin, several factors must be considered: • The body weight of the patient. , ideal) body weight. • The patient’s renal function, preferably evaluated on the basis of estimated creatinine clearance. • The patient’s age.
Infants and children require different doses of digoxin than adults. 5 mg/dL). • Concomitant disease states, concurrent medication or other factors likely to alter the pharmacokinetic or pharmacodynamic profile of digoxin (see 7 WARNINGS AND PRECAUTIONS).
• Digitalis glycosides are contraindicated in ventricular fibrillation. Auro-Digoxin Product Monograph Page 5 of 45 • In a given patient, an untoward effect requiring permanent discontinuation of other digitalis preparations usually constitutes a contraindication to Auro-Digoxin.
• Allergy to digoxin, though rare, does occur. It may not extend to all such preparations, and another digitalis glycoside may be tried with caution. Auro-Digoxin is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Digoxin in Canada.
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Atrioventricular (AV) dissociation, accelerated junctional (nodal) rhythm and atrial tachycardia with block are also common arrhythmias caused by digoxin overdosage. Excessive slowing of the pulse is a clinical sign of digoxin overdosage.
AV block (Wenckebach) of increasing degree may proceed to complete heart block (including asystole).
Note:
The electrocardiogram (ECG) is fundamental in determining the presence and nature of these cardiac disturbances. , PR prolongation, ST depression), which represent digoxin effect and may or may not be associated with digitalis toxicity.
Cardiac toxicity can also occur at therapeutic doses in patients who have conditions which may alter their sensitivity to digoxin (see 7 WARNINGS AND PRECAUTIONS). Gastrointestinal Anorexia, nausea, vomiting, and less commonly diarrhea, are common early symptoms of overdosage.
However, uncontrolled heart failure may also produce such symptoms. Rarely, the use of digoxin has been associated with abdominal pain. It is inadvisable to rely on nausea as an early warning of excessive digoxin as arrhythmias may occur first.
Auro-Digoxin Product Monograph Page 17 of 45 Central Nervous System Visual disturbances (blurred or yellow vision), headache, weakness, apathy, psychosis, and mental disturbances (such as anxiety, depression, delirium, and hallucination) can occur.
Other Gynecomastia is occasionally observed following prolonged use of digoxin. Thrombocytopenia and maculopapular rash and other skin reactions have been rarely observed. Infants and Children Toxicity differs from the adult in a number of respects.
Anorexia, nausea, vomiting, diarrhea and CNS disturbances may be present but are rare as initial symptoms in infants. Cardiac arrhythmias are more reliable signs of toxicity. Digoxin in children may produce any arrhythmia. The most commonly encountered 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 also 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 initially be assumed to be a consequence of digoxin intoxication, until further evaluation proves otherwise.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Table 4 summarizes the incidence of adverse experiences for patients treated with digoxin tablets or placebo from two randomized, double-blind, placebo-controlled withdrawal trials.
Patients in these trials were also receiving diuretics with or without angiotensin-converting enzyme inhibitors. These patients had been stable on digoxin and were randomized to digoxin or placebo. The results shown in Table 4 reflects the experience in patients following dosage titration with the use of serum digoxin concentrations and careful follow-up.
These adverse experiences are consistent with results from a large, placebo-controlled mortality trial (DIG trial) wherein over half the patients were not receiving digoxin prior to enrolment. Table 4 Adverse Experiences in Two Parallel, Double-Blind, Placebo-Controlled Withdrawal Trials with Digoxin Tablets (Number of Patients Reporting) Auro-Digoxin Product Monograph Page 18 of 45 […]
• To minimize toxic side effects, the lowest effective dose should be used as the Auro-Digoxin Product Monograph Page 6 of 45 maintenance dose. 2 Recommended Dose and Dosage Adjustment Serum Digoxin Concentrations In general, the dose of digoxin used should be determined on clinical grounds.
However, measurement of serum digoxin concentrations can be helpful to the clinician in determining the adequacy of digoxin therapy and in assigning certain probabilities to the likelihood of digoxin intoxication. 0 ng/mL. However, digoxin may produce clinical benefits even at serum concentrations below this range.
0 ng/mL. 0 ng/mL do not rule out the possibility that a certain sign or symptom is related to digoxin therapy. 8 ng/mL. Consequently, the serum concentration of digoxin should always be interpreted in the overall clinical context, and an isolated measurement should not be used alone as the basis for increasing or de creasing the dose of the drug.
To allow adequate time for equilibration of digoxin between serum and tissue, sampling of serum concentrations should be done just before the next scheduled dose of the drug. If this is not possible, sampling should be done at least 6 to 8 hours after the last dose, regardless of the route of administration or the formulation used.
On a once-daily dosing schedule, the concentration of digoxin will be 10% to 25% lower when sampled at 24 versus 8 hours, depending upon the patient's renal function. On a twice-daily dosing schedule, there will be only minor differences in serum digoxin concentrations whether sampling is done at 8 or 12 hours after a dose.
If a discrepancy exists between the reported serum concentration and the observed clinical response, the clinician should consider the following possibilities: • Analytical problems in the assay procedure. • Inappropriate serum sampling time.
• Administration of a digitalis glycoside other than digoxin. • Conditions (described in 7 WARNINGS AND PRECAUTIONS) causing an alteration in the sensitivity of the patient to digoxin. • Serum digoxin concentration may decrease acutely during periods of exercise without any associated change in clinical efficacy due to increased binding of digoxin to skeletal muscle.
Heart Failure Adults:
Digitalization may be accomplished by either of two general approaches that vary in Auro-Digoxin Product Monograph Page 7 of 45 dosage and frequency of administration, but reach the same endpoint in terms of total amount of digoxin accumulated in the body.
• Rapid digitalization may be achieved by administering a loading dose based upon projected peak body digoxin stores, then calculating the maintenance dose as a percentage of the loading dose. • More gradual digitalization may be obtained by beginning an appropriate maintenance dose, thus allowing digoxin body stores to accumulate slowly.
Steady-state serum digoxin concentrations will be achieved in approximately 5 half-lives of the drug for the individual patient. Depending upon the patient’s renal function, this will take between 1 and 3 weeks. Rapid Digitalization with a Loading Dose Peak body digoxin stores of 8 to 12 mcg/kg should provide therapeutic effect with minimum risk of toxicity in most patients with […]