Medication info
VindaMax Capsule 61 mg (Tafamidis)

VindaMax Capsule 61 mg (Tafamidis)

Prescription medicationSoft capsuleOral
Ingredient · strength
Tafamidis›61mg / 1 capsule
Manufacturer / importer
Pfizer Pharmaceuticals Korea Limited
Appearance
An opaque brown oblong soft capsule containing a white-pink suspension.
Packaging
30 capsules/box [(10 capsules/PTP x 3)]
Approval status
Active

MFDS item code 202005887 · Approved 2020.08.19 · Insurance code 648903510

Summary

Main use
Reduction of the risk of cardiovascular death and hospitalization in adults with transthyretin amyloid cardiomyopathy
Who takes it
Adults
Adult dose
Administer the recommended dose of 61 mg orally once daily. Swallow the capsule whole; do not crush or cut it. If vomiting occurs immediately after taking this medicine, check the vomitus for the medicine. If the medicine is found in the vomitus, take an additional dose as soon as possible. If no capsule is found, do not take an additional dose and resume taking this medicine as usual the next day.

Ingredients

Importer
Pfizer Pharmaceuticals Korea Limited

Efficacy & effects

Reduction of the risk of cardiovascular death and hospitalization in adults with transthyretin amyloid cardiomyopathy

View approved original text

This medication is used to reduce cardiovascular mortality and cardiovascular-related hospitalizations in adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM).

How to take

Adult dose

Administer the recommended dose of 61 mg orally once daily. Swallow the capsule whole; do not crush or cut it. If vomiting occurs immediately after taking this medicine, check the vomitus for the medicine. If the medicine is found in the vomitus, take an additional dose as soon as possible. If no capsule is found, do not take an additional dose and resume taking this medicine as usual the next day.

Precautions

Women of childbearing potential must use appropriate contraception during treatment and for one month after stopping the medication. This medication contains sorbitol, so it should not be taken by patients with hereditary fructose intolerance. It should not be administered to patients with hypersensitivity to this drug or its components. Clinical trial results indicate that gastrointestinal adverse reactions such as diarrhea and abdominal pain may occur while taking this medication. For patients with mild to moderate liver impairment, dose adjustment is not required, but the effects in patients with severe liver impairment or NYHA class IV heart failure are not known. Clinical trials have not yet been conducted in patients with renal impairment. There is insufficient research on the effects on driving or operating machinery, so caution is advised. This medication does not significantly inhibit or induce the cytochrome P450 enzyme, reducing the likelihood of drug interactions; however, it may inhibit certain drug transporters, so consult a healthcare professional if you are taking other medications. Pregnant or breastfeeding women should avoid taking this medication, especially during breastfeeding. Safety and efficacy in pediatric patients have not been established, and no dose adjustment is required in elderly patients. This medication may reduce total serum thyroxine levels but does not cause thyroid dysfunction. Reported cases of overdose are very rare, and adverse reactions have been mild. This medication should be kept out of the reach of children and stored in its original container to maintain the quality of the drug.

Side effects

  • Diarrhea
  • urinary tract infection
  • vaginal infection
  • upper abdominal pain
  • mild miliaria

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is important to store it in a cool place at room temperature, below 25 degrees Celsius, to maintain its effectiveness.

Appearance and packaging

Appearance

An opaque brown oblong soft capsule containing a white-pink suspension.

Package unit

30 capsules/box [(10 capsules/PTP x 3)]

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.