Index of drugs

Treatment of bleeding caused by overdose of coumarin anticoagulants or treatment of bleeding caused by another acquired deficiency of coagulatory factors of the prothrombin complex (parts II, VII, IX, X).

1 ml of solution contains 10 mg of fitomenadion. The drug contains macrogolglycerol ricinoleate.

Synthetic vitamin K₁, which is necessary for the synthesis of blood coagulation factors - prothrombin, factor VII, IX and X. Lack of vitamin K₁ in the body leads to an increased tendency to bleed. When an antidote needs to be taken after an overdose of anticoagulants, vitamin K should be given₁because the vitamin K derivatives are less effective. In plasma, 90% of vitamin K₁ binds to lipoproteins. After intramuscular administration of 10 mg of vitamin K₁, the plasma concentration is 10 to 20 μg / L (usually in the range of 0.4 to 1.2 μg / L). Availability of vitamin K₁ after intramuscular administration is about 50%, and T_0,5 in plasma it is about 1.5 to 3 hours.

Hypersensitivity to the components of the drug.

Before administration of the drug, an interview should be collected for atypical or allergic reactions to macrogolglycerol ricinoleate or vitamin K₁ - if you have such reactions in the past, do not give the medicine. In case of severe, life-threatening bleeding caused by overdose of coumarin anticoagulants, the drug should be administered slowly intravenously (preferably infused) and should not exceed a dose greater than 40 mg per day. In the absence of improvement, treatment with vitamin K₁ should be combined with treatment that will allow immediate efficacy, ie full blood transfusion or administration of coagulation factor concentrate. If severe or potentially life-threatening bleeding occurs in patients with artificial heart valves, freshly frozen plasma should be given. High doses of vitamin K should be avoided₁ (greater than 40 mg per day), if continuation of treatment with anticoagulants is planned because there is no clinical experience with doses above 40 mg per day, and the use of high doses may result in an increase in unexpected adverse events. Clinical studies have shown a significant reduction in prothrombin time if the drug is used at the recommended doses. If the bleeding is increased, it may be necessary to treat the patient with fresh whole blood while waiting for vitamin K to work₁. After intramuscular administration of vitamin K₁, especially a high dose, a prolonged antagonistic effect to oral anticoagulants may occur. Vitamin K₁ does not inhibit the action of heparin. It is not recommended for premature infants, newborns or children under the age of 2 years. The drug contains macrogolglycerol ricinoleate, which in animal studies elicited anaphylactoid reactions associated with the release of histamine; such reactions can not be ruled out in humans.

During pregnancy, use only if the anticipated benefits outweigh the potential risk to the fetus. The use of the drug in breastfeeding women at therapeutic doses does not involve a risk to the breast-fed baby. Breast-feeding women are not recommended as prophylaxis of newborn hemorrhagic disease.

Inflammation of the face, excessive sweating, shortness of breath, pressure and chest pain, cyanosis and even circulatory collapse may occur after too-rapid intravenous injection of the drug. Very rarely, after intravenous administration of the drug, irritation or phlebitis has been reported. After intramuscular administration of the drug, especially repeated injections, skin reactions may occur at the injection site.

Intravenously.Adults. Severe bleeding, including life threatening: 10-20 mg in infusion or slowly intravenously. After 3 hours of administration, the prothrombin time should be determined and if it is prolonged, the dose should be repeated. The maximum intravenous dose is 40 mg per day.Check the coagulation parameters once a day from the time the medicine is given until the right values ​​are reached. In severe cases, more frequent monitoring is recommended, in the absence of immediate improvement, whole blood should be transfused or a coagulation factor concentrate should be administered.Less severe bleeding: 10-20 mg intramuscularly, if necessary, the dose can be repeated.In other indications 10-20 mg are given. The lowest effective doses are used in the elderly.Children> 2 years: in some cases, the drug is used in this group of patients - children with diseases that interfere with the absorption of vitamin K₁ (chronic diarrhea, cystic fibrosis, bile duct obstruction, hepatitis, celiac disease), liver disease and undernourished children who received antibiotics; the dose should be determined depending on the patient's condition, usually 1-5 mg intravenously after dilution.
Before intravenous administration, dilute 10 mg of the drug in 100 ml of 0.9% NaCl and infused over 20-30 min, store for a maximum of 6 hours. Do not administer as a bolus intravenous injection.