Producer: CJSC Pharmaceutical Firm Darnitsa Ukraine
Code of automatic telephone exchange: B02BA02
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
Active ingredient: menadione;
1 ml of solution contains Vikasolum (bisulphite sodium Menadionum) of 10 mg;
excipients: sodium metabisulphite (Е 223), Acidum hydrochloricum, water for injections.
Pharmacodynamics. Vitamin K exists in several forms. The main form of vitamin K – K1 vitamin (phylloquinone) contains in plants, especially green sheet vegetables. Other form of vitamin K is K2 vitamin (менахинон) which can be soaked up in limited quantity. It is developed by bacteria in the lower part of a small bowel and in a large intestine.
Vikasol-Darnitsa represents a synthetic analog of water-soluble vitamin K and is considered as K3 vitamin (Menadionum), promotes synthesis of a prothrombin and proconvertin, increases coagulability of blood due to synthesis strengthening II, VII, IX, X factors of coagulation. Possesses haemo static action (at deficit of vitamin K there is a raised bleeding). In blood a prothrombin (a factor of II) in the presence of thromboplastin and Ca2+, with the participation of proconvertin (a factor of VII), factors of IX (Kristmass-faktora, X (Stewart-Prauyera's factor) passes into thrombin under the influence of which fibrinogen turns into the fibrin making a basis of a clot (blood clot). Vikasol-Darnitsa as substrate stimulates K-vitaminreduktazu activating vitamin K and providing its participation in hepatic synthesis of K-vitaminzavisimykh of plasma factors of a hemostasis.
The vitamin K role in a human body and animals is not limited to influence on biosynthesis of pro-coagulants. It makes impact on bio-energetics and a number of anabolic processes. It matters for exchange of makroergichesky connections, for formation of ATP. The K-vitamin deficiency results in deficit of ATP and easing of power security of biosynthesis of many connections. Not only pro-coagulants, but also other quickly updated proteins, including a number of the enzymes which are not connected directly with blood coagulation process are among the last. At deficit of vitamin K also biosynthesis of some biologically active agents of the nonprotein nature is weakened: serotonin, histamine, acetylcholine. The beginning of effect – in 8-24 hours after intramuscular introduction.
Pharmacokinetics. After intramuscular introduction it is easily and quickly soaked up in a system blood stream. Linkng with proteins of plasma has reversible character. Blood of patients poorly connects vitamin K with very low content of albumine, or at all does not connect it. Collects mainly in a liver, a spleen, a myocardium. Most intensively process of transformation happens in a myocardium, skeletal muscles, is slightly weaker – in kidneys. It is removed by kidneys and with bile it is almost exclusive in the form of metabolites. Vitamin K metabolites (monosulphate, phosphate and diglucuronide-2-methyl-1,4-naphthoquinone) are removed with urine – to 70%. High concentration of vitamin K in Calais are caused by the fact that it is synthesized by intestinal microflora.
Main physical and chemical properties: transparent colourless or slightly yellowish liquid.
Incompatibility. Vikasolum is incompatible with sulfanamide drugs, PASK, salitsialata, oxycoumarin. It is not compatible in one syringe to solutions of alkalis and acids. Active ingredient of drug quickly breaks up under the influence of direct sunshine.
Indications to use:
Vikasolum is appointed at bleeding and against the background of a prothrombinopenia, caused by jaundice, at acute hepatitises, capillary and parenchymatous bleedings. After surgical interventions and wounds, at bleedings at a peptic ulcer of a stomach and duodenum, the expressed symptoms of an acute radial illness, long nasal and hemorrhoidal bleedings.
Drug is appointed at the hemorrhagic phenomena at premature children, uterine premenopausal and juvenile bleedings, at a hematostaxic, a preparation for surgery if there is a danger of bleeding in the postoperative period, pulmonary bleedings, at the hemorrhagic phenomena against the background of septic diseases.
Besides, indications for purpose of Vikasola-Darnitsa are the bleedings and prothrombinopenias caused by overdose of Phenilinum, neodicoumarin, other anticoagulants – antagonists of vitamin K.
Route of administration and doses:
The drug is administered intramusculary.
The adult a single dose – 10 mg, the maximum single dose – 15 mg, the maximum daily dose – 30 mg.
Treatment duration – 3-4 days, after a 4-day break if necessary repeat a course.
At surgical interventions with possible severe parenchymatous bleeding appoint within 2-3 days before operation.
To children: till 1 year – 2-5 mg/days, 1-2 years – 6 mg/days, 3-4 years – 8 mg/days, 5-9 years – 10 mg/days, 10-18 years – 15 mg/days. The dose is divided into 2 introductions. Treatment duration for children is established by the doctor.
Features of use:
With care appoint during pregnancy.
It is necessary to consider that at use of Vikasolum braking of aggregation of thrombocytes can take place. At hemophilia, a Werlhof's disease and Verlgof's disease drug is inefficient.
It is better to apply phytomenadionum to prevention of a hemorrhagic disease of newborns, than sodium Menadionum bisulphite as causes in newborns less often (including premature) a hyperbilirubinemia and hemolitic anemia.
Ability to influence speed of response at control of motor transport or work with other mechanisms.
Drug does not influence speed of response at control of motor transport or work with other mechanisms. If during treatment dizziness is observed, it is necessary to refrain from control of vehicles and work with mechanisms.
From cardiovascular system: tranzitorny lowering of arterial pressure, tachycardia, weak filling of pulse.
Reactions in an injection site: pain and hypostasis in an injection site, skin discoloration in the form of spots at repeated injections to the same place. Vikasolum can cause a local scleroderma.
Interaction with other medicines:
At simultaneous use with peroral anticoagulants decrease in anticoagulating action is possible. Weakens effect of indirect anticoagulants (including derivative coumarin and an indandion). Does not influence anticoagulating activity of heparin. Simultaneous use with antibiotics of a broad spectrum of activity, quinidine, quinine, salicylates in high doses, sulfonamides is required increases in a dose of vitamin K.
At simultaneous use with hemolitic medicines the risk of manifestation of side effects increases.
At simultaneous use with agregant and inhibitors of a fibrinolysis their haemo static effect is exponentiated.
Use during pregnancy or feeding by a breast.
Vikasol-Darnitsa treats risk drugs at pregnancy. Use of drug in Ι and ΙΙ trimesters is possible according to indications if the advantage for mother exceeds a risk degree for a fruit. Preventive purpose of vitamin K in the III trimester of pregnancy is inefficient owing to low-permeability of a placenta for it.
In case of need drug uses women who nurse for treatment need to stop chest feeding.
Drug is used in pediatric practice.
Symptoms: the hypervitaminosis To which is shown a giperprotrombinemiya and a hyperthrombinemia, a hyperbilirubinemia, jaundice, increase in activity of liver enzymes; abdominal pains, locks or diarrhea, the general excitement, agitation and an enanthesis were noted. In isolated cases at children the toxicosis which is shown spasms develops.
Treatment. Cancel drug. Under control of indicators of coagulant system appoint anticoagulants. Therapy is symptomatic.
To store in protected from light and the place, unavailable to children, at a temperature from 5 to 8 °C. A period of validity - 2 years.
According to the recipe
On 1 ml in an ampoule; on 5 ampoules in a blister strip packaging; on the 2nd blister strip packagings in a pack.