Medication info

Bazecol Tablets (Bazodoxifene Acetate)

Prescription medicationTablet경구Expired
Ingredient · strength
Bazedoxifene Acetate›22.6mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
White or off-white capsule-shaped film-coated tablets
Packaging
28 tablets (28 tablets/PTP)
Approval status
Expired

MFDS item code 201903339 · Approved 2019.05.23

This product's status changed to Expired on 2024.05.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of osteoporosis and vertebral fractures in postmenopausal women
Who takes it
Adults
Adult dose
1 tablet (20 mg as Bazodoxifene) once daily, without regard to meals.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Prevention of osteoporosis and vertebral fractures in postmenopausal women

  • Osteoporosis
  • vertebral fractures
View approved original text

This medication is used for the treatment and prevention of osteoporosis in postmenopausal women. It is effective in reducing the occurrence of vertebral fractures, but its effectiveness for non-vertebral fractures has not been confirmed. Therefore, taking this medication can help protect spinal health.

How to take

Adult dose

1 tablet (20 mg as Bazodoxifene) once daily, without regard to meals.

Precautions

This medication can increase the risk of venous thromboembolism, where blood clots form in the blood vessels and may block them. This risk is particularly high during the first year of starting the medication and requires caution. This medication is intended only for postmenopausal women and should not be taken by premenopausal women or those who may become pregnant. Additionally, women who are breastfeeding should not use this medication. If there is sudden uterine bleeding while taking this medication, it is essential to seek medical attention. This medication is known not to induce endometrial hyperplasia, but bleeding can be an unexpected symptom. The safety of this medication has not been established for breast cancer patients, so it is advisable not to use it for the prevention or treatment of breast cancer. Individuals with a history of allergic reactions or hypersensitivity to this medication, or those with a history of thrombosis, should not take it. It is also not to be administered for unexplained uterine bleeding or symptoms of endometrial cancer. This medication contains lactose, so individuals with lactose intolerance or certain genetic metabolic disorders should avoid taking it. Patients with severe hypertriglyceridemia and those with significantly impaired renal or liver function should use this medication cautiously, as drug concentrations may increase in patients with liver dysfunction, making it not recommended. During treatment, side effects such as facial flushing, leg cramps, drowsiness, dry mouth, skin rash may occur, and if symptoms are severe, medical consultation is required. This medication may cause drowsiness affecting driving or operating machinery, so it is safest to avoid these activities if experiencing visual disturbances or drowsiness. Women who are pregnant or planning to become pregnant should not take this medication, and if pregnancy is confirmed while taking, it should be immediately discontinued, and a doctor should be consulted. This medication is not to be used in children or adolescents, and in elderly patients, the drug concentration may increase due to changes in liver function, but specific dose adjustments are not necessary. In cases of overdose, there is no specific antidote, so appropriate treatment should be received based on the symptoms. This medication must be kept out of the reach of children and should be stored in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • deep vein thrombosis
  • pulmonary embolism
  • retinal vein thrombosis
  • venous thromboembolism
  • hives
  • severe allergic reaction
  • hives
  • vascular disease
  • dyspnea
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  • severe rash with high fever
  • blisters
  • skin peeling
  • pain in mouth/eyes mucosa
  • liver abnormalities (jaundice)
  • severe edema
  • abnormal urination
  • sudden and very severe headache
  • thunderclap headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis

Mild side effects

Vasodilation (facial flushing), leg cramps, drowsiness, dry mouth, rash, itching, peripheral edema, increased serum triglycerides, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), visual impairment, blurred vision, photophobia, visual field defect, visual disturbances, dry eyes, eyelid edema, eyelid twitching, eye pain, swollen eyes

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. A cool place with a temperature below 25 degrees Celsius is suitable for storage.

Appearance and packaging

Appearance

White or off-white capsule-shaped film-coated tablets

Package unit

28 tablets (28 tablets/PTP)

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.