Medicinal Products

DIGOXIN NATIVELLE Adult 0.5 mg / 2 mL

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

IV injectable solution
Box of 6 ampoules of 2 ml
All forms

Indication

· Heart failure.

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

Dosage DIGOXINE NATIVELLE Adult 0.5 mg / 2 mL IV Injection Solution Box of 6 x 2 ml ampoules

adults

Dose of attack : 1 to 2 ampoules a day.

Maintenance dose : ½ to 1 ampoule every day, 3 days a week.

The contents of the ampoules should be injected very slowly.

The dosage of plasma digoxin is necessary to adjust the dosage, especially towards the end of the first week, in severe forms or difficult treatment. The digoxinemia must be measured when an overdose is to be feared (in case of renal insufficiency in particular) or when an increase of the doses seems necessary (action insufficient 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 values ​​are between 0.80 and 1.5 ng / ml (ie 1.02 and 1.91 nmol / l).

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 ).

Adverse effects Digoxin Nativelle Adult

· 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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