Tablets: white or almost white color, a ploskotsilindrichesky form, with an engraving of "D" on one party and a facet (on 10 pieces in blister strip packagings, in a cardboard pack of 1, 2, 3, 5 or 10 packagings; on 50 pieces in polymeric or glass (dark color) banks, in a cardboard pack of 1 bank; on 50 pieces in blister strip packagings, in a cardboard pack 1 or 2 packagings; on 50 pieces in polypropylene bottles, in a cardboard pack 1 bottle; on 50 pieces in polypropylene cases, in a cardboard pack 1 case; on 25 pieces in blister strip packagings, in a cardboard pack 1, 2, or 4 packagings);
Solution for intravenous (in/in) introductions (on 1 ml in ampoules: in a cardboard pack of 10 ampoules; on 5 pieces in blister strip packagings, in a cardboard pack 2 packagings).

Active agent – digoxin:

1 tablet – 0,25 mg or 0,1 mg (Digoksin children's);
1 ml of solution – 0,25 mg.

Auxiliary components as a part of tablets: lactose, sucrose, potato starch, calcium stearate, dextrose, talc.

Indications to use

Tablets

Chronic heart failure of II (at clinical manifestations) and the III-IV functional class on NYHA classification – as a part of complex therapy;
Blinking and atrial flutter of a chronic and paroxysmal current in a takhisistolichesky form, especially at the accompanying chronic heart failure.

Solution for in/in introductions

Chronic heart failure at an atherosclerotic cardiosclerosis, dekompensirovanny valve heart diseases, a myocardium overload at arterial hypertension, especially at a constant form of an atrial flutter or a takhisistolichesky ciliary arrhythmia;
Paroxysmal supraventricular arrhythmias (atrial flutter, ciliary arrhythmia, supraventricular tachycardia).

Contraindications

Glikozidny intoxication;
WPW-syndrome;
Atrioventricular (AV) blockade of the II degree;
The alternating total block;
Breastfeeding period;
Hypersensitivity to drug.

With care, comparing advantage of therapy and possible risk, it is necessary to appoint Digoxin at AV blockade of the I degree, an acute myocardial infarction, premature ventricular contraction, unstable stenocardia, a cardiac tamponade, the isolated mitral stenosis with the rare heart rate (HR), a renal and/or liver failure; to patients of advanced age.

Besides, contraindications to use of tablets:

Age up to 3 years;
Syndrome of glyukozo-galaktozny malabsorption, deficit of lactase, lactose intolerance.

With care patients with a sick sinus syndrome without pacemaker, risk of unstable carrying out on an AV node, heart failure with pathology of diastolic function (a restrictive cardiomyopathy, chronic cardial compression, a heart amyloidosis), the instruction on Morganyi-Adams-Stokes's attacks in the anamnesis, a hypertrophic subaortic stenosis, cardiac asthma against the background of a mitral stenosis (in the absence of a takhisistolichesky form of a ciliary arrhythmia), the arteriovenous shunt, the hypoxia expressed by dilatation of cardial cavities, a pulmonary heart take a pill; at an alkalosis, a hypothyroidism, myocarditis, obesity, and also a hypopotassemia, a hypomagnesiemia, a hypercalcemia, a hypernatremia.

Solution should be applied with care at the expressed bradycardia, ventricular tachycardia, a hypertrophic subaortal stenosis.

Use of Digoxin during pregnancy is appointed according to vital indications if the clinical effect for mother exceeds potential harm for a fruit.

Route of administration and dosage

Tablets

Pill is taken inside.

The dose is selected individually, being careful. For patients who before purpose of digoxin accepted cardiac glycosides the dose should be lowered.

The recommended dosing for patients is more senior than 10 years:

Moderately bystry digitalization at the emergency therapy: a daily dose – 0,75-1,25 mg with frequency rate of reception 2 times a day (under control of an electrocardiography (ECG) before use of each subsequent dose). After achievement of saturation (24-36 hours) of the patient transfer to a maintenance therapy;
Slow digitalization: 0,125-0,5 mg of 1 times a day within 5-7 days, after achievement of saturation pass to the supporting treatment;
Maintenance therapy: the dose is established individually, usually – from 0,125 to 0,75 mg; the period of use the doctor, as a rule, appoints prolonged treatment.

For patients with chronic heart failure the daily dose should not exceed 0,25 mg, at body weight more than 85 kg – no more than 0,375 mg.

To patients of advanced age drug appoint 0,0625-0,125 mg in a dose.

At treatment of children of 3-10 years the sating dose is appointed taking into account the child's weight on 0,05-0,08 mg to 1 kg a day: at moderately bystry digitalization – within 3-5 days, a slow digitalization – 6-7 days, a maintenance dose – 0,01-0,025 mg on 1 kg a day.

Solution for in/in introductions

Solution is entered in/in kapelno or struyno.

The doctor appoints dosing individually, on the basis of clinical indications.

The recommended dosing:

Moderately bystry digitalization – intravenously on 0,25 mg 3 times a day (then the patient is transferred to a maintenance therapy – in/in 0,125-0,25 mg of 1 times a day);
Slow digitalization: to 0,5 mg a day (in 1-2 receptions);
Paroxysmal supraventricular arrhythmia: a daily dose – 0,25-1 mg (in/in kapelno or struyno).

The sating dose for children – 0,05-0,08 mg on 1 kg of weight a day, at moderately bystry digitalization enter it 3-5 days, at a slow digitalization – 6-7 days. A maintenance dose for children – 0,01-0,025 mg on 1 kg of weight of the child a day.

Side effects

Side effects against the background of use of tablets often arise because of overdose and are symptoms of digitalis intoxication:

Cardiovascular system: ventricular premature ventricular contraction; often – polytopic ventricular premature ventricular contraction, a bigeminal pulse, a ventricular Bouveret's disease, a sinus bradycardia, nodal tachycardia, sinoaurikulyarny (SA) blockade, AV blockade, trembling and atrial fibrillation, decrease in a segment of ST on an ECG with formation of a two-phase tooth of T;
Nervous system: headache, sleep disorders, dizziness, radiculitis, neuritis, paresthesias, maniac-depressive syndrome, syncope; seldom – a disorientation, confusion of consciousness, one-color visual hallucinations (it is preferential at atherosclerosis at advanced age);
Alimentary system: abdominal pains, nausea, vomiting, anorexia, diarrhea, intestines necrosis;
Sense bodys: decrease in visual acuity, coloring in flavovirent color of visible objects, micro and a macropsia, flashing of "front sights" before eyes;
System of a hemostasis and bodies of a hemopoiesis: nasal bleedings, Werlhof's disease, petechias;
Allergic reactions: skin rash; seldom – a small tortoiseshell;
Others: gynecomastia, hypopotassemia.

Solution for in/in introductions

Cardiovascular system: AV blockade, bradycardia, disturbances of a cordial rhythm; isolated cases – thrombosis of mezenterialny vessels;
Nervous system: feeling of fatigue, headache, dizziness; seldom – decrease in visual acuity, a xanthopsia, flashing of "front sights" before eyes, macro - and a micropsia, scotomas; isolated cases – sleep disorders, a depression, a syncopal condition, confusion of consciousness, euphoria, a delirious state;
Alimentary system: nausea, vomiting, anorexia, diarrhea;
Endocrine system: a gynecomastia (at prolonged use).

Special instructions

Digoxin should be applied under observation of the doctor, with regular carrying out an ECG, determination of level of content of electrolytes in blood serum.

Co-administration of drugs of a foxglove with parenteral administration of means of calcium is contraindicated.

At a chronic pulmonary heart, coronary insufficiency, disturbance of water and electrolytic balance, a renal or liver failure it is necessary to lower a dose, especially to patients of advanced age.

Patients with the broken secretory function of kidneys need to lower a dose of Digoxin: at the clearance of creatinine (CC) of 50-80 ml/min. – for 50% of a usual dose, KK is less than 10 ml/min. – for 75%.

With care it is necessary to make selection of a dose by the elderly patient as at this category of patients even at functional disorder of kidneys of KK can be within norm (at selection of a dose it is necessary to consider the level of concentration of digoxin in blood serum).

At the expressed renal failure (KK is less than 15 ml/min.) control of content of digoxin in blood serum it is necessary to carry out 1 time in 2 weeks.

At an idiopathic subaortal stenosis use of Digoxin causes increase of expressiveness of obstruction.

At a mitral stenosis cardiac glycosides are appointed at the accompanying right ventricular insufficiency or existence of a ciliary tachyarrhythmia.

With care blockade of the I degree should appoint at AV (treatment has to be followed by regular control of an ECG, if necessary – pharmacological prevention by the improving AV conductivity means).

The risk of glikozidny intoxication increases at a hypomagnesiemia, a hypopotassemia, a hypercalcemia, a hypothyroidism, the hypernatremia, a pulmonary heart expressed to dilatation of cardial cavities, myocarditis; at patients of advanced age. Therefore at purpose of digoxin the digitalization is controlled, using monitoring of its plasma concentration.

The patient has to be informed on obligatory implementation of the following recommendations:

Not to change a dose independently;
To accept drug every day in at one time;
To see immediately a doctor at ChSS it is less than 60 beats per minute;
At the admission of a dose to accept it at once as soon as remembered.

If the patient missed reception drug within more than 2 days or wishes to stop therapy it is necessary to report about it to the attending physician.

It is necessary to see a doctor at emergence of the speeded-up pulse, nausea, vomitings, a diarrhea.

At planned surgery or rendering acute management of the patient has to warn the doctor about Digoxin reception.

Patients with contact lenses during treatment should exclude their use.

Simultaneous use of other means without the permission of the doctor is undesirable.

Content of sucrose, lactose, potato starch, glucose in 1 tablet corresponds to 0,006 grain units.

It is necessary to be careful at control of vehicles and mechanisms.

Medicinal interaction

The risk of development of toxic effect of Digoxin increases at simultaneous use with calcium drugs, diuretics, insulin, glucocorticosteroids, B Amphotericinum, beta-adrenergic agonists and other means causing disturbances of electrolytic balance in this connection the drug dose at appointment should lower and be not to allowed in/in administrations of salts of calcium.

At a combination to Triamterenum, Spironolactonum, quinidine, Amiodaronum, blockers of slow calcium channels, especially verapamil, the content of digoxin in blood serum increases.

At simultaneous use of Digoxin:

Colestyraminum, колестипол, Neomycinum, tetracycline, purgatives, Sulfasalazinum, Neomycinum, phenylbutazone, the antacids (containing salts of aluminum, magnesium), a kaolin, pectin and other adsorbents – reduce its absorption in intestines, concentration in blood and medical action;
Absorbent carbon, drugs of the St. John's Wort which is made a hole a kaolin, astringents, Sulfasalazinum, Metoclopramidum, прозерин – reduce bioavailability of drug;
Erythromycin, antibiotics with a broad spectrum of activity – increase bioavailability of Digoxin;
Barbiturates, Phenytoinum, phenylbutazone, rifampicin, oral contraceptives, antiepileptic means (inductors of a microsomal oxidation) can exponentiate digoxin metabolism;
Sodium phosphate, glyuko-and mineralokortikosteroida, karboangidraza inhibitors, B Amphotericinum, adrenocorticotropic hormone (AKTG), Acidum etacrynicum, буметанид, furosemide, Mannitolum, индапамид, derivatives of a tiazid – can reduce therapeutic effect and promote development of side effects of drug;
Edrofoniya chloride – raising a tone of a parasympathetic nervous system, can lead to the expressed bradycardia;
Quinine, quinidine – lead to sharp increase in concentration of digoxin;
Indometacin, Spironolactonum, captopril, blockers of slow calcium channels – slow down digoxin removal, increasing risk of toxic influence of drug;
Hormones of a thyroid gland – strengthen a metabolism in an organism (obligatory increase in a dose of digoxin is required);
Heparin – decreases its anticoagulating action;
Antiarrhytmic means, pankuroniya bromide, calcium salts, Rauwolfia alkaloids, sympathomimetics, succinylcholine iodide – can cause disturbance of a cordial rhythm;
Amiodaronum – increases to toxic level the content of digoxin in a blood plasma (cancellation or a dose decline of digoxin is shown twice).

Apply sulfate magnesium solution to decrease in toxic influence of cardiac glycosides.

Digoxin distorts the researches of perfusion of a myocardium given when carrying out using thallium of chloride (201 TI), reducing extent of its accumulation in points of damage of a cardiac muscle.