Dicinon tablets 250mg, No. 100

Prevention and treatment of capillary bleeding of various etiologies:
Х before and after surgery on all well-vascularized tissues in dental, otorhinolaryngological, gynecological, obstetric, urological, ophthalmological practice, plastic and reconstructive surgery;
Х hematuria, metrorrhagia, primary menorrhagia, menorrhagia in women with intrauterine contraceptives (in the absence of organic pathology), nosebleeds, bleeding gums, blood vomiting, melena.

Inside.
The optimal daily dose of etamsylate for adults is 10-20 mg / kg of body weight per day, divided into 3-4 doses. In most cases, a single dose is 250-500 mg (1-2 tablets), if necessary, a single dose can be increased to 750 mg (3 tablets).
Adults and adolescents (over 12 years old, weighing more than 40 kg)
In the preoperative period, 250-500 mg (1-2 tablets) 1 hour before the operation.
In the postoperative period , 250-500 mg (1-2 tablets) every 4-6 hours until the risk of bleeding disappears.
To stop bleeding , 500 mg (2 tablets) every 8-12 hours (1000-1500 mg per day) with food or a little water.
In the treatment of metro and menorrhagia500 mg (2 tablets) 3 times a day (1500 mg per day) for 5-10 days.
Children 3 to 12 years old
Half adult dose.

1 tablet contains:

Active ingredient: etamsylate - 250.0 mg.
Excipients: anhydrous citric acid 12.5 mg; corn starch 65.0 mg; povidone K25 10.0 mg; magnesium stearate 2.0 mg; lactose 60.5 mg.

Х Hypersensitivity to the components of the drug.
Х Acute porphyria.
Х Hemoblastosis in children (lymphoblastic and myeloblastic leukemia, osteosarcoma).
Х Thromboembolism, thrombosis.
Х Rare hereditary forms of lactose intolerance, lactase deficiency or malabsorption of glucose / galactose (because the composition contains lactose).
Х Children under 3 years of age (for this dosage form).

Carefully

History of thrombosis, thromboembolism; bleeding against the background of an overdose of anticoagulants, impaired liver and kidney function (there is no clinical experience of use).

Trade name of the drug:

Dicinon.

International non-proprietary name:

etamsylate.

Dosage form:

pills.

Composition

1 tablet contains:

Active ingredient: etamsylate - 250.0 mg.
Excipients: anhydrous citric acid 12.5 mg; corn starch 65.0 mg; povidone K25 10.0 mg; magnesium stearate 2.0 mg; lactose 60.5 mg.

Description

Round biconvex tablets of white or almost white color.

Pharmacotherapeutic group

Hemostatic agent.

ATX code : ¬02¬’01

Pharmacological properties

Pharmacodynamics
Etamsylate is a hemostatic, antihemorrhagic and angioprotective agent, normalizes the permeability of the vascular wall, improves microcirculation. Stimulates the formation of platelets and their release from the bone marrow. Increases platelet adhesion, stabilizes capillary walls, thus reducing their permeability, inhibits the synthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability, which shortens bleeding time and reduces blood loss. Increases the rate of formation of a primary thrombus and enhances its retraction, practically does not affect the concentration of fibrinogen in blood plasma and prothrombin time. With repeated use, thrombus formation increases.
Etamsylate practically does not affect the composition of peripheral blood, its proteins and lipoproteins. The erythrocyte sedimentation rate may decrease slightly. Reduces the release of fluid and diapedesis of blood corpuscles from the vascular bed, improves microcirculation. Does not have a vasoconstrictor effect.
Possessing antihyaluronidase activity and stabilizing ascorbic acid, it prevents destruction and promotes the formation of high molecular weight mucopolysaccharides in the capillary wall, increases capillary resistance, reduces their fragility, and normalizes permeability in pathological processes. This angioprotective effect is manifested in the treatment of various diseases associated with primary and secondary disorders of the microcirculation process.
Pharmacokinetics
After oral administration, the drug is rapidly and almost completely absorbed.
The maximum plasma concentration after administration of 500 mg is reached after 4 hours and is 15 ?g / ml.
Almost completely penetrates the placental barrier. It is not known whether etamsylate passes into breast milk. About 95% of etamsylate binds to blood plasma proteins.
Etamsylate is slightly metabolized.
The half-life after oral administration is about 3.7 hours.
About 72% of the drug is excreted by the kidneys within 24 hours unchanged.
Clinical studies on the use of etamsylate in patients with impaired liver and / or kidney function have not been conducted.

Indications for use

Prevention and treatment of capillary bleeding of various etiologies:
Х before and after surgery on all well-vascularized tissues in dental, otorhinolaryngological, gynecological, obstetric, urological, ophthalmological practice, plastic and reconstructive surgery;
Х hematuria, metrorrhagia, primary menorrhagia, menorrhagia in women with intrauterine contraceptives (in the absence of organic pathology), nosebleeds, bleeding gums, blood vomiting, melena.

Contraindications

Х Hypersensitivity to the components of the drug.
Х Acute porphyria.
Х Hemoblastosis in children (lymphoblastic and myeloblastic leukemia, osteosarcoma).
Х Thromboembolism, thrombosis.
Х Rare hereditary forms of lactose intolerance, lactase deficiency or malabsorption of glucose / galactose (because the composition contains lactose).
Х Children under 3 years of age (for this dosage form).

Carefully

History of thrombosis, thromboembolism; bleeding against the background of an overdose of anticoagulants, impaired liver and kidney function (there is no clinical experience of use).

Application during pregnancy and during breastfeeding

There are no clinical data regarding the possibility of using the drug Dicinon in pregnant women. The use of Dicinon during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.
There are no data regarding the excretion of etamsylate in breast milk.
Therefore, when using the drug during lactation, the issue of stopping breastfeeding should be resolved.

Method of administration and dosage

Inside.
The optimal daily dose of etamsylate for adults is 10-20 mg / kg of body weight per day, divided into 3-4 doses. In most cases, a single dose is 250-500 mg (1-2 tablets), if necessary, a single dose can be increased to 750 mg (3 tablets).
Adults and adolescents (over 12 years old, weighing more than 40 kg)
In the preoperative period, 250-500 mg (1-2 tablets) 1 hour before the operation.
In the postoperative period , 250-500 mg (1-2 tablets) every 4-6 hours until the risk of bleeding disappears.
To stop bleeding , 500 mg (2 tablets) every 8-12 hours (1000-1500 mg per day) with food or a little water.
In the treatment of metro and menorrhagia500 mg (2 tablets) 3 times a day (1500 mg per day) for 5-10 days.
Children 3 to 12 years old
Half adult dose.

Side effect

According to the World Health Organization (WHO), undesirable effects are classified according to their frequency of development as follows: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10000, <1/1000) and very rarely (<1/10000), including individual messages.
On the part of the digestive system,
often: nausea, diarrhea, discomfort in the epigastric region.
Skin and subcutaneous tissue disorders
often: skin rash;
frequency unknown: facial flushing.
On the part of the nervous system,
often: headache;
frequency unknown: dizziness, paresthesia of the lower extremities.
From the side of the cardiovascular system, it is
very rare:thromboembolism;
frequency not known: marked decrease in blood pressure.
From the side of the blood and lymphatic system is
very rare: agranulocytosis, neutropenia, thrombocytopenia.
From the side of the musculoskeletal system,
rarely: arthralgia.
From the side of the immune system,
very rarely: allergic reactions.
Other
often: asthenia;
very rare: fever.
The side effects that occur during treatment are usually reversible when the drug is discontinued.
In case of development of skin reactions or fever, it is necessary to discontinue therapy and inform the attending physician, as this may be a manifestation of a hypersensitivity reaction.

Overdose

To date, no cases of overdose have been described.
If an overdose has occurred, symptomatic therapy should be started.

Interaction with other medicinal products

There is still no data on the interaction of etamsylate with other drugs.
A combination with aminocaproic acid and menadione sodium bisulfite is possible.

special instructions

Before starting treatment, other causes of bleeding should be ruled out.
The drug is not effective in patients with thrombocytopenia.
For hemorrhagic complications associated with an overdose of anticoagulants, it is recommended to use specific antidotes.
The use of the drug Dicinon in patients with impaired indicators of the blood coagulation system is possible, but it should be supplemented by the administration of drugs that eliminate the identified deficiency or defect in the factors of the blood coagulation system.
Clinical studies on the use of the drug Dicinon in patients with impaired liver and kidney function have not been carried out, therefore, caution should be exercised when using etamsylate in this category of patients.
No special precautions are required when disposing of an unused medicinal product.

Influence on the ability to concentrate

No special precautions required.

Release form

Tablets 250 mg, 10 tablets in an aluminum / PVC / PVDC blister.
1, 2, 3, 5 or 10 blisters in a cardboard box along with instructions for use.

Storage conditions

Store at a temperature not exceeding 25 ? C, in a dry, dark place.
Keep out of the reach of children.

Shelf life

5 years.
Do not use after the expiration date.

Vacation conditions

On prescription.