Vikasol solution for intramuscular injection 10mg / ml, 1ml No. 10

Hemorrhagic syndrome associated with hypoprothrombinemia;

Hypovitaminosis K (including obstructive jaundice, hepatitis, liver cirrhosis, prolonged diarrhea);

Bleeding after wounds, trauma and surgery;

As part of the complex therapy of dysfunctional uterine bleeding, menorrhagia.

Treatment and prevention of hemorrhagic disease of the newborn.

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

The drug is administered intramuscularly.

For adults, a single dose is 10-15 mg, the maximum single dose is 30 mg, and 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 old 10 mg / day;

- 10-14 years old 15 mg / day;

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

Duration of treatment is 3-4 days, after a four-day break, 3-4 days are repeated.

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

For surgical interventions with possible severe parenchymal bleeding, it is prescribed for 2-3 days before the operation.

for 1 ml:

Active ingredient: sodium menadione bisulfite (Vicasol) in terms of sodium menadione bisulfite trihydrate - 10.0 mg;

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

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

With care: deficiency of glucose-6-phosphate dehydrogenase, liver failure.

Trade name:

Vikasol

International non-proprietary name:

menadione sodium bisulfite

Dosage form:

solution for intramuscular injection

Composition for 1 ml:

Active ingredient: sodium menadione bisulfite (Vicasol) in terms of sodium menadione bisulfite trihydrate - 10.0 mg;

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

Description:

transparent colorless or slightly colored yellow or green-yellow liquid.

Pharmacotherapeutic group:

vitamin K analog synthetic

ATX code: B02BA02

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics

A water-soluble analogue of vitamin K (vitamin K3), promotes the synthesis of prothrombin and proconvertin, increases blood clotting by increasing the synthesis of coagulation factors II, VII, IX, X. Has a hemostatic effect (with a deficiency of vitamin K, increased bleeding occurs).

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 (Stewart-Prower factor) passes into thrombin, under the influence of which fibrinogen is converted into fibrin, which makes up the basis of a blood clot (thrombus).

Substrate stimulates K-vitamin reductase, activating vitamin K and ensuring its participation in the hepatic synthesis of K-vitamin-dependent plasma factors of hemostasis. The onset of the effect is after 8-24 hours (after intramuscular injection).

Pharmacokinetics

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

INDICATIONS FOR USE:

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

• bleeding after wounds, trauma and surgery;

• as part of the complex therapy of dysfunctional uterine bleeding, menorrhagia.

• Treatment and prevention of hemorrhagic disease of the newborn.

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

CONTRAINDICATIONS:

• Hypersensitivity to the components of the drug.

• Increased blood clotting, thromboembolism.

• Hemolytic disease of the newborn.

• Pregnancy and lactation.

With care: deficiency of glucose-6-phosphate dehydrogenase, liver failure.

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING:

In experimental studies in animals, an adverse effect on the fetus has been revealed. Controlled studies of 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 kernicterus in the fetus and newborn). During the use of the drug, breastfeeding should be discontinued.

DOSAGE AND APPLICATION:

The drug is administered intramuscularly.

For adults, a single dose is 10-15 mg, the maximum single dose is 30 mg, and 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 old 10 mg / day;

- 10-14 years old 15 mg / day;

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

Duration of treatment is 3-4 days, after a four-day break, 3-4 days are repeated.

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

For surgical interventions with possible severe parenchymal bleeding, it is prescribed for 2-3 days before the operation.

SIDE EFFECT:

Allergic reactions: urticaria

Blood disorders: hemolytic anemia, hemolysis in newborns with congenital glucose-6-phosphate dehydrogenase deficiency.

Nervous system disorders: dizziness; change in taste.

Disturbances from the respiratory system, chest and mediastinal organs: bronchospasm.

Disturbances from the cardiovascular system: transient decrease in blood pressure, tachycardia, 'weak' filling of the pulse.

Liver and biliary tract disorders: jaundice (including kernicterus in newborns).

Skin and subcutaneous tissue disorders: facial flushing, skin rash (including erythematous), itching.

General disorders and disorders at the injection site: pain and swelling at the injection site, skin lesions in the form of spots with repeated injections at the same site; Profuse sweat.

Laboratory and instrumental data: hyperbilirubinemia.

Disulfite, which is part of the sodium preparation, can in rare cases cause severe hypersensitivity reactions and bronchospasm.

OVERDOSE:

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

Treatment: drug withdrawal, symptomatic therapy. In some cases, it is possible to prescribe direct anticoagulants (unfractionated heparin) under the control of indicators of the blood coagulation system.

INTERACTION WITH OTHER MEDICINAL PRODUCTS:

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

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

Simultaneous administration with broad-spectrum antibiotics, quinidine, quinine, salicylates in high doses, sulfa drugs requires an increase in the dose of vitamin K.

The simultaneous administration of Vikasol with drugs that can cause hemolysis increases the risk of side effects.

SPECIAL INSTRUCTIONS:

In hemophilia, von Willebrand disease and Werlhof's disease, the drug is ineffective.

In patients with glucose-6-phosphate dehydrogenase deficiency, Vikasol can cause hemolysis.

Parenteral administration of the drug Vikasol is indicated in cases where it is impossible to take vitamin K preparations inside, as well as in diseases leading to a violation of the outflow of bile.

Influence on the ability to drive vehicles and control mechanisms:

During treatment, driving is not recommended, as well as engaging in other activities that require increased concentration of attention and speed of psychomotor reactions.

RELEASE FORM:

Solution for intramuscular injection 10 mg / ml.

1 ml or 2 ml in ampoules of colorless neutral glass type I with a colored break ring or with a colored dot and a notch or without a break ring, a colored dot and a notch. One, two or three colored rings and / or two-dimensional barcode and / or alphanumeric coding or without additional colored rings, two-dimensional barcode, alphanumeric coding can be additionally applied to the ampoules.

5 ampoules in a blister strip made of polyvinyl chloride film and lacquered aluminum foil or polymer film or without foil and without film. Or, 5 ampoules are placed in a pre-made form (tray) made of cardboard with cells for stacking ampoules. 1 or 2 blister packs or cardboard trays, together with instructions for use and a scarifier or ampoule knife, or without a scarifier and an ampoule knife, are placed in a cardboard package (pack).

Storage conditions:

In a dark place at a temperature not exceeding 25 ? C.

Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Vacation conditions:

Dispensed by prescription.