Medication info

MeditoX Vita B1 Injection (Fursultiamine Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Fursultiamine Hydrochloride›Strength being verified
Manufacturer / importer
(주)메디톡스
Appearance
A colorless, odorless liquid with a slightly bitter taste, filled in a brown ampoule containing a clear liquid.
Packaging
10 ampoules/box [10 mL/ampoule x 10]
Approval status
Approval withdrawn

MFDS item code 202004356 · Notified 2020.06.12

This product's status changed to Approval withdrawn on 2023.06.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of neuropathic pain and cardiac disorders related to vitamin B1 deficiency and metabolic disorders
Who uses it
Adults
Adult dosage
For fursultiamine, the usual adult dosage is 5 to 100 mg per day administered subcutaneously, intramuscularly, or intravenously. Adjust dosage appropriately based on symptoms.

Ingredients

Manufacturer
(주)메디톡스

Efficacy & effects

Treatment of neuropathic pain and cardiac disorders related to vitamin B1 deficiency and metabolic disorders

  • Vitamin B1 deficiency
  • debilitating diseases
  • hyperthyroidism
  • Wernicke's encephalopathy
  • beriberi heart disorder
  • neuropathic pain
  • muscle pain
  • joint pain
  • peripheral neuropathy
  • peripheral paralysis
  • myocardial metabolic disorders
  • constipation
View approved original text

This medicine is used for the prevention and treatment of vitamin B1 deficiency. It is also supplied in cases where the demand for vitamin B1 increases and there is insufficient intake from food, such as in debilitating diseases, hyperthyroidism, in pregnant and breastfeeding women, and for those engaged in vigorous physical labor. It is effective for Wernicke's encephalopathy and beriberi heart disorder. Additionally, it may help alleviate various symptoms assumed to be caused by vitamin B1 deficiency or metabolic disorders, such as neuropathic pain, muscle pain, joint pain, peripheral neuropathy and paralysis, myocardial metabolic disorders, constipation due to gastrointestinal motility dysfunction, and postoperative intestinal paralysis. However, caution is advised to avoid indiscriminate use for more than one month if the effect is uncertain. This medication is used to improve various symptoms related to vitamin B1 deficiency.

Dosage and Administration

Adult dosage

For fursultiamine, the usual adult dosage is 5 to 100 mg per day administered subcutaneously, intramuscularly, or intravenously. Adjust dosage appropriately based on symptoms.

Precautions

This medication is an ampoule injection; care must be taken when cutting the glass container to avoid the risk of glass fragments entering. Special attention is required when used in children or the elderly. Patients with a history of allergy to this medication or its components should not use it. Patients with a past history of drug allergy reactions should exercise caution when using this medication. Rarely, severe allergic reactions may cause shock; if symptoms such as hypotension, chest pain, or difficulty breathing occur during administration, the infusion must be stopped immediately, and appropriate treatment should be provided. Moreover, if symptoms of allergy such as rash appear, use should be discontinued. Gastrointestinal symptoms may occasionally include nausea, vomiting, glossitis, and sometimes diarrhea. Symptoms such as headache or frequent urination may also appear from time to time. Pain may occur in the vein during intravenous administration, so the injection rate should be adjusted as slowly as possible. To prevent bacterial contamination when using the injection solution, any remaining liquid should not be reused. When cutting the ampoule, hold the marked part of the ampoule head upward and gently press downward to cut, ensuring to clean the upper part of the ampoule with an alcohol swab to prevent contamination. This medication should be stored out of reach of children and should not be transferred to other containers to prevent accidents and to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Shock
  • hypotension
  • chest pain
  • difficulty breathing

Mild side effects

  • Nausea
  • vomiting
  • glossitis
  • diarrhea
  • headache
  • frequent urination
  • rash

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container that can block light, at a temperature between 1 degree Celsius and 30 degrees Celsius, which is room temperature. Proper storage in this manner helps to maintain the medication's effectiveness.

Appearance and packaging

Appearance

A colorless, odorless liquid with a slightly bitter taste, filled in a brown ampoule containing a clear liquid.

Package unit

10 ampoules/box [10 mL/ampoule x 10]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.