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

Pharmacodynamics:Vitamin K exists in several forms.The basic form of vitamin K is vitamin K₁ (phylloquinone) is found in plants, especially green leafy vegetables. Another form of vitamin K is vitamin K₂ (menaquinone), which can be absorbed in a limited amount. It is produced by bacteria in the lower part of the small intestine and in the large intestine. Vikasol is a synthetic analogue of water-soluble vitamin K and is considered as vitamin K₃ (menadione), 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 Ca²⁺, with the participation of proconvertin (factor VII), factors IX (the factor of Christ, X (the Stewart-Plower factor) passes into thrombin, under the influence of which fibrinogen turns into fibrin, which forms the basis of a blood clot (thrombus). Vikasol as a 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 role of vitamin K in the body of humans and animals is not limited to the influence on the biosynthesis of procoagulants. It has an impact on bioenergetics and a number of anabolic processes. It is important for the exchange of high-energy compounds, for the formation of ATP. K-vitamin deficiency leads to a deficiency of ATP and a weakening of the energy supply to the biosynthesis of many compounds. The latter include not only procoagulants, but other proteins quickly updated, including a number of enzymes that are not directly related to the blood clotting process. When vitamin K deficiency is also weakened biosynthesis of certain biologically active substances nonprotein nature: serotonin, histamine, acetylcholine. The onset of the effect is 8-24 hours (after intramuscular injection).

Pharmacokinetics:After intramuscular injection, it is easily and rapidly absorbed into the systemic bloodstream. Binding to plasma proteins is reversible. The blood of patients with a very low content of albumin weakly binds vitamin K, or does not bind it at all. It accumulates mainly in the liver, spleen, myocardium. The most intensive process of transformation occurs in the myocardium, skeletal muscles,slightly weaker in the kidneys. It is excreted by the kidneys and with bile almost exclusively in the form of metabolites. Metabolites of vitamin K (monosulfate, phosphate and diglucuronide-2-methyl-1,4-naphthoquinone) are excreted in urine - up to 70%. High concentrations of vitamin K in the stool are due to the fact that it is synthesized by the intestinal microflora.

Indications:- Hypoprothrombinemia (prevention and treatment), caused by vitamin K deficiency.

- Violation of coagulation due to a decrease in the content of factors II, VII, IX, X, against the background of taking certain medicines (coumarin and indanedione derivatives, salicylates, some antibiotics), obstructive jaundice, malabsorption syndrome, celiac disease, small intestine, pancreas, resection small intestine, prolonged diarrhea, dysentery, Crohn's disease, sprue, ulcerative colitis, abetalipoproteinemia, parenteral nutrition, in newborns receiving unenriched mixtures or exclusively on the breast feeding.

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

Contraindications:Hypersensitivity to the components of the drug.

Hypercoagulation, thromboembolism.

Hemolytic disease of newborns.

Carefully:With caution appoint with a deficiency of glucose-6-phosphate dehydrogenase, severe hepatic insufficiency, pregnancy.

Pregnancy and lactation:Vikasol refers to the drugs of risk in pregnancy. Its use in pregnancy and lactation is possible only if the potential benefit to the mother exceeds the potential risk to the fetus and the baby.

Children.

The drug is prescribed to children at recommended doses.

Dosing and Administration:The drug is administered intramuscularly.

Adults: single dose - 10-15 mg, daily - 30 mg.

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

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

Maximum doses for adults: single dose - 15 mg, daily - 30 mg.

For newborns - 4 mg / day.

The duration of treatment is 3-4 days, after a 4-day break, the course is repeated if necessary.

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

Side effects:Allergic Reagents: hyperemia of the face, skin rash (incl.erythematous, urticaria), itching of the skin, bronchospasm.

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

Rarely: dizziness, transient lowering of arterial pressure, "profuse" sweat, tachycardia, "weak" filling of the pulse, change in taste sensations.

Overdose:Symptoms: hypervitaminosis K, manifested by hyperprothrombinemia and hyperthrombinemia, hyperbilirubinemia; in isolated cases, children develop toxicosis, manifested by convulsions.

Treatment. Cancel the drug. Under the control of indicators of the coagulation system, anticoagulants are prescribed.

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 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).

The active substance of the drug disintegrates quickly under the influence of direct sunlight. It is not compatible in one syringe with solutions of alkalis and acids.

Effect on the ability to drive transp. cf.and fur:During the treatment with the drug, it is possible to drive vehicles and engage in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Solution for intramuscular injection.

Packaging:1 ml per ampoule of clear glass.

5 ampoules together with a knife for opening; ampoule, or ampoule scapegrifier is placed in a contour mesh package (cassette). Two contour mesh packs, along with the instruction for medical use, are placed in a bundle.

For 10 ampoules, together with the instruction for medical use and the opener for opening ampoules, or the ampoule scaper, are put in a box with a corrugated liner.

When packing ampoules with a colored ring or break point, knives for opening ampoules or amorphous scarifiers are not included

Storage conditions:Keep out of reach of children, at a temperature of 2 ° C to 8 ° C.

Shelf life:2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:P N010099

Date of registration:08.07.2011 / 25.04.2013

Expiration Date:Unlimited

The owner of the registration certificate:DARNITSA PHARMACEUTICAL FIRM, CJSCDARNITSA PHARMACEUTICAL FIRM, CJSC Ukraine

Manufacturer: & nbsp

DARNITSA PHARMACEUTICAL FIRM, PAO Ukraine

Information update date: & nbsp14.02.2017

Illustrated instructions

Instructions

Vikasol-Darnitsa (Vikasol-Darnitsa)