Medicinal Products

DIGIDOT 80 mg Powder for solution for infusion Box of 1 vial of 80 mg

Generic drug of the therapeutic class: Toxicology
active ingredients: Fragment of ovine anti-dermal immunoglobulin
laboratory: Roche

Powder for IV infusion solution
All forms

Indication

Digitalis poisoning (digoxin, digoxin derivatives, digitoxin) that are life-threatening or potentially serious.
The severity criteria are:
- in terms of history: in case of acute intoxication, an ingested dose greater than 10 mg of digoxin in adults and 4 mg of digoxin in children.
- in clinical terms: excitability disorders (ventricular tachycardias, ventricular fibrillations, polymorphic ventricular extrasystoles), conduction disturbances (bradycardia, severe bradyarrhythmia less than 40 beats per minute, 2nd or 3rd degree atrioventricular block); the existence of underlying heart disease is an aggravating factor.
- on the biological level:
. hyperkalemia greater than 5 mmol / L;
. the measurement of serum digoxin or digitoxin concentrations is not a prerequisite for the administration of antidigital antibodies. However, although the interpretation of the concentrations is difficult, serious disorders are generally associated with serum digoxin concentrations greater than 10 ng / ml in case of acute intoxication, and greater than 5 ng / ml in case of chronic overdose. ; Moreover, the serum concentration of digoxin or digitoxin can be used for the calculation of the dose of antibodies to be administered, especially in case of chronic overdose.

Dosage DIGIDOT 80 mg Powder for solution for infusion Box of 1 vial of 80 mg

80 mg of antibody (equivalent to 1 vial of DIGIDOT) binds 1 mg of digoxin, digoxin derivatives or digitoxin present in the body .
When calculating the dose of antibodies to be administered, the following points should be taken into account. In case of vomiting or gastric lavage, the amount of glycoside that may have been absorbed is reduced. Excretion can be accelerated by the administration of laxatives. The amount of glycoside absorbed depends on the bioavailability of the various glycoside preparations. Part of the amount absorbed may already be metabolized in the body.
Calculation of the required dose:
- In case of acute intoxication, the dose of antidigital antibodies to be administered can be estimated from the amount of digitalis ingested, according to the following equations:
. for digoxin: DIGIDOT (mg) = mg of digoxin ingested x 0.6 x 80.
. for digitoxin: DIGIDOT (mg) = mg of digitoxin ingested x 80.
If the amount of digitalis ingested is unknown :
. in the presence of symptoms such as ventricular tachycardias or ventricular fibrillation, administer 320 to 480 mg of DIGIDOT (ie 4 to 6 vials) in 20 to 30 minutes,
. in other cases, administer 160 mg of DIGIDOT (ie 2 vials) in 15 to 20 minutes,
. clinical improvement (rhythm disturbances, in particular) generally begins within 30 minutes after the end of the infusion; in the absence of improvement, a new administration of DIGIDOT will be carried out according to the preceding modalities, one hour after the beginning of the first infusion, if the symptoms are in relation with the digitalis intoxication.
- in case of chronic overdose or in case of acute intoxication (in the latter case, from the 8th hour when the distribution phase is over, see warnings and precautions for use), the dose of antibody may also be estimated according to the serum concentrations of digitalis, according to the following equations:
. for digoxin:
DIGIDOT (mg) = [digoxinemia (ng / ml) x 5.6 x weight x 80] / 1000.
. for digitoxin:
DIGIDOT (mg) = [digitoxinemia (ng / ml) x 0.56 x weight x 80] / 1000.
If the digitalis concentration ingested is unknown :
. in the presence of symptoms such as ventricular tachycardias or ventricular fibrillation, administer 320 to 480 mg of DIGIDOT (ie 4 to 6 vials) in 20 to 30 minutes,
. in other cases, administer 160 mg of DIGIDOT (ie 2 vials) in 15 to 20 minutes,
. clinical improvement (rhythm disturbances, in particular) generally begins within 30 minutes after the end of the infusion; in the absence of improvement, a new administration of DIGIDOT will be carried out according to the preceding modalities, one hour after the beginning of the first infusion, if the symptoms are in relation with the digitalis intoxication.
The following data allow the determination of the number of DIGIDOT flasks to be administered according to the serum concentration and the weight or the amount of ingested digitalis.
DIGIDOT dose to be administered according to weight and digoxinemia :
- Adult 50 kg:
. 2.5 μg / L or ng / ml: 56 mg (1 vial).
. 5 μg / L or ng / ml: 112 mg (1 to 2 vials).
. 10 μg / L or ng / ml: 224 mg (3 vials).
. 15 μg / L or ng / ml: 336 mg (4 flasks).
. 20 μg / L or ng / ml: 448 mg (6 vials).
- Adult 60 kg:
. 2.5 μg / L or ng / ml: 67 mg (1 vial).
. 5 μg / L or ng / ml: 134 mg (1 to 2 vials).
. 10 μg / L or ng / ml: 269 mg (3 to 4 flasks).
. 15 μg / L or ng / ml: 403 mg (5 vials).
. 20 μg / L or ng / ml: 538 mg (7 flasks).
- Adult 70 kg:
. 2.5 μg / L or ng / ml: 78 mg (1 vial).
. 5 μg / L or ng / ml: 157 mg (2 vials).
. 10 μg / L or ng / ml: 314 mg (4 flasks).
. 15 μg / L or ng / ml: 470 mg (6 vials).
. 20 μg / L or ng / ml: 627 mg (8 vials).
- Adult 80 kg:
. 2.5 μg / L or ng / ml: 90 mg (1 vial).
. 5 μg / L or ng / ml: 179 mg (2 to 3 vials).
. 10 μg / L or ng / ml: 358 mg (4 to 5 vials).
. 15 μg / L or ng / ml: 538 mg (7 flasks).
. 20 μg / L or ng / ml: 717 mg (9 flasks).
DIGIDOT dose to be given according to weight and digitoxinemia :
- Adult 50 kg:
. 40 μg / L or ng / ml: 90 mg (1 vial).
. 80 μg / L or ng / ml: 179 mg (2 to 3 vials).
. 120 μg / L or ng / ml: 269 mg (3 to 4 flasks).
. 160 μg / L or ng / ml: 358 mg (4 to 5 flasks).
. 200 μg / L or ng / ml: 448 mg (6 vials).
- Adult 60 kg:
. 40 μg / L or ng / ml: 108 mg (1 to 2 vials).
. 80 μg / L or ng / ml: 215 mg (3 vials).
. 120 μg / L or ng / ml: 323 mg (4 flasks).
. 160 μg / L or ng / ml: 430 mg (5 to 6 vials).
. 200 μg / L or ng / ml: 538 mg (7 flasks).
- Adult 70 kg:
. 40 μg / L or ng / ml: 125 mg (2 vials).
. 80 μg / L or ng / ml: 251 mg (3 flasks).
. 120 μg / L or ng / ml: 376 mg (5 vials).
. 160 μg / L or ng / ml: 502 mg (6-7 vials).
. 200 μg / L or ng / ml: 627 mg (8 vials).
- Adult 80 kg:
. 40 μg / L or ng / ml: 143 mg (2 vials).
. 80 μg / L or ng / ml: 287 mg (3 to 4 flasks).
. 120 μg / L or ng / ml: 430 mg (5 to 6 vials).
. 160 μg / L or ng / ml: 573 mg (7 to 8 vials).
. 200 μg / L or ng / ml: 717 mg (9 flasks).
CP = plasma concentration of digoxin or digitoxin (μg / L or ng / ml).
Vd = volume of distribution (5.6 for digoxin, 0.56 for digitoxin).
P = patient weight (kg).
1 vial of DIGIDOT neutralises 1 mg of digoxin or digitoxin .
Dose of DIGIDOT to be administered according to the quantity (Q) of digitalis ingested known :
- Digoxin:
. 5 mg: 240 mg (3 flasks).
. 10 mg: 480 mg (6 flasks).
. 15 mg: 720 mg (9 flasks).
. 20 mg: 960 mg (12 flasks).
. 25 mg: 1200 mg (15 flasks).
- Digitoxin:
. 3 mg: 240 mg (3 vials).
. 6 mg: 480 mg (6 vials).
. 9 mg: 720 mg (9 flasks).
. 12 mg: 960 mg (12 flasks).
. 15 mg: 1200 mg (15 vials).
1 vial of DIGIDOT neutralises 1 mg of digoxin or digitoxin .
USE IN CHILDREN:
The same terms of administration apply.
USE IN THE INSUFFICIENT RENAL:
Based on experience to date, the same modalities of administration apply to patients with renal impairment; it does not seem necessary to reduce the dosage to be administered. However, it is recommended to follow patients for as long as their renal elimination capacity is reduced (see section pharmacokinetic properties).
METHOD OF ADMINISTRATION :
Intravenous infusion of short duration:
Introduce 20 ml of 0.9% sodium chloride (saline) into each of the required vials, avoiding as much foam as possible, and shake gently to dissolve the contents. Then inject these anti-dentific antibody solutions into infusion vials or mix them with 0.9% sodium chloride (saline) for IV infusion over a period of 20 to 30 minutes.
Immediately prior to infusion, and in the absence of a need to administer the product of extreme urgency, possible product allergy should be investigated as far as possible by intradermal and conjunctival testing (particularly in subjects with a history of allergy or asthma, or in the case of repeated administration of sheep globulins, see the section on warnings and precautions for use) .
All infusion should be under strict medical supervision for signs of anaphylactic shock.
- Emergency treatment of anaphylactic shock :
From the first signs evoking the occurrence of anaphylactic shock (drop in blood pressure, pruritus, facial edema, bronchospasm):
. stop the infusion or injection; leave the catheter in the vein,
. or ask another venous route.
Also use the usual emergency measures (put the patient in a low head position, raised legs, ensure the freedom of the airways).
- Emergency medical treatment :
. Immediately: adrenaline IV.
Dilute 1 ml of epinephrine solution (1/1000) to obtain 10 ml, slowly inject 1 ml of this dilution (= 0.1 mg of adrenaline) while monitoring pulse and blood pressure (risk of arrhythmia) . Adrenaline can be repeated.
. Then: IV glucocorticoids, for example, 250 to 1000 mg of prednisolone (or equivalent amount of one of its derivatives).
The administration of glucocorticoids may be repeated.
Consider the use of other therapeutic measures, such as respiratory assistance, oxygen therapy and antihistamines.
In children, decrease the dosage of adrenaline and glucocorticoids according to age and weight.
Keep patients under strict medical supervision.

Against indications

Allergy known to sheep globulins.

Digidot side effects

Allergic reactions to Fab heterologous fragments can occur in isolated cases. Repeated administration of sheep globulins in sensitized patients may result in acute life-threatening anaphylactic reactions (see section 4.4).

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