Medicinal Products

DIGOXINE NATIVELLE 0.25 mg

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

Compressed
Box of 30
All forms

Indication

· Heart failure.

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

Dosage DIGOXINE NATIVELLE 0.25 mg Tablet Box of 30

Oral way.

The tablets are swallowed with a little water.

Maintenance dose in adults:

0.25 mg per day,

1 tablet of DIGOXIN NATIVELLE 0.25 mg per day.

Elderly:

Due to a physiological decline in renal function and increased sensitivity to digoxin, the dosage should generally be reduced to 0.125 mg per day, ie 1 tablet of HEMIGOXINE NATIVELLE 0.125 mg per day.

Renal insufficiency:

Due to renal clearance of digoxin, the dosage should be reduced depending on the degree of renal impairment assessed by the creatinine clearance measured from the Cockroft formula. As an indication, the recommended maintenance dose in patients with severe renal impairment (Clcreat less than 30ml / min) is 0.125 mg every other day, ie 1 tablet of HEMIGOXINE NATIVELLE 0.125 mg every other day.

In the elderly and renally impaired patients, a dosage of plasma digoxin is necessary to adjust the dose, particularly towards the end of the first week, and if signs suggestive of overdose (anorexia, nausea, vomiting, diarrhea), underdose (no control of heart failure) or electrical abnormalities require it.

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 0.5 and 1.2 ng / ml. The mean digoxinemia of patients in the DIG study was 0.80 ng / ml (ie 1.02 nmol / l) after 12 months (see section 5.1 ).

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.

· Impaired vision especially in the elderly, 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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