Vikasolum

General characteristics. Structure:

Active ingredient: 10 mg of Vikasolum in 1 ml of solution.

Excipients: sodium metabisulphite, Acidum hydrochloricum, water for injections.

Pharmacological properties:

Pharmacodynamics. Vikasolum possesses haemo static action, represents a synthetic analog of water-soluble vitamin K and rassmativatsya as K3 vitamin (Menadionum). Vitamin K or substances with activity of vitamin K play an important role in synthesis of a prothrombin, factors of VII, IX and X, and also factors of anticoagulative system - proteins of C and S due to substrate stimulation K-vitaminreduktazy of hepatocytes.

Vitamin K badly gets through a placental barrier from mother to the child and is practically not emitted with breast milk. At adults the lack of vitamin K leads to the raised bleeding, at a fruit and newborns – to a hemorrhagic disease of newborns. Administration of vitamin K which promotes synthesis of above-mentioned factors of coagulation in a liver can completely change an abnormal condition of coagulation in connection with its deficit.

Pharmacokinetics. After intramuscular introduction it is easily and quickly soaked up.

Linkng with proteins of plasma has reversible character. In insignificant quantities collects in fabrics (mainly in a liver, a spleen, a myocardium). In an organism turns into K2 vitamin. Most intensively process of transformation happens in a myocardium, skeletal muscles, is slightly weaker - in kidneys.

Having quickly passed a cycle of metabolic activation, in a liver is oxidized to a thiol form. It is removed by kidneys and with bile it is almost exclusive in the form of metabolites (monosulphate, phosphate and diglucuronide-2-methyl-1.4-naphthoquinone). High concentration of vitamin K in Calais are caused by its synthesis by intestinal microflora.

The beginning of effect - in 8 - 24 h (after introduction in oil).

Indications to use:

Adult patients: Vikasolum is shown to adults at bleedings as the specific antagonist of coumarinic anticoagulants, and also in complex treatment and prevention of the bleedings caused by the low level of a prothrombin or factor of VII in blood.

Children aged from 1 up to 18 years: before purpose of Vikasolum consultation of the doctor haemo log is recommended. Indications to use for children are limited and include:

- states at which digestion of vitamin K (chronic diarrhea, cystous fibrosis, a biliary atresia, hepatitis, a Gee's disease) is broken;

- liver diseases;

- the anticoagulating therapy by warfarin complicated by bleeding (at the normal or raised indicator of the International Normalized Relation (INR)).

Newborns and babies: for prevention and treatment of the hemorrhagic disease of the newborns caused by deficit vitamin K (who were born from mothers accepting anticoagulants (century т.ч., Phenilinum).

Route of administration and doses:

Intramusculary.

Adult: a single dose – 10 15 mg, daily – 30 mg.

To children: the newborn and aged till 1 year – 0,4 mg/kg/days, up to 2 years д 6 mg/days, 3/4 years of 4 8 mg/days, 5/9 years of 9 10 mg/days, 10/14 years of 1 15 mg/days. Use frequency / 2 3 times/days. Treatment duration - 3-4 days, after a 4-day break repeat a course. Duration of treatment is established by the doctor individually.

After administration of Vikasolum in 3 hours it is necessary to define a prothrombin ratio and if this indicator does not reach normal value, it is necessary to repeat administration of Vikasolum, at the same time the daily dose should not exceed 40 mg.

At surgical interventions with possible severe parenchymatous bleeding appoint within 2 - 3 days before operation.

Elderly patients are, as a rule, more sensitive to replacement of anticoagulating therapy by administration of Vikasolum, in this regard the lower bound of range of dosages is recommended to such patstenta.

Features of use:

At hemophilia and a disease Verlgofa Vikasol is inefficient.

Preventive purpose of vitamin K in the III trimester of pregnancy is inefficient owing to low-permeability of a placenta for it.

Phytomenadionum is more preferable to prevention of a hemorrhagic disease of newborns, than sodium Menadionum bisulphite (Vikasolum) as it causes in newborns less often (including premature) a hyperbilirubinemia and hemolitic anemia.

Treatment of potentially fatal and heavy bleedings has to be followed, in addition to administration of Vikasolum, by performing more effective therapy including transfusion of whole blood or factors of coagulation. It is necessary to consider that the earliest effect of administration of Vikasolum develops in 8 hours and, therefore, the hematologist introduction of factors of coagulation can be recommended to patients with heavy bleeding.

At long administration of Vikasolum indicators of a blood coagulation have to be controlled daily; therapy has to continue before their normalization. Vitamin of K-dependent blood-coagulation factors is necessary also periodic control of contents.

Side effects:

Allergic reactions: skin rash, itch, erythema, small tortoiseshell, bronchospasm.

From system of blood: hemolitic anemia, hemolysis at newborn children with inborn deficit glyukozo-6-fosfatdegidrogenazy.

Local reactions: pain also swelled in an injection site, damage of skin in the form of spots at repeated injections to the same place.

Others: a hyperbilirubinemia, jaundice (including a kernicterus at babies); seldom - dizziness, a tranzitorny lowering of arterial pressure, "profuse" sweat, tachycardia, "weak" filling of pulse, change of flavoring feelings.

Interaction with other medicines:

Weakens effect of indirect anticoagulants (including derivative coumarin and an indandion).

Does not influence anticoagulating activity of heparin.

Co-administration with antibiotics of a broad spectrum of activity, quinidine, quinine, salicylates in high doses, antibacterial sulfonamides demands increase in a dose of vitamin K.

Co-administration of Vikasolum with the medicines capable to cause hemolitic crisis in persons with deficit of glyukozo-6-fosfatdegidrogenazy (G-6-FDG), increases risk of manifestation of side effects.

For the patients receiving warfarin it is necessary to estimate need of administration of Vikasolum, in view of the reasons purpose of warfarin and need of continuation of anticoagulating therapy (for example, patients with the mechanical valve have hearts silt repeated tromboembolic episodes) as purpose of Vikasolum can interfere with anticoagulating therapy by warfarin within 2 - 3 weeks.

Contraindications:

The increased coagulability of blood (hypercoagulation), thromboembolisms, hypersensitivity to Vikasolum, a hemolitic disease of newborns.

With care. Deficit glyukozo-6-fosfatdegidrogenazy, liver failure, pregnancy.

Overdose:

Symptoms: giperprotrombinemiya, hyperbilirubinemia (vitamin K hypervitaminosis); in isolated cases, especially at children, the toxicosis which is followed by spasms develops.

Treatment: drug withdrawal, purpose of anticoagulants.

Storage conditions:

In the place protected from light, at a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 3 years. Not to use after the termination of a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 1 ml in ampoules, in packaging No. 10, No. 10 x 1.