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Digoxin 0.25 mg (50 tablets)




The instruction for use
of medicine for experts


the Trade name

The international unlicensed

name Digoxinum Lekarstvennaya a form
of the Tablet of 0.25 mg

One tablet contains
active agent – digoxin of 0.25 mg,
fillers: sucrose – 20.40 mg, potato starch – 15.30 mg,
binding substances: sucrose – 4.20 mg, glucose monohydrate – 8.50 mg,
the sliding substances: talc – 0.9 mg, calcium stearate – 0.25 mg,
surface-active agent: liquid paraffin – 0.20 mg.

of the Tablet of white color, ploskotsilindrichesky

Pharmacotherapeutic group
Cardiac glycosides. Foxglove glycosides.

The Pharmacological

Pharmacokinetics At properties reception orally digoxin is usually soaked up by automatic telephone exchange code of C01AA05 within 60-85% (generally from a small intestine). Food slows down drug absorption speed. Action comes within 2 hours and reaches a maximum in 6 hours. Therapeutic concentration in plasma is individual and makes 0.5-2 ng/ml. Digoxin contacts blood proteins within 20-30%, the free fraction gets into fabrics, first of all into a cardiac muscle. Concentration of digoxin in a cardiac muscle is more, than in plasma. As the most part of medicine is in fabrics, at a hemodialysis digoxin is badly dialyzed (3% within 5 hours). Digoxin is emitted with breast milk. Eliminative elimination half-life – 1.5-2 days. Digoxin is emitted through kidneys (by glomerular filtration and tubular secretion), generally in not changed look. Discharge depends on the speed of glomerular filtration.
The pharmacodynamics
Digoksin is the cardiac glycoside received from Digitalis lanata. The mechanism of action is based on inhibition of the Na-K-pump of a cell membrane. Therefore extracellular concentration of potassium ions and intracellular concentration of ions of sodium increases. With the participation of intracellular ions of sodium the maintenance of calcium ions in a cell increases therefore increases Atfaznaya activity of myosin. Medicine has positive inotropic and negative chronotropic effect.

– chronic heart failure
– supraventricular tachyarrhythmias (in particular an atrial fibrillation)

the Route of administration and doses
For opening of the blister packing slightly to press indications a tablet and to take it from a foil.
At intake the saturation dose at fast digitalization makes 0.5-1 mg then every 6 hours give 0.25 mg before achievement of desirable therapeutic effect. The highest daily dose makes 1.5 mg. If the patient does not need such fast digitalization, it is possible to accept 0.25 mg 1-2 times a day. Constant concentration in plasma is usually reached within 7 days. A usual maintenance dose – 0.125-0.25 mg a day. The patient of advanced age should apply small doses of drug, beginning treatment with slow digitalization.
In a renal failure the dose should be reduced according to the speed of glomerular filtration (GFR) (GFR of 20-50 ml/min. – 0.25 mg a day, GFR of 10-20 ml/min. – 0.125-0.25 mg a day, GFR
Patients of advanced age. Owing to the lowered function of kidneys and small body weight the patients of advanced age have to have applied doses less, than at people of middle age. At patients of advanced age it is necessary to control digoxin content in serum and to avoid a hypopotassemia.

Side effects
– symptoms of poisoning with digoxin are various disturbances of a warm rhythm and conductivity
– ventrikulyarny extrasystoles of type of bigeminals pulse or trigeminies
– quite often arterial tachycardia with atrioventricular block at which the pulse rate can be and small
– lengthening of an interval of PR and a depression of a segment of ST on the ECG that in the absence of other symptoms does not testify to poisoning with digoxin
– lack of appetite is also observed, nausea, vomiting and a diarrhea
– weakness, apathy, fatigue, a headache, disorders of vision, a depression and even psychosis
– after long-term treatment by digoxin was observed a gynecomastia
– a skin itching, an urtikariya and thrombocytopenia
– seldom intestines ischemia, intestines necrosis.

– ventrikulyarny tachycardia
– fibrillation of ventricles
– a hypertrophic subaortic stenosis (except for a case of heavy heart failure)
– a WPW-syndrome (especially at the accompanying fibrillation of auricles)
– periodic total atrioventricular block or atrioventricular block of the II degree
– hypersensitivity to digoxin or other cardiac glycosides
– at the disturbances of a warm rhythm caused by digital intoxication
– children’s age.

Medicinal interactions
Use of tiazid and loopback diuretics can cause reduction of content of potassium and magnesium and to promote developing of cardiac arrhythmia. The hypopotassemia can arise also at use of glucocorticosteroids, Amphotericinum. The hypercalcemia can increase toxicity of digoxin therefore it is necessary to avoid intravenous use of calcium during use of cardiac glycosides.
Use of quinidine, Amiodaronum and propafenon during treatment by digoxin increases concentration of digoxin in plasma. Simultaneous use of antiarrhytmic drugs increases the frequency of manifestation of side effects. Simultaneous use of b-adrenoblockers and digoxin can strengthen bradycardia. Verapamil increases concentration of digoxin in plasma, nifedipine can increase concentration of digoxin in plasma, but can not do it.
Erythromycin, tetracycline, Trimethoprimum, inhibitors of angiotensin-converting enzyme (captopril), blockers angiotensin – II receptors (for example, telmisartan), blockers of the proton pump (for example, omeprazolum) and also nonsteroid anti-inflammatory substances can increase digoxin content in plasma.
Owing to acceleration of the biotransformation caused by induction of enzymes of a liver, rifampicin reduces digoxin content in blood plasma.
Holestiramin, holestipol, Sulfasalazinum, sukralfat, Neomycinum, laxatives containing magnesium and antacids reduce digoxin absorption. Effect of digoxin weakens also Metoclopramidum.
At simultaneous use of digoxin together with verapamil and beta-blockers the possibility of atrioventricular block increases.

Special instructions
patients Should apply carefully digoxin with intense injury of a myocardium (myocarditis, a fresh heart attack), when deepening heart failure or a serious pulmonary illness. It is necessary to avoid big disposable dosed
it is Also necessary to be careful at atrioventricular block of varying severity and in a sick sinus syndrome if at the patient atrial fibrillation attacks are observed.
If within two last weeks the patient applied cardiac glycosides, it is recommended to reduce an initial dose of digoxin.
Treatment by digoxin is recommended to be stopped in 24-48 hours prior to carrying out planned cardioversion as the danger of emergence of life-threatening disturbances of a rhythm appears.
In renal failures and also at use of digoxin for patients of advanced age or premature children it is necessary to reduce doses and to watch concentration of digoxin in plasma.
Effect of digoxin can amplify at a hypopotassemia, a hypomagnesiemia, a hypercalcemia, a hypoxia and a hypothyroidism. In these cases it is necessary to reduce digoxin doses. In a hyperthyroidism there can be a relative resistance to digoxin.
At use of medical doses of digoxin on the ECG there can be a lengthening of an interval of PR and a depression of a segment of ST. Under the influence of digoxin at physical activity on the ECG there can be false positive changes of ST-T of a segment that is not symptoms of poisoning but only the taking place natural changes caused by the mechanism of effect of medicine.
Pregnancy and a lactation
Digoksin gets through a placental barrier. At use of digoxin in therapeutic doses at a fruit and the newborn of special side effects it is not revealed. Use of digoxin during pregnancy can be the cause of small weight of the child at the birth. The overdose of digoxin during pregnancy can lead to fruit death. During pregnancy the clearance of digoxin increases.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to drive transport and to work with technical devices.

Width of therapeutic effect of drug small. Reception of 10-15 mg of digoxin can cause death owing to overdose in 50% of adults. Symptoms of poisoning develop gradually and are described in the part concerning side effects. The greatest danger – disturbances of a warm rhythm which can cause death owing to ventricular fibrillation or the asystolia caused by blockade. If medicine is taken in very high dose accidentally or for the purpose of suicide, then it is possible to make gastric lavage directly after overdose. Activated carbon, connecting digoxin, interferes with its absorption from a digestive tract. Dialysis is not effective in life-threatening poisoning with digoxin.
The bradyarrhythmia accompanying poisoning it is possible to treat, applying atropine or connecting a temporary pacemaker. Ventrikulyarny arrhythmias are treated by lidocaine or Phenytoinum. In bradyarrhythmia and ventrikulyarny arrhythmia it is possible to apply antibodies, specific to digoxin, – fragments of F(ab) (Wellcome).

A form of release and packing
of the Tablet on 0.25 mg, 25 pieces in the blister packing, on 2 blister packs in a pack.

To Store storage conditions in the place protected from light at a temperature not above 25 °C.
To store out of children’s reach!

Not to use an expiration date of 5 years After the expiration date specified on packing!

Prescription status
According to the prescription

JSC Grindeks (Grindex) Producer, Krustpils 53 St., Riga, LV-1057 Latvia.

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