Korglikard solution for injection 0.6mg / ml, No. 10

As part of the complex therapy of chronic heart failure II-IV functional class (in the presence of clinical manifestations), the tachysystolic form of atrial fibrillation and atrial flutter of paroxysmal and chronic course (especially in combination with chronic heart failure).

Injected intravenously slowly over 5-6 minutes (in 10-20 ml of 20% or 40% dextrose solution) 1-2 times a day. Adults are injected in a single dose of 0.5-1 ml, children aged 2 to 5 years - 0.2-0.5 ml each, from 6 to 12 years old - 0.5-0.75 ml each. When administered 2 times a day, the interval between injections is 8-10 hours.
Higher doses for adults in a vein: single - 1.0 ml, daily - 2.0 ml.

Active substance : korglikon - 0.60 mg

Excipients : chlorobutanol hydrate, water for injection.

• Glycosidic intoxication,

• hypersensitivity to the drug,

• atrioventricular block (AV) II degree,

• Wolff-Parkinson-White syndrome,

• intermittent complete blockade,

• pregnancy and lactation.

Carefully(comparing benefit / risk): grade I atrioventricular block, sick sinus syndrome without a pacemaker, the likelihood of unstable conduction through the atrioventricular node, a history of Morgagni-Adams-Stokes attacks, hypertrophic subaortic stenosis, isolated mitral stenosis with a rare heart rate , cardiac asthma in patients with mitral stenosis (in the absence of a tachysystolic form of atrial fibrillation), acute myocardial infarction, unstable angina pectoris, arteriovenous shunt, hypoxia, heart failure with impaired diastolic function (restrictive cardiomyopathy, cardiac amyloidosis, cardiac constrictive peri-rasaca) , pronounced dilatation of the cavities of the heart, pulmonary heart, electrolyte disturbances: hypokalemia, hypomagnesemia, hypercalcemia,hyponatremia; hypothyroidism, alkalosis, myocarditis, old age, renal-hepatic failure, obesity.

Trade name of the drug : Korglikard

International Non-Proprietary Name (INN) : lily of the valley glycoside

Dosage form : solution for intravenous administration

Composition : 1 ml of solution contains
Active ingredient : korglikon - 0.60 mg
Excipients : chlorobutanol hydrate, water for injection.

Description : transparent liquid, slightly yellowish.

Pharmacotherapeutic group : cardiotonic agent - cardiac glycoside.
ATX code —01ј’

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Purified preparation from the leaves of lily of the valley and its varieties. Cardiac glycoside, has a positive inotropic effect. This is due to the direct inhibitory effect of Na + / K + ATP-ase on the membranes of cardiomyocytes, which leads to an increase in the intracellular content of sodium ions and, accordingly, a decrease in potassium ions. An increased content of sodium ions causes the activation of sodium / calcium metabolism, an increase in the content of calcium ions, as a result of which the force of myocardial contraction increases.
As a result of an increase in myocardial contractility, the stroke volume of blood increases, the end systolic and end diastolic volumes of the heart decrease, which, along with an increase in myocardial tone, leads to a decrease in its size and, thus, to a decrease in myocardial oxygen demand.
It has a negative chronotropic effect, reduces excessive sympathetic activity by increasing the sensitivity of cardiopulmonary baroreceptors. Due to an increase in the activity of the vagus nerve, it has an antiarrhythmic effect due to a decrease in the speed of impulses through the atrioventricular node and a lengthening of the effective refractory period. This effect is enhanced by direct action on the atrioventricular node and sympatholytic action.
The negative dromotropic effect is manifested in an increase in the refractoriness of the atrioventricular (AV) node.
With atrial fibrillation, cardiac glycosides slow down ventricular contractions, lengthen diastole, and improve intracardiac and systemic hemodynamics. The positive batmotropic effect is manifested in subtoxic and toxic doses. It has a direct vasoconstrictor effect, which is most clearly manifested in the absence of congestive peripheral edema. At the same time, the indirect vasodilating effect (in response to an increase in the minute blood volume and a decrease in excessive sympathetic stimulation of vascular tone), as a rule, prevails over the direct vasoconstrictor effect, as a result of which the total peripheral vascular resistance (OPSR) decreases.
When administered intravenously, the action begins in 3-5 minutes and reaches a maximum in 25-30 minutes.

Pharmacokinetics :
Distribution : the binding to blood plasma proteins is negligible.
Excretion : practically does not undergo biotransformation in the liver and is excreted unchanged in the urine.

INDICATIONS FOR USE
As part of the complex therapy of chronic heart failure of the II-IV functional class (in the presence of clinical manifestations), the tachysystolic form of atrial fibrillation and atrial flutter of paroxysmal and chronic course (especially in combination with chronic heart failure).

CONTRAINDICATIONS

• Glycosidic intoxication,

• hypersensitivity to the drug,

• atrioventricular block (AV) II degree,

• Wolff-Parkinson-White syndrome,

• intermittent complete blockade,

• pregnancy and lactation.

Carefully(comparing benefit / risk): grade I atrioventricular block, sick sinus syndrome without a pacemaker, the likelihood of unstable conduction through the atrioventricular node, a history of Morgagni-Adams-Stokes attacks, hypertrophic subaortic stenosis, isolated mitral stenosis with a rare heart rate , cardiac asthma in patients with mitral stenosis (in the absence of a tachysystolic form of atrial fibrillation), acute myocardial infarction, unstable angina pectoris, arteriovenous shunt, hypoxia, heart failure with impaired diastolic function (restrictive cardiomyopathy, cardiac amyloidosis, cardiac constrictive peri-rasaca) , pronounced dilatation of the cavities of the heart, pulmonary heart, electrolyte disturbances: hypokalemia, hypomagnesemia, hypercalcemia,hyponatremia; hypothyroidism, alkalosis, myocarditis, old age, renal-hepatic failure, obesity.

METHOD OF APPLICATION AND DOSES
Introduce slowly intravenously over 5-6 minutes (in 10-20 ml of 20% or 40% dextrose solution) 1-2 times a day. Adults are injected in a single dose of 0.5-1 ml, children aged 2 to 5 years - 0.2-0.5 ml each, from 6 to 12 years old - 0.5-0.75 ml each. When administered 2 times a day, the interval between injections is 8-10 hours.
Higher doses for adults in a vein: single - 1.0 ml, daily - 2.0 ml.

SIDE EFFECTS
Side effects of Korglikard are associated with increased sensitivity of the patient to cardiac glycosides or overdose. From the side of the cardiovascular system: arrhythmia, AV block.
From the side of the central nervous system and sensory organs : drowsiness, confusion, sleep disturbances, headache, dizziness, delirious psychosis, decreased visual acuity.
From the side of hematopoiesis : thrombocytopenia, thrombocytopenic purpura, nosebleeds.
From the digestive system : anorexia.
Others : allergic reactions.

OVERDOSE
From the side of the cardiovascular system : paroxysmal ventricular tachycardia, ventricular premature beats (often bigeminia, polytopic ventricular premature beats), nodal tachycardia, atrial fibrillation and flutter, AV block.
From the digestive tract : anorexia, vomiting, diarrhea, abdominal pain, intestinal necrosis.
From the nervous system and sensory organs : neuritis, manic-depressive syndrome, staining of visible objects in a yellow-green color, flickering of 'flies' in front of the eyes, decreased visual acuity, perception of objects in a reduced or enlarged form.
Treatment:
abolition of cardiac glycosides, administration of antidotes (unitiol, ethylenediaminetetraacetic acid), symptomatic therapy. As antiarrhythmic drugs - class I drugs (lidocaine, phenytoin). In case of hypokalemia - intravenous administration of potassium chloride (6-8 g / day at the rate of 1-1.5 g per 0.5 L of isotonic dextrose solution and 6-8 U of insulin; injected drip, for 3 hours). With severe bradycardia, AV blockade - M-anticholinergics. It is dangerous to administer beta-adrenostimulants, due to the possible potentiation of the arrhythmogenic action of cardiac glycosides. With a complete transverse blockade with attacks of Morgagni-Adams-Stokes, temporary pacing.

INTERACTION WITH OTHER MEDICINAL PRODUCTS
Adrenomimetic drugs . The combined use of ephedrine hydrochloride, epinephrine hydrochloride or norepinephrine hydrotartrate, as well as selective beta-adrenergic agonists with cardiac glycosides can contribute to the occurrence of cardiac arrhythmias.
Aminazine and other phenothiazine derivatives . The action of cardiac glycosides is reduced.
Anticholinesterase drugs . With the simultaneous use of anticholinesterase drugs with cardiac glycosides, bradycardia increases. If necessary, it can be eliminated or weakened by the introduction of atropine sulfate.
Glucocorticosteroids... If hypokalemia occurs as a result of prolonged treatment with glucocorticosteroids, an increase in the undesirable effect of cardiac glycosides is possible.
Diuretics . When combining diuretics (cause hypokalemia and hypomagnesemia, but increase the concentration of calcium ions in the blood) with cardiac glycosides, the effect of the latter is enhanced. With their simultaneous use, you must adhere to the optimal dosage. You can periodically prescribe potassium-sparing diuretics (spironolactone, triamterene), which eliminate hypokalemia. However, this can lead to hyponatremia.
Potassium preparations . Under the influence of potassium preparations, the undesirable effects of cardiac glycosides are reduced.
Calcium preparations... When treating with cardiac glycosides, parenteral use of calcium preparations is dangerous, since the cardiotoxic effects (cardiac arrhythmias, etc.) are enhanced.
Acids ethylenediaminetetraacetic disodium salt . There is a decrease in the effectiveness and toxicity of cardiac glycosides.
Corticotropin preparations . The action of cardiac glycosides under the influence of corticotropin may be enhanced.
Xanthine derivatives . Caffeine or theophylline preparations sometimes contribute to cardiac arrhythmias.
Sodium adenosine triphosphate . Sodium adenosine triphosphate should not be administered concurrently with cardiac glycosides.
Ergocalciferol... With hypervitaminosis caused by ergocalciferol, it is possible to enhance the action of cardiac glycosides, due to the development of hypercalcemia.
Narcotic analgesics . The combination of fentanyl and cardiac glycosides may cause hypotension.
Naproxen . In healthy people, the combined use of cardiac glycosides with naproxen does not affect the results of psychological testing.
Paracetamol . The clinical significance of this interaction has not been sufficiently studied, but there is evidence of a decrease in the excretion of cardiac glycosides by the kidneys under the influence of paracetamol.

SPECIAL INSTRUCTIONS
The likelihood of intoxication increases with hypokalemia, hypomagnesemia, hypercalcemia, hypernatremia, hypothyroidism, severe dilatation of the heart cavities, cor pulmonale, myocarditis, obesity, old age. With severe mitral stenosis and normo- or bradycardia, heart failure develops due to a decrease in diastolic filling of the left ventricle. Strofantin, increasing the contractility of the right ventricular myocardium, causes a further increase in pressure in the pulmonary artery system, which can provoke pulmonary edema or aggravate left ventricular failure. Patients with mitral stenosis are prescribed cardiac glycosides with the addition of right ventricular failure, or in the presence of atrial fibrillation. Korglikon in WPW syndrome, reducing AV conduction,promotes the conduction of impulses through accessory pathways - bypassing the AV node, provoking the development of paroxysmal tachycardia. As one of the methods to control the level of digitalization when prescribing cardiac glycosides, monitoring of their plasma concentration is used.

FORM OF RELEASE
Solution for intravenous administration of 0.60 mg / ml in ampoules.
10 ampoules, together with instructions for use and an ampoule scarifier, are placed in a carton box.

SHELF LIFE
3 years.
Do not use after the date indicated on the package.

STORAGE CONDITIONS
List B. In a place protected from light and out of reach of children, at a temperature not exceeding 25 ? C.

TERMS OF RELEASE FROM PHARMACIES
By prescription.

MANUFACTURING ENTERPRISE
LLC 'Experimental Plant' GNTSLS '.
Address : Ukraine, 61057, Kharkov, st. Vorobyov, 8