Dicinone - instructions for use, dose, side effects, contraindications

Etamsylate is a hemostatic, antihemorrhagic and angioprotective agent, normalizes permeability of the vascular wall, improves microcirculation. Stimulates the formation of platelets and their exit from the bone marrow. Increases the adhesion of platelets, stabilizes the walls of capillaries, thus reducing their permeability, inhibits the synthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability, which reduces bleeding time and reduces blood loss. Increases the rate of formation of the primary thrombus and enhances its retraction, practically does not affect the concentration of fibrinogen in the blood plasma and prothrombin time. With repeated use, thrombus formation is intensified.

Etamsylate practically does not affect the composition of peripheral blood, its proteins and lipoproteins. The rate of erythrocyte sedimentation may decrease slightly.

Reduces the yield of fluid and diapedesis of blood elements from the vascular bed, improves microcirculation. Does not have vasoconstrictive action.

Having anti-hyaluronidase activity and stabilizing ascorbic acid,prevents destruction and promotes the formation in the capillary wall of mucopolysaccharides with a large molecular weight, increases the resistance of capillaries, reduces their "brittleness", normalizes permeability in pathological processes. This angioprotective action is manifested in the treatment of various diseases associated with primary and secondary disturbances of the microcirculation process.

Pharmacokinetics:

After ingestion, the drug is quickly and almost completely absorbed. The maximum concentration in plasma after application of 500 mg is achieved after 4 hours and is 15 μg / ml.

Virtually completely penetrates the placental barrier. It is not known whether the ethamylate in mother's milk. About 95% of etamzilate 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 etamzilate in patients with impaired liver and / or kidney function were not performed.

Indications:

Prevention and treatment of capillary bleeding of various etiologies:

- before and after surgical interventions on all well-vascularized tissues in dental, otorhinolaryngological, gynecological, obstetric, urological, ophthalmic practice, plastic and reconstructive surgery;

- hematuria, metrorrhagia, primary menorrhagia, menorrhagia in women with intrauterine contraceptives (in the absence of organic pathology), nosebleeds, bleeding gums, vomiting of blood, melena.

Contraindications:

- Hypersensitivity to the components of the drug;

- acute porphyria;

- hemoblastosis in children (lymphoblastic and myeloblastic leukemia, osteosarcoma);

- thromboembolism, thrombosis;

- rare hereditary forms of lactose intolerance, lactase deficiency or impaired absorption of glucose / galactose (because the composition contains lactose);

- Children under 3 years old (for this dosage form).

Carefully:

- A thrombosis, a thromboembolism in the anamnesis;

- bleeding against the background of an overdose of anticoagulants;

- a violation of the liver and kidneys (there is no clinical experience of use).

Pregnancy and lactation:

There are no clinical data on the possible use of Dicycin in pregnant women.Dicycin during pregnancy is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.

There is no data on the release of etamzilate in breast milk. Therefore, when using the drug during lactation, the question of stopping breastfeeding should be addressed.

Dosing and Administration:

Inside.

The optimal daily dose of etamzilate 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 teenagers (over 12 years old, weighing more than 40 kg)

In the preoperative period 250-500 mg (1-2 tablets) for 1 hour before surgery.

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 small amount of water.

When treating metro- and menorrhagia 500 mg (2 tablets) 3 times a day (1500 mg per day) for 5-10 days.

Children from 3 to 12 years old

Half the dose for adults.

Side effects:

According to the World Health Organization (WHO), unwanted 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.

From the digestive system

often: nausea, diarrhea, discomfort in the epigastric region.

From the skin and subcutaneous tissues

often: skin rash;

frequency is unknown: hyperemia of the facial skin.

From the nervous system

often: headache;

frequency is unknown: dizziness, paresthesia of the lower extremities.

From the side of the cardiovascular system

rarely: thromboembolism;

frequency not known: marked reduction in blood pressure.

On the part of the blood and lymphatic system

rarely: agranulocytosis, neutropenia, thrombocytopenia.

From the side of the musculoskeletal system

rarely: arthralgia.

From the immune system

rarely: allergic reactions.

Other

often: asthenia; rarely: fever.

The adverse events that arise during treatment are usually reversible upon cancellation of the drug.

In case of development of skin reactions or fever, it is necessary to stop therapy and inform the attending physician about this, 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, you need to start symptomatic therapy.

Interaction:

Until now, there is no data on the interaction of etamzilate with other drugs.

Possible combination with aminocaproic acid and menadione sodium bisulfite.

Special instructions:

Before starting treatment, other causes of bleeding should be ruled out.

The drug is not effective in patients with thrombocytopenia.

With hemorrhagic complications associated with an overdose anticoagulants, it is recommended to use specific antidotes. The use of Dicycin in patients with impaired blood coagulation is possible, but it should be supplemented by the introduction of drugs that eliminate the revealed deficiency or defect factors of the coagulation system.

Clinical studies on the use of Dicycin in patients with impaired liver and kidney function were not performed, so caution should be exercised when using etamzilate in this category of patients.

Special precautions for the destruction of unused a drug is not required.

Effect on the ability to drive transp. cf. and fur:

No special precautions are required.

Form release / dosage:Tablets, 250 mg.

Packaging:

For 10 tablets in a blister of aluminum / PVC / PVDC.

For 1, 2, 3, 5 or 10 blisters in a cardboard box together with instructions for use.

Storage conditions:

Store at a temperature of no higher than 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.

Terms of leave from pharmacies:On prescription

Registration number:П N013946 / 01

Date of registration:26.11.2007

The owner of the registration certificate: Lek dd Lek dd Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp05.10.2015

Illustrated instructions

Instructions

Dicycin (Dicynone)