Kowa (Japan) Parmodia (PemaBet) Parmodia Tablets 0.1 mg: 100 tablets—Reduces triglyceride levels in non-familial hypertriglyceridemia

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PemaBet Palmodia Tablets 0.1 mg
PARMODIA® Tablets 0.1 mg

Package Insert No. 2183007F1025_1_14 | Company Code 270072
November 2023 (1st Edition) / Revised August 2024 (2nd Edition)

Pemafibrate | Selective PPARα Modulator | Hyperlipidemia (including familial)

PemaBet Palmodia Tablets 0.1 mg

Product Details / Approvals, etc.

Japan Standard Commodity Classification Code 872183
Pharmacological Classification Name Hyperlipidemia Treatment Agents
General Name Pemafibrate
Pemafibrate
Specifications Parmodia Tablets 0.1 mg / PARMODIA TABLETS 0.1 mg
YJ 2183007F1025
Approved 22900AMX00581
On Sale: June 2018
Storage Instructions / Expiration Date Store at room temperature / 3 years
Regulatory Classification –
Manufacturing and Sales Yuan Xinghe Co., Ltd.
4-14, Nihonbashi-Honcho 3-chome, Chuo Ward, Tokyo
Packaging PTP 100/500/1,000 tablets; bulk bottle of 500 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. Conditions for Recognition

A drug risk management plan must be developed and properly implemented.

2. Composition and Properties (3.)

Each tablet contains 0.10 mg of pemafibrate. White, round, scored, film-coated tablets labeled “Palmodia 0.1.” Diameter: 7.1 mm; thickness: 2.9 mm; weight: 125 mg.

3. Mechanism of Action (18.)

Pemafibrate binds to and selectively activates PPARα, regulates target genes, reduces plasma TG, and increases HDL-C. It inhibits hepatic TG synthesis and secretion, increases LPL activity, reduces ApoC-III/ANGPTL3, promotes fatty acid β-oxidation and TG clearance, and increases FGF21.

Structural Formula

C28H30N2O6 Molecular weight: 490.55; Melting point: 95–101°C

4. Indications and Dosage (4.–7.)

Indications:Hyperlipidemia (including familial hyperlipidemia). This product is not the first-line treatment for patients with elevated LDL-C alone. A thorough evaluation and confirmed diagnosis are required prior to use.

Directions:The usual adult dose of pemafibrate is 0.1 mg twice daily, taken orally in the morning and evening. The dose may be adjusted based on age and symptoms, up to a maximum of 0.2 mg twice daily.

When eGFR is <30 mL/min/1.73 m², start with a low dose, reduce the dose, or extend the dosing interval; the maximum daily dose is 0.2 mg.

5. Contraindications and Precautions (2./8./9./10.)

  1. Allergy to any ingredient in this product
  2. Severe hepatic impairment, Child-Pugh Class B/C cirrhosis, or biliary obstruction
  3. Gallstones
  4. Pregnant women or women who may be pregnant
  5. Currently taking cyclosporine and rifampicin

Begin with dietary therapy, and consider exercise and risk factors for ischemic heart disease. Check blood lipid levels regularly; if treatment is ineffective, do not continue it indiscriminately. Perform regular liver function tests. LDL-C levels may rise during treatment, so regular monitoring is required.

In patients with impaired renal function, HMG-CoA reductase inhibitors should be used in combination only when clinically necessary; if myalgia, weakness, or elevated CK, myoglobin, or creatinine levels occur, the medication must be discontinued immediately. Use is not recommended during breastfeeding. No clinical trials have been conducted in children. Use with caution in the elderly.

It is primarily metabolized by CYP2C8, 2C9, and 3A, and is a substrate for OATP1B1 and 1B3. Concomitant use precautions: statins, clopidogrel, etc. (See the original version for details.)

PK

6. Clinical Summary

International Trial on Dyslipidemia in Type 2 Diabetes (n=10,497, median follow-up 3.32 years): HR for the primary cardiovascular composite endpoint with this drug versus placebo was 1.03 [0.92–1.16]. The difference in the rate of change in fasting triglycerides (TG) over 4 months was approximately −24.41 TP3T. Major adverse events included elevated CK levels and myalgia. The incidence of pulmonary embolism/deep vein thrombosis was higher in the treatment group, but a causal relationship with the drug was ruled out in all cases.

20–26. Other Official Information

20. Keep away from moisture after opening. Store in a dry place at room temperature after cutting, and use within 4 months.

22. PTP 100/500/1,000 tablets; bulk bottle of 500 tablets

24. Kohwa Co., Ltd. Medication Consultation Center Phone: 0120-508-514 / 03-3279-7587 (9:00 a.m.–5:00 p.m.)

26. Manufacturer and Distributor: Kowa Co., Ltd., 4-14 Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo

※ This page was translated by Hkeemall based on PMDA Package Insert 2183007F1025_1_14; it is not a substitute for a doctor’s prescription or the original Japanese version.
Enter "Palmodia" in the PMDA "Package Insert Information" search field to view 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

Kowa Pemabet Palmodia Tablets 0.1 mg

1 review for 日本興和 Parmodia 佩瑪貝特 培馬貝特 パルモディア錠 0.1mg:100錠 降低非家族性血症甘油三酯

5.00

Average of 1 review

  1. Ling Cheung –

    Taken for two weeks, the blood test numbers look good, triglycerides dropped noticeably, and it's worth the price.

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