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Dicinon® 250 mg/2 ml Solution for Injection Product Name Dicinon® International Nonproprietary Name Etamsylate/ETAMSYLATE Dosage Form Solution for Injection Composition Active substance: Etamsylate. 2 ml solution (one ampoule) contains 250 mg of Etamsylate. 1 ml solution contains 125 mg of Etamsylate. Excipients: Sodium metabisulfite (E223), sodium bicarbonate, water for injection. Description Colorless, transparent solution. Pharmacotherapeutic Group Hemostatic agents. Vitamin K and hemostatic agents. ATC code: B02BX01 See blog: Dicinon Annotation Made Easy: When to Use, How to Take, and What Side Effects It Can Cause Pharmacological Properties Pharmacodynamics Etamsylate is a synthetic hemostatic and angioprotective agent that acts at the initial stage of hemostasis (at the stage of interaction between endothelium and platelets). By improving platelet adhesion and restoring capillary resistance, it reduces bleeding time and blood loss volume. Etamsylate has no vasoconstrictive effect, it does not affect fibrinolysis or plasma coagulation factors. Pharmacokinetics A peak plasma level of 50 mcg/ml is observed 10 minutes after intravenous administration of a 500 mg dose of Etamsylate. When the same dose of Etamsylate is administered intramuscularly, a peak plasma level of 30 mcg/ml is observed one hour later. Plasma protein binding is approximately 95%. Etamsylate crosses the placental barrier. Similar drug levels are observed in maternal and umbilical cord blood. Whether Etamsylate penetrates into breast milk is unknown. Etamsylate is weakly metabolized. Etamsylate is mainly excreted by the kidneys, with 85% excreted unchanged. The plasma half-life is 2.1 hours (intramuscularly) and 1.9 hours (intravenously). Approximately 70-80% of the dose is excreted in the urine within the first 24 hours. Whether the pharmacokinetics of Etamsylate change in patients with impaired renal and/or hepatic function is unknown. Indications for Use - Prophylaxis of pre-, intra-, or postoperative capillary bleeding during complex surgeries or surgeries on well-vascularized tissues: in otorhinolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology, or plastic and reconstructive surgery. - Treatment of capillary bleeding of any origin and localization. - Prevention of periventricular hemorrhages in premature infants. Contraindications - Acute porphyria. - Bronchial asthma, hypersensitivity to sulfites. - Hypersensitivity to any component of the preparation. Precautions Due to the risk of blood pressure drop, caution should be exercised in patients with unstable blood pressure or hypotension during parenteral administration (see "Side Effects"). The preparation contains sodium metabisulfite, which can cause allergic reactions, nausea, and diarrhea in sensitive patients. Allergic reactions can be severe, even leading to anaphylactic shock, and can cause life-threatening asthma attacks. The prevalence of such allergic reactions is unknown, but is likely not high. Patients with bronchial asthma are more frequently hypersensitive to sulfites than individuals without this condition (see "Contraindications"). In case of hypersensitivity reactions, administration of the preparation should be immediately discontinued. In case of skin reactions or increased temperature, treatment should be discontinued and the attending physician should be notified, as similar symptoms may be signs of a hypersensitivity reaction. If the preparation is prescribed to reduce excessive and/or prolonged menstrual bleeding and the desired effect is not achieved, the existence of other pathology that can cause such a condition should be ruled out. Children The preparation is suitable for use in children at recommended doses. The preparation can be prescribed to premature infants for the prevention of periventricular hemorrhages. See "Method of Administration and Dosage" for dosage recommendations. Patients with Renal Impairment The safety and efficacy of Etamsylate treatment in patients with renal impairment have not been studied. Since Etamsylate is completely excreted by the kidneys, dose reduction may be necessary in case of renal impairment. Laboratory Test Results Etamsylate used at therapeutic doses may affect the results of enzymatic determination of creatinine, leading to a decrease in values. To rule out any influence of the preparation on laboratory parameters, baseline analyses (e.g., blood tests) that will be needed during treatment should be performed before the first use of Dicinon. Pregnancy and Lactation Data on the use of the preparation by pregnant women are limited. Animal experiments have not revealed any direct or indirect toxicity affecting reproductive function. As a precautionary measure, it is best to avoid the use of the preparation during pregnancy. Due to the lack of data on the preparation's ability to penetrate breast milk, breastfeeding is not recommended during treatment. If breastfeeding continues, the use of the preparation should be discontinued. Effect on Ability to Drive and Use Machines No effect. Method of Administration and Dosage Adults and Adolescents Before surgery: 1-2 ampoules intravenously or intramuscularly one hour before surgical intervention. During surgery: 1-2 ampoules intravenously, repeated as needed. After surgery: 1-2 ampoules, repeated every 4-6 hours, for as long as the risk of bleeding persists. In emergencies and depending on the severity of the condition: 1-2 ampoules intravenously or intramuscularly, repeated every 4-6 hours until the risk of bleeding is eliminated. Local use: Moisten a gauze pad with the contents of one ampoule and apply to the bleeding area or into the socket after tooth extraction. Repeat application if necessary. Combination with oral or parenteral administration is possible. Children Half the adult dose. Newborns 10 mg per kg of body weight (0.1 ml = 12.5 mg) by intramuscular injection within the first 2 hours of birth, then every 6 hours for 4 days. Patients with Hepatic or Renal Impairment Clinical studies have not been conducted in patients with hepatic or renal impairment. Therefore, caution should be exercised when prescribing Dicinon solution for injection to such patients. The solution for injection is not compatible with solutions containing sodium bicarbonate or lactate. Dicinon solution cannot be mixed with other medicinal products in the same syringe. If the preparation is mixed with physiological saline, it should be used immediately. Side Effects The following side effects have been observed with the use of Etamsylate. Very common (≥ 1/10), Common (≥ 1/100, < 1/10), Uncommon (≥ 1/1,000, < 1/100), Rare (≥ 1/10,000, < 1/1,000), Very rare (< 1/10,000), Frequency unknown (cannot be determined from available data). Gastrointestinal disorders Common: Nausea, diarrhea, abdominal discomfort. Rare: Bitter taste. Skin and subcutaneous tissue disorders Common: Rash. General disorders and administration site conditions Common: Asthenia. Very rare: Fever. Nervous system disorders Common: Headache. Vascular disorders Very rare: Thromboembolism, arterial hypotension. Blood and lymphatic system disorders Very rare: Agranulocytosis, neutropenia, thrombocytopenia. Musculoskeletal and connective tissue disorders Rare: Joint pain, back/lumbar pain. Immune system disorders Very rare: Hypersensitivity, anaphylactic shock. Metabolism and nutrition disorders Very rare: Acute porphyria. These reactions are usually reversible after discontinuation of treatment. If side effects worsen or if side effects not listed in these instructions occur, inform your doctor or pharmacist. Overdose No cases of overdose have been reported. Standard medical measures are used for the treatment of overdose. Interactions with Other Medicinal Products The contents of the ampoule cannot be mixed with other medicinal products in the same syringe. The solution for injection is not compatible with solutions containing sodium bicarbonate or lactate. If the preparation is mixed with physiological saline, it should be used immediately. The sulfite present in the preparation inactivates thiamine (vitamin B1). If dextran infusion is required, Dicinon should be administered beforehand. Packaging 2 ml solution in Type I colorless glass ampoules. 50 ampoules in a package with instructions for use. Storage Conditions Keep out of reach of children. Store at a temperature not exceeding 25 °C, protected from light. Shelf Life 5 years. Do not use after the expiry date indicated on the packaging and ampoule. The expiry date expires on the last day of the specified month. Do not use the preparation if the contents of the ampoule have become discolored. Conditions of Sale Pharmaceutical product group II, dispensed with prescription form №3.
