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 increasing 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 Ca2 +, 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 almost exclusively 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: impairment, coagulation due to decrease in the content of factors II, VII, IX, X, against the intake of certain drugs (coumarin and indanedione derivatives, salicylates, some antibiotics), obstructive jaundice, malabsorption syndrome , celiac disease, dysfunction of the small intestine, pancreas, small intestine resection, prolonged diarrhea, dysentery, Crohn's disease, sprue, ulcerative colitis, abetalipoproteinemia, parenteral nutrition, in neonates receiving n enriched mixture or are exclusively breastfed.

Hemorrhagic disease in newborns (prevention and treatment), including those in high-risk newborns - those born from mothers who received anticoagulants (incl. phenytoin).

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

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

Pregnancy and lactation:Data on the adverse effects of the drug on the fetus and infants who are breastfed are absent.The drug in pregnancy is recommended to be prescribed only in cases when the expected benefit from its reception for the mother exceeds the potential risk for the fetus.

Dosing and Administration:The drug is administered intramuscularly.

Single dose for adults and children over 14 years - 10-15 mg, daily - 30 mg.

Children: 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.

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 rash (including erythematous, urticaria), skin itching, bronchospasm.

On the part of the blood system: hemolytic anemia, hemolysis in newborn infants 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.

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

Overdose:If overdose occurs hypervitaminosis K manifested giperprotrombinemiey, hyperbilirubinemia, rarely, children may have seizures.

Treatment simtomatic.

Interaction:Weaken the effect of indirect anticoagulants (including derivatives of coumarin and indanedione). 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. Preventive prescription of vitamin K in the III trimester of pregnancy is ineffective due to low permeability for the placenta.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:The adverse effect of the drug on the ability to drive a car and other activities that require concentration and speed of psychomotor reactions have not been reported.

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

Packaging:1 ml or 2 ml into neutral glass ampoules.

For 10 ampoules with instruction for use and a knife for opening ampoules or a scarifier ampullum is placed in a box of cardboard.

5 or 10 ampoules are placed in a contoured cell pack of a polyvinylchloride film or polyethylene terephthalate tape and aluminum foil or paper with a polyethylene coating or without a foil, or without paper.

For 1 or 2 contour packs with instructions for use and a knife for opening ampoules or a scarifier ampullum is placed in a pack of cardboard.

When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.

Storage conditions:In the dark place at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N003935 / 01

Date of registration:17.06.2011

Expiration Date:Unlimited

The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia

Manufacturer: & nbsp

NOVOSIBHIMFARM, OJSC Russia

Information update date: & nbsp14.02.2017

Illustrated instructions

Instructions

Vikasol (Vikasol)