Vikasol (Tablets, Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

B02BA02 (Menadione)

Active Substance

Menadione (BAN)

Clinical-Pharmacological Group

Hemostatic agent. Vitamin K preparation

Pharmacotherapeutic Group

Hemostatic agents; vitamin K and other hemostatic agents; vitamin K

Pharmacological Action

Antihaemorrhagic agent. It is a synthetic analogue of vitamin K. It is a co-factor for the synthesis of prothrombin and other blood clotting factors (VII, IX, X) in the liver, and helps to normalize the blood clotting process.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract. Binding to plasma proteins is reversible. It accumulates mainly in the liver, spleen, and myocardium. In the body, it is converted into vitamin K₂. The conversion process is most intensive in the myocardium and skeletal muscles, and somewhat less so in the kidneys.

Vitamin K metabolites (monosulfate, phosphate, and diglucuronide-2-methyl-1,4-naphthoquinone) are excreted in the urine – up to 70%.

Indications

Haemorrhagic syndrome associated with hypoprothrombinemia; vitamin K deficiency (including in obstructive jaundice, hepatitis, liver cirrhosis, prolonged diarrhea); bleeding after wounds, injuries, and surgical interventions; as part of complex therapy for dysfunctional uterine bleeding, menorrhagia; haemorrhagic disease of the newborn (treatment and prevention); prophylactically during surgical interventions with possible severe parenchymal bleeding. Overdose of vitamin K antagonist drugs (warfarin, phenindione, acenocoumarol).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
D68.2	Hereditary deficiency of other clotting factors
E56.1	Vitamin K deficiency
N92	Excessive, frequent and irregular menstruation
N93	Other abnormal uterine and vaginal bleeding
P53	Hemorrhagic disease of fetus and newborn
R58	Hemorrhage, not elsewhere classified
T88.8	Other specified complications of surgical and medical care, not elsewhere classified
Y44.2	Anticoagulants

ICD-11 code	Indication
3B14.0	Hereditary factor I deficiency (a/hypofibrinogenaemia)
3B14.1	Congenital factor X deficiency
3B14.2	Combined deficiency of vitamin K-dependent clotting factors
3B14.Z	Other hereditary deficiency of blood clotting factor with tendency to bleeding, unspecified
3B15	Hereditary deficiency of blood clotting factor without tendency to bleeding
3B1Z	Congenital or constitutional hemorrhagic condition, unspecified
5B59	Vitamin K deficiency
GA20.Z	Menstrual cycle disorders associated with bleeding, unspecified
GA2Z	Abnormal uterine or vaginal bleeding, unspecified
KA8F.0	Diffuse hemorrhagic diathesis due to vitamin K deficiency of the fetus or newborn
MG27	Hemorrhage, not elsewhere classified
NE8Z	Injury or harm caused as a result of surgical or therapeutic interventions, not elsewhere classified, unspecified
PL00	Drugs, medicaments or biological substances causing injury or harm in therapeutic use

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally or intramuscularly. Determine the dose, route, and frequency individually based on indication, patient age, and clinical condition.

For adults, the typical oral dose is 15-30 mg per day. Divide the total daily dose into 2-3 single doses.

For severe hypoprothrombinemia or anticoagulant overdose, use doses at the upper end of the range as clinically indicated.

For pediatric patients, calculate the dose based on body weight. The usual dose is 0.5-1.0 mg/kg body weight per day, divided into multiple administrations.

In obstructive jaundice or other conditions with impaired bile flow, prefer the parenteral route due to reduced oral absorption.

For prophylaxis of hemorrhagic disease in newborns, administer 0.5-1.0 mg intramuscularly once shortly after birth.

For treatment of hemorrhagic disease in newborns, administer 1.0-2.0 mg intramuscularly daily for 2-3 days.

Adjust the dosage and duration of therapy based on prothrombin time or other relevant coagulation parameters.

Do not exceed the maximum daily dose without specific medical justification. Monitor for signs of hyperbilirubinemia, especially in neonates.

Adverse Reactions

From the hematopoietic system hemolytic anemia, hemolysis in newborn children with congenital glucose-6-phosphate dehydrogenase deficiency.

From the respiratory system bronchospasm.

From the nervous system dizziness, altered taste sensations.

From the cardiovascular system transient decrease in blood pressure, tachycardia, “weak” pulse filling.

From the liver and biliary tract jaundice (including kernicterus in newborn children).

Allergic reactions: facial flushing, skin rash (including erythematous, urticaria), skin itching.

Other hyperbilirubinemia, “profuse” sweating.

Local reactions with intramuscular injection – pain and swelling at the injection site, skin lesions in the form of spots with repeated injections in the same place.

Contraindications

Hypersensitivity to menadione, increased blood clotting (hypercoagulation), thromboembolism, hemolytic disease of the newborn (for parenteral use), pregnancy, lactation (breastfeeding); children under 3 years of age – depending on the dosage form.

With caution glucose-6-phosphate dehydrogenase deficiency, hepatic insufficiency.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding). If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Should be used with caution in patients with hepatic insufficiency.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the menadione drug leaflets regarding contraindications for the use of specific menadione dosage forms in children of different ages.

Special Precautions

In diseases leading to impaired bile outflow, parenteral administration of menadione is recommended. Menadione is ineffective in hemophilia, Werlhof’s disease and thrombocytopenic purpura (Werlhof’s disease).

Menadione does not normalize the function of pathologically altered platelets. In patients with glucose-6-phosphate dehydrogenase deficiency, Menadione may cause hemolysis.

Effect on ability to drive vehicles and operate machinery

During treatment, it is not recommended to drive vehicles or engage in other activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Menadione reduces or blocks the anticoagulant effect of indirect anticoagulants – warfarin, phenindione and acenocoumarol. It does not affect the anticoagulant activity of direct anticoagulants (including heparin).

Antacids reduce the absorption of menadione due to the precipitation of bile salts in the initial part of the small intestine.

Concomitant use with broad-spectrum antibiotics, quinidine, quinine, high-dose salicylates, sulfonamides requires an increase in the dose of vitamin K (due to disruption of its synthesis by the intestinal microflora).

Cholestyramine, colestipol, mineral oils, sucralfate, dactinomycin reduce the absorption of vitamin K, which requires an increase in its dose.

When used concomitantly with drugs that cause hemolysis, the risk of adverse events increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Vikasol [Atoll LLC (Russia)]
Solution for intramuscular injection 10 mg/ml: 1 ml or 2 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Vikasol

Solution for intramuscular injection 10 mg/ml: 1 ml or 2 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection transparent, colorless or slightly colored.

	1 ml
Menadione sodium bisulfite	10 mg

Excipients : sodium disulfite 1 mg, hydrochloric acid solution 0.1 M to pH 2.2-3.5, water for injection up to 1 ml.

1 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml – ampoules (5) – cardboard trays (1) – cardboard packs.
1 ml – ampoules (5) – cardboard trays (2) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (5) – cardboard trays (1) – cardboard packs.
2 ml – ampoules (5) – cardboard trays (2) – cardboard packs.

Vikasol [Biosintez, PJSC (Russia)]
Tablets 15 mg: 10, 20 or 30 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Vikasol

Tablets 15 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Menadione sodium bisulfite	15 mg

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – dark glass jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Vikasol [Biosintez, PJSC (Russia)]
Solution for intramuscular injection 10 mg/1 ml: amp. 10 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Vikasol

Solution for intramuscular injection 10 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection	1 ml
Menadione sodium bisulfite	10 mg

1 ml – ampoules (10) – cardboard packs.

Vikasol [Biosintez, PJSC (Russia)]
Solution for intramuscular injection 20 mg/2 ml: amp. 10 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Vikasol

Solution for intramuscular injection 20 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection	1 ml	1 amp.
Menadione sodium bisulfite	10 mg	20 mg

2 ml – ampoules (10) – cardboard packs.

Vikasol [Velpharm, LLC (Russia)]
Solution for intramuscular injection 10 mg/ml: 1 ml or 2 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Vikasol

Solution for intramuscular injection 10 mg/ml: 1 ml or 2 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection colorless or slightly colored, transparent.

	1 ml
Menadione sodium bisulfite	10 mg

Excipients : sodium disulfite, hydrochloric acid 0.1M solution, water for injection.

1 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Vikasol [Dalkhimpharm, JSC (Russia)]
Intramuscular injection solution 10 mg/1 ml: 1 ml or 2 ml amp. 10 pcs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Vikasol

Intramuscular injection solution 10 mg/1 ml: 1 ml or 2 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection transparent, colorless or with a greenish-yellowish tint.

	1 ml
Menadione sodium bisulfite trihydrate	10 mg

Excipients : sodium disulfite (sodium metabisulfite) – 1 mg, hydrochloric acid solution 0.1M – to pH 2.2-3.5, water for injection – up to 1 ml.

1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml – ampoules (10) – cardboard boxes.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (10) – cardboard boxes.

Vikasol [Irbit Chemical Pharmaceutical Plant, JSC (Russia)]
Tablets 15 mg: 30 pcs.

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Vikasol

Tablets 15 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Menadione sodium bisulfite	15 mg

30 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Vikasol [N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)]
Solution for intramuscular injection 10 mg/1 ml: amp. 10 pcs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Vikasol

Solution for intramuscular injection 10 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection	1 ml
Menadione sodium bisulfite	10 mg

1 ml – ampoules (10) – cardboard packs.

Vikasol [Novosibkhimpharm, JSC (Russia)]
Solution for intramuscular injection 10 mg/1 ml: amp. 1 ml, 2 ml or 3 ml 5, 10 or 20 pcs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Vikasol

Solution for intramuscular injection 10 mg/1 ml: amp. 1 ml, 2 ml or 3 ml 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection in the form of a transparent, colorless or greenish-yellowish liquid.

	1 ml
Menadione sodium bisulfite in terms of menadione sodium bisulfite trihydrate (vikasol)	10 mg

Excipients : sodium disulfite (sodium metabisulfite, sodium pyrosulfite) – 1 mg, hydrochloric acid solution 0.1M – to pH 2.2-3.5, water for injection – up to 1 ml.

1 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml – ampoules (10) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (10) – contour cell packs (2) – cardboard packs.
1 ml – ampoules (10) – cardboard boxes.
2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (10) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (10) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (10) – cardboard boxes.
3 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
3 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
3 ml – ampoules (10) – contour cell packs (1) – cardboard packs.
3 ml – ampoules (10) – contour cell packs (2) – cardboard packs.
3 ml – ampoules (10) – cardboard boxes.

Vikasol [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Tablets 15 mg: 10, 20, 30, 50, or 60 pcs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Vikasol

Tablets 15 mg: 10, 20, 30, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel.

	1 tab.
Menadione sodium bisulfite trihydrate (calculated as the anhydrous substance)	17.9 mg (15 mg)

Excipients: lactose monohydrate – 66.8 mg, potato starch – 14.1 mg, calcium stearate – 1 mg, sodium disulfite – 0.2 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Vikasol [Pharmstandard-Lexredstva OJSC (Russia)]
Tablets 15 mg: 10, 20, 30, 40, or 60 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Vikasol

Tablets 15 mg: 10, 20, 30, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical in shape, with a bevel.

	1 tab.
Menadione sodium bisulfite trihydrate	15 mg

Solution for intramuscular injection

	1 ml
Menadione sodium bisulfite trihydrate	10 mg

1 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
1 ml – ampoules (5 pcs.) – cardboard packs – Prescription only
2 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
2 ml – ampoules (5 pcs.) – cardboard packs – Prescription only

Vikasol-Darnitsa [Darnitsa Pharmaceutical Firm, PJSC (Ukraine)]
Solution for intramuscular injection 10 mg/1 ml: amp. 10 pcs.