Etamsylate-kv
Ukraine
Table of Contents
I N S T R U C T I O N for medical use of the medicinal product ETAMSYLATE-KV (ETAMSYLATE-KV)
Composition:
Active substance: 1 tablet contains 250 mg of etamsylate;
Excipients: lactose monohydrate; corn starch; citric acid monohydrate; povidone; magnesium stearate.
Pharmaceutical form. Tablets.
Main physicochemical properties: white or almost white, round-shaped tablets with a double-convex surface. Marbling on the tablet surface is permissible.
Pharmacotherapeutic group. Antihemorrhagic agents. Other systemic hemostatic agents. ATC code B02B X01.
Pharmacological Properties.
Pharmacodynamics.
Etamsylate is a hemostatic agent used for the prevention and control of bleeding. It acts on the first stage of the hemostasis mechanism (the interaction between endothelium and platelets). The drug enhances platelet adhesiveness, normalizes capillary wall resistance, thereby reducing capillary permeability, and inhibits the biosynthesis of prostaglandins that cause platelet disaggregation, vasodilation, and increased capillary permeability. As a result, bleeding time is significantly reduced and blood loss is diminished.
Pharmacokinetics.
Etamsylate is almost completely absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 4 hours after administration. Approximately 95% of the drug is bound to plasma proteins.
About 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.
Clinical characteristics.
Indications.
Prevention and control of hemorrhages in superficial and internal capillaries of various etiologies, especially when bleeding is caused by endothelial damage:
- prevention and treatment of bleeding during and after surgical procedures in otorhinolaryngology, 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 contraceptive devices, epistaxis, gingival bleeding.
Contraindications.
Hypersensitivity to etamsylate or to any other component of the medicinal product. Acute porphyria, increased blood coagulation, thrombosis, thromboembolism. Hemoblastosis (lymphatic and myeloid leukemia, osteosarcoma) in children.
Interaction with other medicinal products and other forms of interaction.
Administration of etamsylate prior to dextrans (e.g. reopoliglucin) prevents their anti-aggregant effect; when administered after dextrans, it does not exert a hemostatic effect. Interaction with aminocaproic acid and vikasol is permissible.
Special precautions for use.
Use with caution in patients who have previously experienced thrombosis or thromboembolic events. The medicinal product is ineffective in cases of reduced platelet count.
In hemorrhagic complications associated with anticoagulant overdose, specific antidotes are recommended.
Before initiating treatment, other causes of bleeding should be ruled out.
If Etamzilat-KV is used to reduce excessive and/or prolonged menstrual bleeding and improvement is not observed, possible pathological causes should be excluded (e.g., presence of uterine fibroids).
If skin reactions or fever occur, treatment should be discontinued and a physician should be notified, as these may be signs of hypersensitivity.
The medicinal product contains lactose; therefore, it should not be administered to patients with rare hereditary disorders of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.
Use in patients with renal impairment.
The safety and efficacy of etamsilate have not been studied in patients with renal impairment. Since etamsilate is almost entirely excreted by the kidneys, the dose of the medicinal product should be reduced in cases of renal insufficiency.
Laboratory tests.
At therapeutic doses, etamsilate may reduce serum creatinine levels in laboratory tests.
Use during pregnancy or breastfeeding.
There are no reliable data on the effects of the medicinal product on the fetus during pregnancy.
The medicinal product is contraindicated during the first trimester of pregnancy. During the second and third trimesters of pregnancy, the medicinal product may be used only if the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding should be discontinued during treatment with this medicinal product.
Ability to influence reaction speed when driving or operating machinery.
No significant effect; however, dizziness may occur during treatment, which should be taken into account when driving or operating machinery.
Method of administration and doses.
For oral use. Take the tablets during or after meals with a small amount of water.
The usual daily dose for adults is 2 tablets 2–3 times a day (1000–1500 mg).
Before surgery, administer 1–2 tablets (250–500 mg) 1 hour prior to the procedure.
After surgery, administer 1–2 tablets (250–500 mg) every 4–6 hours until the risk of bleeding has subsided.
For menorrhagia, take 2 tablets 3 times a day (1500 mg) for 10 days, starting on the 5th day before the expected onset of menstruation until the 5th day of the following menstrual cycle.
The daily dose for children is half the adult dose. To ensure appropriate dosing in children, other dosage forms of ethamsylate should be used.
The medicinal product should be administered with caution to patients with hepatic or renal insufficiency.
Children.
The medicinal product can be administered to children aged 6 years and older. Do not administer to children with hemoblastosis.
Overdose.
Data are lacking. In case of overdose, symptomatic treatment should be applied.
Adverse Reactions.
Central nervous system: headache, dizziness, hot flushes, paresthesia of the lower limbs.
Gastrointestinal system: nausea, vomiting, diarrhea, abdominal discomfort.
Immune system: hypersensitivity, allergic reactions, skin rashes, urticaria, pruritus; one case of angioneurotic edema has been reported.
Musculoskeletal system: arthralgia.
Blood and lymphatic system: agranulocytosis, neutropenia, thrombocytopenia.
Vascular system: thromboembolism.
Other: asthenia, fever, acute porphyria.
All adverse effects are mild and transient.
In children treated with ethamsylate to prevent bleeding in acute lymphatic and myeloid leukemia, severe leukopenia was more frequently observed.
Shelf life. 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 per blister; 5 blisters per carton.
Prescription status. Prescription only.
Manufacturer. JSC "KYIV VITAMIN PLANT".
Manufacturer’s address and location of its business activities.
38 Kopilivska Street, Kyiv, 04073, Ukraine.
Web-site: www.vitamin.com.ua.
INSTRUCTION
for medical use of the medicinal product
ETHAMSYLATE-KV
(ETAMSYLATE-KV)
Composition:
Active ingredient: 1 tablet contains ethamsylate 250 mg;
Excipients: lactose monohydrate; corn starch; citric acid monohydrate; povidone; magnesium stearate.
Pharmaceutical form. Tablets.
Main physicochemical properties: white or almost white, round, biconvex tablets. Marbling on the tablet surface is permissible.
Pharmatherapeutic group. Antihemorrhagic agents. Other systemic hemostatics. ATC code B02BX01.
Pharmacological properties.
Pharmacodynamics.
Ethamsylate is a drug used to prevent and stop bleeding. It acts on the first stage of the hemostasis mechanism (interaction between endothelium and platelets).
The drug enhances platelet adhesion, normalizes capillary wall resistance thereby reducing their permeability, and inhibits the biosynthesis of prostaglandins, which cause platelet disaggregation, vasodilation, and increased capillary permeability. As a result, bleeding time is significantly reduced and blood loss is decreased.
Pharmacokinetics.
Ethamsylate is almost completely absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 4 hours after administration. Approximately 95% of the drug binds to plasma proteins.
About 72% of the administered dose is excreted unchanged in the urine within the first 24 hours. Ethamsylate crosses the placental barrier. It is unknown whether ethamsylate passes into breast milk.
Clinical characteristics.
Indications.
Prevention and control of hemorrhages in superficial and internal capillaries of various etiologies, especially when bleeding is due to endothelial damage:
- Prevention and treatment of bleeding during and after surgical procedures in otorhinolaryngology, 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 contraceptive devices, epistaxis, gingival bleeding.
Contraindications.
Hypersensitivity to ethamsylate or to any other component of the medicinal product. Acute porphyria, increased blood coagulability, thrombosis, thromboembolism. Hemoblastosis (lymphatic and myeloid leukemia, osteosarcoma) in children.
Interaction with other medicinal products and other forms of interaction. Administration of ethamsylate before infusion of dextrans (e.g. reopoliglucin) prevents their anti-aggregatory effect; if administered after dextrans, ethamsylate has no hemostatic effect. Concomitant use with aminocaproic acid and vitamin K1 (vikasol) is acceptable.
Special precautions.
Use with caution in patients with a history of thrombosis or thromboembolism. The drug is ineffective in patients with low platelet count.
In hemorrhagic complications related to anticoagulant overdose, specific antidotes should be used.
Before initiating treatment, other causes of bleeding should be ruled out.
If Ethamsylate-KV is used to reduce excessive and/or prolonged menstrual bleeding and no improvement is observed, possible pathological causes (e.g. uterine fibroids) should be excluded.
If skin reactions or fever occur, treatment should be discontinued and a physician should be consulted, as these may be signs of hypersensitivity.
The drug contains lactose and therefore should not be administered to patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.
Use in patients with renal impairment.
The safety and efficacy of ethamsylate have not been studied in patients with renal impairment. Since ethamsylate is almost entirely excreted by the kidneys, the dose should be reduced in patients with renal insufficiency.
Laboratory tests.
At therapeutic doses, ethamsylate may reduce serum creatinine test values.
Use during pregnancy or breastfeeding.
There are no reliable data on the effect of the drug on the fetus during pregnancy. The drug is contraindicated during the first trimester of pregnancy. In the second and third trimesters, the drug may be used only if the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding should be discontinued during treatment with this medicinal product.
Ability to affect reaction speed when driving or operating machinery.
No significant effect; however, dizziness may occur during treatment, which should be taken into account when driving or operating machinery.
Administration and dosage.
Oral use. Tablets should be taken during or after meals with a small amount of water.
The usual daily dose for adults is 2 tablets 2–3 times daily (1000–1500 mg).
Before surgery: 1–2 tablets (250–500 mg) should be taken 1 hour before the procedure.
After surgery: 1–2 tablets (250–500 mg) every 4–6 hours until the risk of bleeding has passed.
For menorrhagia: 2 tablets 3 times daily (1500 mg) for 10 days, starting on the 5th day before the expected onset of menstruation until the 5th day of the next menstrual cycle.
The daily dose for children is half the adult dose. For appropriate pediatric dosing, other dosage forms of ethamsylate should be used.
The drug should be used with caution in patients with hepatic or renal impairment.
Children.
The drug is indicated for children aged 6 years and older. Should not be administered to children with hemoblastosis.
Overdose.
No data available. In case of overdose, symptomatic treatment is recommended.
Adverse reactions.
Nervous system: headache, dizziness, hot flushes, paresthesia of the lower limbs.
Gastrointestinal system: nausea, vomiting, diarrhea, abdominal discomfort.
Immune system: hypersensitivity, allergic reactions, skin rash, urticaria, pruritus; one case of angioneurotic edema has been reported.
Musculoskeletal system: arthralgia.
Blood and lymphatic system: agranulocytosis, neutropenia, thrombocytopenia.
Vascular system: thromboembolism.
Other: asthenia, fever, acute porphyria.
All adverse effects are mild and transient.
In children treated with ethamsylate to prevent bleeding in acute lymphatic and myeloid leukemia, severe leukopenia was more frequently observed.
Shelf life. 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 per blister; 5 blisters per carton.
Prescription status. Prescription only.
Manufacturer. JSC "KYIV VITAMIN PLANT".
Manufacturer’s address and location of its business activities.
38 Kopilivska Street, Kyiv, 04073, Ukraine.
Web-site: www.vitamin.com.ua.