Instructions for use Etamzilat-KV tablets 250 mg blister No. 50
Composition
active ingredient: 1 tablet contains etamzilate 250 mg;
Excipients: lactose, monohydrate; corn starch; citric acid, monohydrate; povidone; magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round tablets with a biconvex surface of white or almost white color. Marbling is allowed on the surface of the tablet.
Pharmacotherapeutic group
Antihemorrhagic agents. Other hemostatic agents for systemic use. ATX code B02B X01.
Pharmacological properties
Pharmacodynamics
Etamzilat is a means for preventing and stopping bleeding. It affects the first stage of the hemostasis mechanism (interaction between the endothelium and platelets). The drug increases platelet adhesion, normalizes the stability of capillary walls, thereby reducing their permeability, inhibits the biosynthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability. As a result, bleeding time is significantly reduced, blood loss is reduced.
Pharmacokinetics
Etamsylate is almost completely absorbed from the gastrointestinal tract, reaching peak serum concentrations 4 hours after administration. Approximately 95% of the drug is bound to plasma proteins.
Approximately 72% of the administered dose is excreted unchanged in the urine within the first 24 hours. Etamsylate crosses the placental barrier. It is unknown whether etamsylate is excreted in breast milk.
Indication
Prevention and control of hemorrhages in superficial and internal capillaries of various etiologies, especially if the bleeding is caused by endothelial damage:
prevention and treatment of bleeding during and after surgical operations in otolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology and plastic surgery; prevention and treatment of capillary bleeding of various etiologies and localizations: hematuria, metrorrhagia, primary hypermenorrhea, hypermenorrhea in women with intrauterine contraceptives, nosebleeds, bleeding gums.
Contraindication
Hypersensitivity to etamzilate or to any other component of the drug. Acute porphyria, increased blood clotting, thrombosis, thromboembolism. Hemoblastosis (lymphatic and myeloid leukemia, osteosarcoma) in children.
Interaction with other medicinal products and other types of interactions
Taking etamsylate before the administration of dextrans (e.g., rheopoliglyukin) prevents their antiplatelet effect, and after the administration of the latter, it does not have a hemostatic effect. Interaction with aminocaproic acid, vikasol is possible.
Application features
Use with caution in patients with a history of thrombosis or thromboembolism. The drug is ineffective in cases of low platelet count.
In case of hemorrhagic complications associated with anticoagulant overdose, it is recommended to use specific antidotes.
Other causes of bleeding should be ruled out before starting treatment.
If Etamsylate-KV is used to reduce excessive and/or prolonged menstrual bleeding and no improvement is observed, possible pathological causes (e.g., the presence of uterine fibroids) should be excluded.
In case of skin reactions or fever, treatment should be discontinued and a doctor should be informed, as this may be a sign of hypersensitivity.
The medicinal product contains lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Use in patients with renal failure.
The safety and efficacy of etamzilate have not been studied in patients with renal insufficiency. Since etamzilate is almost completely excreted by the kidneys, the dose of the drug should be reduced in cases of renal insufficiency.
Laboratory tests.
In therapeutic doses, etamzilate may reduce the test results for determining creatinine levels.
Ability to influence reaction speed when driving vehicles or other mechanisms
It has no effect, but dizziness may occur when using the drug, which should be taken into account when driving or working with other mechanisms.
Use during pregnancy or breastfeeding
There is no reliable data on the effect of the drug on the fetus during pregnancy.
The drug is contraindicated in the 1st trimester of pregnancy. In the 2nd and 3rd trimesters of pregnancy, the use of the drug is possible if the benefit to the mother outweighs the risk to the fetus.
Breastfeeding should be discontinued when using the drug.
Method of administration and doses
For oral use. Take the tablets during or after meals, with a small amount of water.
The daily dose for adults is usually 2 tablets 2–3 times a day (1000–1500 mg).
Before surgery, take 1–2 tablets (250–500 mg) 1 hour before surgery.
For menorrhagia, take 2 tablets 3 times a day (1500 mg) for 10 days, starting from the 5th day of the expected onset of menstruation until the 5th day of the next menstrual cycle.
The daily dose for children is half the adult dose. Other dosage forms of etamzilate are used to maintain the appropriate dose for children.
The drug should be used with caution in patients with hepatic or renal insufficiency.
Children
The drug should be used in children over 6 years of age. Do not prescribe to children with hemoblastosis.
Overdose
No data available. In case of overdose, treatment is symptomatic.
Adverse reactions
From the nervous system: headache, dizziness, hot flashes, paresthesia of the lower extremities.
On the part of the digestive system: nausea, vomiting, diarrhea, abdominal discomfort.
On the part of the immune system: hypersensitivity, allergic reactions, skin rashes, urticaria, itching, a case of angioedema has been described.
Musculoskeletal system: arthralgia.
From the side of the circulatory and lymphatic system: agranulocytosis, neutropenia, thrombocytopenia.
Vascular disorders: thromboembolism.
Others: asthenia, fever, acute porphyria.
All side effects are mild and transient.
Severe leukopenia was more common in children treated with etamsylate to prevent bleeding in acute lymphoblastic and myeloid leukemia.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister, 5 blisters in a pack.
Vacation category
According to the recipe.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
