Generic name: OVINE DIGOXIN IMMUNE FAB 38mg
Dosage form: injection, powder, for solution
Medically reviewed by Drugs.com. Last updated on Jan 16, 2020.
The dosage of DIGIBIND varies according to the amount of digoxin (or digitoxin) to be neutralized. The average dose used during clinical testing was 10 vials.
Dosage for Acute Ingestion of Unknown Amount
Twenty (20) vials (760 mg) of DIGIBIND is adequate to treat most life-threatening ingestions in both adults and children. However, in children it is important to monitor for volume overload. In general, a large dose of DIGIBIND has a faster onset of effect but may enhance the possibility of a febrile reaction. The physician may consider administering 10 vials, observing the patient’s response, and following with an additional 10 vials if clinically indicated.
Dosage for Toxicity During Chronic Therapy
For adults, six vials (228 mg) usually is adequate to reverse most cases of toxicity. This dose can be used in patients who are in acute distress or for whom a serum digoxin or digitoxin concentration is not available. In infants and small children (≤20 kg) a single vial usually should suffice.
Methods for calculating the dose of DIGIBIND required to neutralize the known or estimated amount of digoxin or digitoxin in the body are given below (see DOSAGE CALCULATION section).
When determining the dose for DIGIBIND, the following guidelines should be considered:
- Erroneous calculations may result from inaccurate estimates of the amount of digitalis ingested or absorbed or from nonsteady-state serum digitalis concentrations. Inaccurate serum digitalis concentration measurements are a possible source of error. Most serum digoxin assay kits are designed to measure values less than 5 ng/mL. Dilution of samples is required to obtain accurate measures above 5 ng/mL.
- Dosage calculations are based on a steady-state volume of distribution of approximately 5 L/kg for digoxin (0.5 L/kg for digitoxin) to convert serum digitalis concentration to the amount of digitalis in the body. The conversion is based on the principle that body load equals drug steady-state serum concentration multiplied by volume of distribution. These volumes are population averages and vary widely among individuals. Many patients may require higher doses for complete neutralization. Doses should ordinarily be rounded up to the next whole vial.
- If toxicity has not adequately reversed after several hours or appears to recur, readministration of DIGIBIND at a dose guided by clinical judgment may be required.
- Failure to respond to DIGIBIND raises the possibility that the clinical problem is not caused by digitalis intoxication. If there is no response to an adequate dose of DIGIBIND, the diagnosis of digitalis toxicity should be questioned.