Usual Adult Dose for Digitalis Glycoside Toxicity

Acute ingestion and digoxin toxicity, serum digitalis concentration and amount ingested unknown:
Initial dose: 10 vials intravenously
Follow with an additional 10 vials, if needed, to avoid a febrile reaction

Acute ingestion, amount of digoxin ingested is known: Dose (in # of vials) = (amount of digoxin ingested in mg) / (0.5 mg/vial).

Chronic digoxin toxicity, serum digitalis concentration unknown: 6 vials intravenously

Chronic digoxin toxicity, serum digitalis concentration is known: Dose (in # of vials) = (serum digoxin ng/mL)x(weight in kg) / 100

Comments:

• A lack of response to treatment may indicate the problem is not caused by digitalis toxicity.
• Each vial contains 40 mg of digoxin-specific Fab, which binds approximately 0.5 mg of digoxin.
• Many patients require higher doses for complete neutralization.
• Doses should be rounded up to the nearest whole vial.
• If toxicity is not adequately reversed in several hours, or recurs, use clinical judgement regarding additional dosing; measure free (unbound) serum digitalis concentration for dosing as Fab may still be present.

Use(s): Treatment of life-threatening or potentially life-threatening digoxin toxicity or overdose

Usual Pediatric Dose for Digitalis Glycoside Toxicity

Acute ingestion and digoxin toxicity, serum digitalis concentration and amount ingested unknown:
Initial dose: 10 vials intravenously
Follow with an additional 10 vials, if needed, to avoid a febrile reaction

• Monitor for volume overload in small (under 20 kg) children

Acute ingestion, amount of digoxin ingested is known: Dose (in # of vials) = (amount of digoxin ingested in mg) / (0.5 mg/vial).

Chronic digoxin toxicity, serum digitalis concentration unknown:
Children 20 kg and over: 6 vials intravenously
Children under 20 kg and infants: 1 vial intravenously

Chronic digoxin toxicity, serum digitalis concentration is known: Dose (in # of vials) = (serum digoxin ng/mL)x(weight in kg) / 100

Comments:

• A lack of response to treatment may indicate the problem is not caused by digitalis toxicity.
• Each vial contains 40 mg of digoxin-specific Fab, which binds approximately 0.5 mg of digoxin.
• Many patients require higher doses for complete neutralization.
• Doses should be rounded up to the nearest whole vial.
• If toxicity is not adequately reversed in several hours, or recurs, use clinical judgement regarding additional dosing; measure free (unbound) serum digitalis concentration for dosing as Fab may still be present.

Use(s): Treatment of life-threatening or potentially life-threatening digoxin toxicity or overdose

Renal Dose Adjustments

Data not available

• The elimination half life in renal failure has not been clearly identified.
• Monitor severe renal failure patients for digitalis toxicity for a prolonged period because of possible recurrence of toxicity.
• Monitoring free (unbound) digoxin concentrations may be appropriate to establish recrudescent toxicity in renal failure patients.

Liver Dose Adjustments

Data not available

Dose Adjustments

Alternate dosing formulas:

Dose (in number of vials) = total digitalis body load in mg / (0.5 mg of digitalis bound/vial)

Dose (in number of vials) = (serum digoxin concentration in ng/mL x weight in kg) / 100

Pediatric:
Dose (in mg) = (dose in number of vials) x (40 mg/vial)

Dose (in number of vials) = (serum digoxin concentration in ng/mL x weight in kg) / 1000

Precautions

CONTRAINDICATIONS: None

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer as a slow IV infusion over at least 30 minutes.
• Stop administration for infusion rate-related anaphylactoid reactions (e.g. hypotension, wheezing, urticaria); may restart at a lower rate.
• May give as a bolus injection if cardiac arrest is imminent.
• Infants and small children needing very small doses may be given this product undiluted using a tuberculin syringe.
• Very small doses can be diluted with 36 mL of isotonic saline to achieve a concentration of 1 mg/mL.

Storage requirements:

• Refrigerate; do not freeze

Reconstitution/preparation techniques:

• Reconstitute each vial with 4 mL of sterile water for injection, mix gently.
• Use reconstituted product promptly; if not used immediately, refrigerate (36 to 46F) for up to 4 hours.
• Add reconstituted product to an appropriate volume of 0.9% sodium chloride for injection.