Strofantin-K solution 0.25 mg / ml 1 ml ampoule № 10

Author Ольга Кияница

2017-05-11

Amount in a package 10
Product form Ampoules
Manufacturer Galichpharm AOOT (Ukraine, Lviv)
Registration certificate UA/5059/01/01
The main medicament Strophantine
morion code 5149

Strophantine-K (Strophanthin K) instructions for use

Composition:

active ingredient: strophanthin K; 1 ml of the solution contains strophantine K 0.25 mg;
auxiliary substances: ethanol 96%, water for injection.

Dosage form

Injection.

Pharmacotherapeutic group

Cardiac glycosides. The code of automatic telephone exchange С01А С01.

Clinical characteristics

Indications

Acute cardiovascular failure, chronic heart failure of II B-III stage (supraventricular arrhythmias, fibrillation and atrial flutter).

Contraindications

Organic damage to the heart and vessels, acute myocarditis, endocarditis, severe cardiosclerosis, acute myocardial infarction, atrioventricular blockade of the 2nd and 3rd degree, severe bradycardia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, hypercalcemia, hypokalemia, carotid sinus syndrome, thoracic aortic aneurysm, weakness syndrome sinus node, WPW-syndrome, glycoside intoxication, pregnancy and the period of breastfeeding.

Dosing and Administration

Strofantin K is used intravenously (sometimes - intramuscularly). For intravenous administration, the drug is diluted in 10-20 ml of isotonic sodium chloride solution. Enter the drug slowly, for 5-6 minutes. In the first 2 days you can enter 2 times a day.

Solution Strofantina K can be administered and intravenously drip (in 100 ml of isotonic sodium chloride solution), since this form of administration less likely to develop a toxic effect. If Strophantine K can not be inserted into a vein, then it is prescribed intramuscularly. At the same time, the dose of the drug is increased 1.5 times.

The maximum dose of Strofantin K for adults is intravenous: single dose - 0.0005 g (0.5 mg), daily - 0.001 g (1 mg).

Daily doses, they are - the dose of saturation with the application of 0.25 mg / ml solution of Strophantine K: from birth to 2 years - 0.01 mg / kg / day (0.04 ml / kg); from 2 years - 0,007 mg / kg / day (0,03 ml / kg).

The maintenance dose is ½ to 1/3 of the saturation dose.

Adverse Reactions

From the gastrointestinal tract: decreased appetite, nausea, vomiting, diarrhea.

From the cardiovascular system: ventricular arrhythmias, bradycardia, atrioventricular block.

From the nervous system: headache, dizziness, sleep disturbance, fatigue, rarely - violation of color vision, depression, psychosis.

Others: allergic reactions, hives, thrombocytopenia, thrombocytopenic purpura, nosebleeds, petechiae, gynecomastia.

Overdose

Symptoms of an overdose are varied.

From the cardiovascular system: arrhythmias, including bradycardia, atrioventricular block, ventricular tachycardia or extrasystole, ventricular fibrillation.

From the gastrointestinal tract: anorexia, nausea, vomiting, diarrhea.

From the central nervous system and sensory organs: headache, increased fatigue, very rarely - confusion, syncope.

Treatment: withdrawal of the drug or reduction of subsequent doses and increasing the time intervals between drug administration, administration of antidotes (unitiol, EDTA), symptomatic therapy (antiarrhythmic drugs - lidocaine, phenytoin, amiodarone, potassium preparations, holinoblockers - atropine sulfate).

Use during pregnancy or lactation

The drug is contraindicated during pregnancy or lactation due to the lack of safety data.

Children

By strict indications apply from birth.

Application features

With caution should prescribe the drug for hypomagnesemia, hypernatremia, hypothyroidism, severe dilatation of the heart cavities, "pulmonary" heart, myocarditis, with obesity and in old age, because in these cases the risk of intoxication increases.

With rapid intravenous administration of the drug may develop bradyarrhythmia, ventricular tachycardia, atrioventricular blockade and cardiac arrest. At the maximum of the action may appear extrasystole, sometimes in the form of bigeminy.To prevent this effect, the dose can be divided into 2-3 intravenous injections, or the first dose should be administered intramuscularly. In the case of previous treatment with other cardiac glycosides, intravenous Strophantine K is given a break (otherwise the toxic effect of summation of the action of glycosides may occur). The duration of the break is from 5 to 24 days, depending on the manifestations of the cumulative properties of the previous drug.

Due to the pronounced cardiotropic effect of the drug and its rapidity, the maximum accuracy in dosages and indications for use is required.

The treatment is carried out under constant ECG control.

The ability to influence the reaction rate when driving or working with other machinery

During the application of Strophantine K, it is not recommended to engage in activities that require the speed of psychomotor reactions.

Interaction with other drugs and other interactions

When using Strofantin K along with barbiturates (phenobarbital, etaminal sodium, etc.), the cardiotonic effect of glycoside decreases. Simultaneous use of Strophantine K with sympathomimetics, methylxanthines, reserpine and tricyclic antidepressants increases the risk of arrhythmia. The concentration of Strophantin K in the blood plasma increases with the simultaneous administration of quinidine, amiodarone, captopril, calcium antagonists, erythromycin and tetracycline. Against the background of magnesium sulfate, the possibility of slowing the conduction and occurrence of atrioventricular blockade of the heart increases.

Saluretics, adrenocorticotropic hormones, glucocorticosteroids, insulin, calcium preparations, laxatives, carbenoxolone, amphotericin B, benzylpenicillin, salicylates increase the risk of developing glycosidic intoxication. Antiarrhythmic drugs, including beta-adrenoreceptor blockers, potentiate the negative chrono- and dromotropic action of the glycoside.Inducers of microsomal liver enzymes (phenytoin, rifampicin, phenobarbital, phenylbutazone, spironolactone), as well as neomycin and cytostatic agents reduce the concentration of Strophantine K in the blood plasma. Calcium preparations increase the sensitivity to cardiac glycosides.

Pharmacological properties

Pharmacodynamics. Strophantine K is a mixture of cardiac glycosides (K-strophanthin-β, K-staphantoside, etc.) from the seeds of the tropical liana Strophathus Kombe Oliver and refers to a group of so-called polar (hydrophilic) cardiac glycosides that are poorly soluble in lipids and poorly absorbed from the gastrointestinal tract. The mechanism of action is associated with blockade of Na + -K + -ATPase, an effect on Na + -Ca2 + metabolism, which improves myocardial contractility. The drug potentiates the force and speed of contractions of the heart, lengthens the diastole, improves the flow of blood to the ventricles of the heart, increases the shock volume, has little effect on the function
n. vagus.

Pharmacokinetics . The therapeutic effect is noted only 5-10 minutes after intravenous administration and reaches a maximum after 15-30 minutes. The half-life of Strophantine K from plasma is an average of 23 hours. There is practically no cumulative effect.

Pharmaceutical characteristics

Basic physical and chemical properties:

transparent colorless or yellowish liquid.

Incompatibility

Unknown.

Shelf life

3 years.

Storage conditions. Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Packaging

1 ml per ampoule, 10 ampoules per box;
For 1 ml in an ampoule, 10 ampoules in a contour squad package, 1 package per pack.

Category of leave

On prescription.


0.00 avg. rating (0% score) - 0 votes - votes