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Sawai (Japan) Mecobalamin Tablets 500 “SW”: 100 tablets Treatment for peripheral neuropathy

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描述

Direct overseas shipping (Direct shipping from Japan)

Methylcobalamin 500 μg Tablets “SW”
Mecobalamin Tablets 500 μg “SW”

Package Insert No. 3136004F2278_2_02 | Company Code 300119
Prepared in February 2024 (1st Edition)

Methylcobalamin | Peripheral Neuropathy | Methylvitamin B₁₂ | Numbness in the Hands and Feet

Sawai (Japan) Mecobalamin Tablets

Product Details / Approvals, etc.

Japan Standard Commodity Classification Code 873136
Pharmacological Classification Name Therapeutic Agents for Peripheral Neuropathy
Generic Name / Standard Name Methylcobalamin / Methylcobalamin Tablets
Specifications Mecobalamin Tablets 500 μg “SW”
YJ 3136004F2278
Approved 22700AMX00296000
Sales began in June 1984
Identification Code SW 376
trait Light yellow sugar-coated tablet; diameter 6.0 mm, thickness 3.6 mm, weight approximately 100 mg
Storage Instructions / Expiration Date Store at room temperature / 3 years
Manufacturing and Sales Yuan Sawai Pharmaceutical Co., Ltd.
5-2-30 Miyahara, Yodogawa Ward, Osaka City
Sales Yuan Chemifa Co., Ltd., Japan
2-2-3 Iwamotocho, Chiyoda Ward, Tokyo
Packaging PTP 100 tablets / 1,000 tablets; bulk 1,000 tablets
Shipping method Direct overseas shipping (Direct shipping from Japan)
Preparation and shipping time Once payment is confirmed, we typically ship the order within 4 to 7 business days.

1. Composition and Physical and Chemical Properties (3/19)

Each tablet contains 500 μg of mecobalamin (China National Pharmaceutical Bureau). Contains Yellow No. 4 (tartrazine) aluminum lake.

C63H91CoN13O14P Molecular weight 1344.38; dark red crystals or crystalline powder; decomposes upon exposure to light.

Structural Formula

2. Mechanism of Action (18.)

One of the coenzyme forms of vitamin B₁₂ in the body, it acts as a coenzyme for methionine synthase and is involved in methylation. It penetrates neural organelles more easily than cobalamin, promoting nucleic acid and protein synthesis, axonal transport and regeneration, and myelin (phospholipid) formation, while also improving delayed synaptic transmission and addressing reduced levels of neurotransmitters.

3. Indications and Usage (4./6.)

Indications:Peripheral neuropathy.

Directions:The usual adult dose is 3 tablets (1,500 μg of mecobalamin) per day, taken orally in 3 divided doses. The dose may be adjusted based on age and symptoms.

4. Pharmacokinetics and Bioequivalence

Peak levels are reached approximately 3 hours after a single oral dose. After 12 weeks of continuous administration at 1,500 μg/day, serum total B₁₂ levels increased to approximately 2.8 times the pre-treatment level; 4 weeks after discontinuation, levels remained at approximately 1.8 times the pre-treatment level. Bioequivalent to Methycobal 500 μg tablets.

Single-Player PK
BE

5. Clinical Summary

Chronic/stable peripheral neuropathy, 4 weeks: 1,500 μg/day—“Improvement or better” 17.61 TP3T, “Slight improvement or better” 64.71 TP3T, superior to 120 μg. In the control group treated with cobamamide and placebo, 38.61 TP3T (17/44) showed moderate improvement or better.

6. Precautions and Side Effects

Do not use continuously for several months if the treatment is ineffective. No clinical trials have been conducted in children. Workers who handle mercury and its compounds should not receive long-term, high-dose treatment.

Gastrointestinal (0.1–51 TP3T, not yet reached): Loss of appetite, nausea and vomiting, diarrhea. Allergic reactions (0.11 TP3T, not yet reached): Rash.

PTP tablets must be removed from the blister pack before use; if accidentally swallowed, they may pierce the esophagus or even cause a perforation. Keep PTP tablets protected from light after opening the blister pack; keep loose tablets in the aluminum pouch protected from moisture and light after opening.

22–26. Other Official Information

22. PTP 100/1,000 tablets; bulk 1,000 tablets

24. Chemifa Co., Ltd., Japan; Safety Management Department; Tel: 0120-47-9321 / 03-3863-1225

26. Manufacturer: Sawai Pharmaceutical Co., Ltd. / Distributor: Nippon Chemipha Co., Ltd.

※ This page was translated by Hkeemall based on PMDA Package Insert 3136004F2278_2_02; it is not a substitute for a doctor’s prescription or the original Japanese version.
Enter "Mecobalamin SW" 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

Sawai Mecobalamin Mecobalamin Tablets 500 μg

1 review for 日本沢井 Mecobalamin メコバラミン錠 甲鈷胺 500「SW」:100錠 末梢性神經疾患治療劑

4.00

Average of 1 review

  1. Cactus Chick –

    The numbness and weakness in my hands and feet have improved a lot, and the nerve pain has completely eased. Sawai's Mecobalamin really works fast!

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