Corglycard (Solution) Instructions for Use

Marketing Authorization Holder

Experimental Plant SRLS, LLC (Ukraine)

ATC Code

C01AX (Other cardiac glycosides)

Dosage Form

Corglycard

Solution for intravenous administration 600 mcg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

1 ml – ampoules (10) – cardboard packs.
1 ml – ampoules (10) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Cardiac glycoside

Pharmacotherapeutic Group

Cardiotonic agent – cardiac glycoside

Pharmacological Action

A purified preparation from the leaves of Convallaria majalis and its varieties. It is a cardiac glycoside that exerts a positive inotropic effect.

This is due to a direct inhibitory action on Na+/K+ ATPase on cardiomyocyte membranes, leading to an increase in intracellular sodium ion content and, accordingly, a decrease in potassium ions.

The increased sodium ion content causes activation of the sodium/calcium exchange, increasing calcium ion content, which results in increased myocardial contractile force.

As a result of increased myocardial contractility, the stroke volume of blood increases, and the end-systolic and end-diastolic volumes of the heart decrease, which, along with increased myocardial tone, leads to a reduction in its size and thus a decrease in myocardial oxygen demand.

It exerts a negative chronotropic effect, reducing excessive sympathetic activity by increasing the sensitivity of cardiopulmonary baroreceptors.

Due to increased vagus nerve activity, it has an antiarrhythmic effect caused by a decrease in the impulse conduction velocity through the atrioventricular node and prolongation of the effective refractory period. This effect is enhanced by a direct action on the atrioventricular node and a sympatholytic action.

The negative dromotropic effect is manifested in increased refractoriness of the atrioventricular (AV) node.

In tachyarrhythmic atrial fibrillation, cardiac glycosides contribute to slowing ventricular contractions, prolong diastole, and improve intracardiac and systemic hemodynamics. A positive bathmotropic effect is manifested in subtoxic and toxic doses.

It exerts a direct vasoconstrictor effect, which is most clearly manifested in the absence of congestive peripheral edema.

At the same time, the indirect vasodilatory effect (in response to increased minute volume of blood and reduced excessive sympathetic stimulation of vascular tone) generally prevails over the direct vasoconstrictor action, resulting in a decrease in total peripheral vascular resistance (TPVR).

When administered intravenously, the action begins within 3-5 minutes and reaches its maximum within 25-30 minutes.

Pharmacokinetics

Distribution binding to plasma proteins is insignificant.

Excretion it is practically not biotransformed in the liver and is excreted unchanged in the urine.

Indications

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

ICD codes

Dosage Regimen

It is administered intravenously slowly over 5-6 minutes (in 10-20 ml of 20% or 40% dextrose solution) 1-2 times a day. Adults are administered a single dose of 0.5-1 ml, children aged 2 to 5 years – 0.2-0.5 ml, 6 to 12 years – 0.5-0.75 ml. When administered twice a day, the interval between injections is 8-10 hours.

Maximum doses for adults intravenously: single – 1.0 ml, daily – 2.0 ml.

Adverse Reactions

Side effects of Corglycard are associated with increased patient sensitivity to cardiac glycosides or overdose.

From the cardiovascular system arrhythmia, AV block.

From the central nervous system and sensory organs drowsiness, confusion, sleep disorders, headache, dizziness, delirious psychosis, decreased visual acuity.

From the hematopoietic system thrombocytopenia, thrombocytopenic purpura, nosebleeds.

From the digestive system anorexia.

Other allergic reactions.

Contraindications

• Glycoside intoxication;
• Hypersensitivity to the drug;
• Second-degree atrioventricular block;
• Wolff-Parkinson-White syndrome;
• Intermittent complete block;
• Pregnancy and lactation period.

With caution (weighing benefit/risk) first-degree atrioventricular block, sick sinus syndrome without a pacemaker, likelihood of unstable conduction through the atrioventricular node, history of Morgagni-Adams-Stokes attacks, hypertrophic subaortic stenosis, isolated mitral stenosis with low heart rate, cardiac asthma in patients with mitral stenosis (in the absence of tachysystolic form of atrial fibrillation), acute myocardial infarction, unstable angina, arteriovenous shunt, hypoxia, heart failure with impaired diastolic function (restrictive cardiomyopathy, cardiac amyloidosis, constrictive pericarditis, cardiac tamponade), extrasystole, severe dilation of the heart chambers, cor pulmonale, electrolyte disturbances: hypokalemia, hypomagnesemia, hypercalcemia, hyponatremia; hypothyroidism, alkalosis, myocarditis, old age, renal-hepatic insufficiency, obesity.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency.

Pediatric Use

Use is possible according to the dosing regimen.

Geriatric Use

Use with caution in the elderly.

Special Precautions

The likelihood of intoxication increases with hypokalemia, hypomagnesemia, hypercalcemia, hypernatremia, hypothyroidism, severe dilation of the heart chambers, cor pulmonale, myocarditis, obesity, and old age.

In pronounced mitral stenosis with normo- or bradycardia, heart failure develops due to reduced diastolic filling of the left ventricle. Strophanthin, by 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 worsen left ventricular failure.

In patients with mitral stenosis, cardiac glycosides are prescribed when right ventricular failure is associated, or in the presence of tachyarrhythmic atrial fibrillation.

Corglycon, in WPW syndrome, by reducing AV conduction, promotes impulse conduction through accessory pathways – bypassing the AV node, provoking the development of paroxysmal tachycardia.

As one of the methods for monitoring the level of digitalization when prescribing cardiac glycosides, monitoring of their plasma concentration is used.

Overdose

From the cardiovascular system ventricular paroxysmal tachycardia, ventricular extrasystole (often bigeminy, polytopic ventricular extrasystole), 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, coloring of visible objects in yellow-green, flickering of “flies” before the eyes, decreased visual acuity, perception of objects in reduced or enlarged form.

Treatment: discontinuation of cardiac glycosides, administration of antidotes (unithiol, ethylenediaminetetraacetic acid), symptomatic therapy. As antiarrhythmic agents – class I drugs (lidocaine, phenytoin). For hypokalemia – intravenous administration of potassium chloride (6-8 g/day based on 1-1.5 g per 0.5 l of isotonic dextrose solution and 6-8 units of insulin; administered by drip over 3 hours). For severe bradycardia, AV block – m-cholinoblockers. It is dangerous to administer beta-adrenergic stimulants due to the possible potentiation of the arrhythmogenic effect of cardiac glycosides. For complete transverse block with Morgagni-Adams-Stokes attacks – temporary electrocardiostimulation.

Drug Interactions

Adrenomimetic agents

Concomitant use of ephedrine hydrochloride, epinephrine hydrochloride or norepinephrine bitartrate, as well as selective beta-adrenomimetic agents with cardiac glycosides may contribute to the occurrence of cardiac arrhythmia.

Aminazine and other phenothiazine derivatives

The effect of cardiac glycosides is reduced.

Anticholinesterase drugs

When anticholinesterase drugs are used simultaneously with cardiac glycosides, bradycardia intensifies. If necessary, it can be eliminated or weakened by the administration of atropine sulfate.

Glucocorticosteroids

With the occurrence of hypokalemia as a result of prolonged treatment with glucocorticosteroids, an increase in the undesirable effects of cardiac glycosides is possible.

Diuretic agents

When combining diuretic agents (which cause hypokalemia and hypomagnesemia, but increase the concentration of calcium ions in the blood) with cardiac glycosides, the effect of the latter is enhanced. When using them simultaneously, optimal dosing must be adhered to. Potassium-sparing diuretics (spironolactone, triamterene) can be periodically prescribed, which eliminate hypokalemia. However, hyponatremia may develop in this case.

Potassium preparations

Under the influence of potassium preparations, the undesirable effects of cardiac glycosides are reduced.

Calcium preparations

During treatment with cardiac glycosides, parenteral use of calcium preparations is dangerous, since cardiotoxic effects (cardiac arrhythmias, etc.) are enhanced.

Edetate disodium

A decrease in the effectiveness and toxicity of cardiac glycosides is observed.

Corticotropin preparations

The action of cardiac glycosides may be enhanced under the influence of corticotropin.

Xanthine derivatives

Caffeine or theophylline preparations sometimes contribute to the occurrence of cardiac arrhythmia.

Sodium adenosine triphosphate

Sodium adenosine triphosphate should not be prescribed simultaneously with cardiac glycosides.

Ergocalciferol

With hypervitaminosis caused by ergocalciferol, an enhancement of the action of cardiac glycosides is possible, 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 renal excretion of cardiac glycosides under the influence of paracetamol.

Storage Conditions

List B. In a place protected from light and inaccessible to children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.