It is not clear if detoxification or reintoxification will occur therefore, prolonged monitoring for digoxin toxicity is recommended. In patients functionally anephric, digoxin immune Fab is not excreted and may be eliminated by the reticuloendothelial system. No dose reduction or escalation is needed for patients with impaired kidney function. However, in a study, toxicity recurrence was only associated with an inadequate initial dose. For example, a functionally anephric patient had recurrence of atrioventricular block due to digoxin 10 days after reversal by digoxin immune Fab.
#DIGOXIN ANTIDOTE FREE#
Free digoxin could cause toxicity to recur. The risk of digoxin release from the Fab fragment-digoxin complex is potentially increased when excretion of the complex is slowed. Elimination of digoxin immune Fab-digoxin complexes may be delayed in patients with reduced renal function. Geriatric patients often have reduced renal function. Geriatric, renal failure, renal impairmentĭigoxin immune Fab should be used with caution in patients with renal impairment or renal failure. Some dust mite allergens and some latex allergens share antigenic structures with papain. Patients with a history of an allergy to antibiotics, latex, or dust mites may also be at risk for an allergic reaction to digoxin immune Fab.
Do not administer digoxin immune Fab to a patient with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available. Patients with papain hypersensitivity or allergies to chymopapain, other papaya extracts, or the pineapple extract bromelain may have an allergic response to the product. Digoxin immune Fab is prepared by isolating the immunoglobulin fraction of the ovine serum, digesting it with papain, and isolating the digoxin-specific Fab fragments by affinity chromatography. Use digoxin immune Fab cautiously in patients with known ovine protein hypersensitivity. Ovine protein hypersensitivity, papain hypersensitivityĭigoxin immune Fab is a foreign (sheep-derived) protein. An increased incidence of infusion-related reactions may be expected with bolus injection. If cardiac arrest is imminent, bolus administration is acceptable. If infusion rate-related reactions occur, stop the infusion and restart at a slower rate. Infuse IV slowly over at least 30 minutes. Storage: If reconstituted digoxin immune Fab is not used immediately, it may be stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 4 hours.
The reconstituted product may be diluted with 0.9% Sodium Chloride Injection to a convenient volume.įor patients receiving relatively small doses, the appropriate dose of the reconstituted solution may be withdrawn using a tuberculin syringe and then injected IV or diluted in 0.9% Sodium Chloride Injection and infused or injected IV.įor patients receiving doses less than 3 mg, dilute the reconstituted solution with 36 mL of 0.9% Sodium Chloride Injection to give a solution containing 1 mg/mL of digoxin immune Fab. The resulting solution should be clear, colorless, approximately isosmotic, and contain 10 mg/mL of digoxin immune Fab. Reconstitute by adding 4 mL of Sterile Water for Injection to the vial and gently mixing. Digoxin immune Fab is administered by intravenous infusion or bolus injection.Ĭlosely monitor the patient's temperature, blood pressure, electrocardiogram, and serum potassium concentration before and after digoxin immune Fab administration.
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