Vikasol - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Water-soluble analogue of vitamin K (vitamin K₃), promotes the synthesis of prothrombin and proconvertin, increases the coagulability of blood by enhancing the synthesis of II, VII, IX, X coagulation factors. Has a hemostatic effect (with a deficiency of vitamin K there is 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 (the Crystal Factor), X (Stewart-Plower factor) thrombin, under the influence of which fibrinogen turns into fibrin, which forms the basis of a blood clot (thrombus). Substrate stimulates K-vitamin reductase, which activates vitamin K and ensures its participation in the hepatic synthesis of K-vitamin-dependent plasma factors of hemostasis. The onset of the effect is 8-24 hours (after intramuscular injection).

Pharmacokinetics:After intramuscular injection, it is absorbed easily and quickly. In small amounts, it accumulates in the tissues. After passing the 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 the feces are due to its synthesis by intestinal microflora.

Indications:Hemorrhagic syndrome associated with hypoprothrombinemia; hypovitaminosis K (including with obstructive jaundice, hepatitis, liver cirrhosis, prolonged diarrhea); bleeding after wounds, injuries and surgical interventions; in the complex therapy of dysfunctional uterine bleeding, menorrhagia. Treatment and prevention of hemorrhagic disease of newborns. Overdose of antagonists of vitamin K (warfarin, fenindion, acenocoumarol).

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

Carefully:Deficiency of glucose-6-phosphate dehydrogenase, hepatic insufficiency.

Pregnancy and lactation:In experimental studies in animals, adverse effects on the fetus have been identified. Controlled studies of the use of the drug Vikasol in pregnant women have not been conducted. Application during pregnancy and during labor is contraindicated (risk of hemolytic anemia, hyperbilirubinemia and nuclear jaundice in the fetus and newborn).

For the duration of the drug should stop breastfeeding.

Dosing and Administration:The drug is administered intramuscularly.

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

In pediatrics:

newborn	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 in the same way as adult patients. Duration of treatment 3-4 days, after a four-day break, again 3-4 days. The daily dose can be divided into 2-3 doses. When surgical interventions with possible severe parenchymal hemorrhage are prescribed within 2-3 days before the operation.

Side effects:Allergic reactions: hives

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

Impaired nervous system: dizziness; change in taste.

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

Disorders from the cardiovascular system: transient decrease in arterial pressure, tachycardia, "weak" filling of the pulse.

Disorders from the liver and bile ducts: jaundice (including nuclear jaundice in newborns).

Disturbances from the skin and subcutaneous tissues: hyperemia of the face, skin rash (including erythematous), itchy skin.

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

Laboratory and instrumental data: hyperbilirubinemia.

The disulfite included in the preparation of sodium is able in rare cases to cause severe hypersensitivity reactions and bronchospasm.

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

Treatment: withdrawal of the drug, symptomatic therapy. In some cases, the appointment of direct anticoagulants (unfractionated heparin) under the control of the coagulation system.

Interaction:Weaken the effect of indirect anticoagulants (including derivatives of coumarin and indanedione).

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

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

Simultaneous administration of the drug Vikasol with drugs that can cause hemolysis, increases the risk of side effects.

Special instructions:In hemophilia, Willebrand disease and Verlhof disease, the drug is ineffective.

In patients with a deficiency of glucose-6-phosphate dehydrogenase, the drug Vikasol can cause hemolysis.

Parenteral administration of the drug Vikasol is indicated in cases when it is impossible to take vitamin K preparations inside, and also in diseases that lead to a violation of bile flow.

Effect on the ability to drive transp. cf. and fur:During treatment, it is not recommended to drive vehicles, as well as engage in other activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Solution for intramuscular injection 10 mg / ml.

Packaging:1 ml or 2 ml per ampoule of colorless neutral glass type 1 with a colored break ring or with a colored dot and a notch or without a kink ring, a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding can additionally be applied to the ampoules.

5 ampoules per circuit cell packaging made of polyvinylchloride film and aluminum foil foil or polymer film or without foil and without film. Or 5 ampoules are placed in a prefabricated form (tray) made of cardboard with cells for laying ampoules.

1 or 2 contour squares or cardboard trays, together with the instructions for use and a scarifier or knife with an ampoule, or without a scarifier and an ampoule knife, are placed in a cardboard package.

Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002130

Date of registration:05.07.2013 / 27.10.2015

Expiration Date:05.07.2018

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp14.02.2017

Illustrated instructions

Instructions

Vikasol (Vicasol)