Centoxin® 0.25 mg Tablet: Each tablet contains digoxin USP 0.25 mg.
Centoxin® 60 ml Solution: Each ml contains digoxin USP 50 mcg (0.05 mg).
Indications: Digoxin is indicated for the treatment of chronic heart failure. Digoxin is also indicated in the management of atrial fibrillation.
Dosage and administration: Recommended dosage 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.
Rapid digitalization with a loading dose:Tablet: If the patient’s clinical response necessitates a change from the calculated loading dose of digoxin, then base calculation of the maintenance dose upon the amount actually given.
A single initial dose of 500 to 750 mcg (0.5 to 0.75 mg) of digoxin tablets usually produces a detectable effect in 0.5 to 2 hours that becomes maximal in 2 to 6 hours. Give additional doses of 125 to 375 mcg (0.125 to 0.375 mg) cautiously at 6 to 8 hour intervals until clinical evidence of an adequate effect is noted. The usual amount of digoxin tablets that a 70 kg patient requires to achieve 8 to 12 mcg/kg peak body stores is 750 to 1,250 mcg (0.75 to 1.25 mg).
Solution: Digitalizing and daily maintenance doses for each age group are given below and should provide therapeutic effect with minimum risk of toxicity in most patients with heart failure and normal sinus rhythm. These recommendations assume the presence of healthy renal function.
Usual Digitalizing and Maintenance Dosages for Digoxin Pediatric Solution in Children with Healthy Renal Function Based on Lean Body Weight.
Age.
Oral digitalizinga dose (mcg/kg).
Daily maintenance doseb (mcg/kg).
Premature.
20 to 30.
20% to 30% of oral digitalizing dosec.
Full-term.
25 to 35.
25% to 35% of oral digitalizing dosec.
1 to 24 months.
35 to 60.
2 to 5 years.
30 to 40.
5 to 10 years.
20 to 35.
Over 10 years.
10 to 15.
a IV digitalizing doses are 80% of oral digitalizing doses. b Divided daily dosing is recommended for children younger than 10 years age. c Projected or actual digitalizing dose providing clinical response.
In children with renal disease, carefully titrate digoxin dosing based upon desired clinical response.
Maintenance dose: The doses of digoxin tablets used in controlled trials in patients with heart failure have ranged from 125 to 500 mcg (0.125 to 0.5 mg) once daily. In these studies, the digoxin dose has been generally titrated according to the patient’s age, lean body weight and renal function. Therapy is generally initiated at a dosage of 250 mcg (0.25 mg) once daily in patients younger than 70 years of age with good renal function and at a dosage of 125 mcg (0.125 mg) once daily in patients older than 70 years of age or with impaired renal function and at a dosage of 62.5 mcg (0.0625 mg) once daily in patients with marked renal impairment. Doses may be increased every 2 weeks according to clinical response.
a Ccr is creatinine clearance, corrected to 70 kg body weight or 1.73 m² body surface area. For adults, if only serum creatinine concentrations (Scr) are available, a Ccr (Corrected to 70 kg body weight) may be estimated in men as (140 – age)/Scr. For women multiply this result by 0.85.
Note: This equation cannot be used for estimating in infants or children. b If no loading dose administration. c 62.5 mcg = 0.0625 mg.
Atrial fibrillation: Peak Digoxin body stores larger than the 8 to 12 mcg/kg required for most patients with heart failure and normal sinus rhythm have been used for control of ventricular rate in patients with atrial fibrillation. Titrate doses of Digoxin.
Usual Daily Maintenance Dose Requirements (mcg) of Digoxin for Estimated Peak Body Stores of 10 mcg/kg.
Lean Body Weight.
No. of Days Before Steady State Achievedb.
Digoxin is indicated for the treatment of chronic heart failure. Digoxin is also indicated in the management of atrial ibrillation.
Recommended dosage 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.
Rapid digitalization with a loading dose: Tablet: the patient s clinical response necessitates a change from the calculated loading dose of digoxin, then base calculation of the maintenance dose upon the amount actually given. A single initial dose of 500 to 750 mcg (0.5 to 0.75 mg) of digoxin tablets usually produces a detectable effect in 0.5 to 2 hours that becomes maximal in 2 to 6 hours. Give additional doses of 125 to 375 mcg (0.125 to 0.375 mg) cautiously at 6 to 8 hour intervals until clinical evidence of an adequate effect is noted. The usual amount of digoxin tablets that a 70 kg patient requires to achieve 8 to 12 mcg/kg peak body stores is 750 to 1,250 mcg (0.75 to 1.25 mg).
Solution: Digitalizing and daily maintenance doses for each age group are given below and should provide therapeutic effect with minimum risk of toxicity in most patients with heart failure and normal sinus rhythm. These recommendations assume the presence of healthy renal function.
Usual Digitalizing and Maintenance Dosages for Digoxin Pediatric Solution in Children with Healthy Renal Function Based on Lean Body Weight Age Oral digitalizing? dose (mcg/kg) Daily maintenance (mcg/kg) Premature 20 to 30 20% to 30% of oral digitalizing Full-term 25 to 35 25% to 35% of oral T to 24 months 35 to 60 digitalizing dose 2 to 5 years 30 to 40 5 to 10 years 20 to 35 Over 10 years 10 to 15.
ay digitalizing doses are 80% of oral digitalizing doses. Divided daily dosing is recommended for children younger than 10 years age. c Projected or actual digitalizing dose providing clinical response. In children with renal disease, carefully titrate digoxin dosing based upon desired clinical response. Maintenance dose: The doses of digoxin tablets used in controlled trials in patients with heart failure have ranged from 125 to 500 mcg (0.125 to 0.5 mg) once daily. In these studies, the digoxin dose has been generally titrated according to the patient s age, lean body weight and renal function. Therapy is generally initiated at a dosage of 250 mcg (0.25 mg) once daily in patients younger than 70 years of age with good renal function, at a dosage of 125 mcg (0.125 mg) once daily in patients older than 70 years of age or with impaired renal function and at a dosage of 62.5 mcg (0.0625 mg) once daily in patients with marked renal impairment. Doses may be increased every 2 weeks according to clinical response. Cer is creatinine clearance, corrected to 70 kg body weight or 1.73 m? body surface area. For adults, if only serum creatinine concentrations (Scr) are available, a Ccr (Corrected to 70 kg body weight) may be estimated in men as (140 age)/Scr. For women multiply this result by 0.85.
Note: This equation cannot be used for estimating in infants or children. loading dose administration. 62.5 mcg = 0.0625 mg.
Atrial fibrillation. Peak Digoxin body stores larger than the 8 to 12 mcg/kg required for most patients with heart failure and normal sinus rhythm have been used for control of ventricular rate in patients with atrial fibrillation. Titrate doses of Digoxin.
Usual Daily Maintenance Dose Requirements (mcg) of Digoxin for Estimated Peak Body Stores of 10 mcg/kg Corrected Lean Body Weight No. of Days Cer Before Steady (ml/min kg 50 60 70 80 100 State per 70 kg)* [Ib 110 132 154 176 198 220 Achieved? 62.5 125 125 125 187.5 187.5 22 10 125 125 187.5 187.5 187.5 19 20 125 125 187.5 187.5 187.5 250 16 30 125 187.5 187.5 187.5 250 250 14 40 125 187.5 187.5 250 250 250 13 50 187.5 187.5 250 250 250 250 12 60 187.5 187.5 250 250 250 375 11 70 250 250 250 250 375 10 80 250 250 250 375 375 9 90 250 250 250 375 500 8 100 250 250 250 375 375 500 7 used for the treatment of chronic atrial fibrillation to the minimum dose that achieves the desired ventricular rate control without causing undesirable side effects.
Potassium-depleting diuretics are a major contributing factor to digoxin toxicity. 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 raise the serum digoxin concentration Erythromycin, clarithromycin and tetracycline may increase digoxin absorption. Propantheline and diphenoxylate may increase digoxin absorption. Antacids, kaolin-pectin, sulfasalazine, neomycin, cholestyramine, certain anticancer drugs, and metoclopramide may interfere with intestinal digoxin absorption, resulting in unexpectedly low serum concentrations.
Over dosage: Digoxin should be temporarily discontinued until the adverse reaction resolves. Every effort should also be made to correct factors that may contribute to the adverse reaction (such as electrolyte disturbances or concurrent medications). Once the adverse reaction is resolved, therapy with digoxin may be re-instituted, following a careful reassessment of dose. Withdrawal of digoxin may be all that is required to treat the adverse reaction. However, when the primary manifestation of digoxin overdosage is a cardiac arrhythmia, additional therapy may be needed. If heart block occurs, insertion of a temporary cardiac pacemaker may be required.
The use of digoxin in pregnancy is not contraindicated. Use should be considered only when the expected clinical benefit of the treatment to the mother outweighs any possible risk to the developing foetus. Although digoxin is excreted in breast milk, the quantities are minute and breast feeding is not contraindicated.
Digoxin is primarily excreted by the kidneys; therefore, patients with impaired renal function require smaller than usual maintenance doses of digoxin. Hypokalemia or hypomagnesemia sensitizes the myocardium to digoxin. Hypothyroidism may require low dose and hyperthyroidism and malabsorption may require larger dose. 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.
Keep out of reach of children. Store in a cool and dry place, protected from light.