Medicinal Products

DIGOXIN NATIVELLE 5 micrograms / 0.1 mL

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Digoxin
laboratory: Teofarma

Oral solution drops
Bottle (+ graduated dosing pipette) of 60 ml
All forms

Indication

· Heart failure.

· Disorders of supraventricular rhythm: slowing or reducing atrial fibrillation or atrial flutter.

Dosage DIGOXINE NATIVELLE 5 micrograms / 0.1 mL Oral solution in drops Bottle (+ graduated dosing pipette) 60 ml

children

Oral route (oral solute for pediatric use).

The solute bottle is accompanied by a dosing pipette, graduated in twentieth milliliter (0.05 ml). 1 ml contains 0.05 mg or 50 micrograms (mcg) of digoxin.

The product should be administered directly into the mouth of the infant or child using the dosing pipette, not the bottle.

The treatment is started with an initial dose administered in one dose. It is followed 8 hours later by maintenance doses divided into 2 or 3 doses per 24 hours: one third of the initial dose is administered every 8 hours. The doses vary, not according to the apparent gravity of the condition to be treated but with the weight of the child.

Dosage of oral digoxin in children with normal renal function.

Weight of the child
(in kg)

Initial dose
(in mcg / kg and in ml / kg)

Maintenance dose in 2 or 3 doses per day
(in mcg / kg / day)

Less than 12

15 mcg (0.3 ml)

15

12 to 24

10 mcg (0.2 ml)

10

More than 24

7 mcg (≃ 0.1 ml)

7

In cases of renal insufficiency, which is often observed in left cardiopathies by reduction of renal arterial flow and can be roughly appreciated by the determination of serum creatinine or azotemia, the maintenance dose should be reduced. by applying a coefficient all the more severe as the renal failure is more serious.

creatinine
(in μmol / l)

azotemia
(in mmol / l)

Multiply the maintenance dose by

70 to 100

8 to 17

0.6

100 to 200

17.1 to 25

0.3

201 to 400

25.1 to 33

0.15

The determination of plasma digoxin is necessary to adjust the dosage, especially towards the end of the first week, in severe or difficult-to-treat forms and in the newborn (especially less than 72 hours, in which renal function n is not easy to appreciate). Digoxinemia must be measured when an overdose is to be feared (in case of renal insufficiency in particular) or when an increase in doses seems necessary (insufficient action of the usual doses).

Sampling (by micromethod) should be done at equilibrium, that is, at the end of the 1st week, and at least 8 hours after the last dose.

The recommended concentrations are between 2 and 3 ng / ml (ie 2.55 and 3.8 nmol / l) for infants under 2 years old and between 1 and 2 ng / ml (ie 1.3 and 2.55 mg / ml). nmol / l) for children over 2 years old. It is prudent not to exceed these values.

Against indications

This medicine should never be used in case of:

· Non-paired 2nd and 3rd degree atrioventricular blocks,

· Ventricular hyperexcitability (especially extrasystoles) occurring when the patient is still under the action of a digitalis (see section Special warnings and precautions for use ),

· Atrial tachycardias (flutter, tachysystole) and atrial fibrillation associated with Wolff-Parkinson-White syndrome,

· Ventricular tachycardia and fibrillation,

· Uncorrected hypokalemia,

· Combination with sultopride, calcium (salts of) IV, St. John's Wort (see section 4.5 ).

Undesirable effects Digoxin Nativelle

· Ventricular hyperexcitability (see Warnings and Precautions section ).
Digitalis should be stopped in case of hypersensitivity or overdose (see section 4.4 ).

· Digestive disorders (nausea, vomiting, diarrhea) are the first frequent and early symptoms of digitalis toxicity. They stop quickly when treatment is stopped.

· Disorders of the vision especially in the old subject, having to suspect an overdose.

· Psychiatric disorders (convulsions, delusions, hallucinations, psychosis) especially in the elderly subject, who should suspect an overdose.

· Exceptional gynecomastia.

· Exceptional allergic manifestations (cutaneous reactions).

· Thrombocytopenia, exceptional outside of an overdose.

· At the ECG, the aspect in cupule of the segment ST is usual and translates a digital impregnation and in no way an overdose.

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