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

Pharmacodynamics:Synthetic water-soluble analogue of vitamin K (vitamin K3), promotes the synthesis of prothrombin and proconvertin, increases blood coagulability 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, with the participation of proconvertin (factor VII), factors IX (the Crystal Factor), X (the 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 effect starts in 8-24 hours.

Pharmacokinetics:After intramuscular injection, it is absorbed easily and quickly. In small amounts, it accumulates in the tissues. After a cycle of metabolic activation, it is oxidized to a diol form. They are excreted by the kidneys (up to 70%) and with bile solely in the form of metabolites. High concentrations of vitamin K in the feces are due to its synthesis by intestinal microflora.

Indications:Hypoprothrombinemia (prevention and treatment) due to vitamin K deficiency: a violation of coagulation due to a decrease in the content of factors II, VII, IX, X,on the background of taking some medicines (coumarin and indanedione derivatives, salicylates, some antibiotics), obstructive jaundice, malabsorption syndrome, celiac disease, small bowel function, pancreas, small intestine resection, prolonged diarrhea, dysentery, Crohn's disease, sprue, ulcerative colitis , abetalipoproteinemia, parenteral nutrition, in newborns receiving unrefined mixtures or exclusively breastfed. Hemorrhagic disease in newborns (prevention and treatment), including those in high-risk newborns - born from mothers who received anticoagulants (including phenytoin).

Contraindications:Hypersensitivity, hypercoagulation, thromboembolism, hemolytic disease of the newborn.

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

Pregnancy and lactation:The use of the drug during pregnancy and lactation is possible, but under the strict supervision of a doctor.

The action category for fetus by FDA-C (study of reproduction on animals revealed an adverse effect on the fetus,but strictly controlled studies in pregnant women have not been conducted, but the potential benefits associated with the use of the drug in pregnant women can justify its use, despite the possible risk). Prophylactic administration of the drug in the III trimester of pregnancy is ineffective due to low permeability for the placenta.

Dosing and Administration:Intramuscularly. Single dose for adults - 10-15 mg, daily - 30 mg.

Children: newborns - up to 4 mg / day, up to 1 year - 2-5 mg / day, up to 2 years - 6 mg / day, 3-4 years-8 mg / day, 5-9 years - 10 mg / day, 10-14 years - 15 mg / day.

Duration of treatment is 3-4 days, after a 4-day break, the course is repeated.

When surgical interventions with possible severe parenchymal hemorrhage are prescribed within 2-3 days before the operation.

Side effects:Allergic reactions: hyperemia of the face, skin itching, skin rash, bronchospasm.

On the part of the blood system: hemolytic anemia, hemolysis in newborns with congenital deficiency of glucose-6-phosphate dehydrogenase, hemolytic disease of newborns.

Local reactions: pain and swelling at the injection site, skin lesions in the form of spots with repeated injections in the same place.

Other: hyperbilirubinemia, jaundice (including nuclear jaundice in infants), dizziness, transient lowering of arterial pressure, "profuse" sweat, tachycardia, "weak" pulse filling, change in taste sensations.

Overdose:Rarely, hypervitaminosis K, manifested by hyperprotrombin- and hyperthrombinemia, hyperbilirubinemia, increased blood coagulability, thromboembolism. Treatment is symptomatic.

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

Antacids reduce absorption due to precipitation of bile salts in the initial part of the small intestine.

Does not affect the anticoagulant activity of heparin.

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

Kolestyramine, colestipol, mineral oils, sucralfate, dactinomycin reduce the absorption of vitamin K, which requires an increase in its dose.

Simultaneous administration with hemolytic drugs increases the risk of side effects.

Special instructions:In diseases that lead to a violation of the outflow of bile, parenteral administration is recommended. With hemophilia and Verlhof disease, the drug is ineffective.

For prevention of hemorrhagic disease of newborns, phytonadione is more preferable than menadione sodium bisulfite, as it rarely causes hyperbilirubinemia and hemolytic anemia in newborns (including prematurity).

Effect on the ability to drive transp. cf. and fur:During the treatment with the drug should refrain from driving and other potentially dangerous 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 in ampoules.

10 ampoules are placed in a box of cardboard with corrugated septa.

5 ampoules are placed in a contour mesh package made of a polyvinyl chloride film. 2 contour squares are placed in a pack of cardboard.

Each instruction box contains instructions for use, an ampoule knife or a scarifier ampoule (when packing ampoules with a break ring, a point and an incision, an ampoule knife or scarifier does not deposit).

Storage conditions:In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-002477

Date of registration:05.04.2012

Expiration Date:Unlimited

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp14.02.2017

Illustrated instructions

Instructions

Vikasol (Vikasol)