Epadel Eicosapentaenoic Acid Ethyl Ester Capsules S900 84 Packs Epadel Capsule 900

The main ingredient of Epadel Eicosapentaenoic Acid Ethyl Ester Capsules is eicosapentaenoic acid ethyl ester (EPA ethyl ester), which belongs to the class of unsaturated fatty acid drugs. Its mechanism of action is mainly to inhibit the synthesis of triglycerides and promote their metabolism, thereby reducing the level of triglycerides in the blood. At the same time, it may have certain effects in resisting platelet aggregation and improving vascular endothelial function. It is mainly used clinically to treat hypertriglyceridemia, and can also be used as an adjuvant treatment for cardiovascular diseases such as coronary heart disease to reduce the risk of cardiovascular events.

1. Basic information of the drug

1. Common name : Ethyl Icosapentate

2. English name : EPADEL S Capsules 300/600/900 (corresponding to various specifications)

3. Product name : Edotron S300, Edotron S600, Edotron S900

4. Dosage form : slightly yellow transparent soft capsule, spherical with a diameter of about 4mm, and the sub-packaging labels are MO209 (S300), MO20A (S600), and MO20D (S900).

5. Ingredients : Active ingredient: Each pack contains 300mg, 600mg, and 900mg of icosapent acid ethil;

a. Additives: The content contains Tetrafluoroethylene, and the capsule contains Tetrafluoroethylene, D-Tetrafluoroethylene, etc.

6. Storage and shelf life : Store at room temperature, shelf life is 3 years; avoid high temperature, moisture and light after opening.

2. Indications

1. Improvement of ulcers, pain and cold sensation associated with occlusive arteriosclerosis.

2. Hyperlipidemia.

3. Usage and Dosage

1. Occlusive arteriosclerosis : Take icosapote ethil as an adult: 600 mg each time, 3 times a day, orally immediately after each meal (adjustable according to age and symptoms).

2. Hyperlipidemia : usually 900 mg twice a day or 600 mg three times a day, taken after meals; when triglyceride is abnormal, the dosage can be increased to 900 mg three times a day.

4. Taboos

1. Patients with bleeding (such as hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract bleeding, etc.): may cause difficulty in stopping bleeding.

2. Patients who are using Mifepristone and Misoprostol: Uterine bleeding may be aggravated (the antiplatelet effect of this drug increases the risk of bleeding).

5. Notes

1. Special populations :

a. Pregnant women: Use only when the benefits of treatment outweigh the risks.

b. Breastfeeding women: The nutritional benefits of treatment and breast milk need to be weighed. Animal experiments show that the ingredients can enter breast milk.

c. Children: No clinical studies on effectiveness and safety have been conducted.

d. Those with bleeding tendency (menstrual period, before surgery, etc.): The risk of bleeding needs to be closely monitored.

e. Patients with liver/renal dysfunction: Regular check-ups are required (may affect metabolism or excretion).

2. Medication instructions :

a. It must be taken after meals (empty stomach affects absorption) and should not be chewed.

b. Treatment of hyperlipidemia requires diet and exercise therapy first, and control of cardiovascular risk factors such as hypertension and smoking.

c. Regularly test blood lipid levels, and stop taking the medication and change the treatment if it is ineffective; Treatment of occlusive arteriosclerosis requires regular blood tests, and change the medication in a timely manner if it is ineffective.

VI. Adverse Reactions

1. Serious side effects :

a. Liver dysfunction, jaundice (elevated AST/ALT, bilirubin, etc., frequency unknown).

b. Atrial fibrillation, atrial flutter (overseas high-dose studies have shown an increased risk, and the maximum approved daily dose of this drug is 2700 mg).

2. Other common side effects :

a. Allergic reaction: rash, itching (0.1~5%).

b. Bleeding tendency: subcutaneous bleeding (0.1~5%), hematuria, gingival bleeding, etc. (frequency unknown).

c. Digestive system: nausea, abdominal pain, diarrhea, etc. (0.1~5%).

d. Abnormal liver and kidney function indicators: increased AST/ALT, increased BUN/creatinine, etc. (0.1~5%).

7. Drug Interactions

1. Concomitant use is prohibited : Mitsubishi Materia Medica (increases the risk of bleeding).

2. Use with caution : Anticoagulants (such as warfarin) and antiplatelet drugs (such as aspirin, Indolemethacin): They may additively enhance bleeding tendency (because this drug has antiplatelet effects).

8. Pharmacokinetics

1. Absorption : Peak blood concentration is reached about 6 hours after taking the drug for a meal, and steady state is reached in about 1 week.

2. Distribution : Mainly distributed in liver, white fat, muscle and skin, plasma protein binding rate 86.7~98.8% (rats), 96.7~98.7% (dogs).

3. Metabolism : Deethylated to EPA in the small intestine, metabolized to acetyl CoA via β-oxidation, and participates in the TCA cycle.

4. Excretion : Within 168 hours after administration, 2.7% is excreted via urine, 16.7% via feces, and 44.4% via exhaled air.

IX. Clinical Results

1. Occlusive arteriosclerosis : Domestic Phase III trials showed that the rate of "more than effective" for improving ulcers and pain at a dose of 1800 mg/day was 55.9%, the rate of "slightly more than effective" was 88.2%, and the incidence of side effects was 6.9% (mainly digestive symptoms).

2. Hyperlipidemia : Long-term use can reduce serum total cholesterol (3~6%) and triglycerides (14~20%) with stable effects.

a. Domestic trials have shown that for patients with high triglycerides, the efficacy of dosing twice or three times a day is equivalent (non-inferior), and the incidence of side effects is about 3.7~3.8% (mainly constipation, increased ALT, etc.).

3. Combination therapy : Combination with statins can reduce cardiovascular events (JELIS study showed a 19% risk reduction).

10. Production Information

● Manufacturer and distributor: Mochida Pharmaceutical Co., Ltd.

● Packaging: Structural packaging (S300: 84 packages, 420 packages; S600: 84 packages, 420 packages; S900: 56 packages, 84 packages, 420 packages).