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One ampoule (1 ml of solution) contains: active substance: vicasol - 10 mg; excipients: sodium metabisulfite E223, hydrochloric acid, water for injection.
Pharmacotherapeutic group
Vitamin K and other hemostatics.
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 strengthening of coagulation factors II, VII, IX, X. Possesses hemostatic (with a deficiency of vitamin K, increased bleeding).
In the blood, prothrombin (factor II) in the presence of thromboplastin and calcium supply, with the participation of proconvertin (factor VII), factors IX (Christmass factor), X (Stewart-Prower factor) is converted into thrombin, under which fibrinogen is converted into fibrin, which is the basis 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 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 vitamins 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 newborns;
• overdose of vitamin K antagonist drugs (phenindione, acenocoumarol, etc.).

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.
Method of administration and dosage regimen
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 - 0.4 mg / kg / 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 3-4 days, after a four-day break, re-treatment 3-4 days. The daily dose can be divided into 2-3 doses. For surgical interventions with possible severe parenchymal bleeding, it is prescribed 2-3 days before the operation.
In patients with hepatic insufficient dose, the drug should be prescribed with caution.
Application in geriatric practice
The lower end of the dosage range is recommended for elderly patients.
Application in obstetric and gynecological practice
The use of the drug during pregnancy and lactation is contraindicated.
Side effect
Allergic reactions: facial flushing, skin rash (including erythematous, urticaria), itching of the skin, bronchospasm.
From the side of the blood system: hemolytic anemia, hemolysis in newborns with congenital deficiency of glucose-6-phosphate dehydrogenase.
Local reactions: pain and swelling at the injection site, skin lesions in the form of spots with repeated injections in the same place.
Others: hyperbilirubinemia, jaundice (including kernicterus in infants), dizziness, transient decrease in blood pressure, "profuse" sweat, tachycardia, "weak" pulse filling, changes in taste.
Precautions
In hemophilia, von Willebrand disease and Werlhof disease, the drug is ineffective. With a deficiency of glucose-6-phosphate dehydrogenase, it can cause hemolysis.
With prolonged use of Vikasol drugs, blood coagulation indicators should be monitored daily; therapy should continue until they are normalized. Periodic monitoring of vitamin K-dependent blood coagulation factors is also required.
Application during pregnancy and lactation
Use during pregnancy and childbirth is contraindicated (risk of hemolytic anemia, hyperbilirubinemia and nuclear jaundice in the fetus and newborn). In these cases, the use of vitamin K is prescribed phytomenadione.
During the use of the drug, breastfeeding is stopped.
Influence on the ability to drive vehicles and control mechanisms
During treatment, driving is not recommended, as well as methods of other activities that require increased attention and speed of psychomotor methods.
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.
Cholestyramine, colestipol, mineral oils, sucralfate, dactinomycin reduce the absorption of vitamin K, which requires an increase in its dose.
Concomitant administration with hemolytic drugs increases the risk of side effects.
Overdose
Symptoms: hypervitaminosis K, manifested by hyperpro-thrombinemia (which may be accompanied by thrombosis), hemolytic anemia, hyperbilirubinemia. In isolated cases, especially in children, convulsions develop.
Treatment: drug withdrawal. Anticoagulants are prescribed under the control of the blood coagulation system.
Packaging
1 ml in glass ampoules.
10 ampoules together with a leaflet for medical use are placed in a cardboard box with a cardboard insert.
10 ampoules are placed in a polyvinyl chloride film insert. 1 insert with ampoules together with the package insert for medical use is placed in a carton box.
Storage conditions
In a dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life
3 years. Do not use after the expiration date.