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Japan Selara Eplerenone (Selara Tablets): 100 tablets Premium Antihypertensive Medication Hypertension Myocardial Ischemia Chronic Heart Failure Cardiovascular

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Direct overseas shipping (Direct shipping from Japan)

Eplerenone Serala Tablets
Selara® Tablets
25 mg / 50 mg / 100 mg

Package Insert No. 2149045F1029_4_09 | Company Code 671450
May 2025 (9th Edition) / Revised March 2026 (10th Edition)

Eplerenone | Hypertension | Chronic Heart Failure

Selara Eplerenone Selara Tablets

Product Details / Approvals, etc.

Japan Standard Commodity Classification Code 872149
Pharmacological Classification Name Selective mineralocorticoid receptor antagonists
Generic Name / Standard Name Eplerenone / Eplerenone Tablets
Eplerenone
25mg Serala Tablets 25 mg YJ 2149045F1029
Approved 21900AMY00033; Sales began in November 2007
50mg Serala Tablets 50 mg YJ 2149045F2025
Approved 21900AMY00031; Sales began in November 2007
100mg Serala Tablets 100 mg YJ 2149045F3021
Approved 21900AMY00032 Sales began in November 2007
Storage Instructions / Expiration Date Store at room temperature / 3 years
Regulatory Classification –
Manufacturing and Sales Yuan Viatris Pharmaceuticals, LLC
1-3-1 Azabudai, Minato Ward, Tokyo
Packaging 25 mg: 100 PTP tablets
50 mg: PTP 100/700 tablets, bottle of 500 tablets
100 mg: PTP 100 tablets
Shipping method Direct overseas shipping (Direct shipping from Japan)
Preparation and shipping time After verifying payment and prescription eligibility,
Orders are typically shipped within 4 to 7 business days.

1. Specifications and Properties (3.2)

Strengths: 25 mg, 50 mg, 100 mg
Identification: VLE/NSR25, VLE/NSR50, VLE/NSR100
Diameter: / Thickness / Weight, 5.6 mm / 3.3 mm / 89 mg, 7.1 mm / —, —
Color: Yellow film-coated tablets, film-coated tablets

2. Composition and Physical and Chemical Properties (3.1/19.)

1 tablet of Eprelenone (China National Pharmaceutical Group) 25.00/50.00/100.00 mg.

C24H30O6 Molecular weight: 414.49. A white crystalline powder with multiple crystalline forms.

Structural Formula

3. Mechanism of Action (18.)

Selectively binds to the mineralocorticoid receptor to block aldosterone. Its affinity for glucocorticoid, androgen, and progesterone receptors is less than 1/20 that for the mineralocorticoid receptor. It lowers blood pressure by blocking the effects of aldosterone in non-epithelial tissues such as the kidneys, heart, blood vessels, and brain; it also improves cardiac function and inhibits remodeling in animal models of heart failure. It may cause a sustained increase in plasma renin activity and serum aldosterone levels, but this does not diminish the drug’s efficacy.

4. Indications and Usage

Hypertension:Approved in China: 50–100 mg once daily.

Chronic heart failure (systolic dysfunction, NYHA Class II–IV):Added to standard therapy. Treatment is typically initiated at 25 mg once daily (25 mg every other day for eGFR 30–<50), adjusted according to serum potassium levels; for eGFR ≥50, the dose should not exceed 50 mg/day, and for eGFR 30–<50, it should not exceed 25 mg/day.

PK

5. Contraindications and Precautions (2.)

"Adaptation (General)"

  1. Allergy to any ingredient in this product
  2. Hyperkalemia, or an initial serum potassium level > 5.0 mEq/L
  3. Severe renal impairment (Ccr < 30 mL/min)
  4. Severe hepatic impairment (Child-Pugh Class C)
  5. Currently taking a potassium-sparing diuretic or a mineralocorticoid receptor antagonist
  6. Currently taking itraconazole, voriconazole, posaconazole, ritonavir-containing formulations, cobicistat-containing formulations, ceritinib, ensitrelvir fumarate, or lonafarnib

"Hypertension"

  1. Patients with diabetes who have microalbuminuria or proteinuria
  2. Moderate or severe renal impairment (Ccr < 50 mL/min)
  3. Currently taking potassium supplements (except for potassium iodide used for thyroid protection or to reduce radioactive iodine)

Major side effects include hyperkalemia, headache, dizziness, and nausea. Serum potassium levels must be monitored. For detailed contraindications regarding drug interactions and dosage adjustments, refer to the original Japanese version.

6. Clinical Summary

Chronic Heart Failure EMPHASIS-HF:Cardiovascular death or hospitalization for heart failure: HR 0.63 [0.54–0.74] (p < 0.0001). In the domestic J-EMPHASIS-HF study: HR 0.85 [0.53–1.36].

Hypertension can be treated with this medication alone or in combination with ACE inhibitors, ARBs, CCBs, or beta-blockers; the approved dosage in China is 50–100 mg per day.

22–26. Other Official Information

22. 25 mg PTP 100 tablets; 50 mg PTP 100/700 tablets, bottle of 500 tablets; 100 mg PTP 100 tablets

24. Viatris Pharmaceuticals LLC, Medical Information Department, Toll-Free: 0120-419-043

26. Manufacturer and Distributor: ViaTis Pharmaceuticals LLC, 1-3-1 Azabudai, Minato-ku, Tokyo

※ This page was translated by Hkeemall based on PMDA Package Insert 2149045F1029_4_09; it is not a substitute for a doctor's prescription or the original Japanese version.
Enter "Serala" in the PMDA "Package Insert Information" field to search for the original version.

[Disclaimer]

  1. The information regarding medications, treatments, or health management contained in this article is compiled from international authoritative medical journals and official clinical literature, and is intended for general science and educational reference only.
  2. The indications, side effects, and contraindications of related medications may vary depending on national regulations and individual physical conditions. Do not blindly take medication on your own or change your treatment plan.
  3. The author and publishing platform assume no legal liability for any medical delays, adverse reactions, or direct or indirect losses caused by the use of the information in this article. All medical decisions should be discussed with your attending physician before being made.

Additional information

Specifications

Pfizer Eplerenone Serala Tablets 50 mg

1 review for 日本 Selara 依普利酮 Eplerenone セララ錠:100錠 高級降壓藥 高血壓 心肌缺血 慢性心肌不全 心血管

5.00

Average of 1 review

  1. dicedice Lai –

    Both blood pressure and heart rate have stabilized completely, my heart doesn't feel as tired, and I feel much more energetic after taking it. Truly a high-quality blood pressure medication!

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