Vicasol, 10 mg/ml 1 ml 10 pcs

Pharmacotherapeutic group: vitamin K analogue synthetic

ATX code: B02BA02

Pharmacological properties:

Pharmacodynamics

The water-soluble analogue of vitamin K (vitamin K3), promotes the synthesis of prothrombin and proconvertin, increases blood clotting by enhancing the synthesis of II, VII, IX, X clotting factors. It has a hemostatic effect (with a deficit of vitamin K occurs increased bleeding).

In the blood prothrombin (factor II) in the presence of thromboplastin and calcium ions, with the participation of proconvertin (factor VII), factors IX (Christmass-factor), X (Stuart-Prouwer factor) is converted into thrombin, which converts fibrinogen into fibrin, which is the basis of the blood clot (thrombus).

The substrate stimulates K-vitamin reductase, which activates vitamin K and ensures its participation in hepatic synthesis of K-vitamin-dependent plasma hemostatic factors. The onset of effect is 8-24 hours (after intramuscular injection).

Pharmacokinetics

After intramuscular administration it is easily and quickly absorbed. It is accumulated in small amounts in tissues. After metabolic activation it is oxidized in liver to diol form. It is excreted by kidneys and in bile mainly as metabolites. High concentrations of vitamin K in the feces are due to its synthesis by intestinal microflora.

Indications

• Hemorrhagic syndrome associated with hypoprothrombinemia; hypovitaminosis K (including obstructive jaundice, hepatitis, cirrhosis of the liver, prolonged diarrhea);

• Bleeding after injuries, trauma and surgery;

• in the complex treatment of dysfunctional uterine bleeding, menorrhagia.

• The treatment and prevention of hemorrhagic disease of newborns.

• Overdose of vitamin K antagonist drugs (warfarin, phenyndione, acenocoumarol).

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Composition

Per 1 ml:

Active ingredient: sodium bisulfite menadione (Vikasol) in terms of sodium bisulfite trihydrate menadione – 10.0 mg;

Excipients: Sodium disulfite – 1.0 mg, 0.1 M hydrochloric acid solution – to pH 2.2-3.5, water for injection – to 1.0 ml.

How to take, the dosage

The drug is administered intramuscularly.

In adults the single dose is 10-15 mg, the maximum single dose is 30 mg, the maximum daily dose is 60 mg.

In pediatrics:

– newborns up to 4 mg/day;

– up to 1 year 2-5 mg/day;

– 1-2 years 6 mg/day;

– 3-4 years 8 mg/day;

– 5-9 years 10 mg/day;

– 10-14 years 15 mg/day;

From the age of 15, the drug is prescribed the same way as in adult patients.

The duration of treatment is 3-4 days, after a four-day break, repeated 3-4 days.

The daily dose may be divided into 2-3 doses.

In surgical interventions with possible severe parenchymal bleeding, it is prescribed for 2-3 days before surgery.

Interaction

Weakens the effect of indirect anticoagulants (including coumarin and indandion derivatives).

It does not affect the anticoagulant activity of direct anticoagulants (including heparin).

Concomitant administration with broad-spectrum antibiotics, quinidine, quinine, high-dose salicylates, sulfonamides requires increasing the dose of vitamin K.

The simultaneous use of Vicasol with drugs that can cause hemolysis increases the risk of side effects.

Special Instructions

The drug is ineffective in hemophilia, Willebrand disease and Verlhof disease.

In patients with glucose-6-phosphate dehydrogenase deficiency Vicasol may cause hemolysis.

Parenteral administration of Vikasol is indicated in cases when oral administration of vitamin K is not possible, as well as in diseases leading to impaired bile flow.

Impact on the ability to drive vehicles and operate machinery:

During treatment, it is not recommended to drive vehicles, as well as engage in other activities that require increased concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity to the components of the drug. Increased blood clotting, thromboembolism. Hemolytic disease of newborns. Pregnancy and lactation period.

With caution: glucose-6-phosphate dehydrogenase deficiency, hepatic insufficiency.

Overdose

Symptoms: hypervitaminosis K, manifested by hyperprothrombinemia (which may be accompanied by thrombosis), hemolytic anemia, hyperbilirubinemia. In isolated cases, especially in children, seizures develop.

The treatment: withdrawal of the drug, symptomatic therapy. In individual cases it is possible to prescribe direct anticoagulants (unfractionated heparin) under control of the parameters of the blood coagulation system.

Pregnancy use

Experimental studies in animals revealed adverse effects on the fetus. Controlled studies on the use of the drug Vikasol in pregnant women have not been conducted. Use during pregnancy and childbirth is contraindicated (risk of hemolytic anemia, hyperbilirubinemia and nuclear jaundice in fetus and newborn). Breast-feeding should be stopped during the use of the drug.