Medication info

Bivozon Loxifene Hydrochloride Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Raloxifene Hydrochloride›60mg / 1 tablet
Manufacturer / importer
(주)비보존제약
Appearance
White oval film-coated tablet
Packaging
28 tablets (14 tablets PTP x 2)
Approval status
Expired

MFDS item code 201903121 · Approved 2019.05.14

This product's status changed to Expired on 2024.05.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women
Who takes it
Adults
Adult dose
Take 60 mg orally once daily as Loxifene Hydrochloride.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Treatment and prevention of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This drug is used to treat and prevent osteoporosis in postmenopausal women. Osteoporosis is a condition where bone density decreases, increasing the risk of fractures, and is commonly found in postmenopausal women. Taking this medication can help strengthen bones and reduce the risk of fractures. Therefore, it aids in maintaining healthy bones and preventing osteoporosis-related complications.

How to take

Adult dose

Take 60 mg orally once daily as Loxifene Hydrochloride.

Precautions

This medication may increase the risk of blood clots in the blood. If you are immobile for an extended period, you should discontinue this medication and may resume it once your condition improves. This drug is primarily metabolized in the liver, so it is not advisable for patients with poor liver function. Regular liver function tests should be conducted if liver dysfunction is suspected. The use of this drug is not recommended for premenopausal women. It should be used with caution in postmenopausal women with cardiovascular disease or at high risk, as the risk of stroke may also increase. This medication should not be used for the prevention of cardiovascular disease. Additionally, the concurrent use of systemic estrogen is not recommended. Women who are pregnant or may become pregnant, or breastfeeding, should not take this medication. Patients with a history of thrombosis, liver dysfunction, unexplained uterine bleeding, or suspected endometrial cancer should also avoid this drug. Patients who are immobile for a prolonged period or those with antiphospholipid syndrome should not be administered this medication. Patients with certain genetic metabolic disorders such as lactose intolerance should also refrain from taking this drug. Patients with a history of elevated triglycerides in the blood or poor kidney function should use this medication with caution and carefully monitor their condition. During treatment with this medication, symptoms such as leg cramps, facial flushing, cold symptoms, and peripheral edema may occur, especially during the first six months of treatment. Because of the risk of thrombosis, any unusual symptoms should be discussed immediately with healthcare professionals. While this medication does not cause endometrial hyperplasia, if uterine bleeding occurs while taking it, a specialist evaluation is necessary. The safety for patients with breast cancer has not been sufficiently established; thus, it is advisable to take this medication after completing therapy for breast cancer. This drug is for use only in postmenopausal women and should not be given to men or children. It is recommended to supplement calcium and vitamin D if intake is insufficient, and improving smoking and drinking habits is advised. While most drug concentrations remain largely unaffected when used in conjunction with other medications, caution is needed with certain drugs. In the event of an overdose, leg cramps or dizziness may occur, so it is essential to adhere to the prescribed dosage. Children, pregnant women, and nursing mothers should not take this drug, and it should be kept out of reach of children for their safety.

Side effects and when to seek care immediately

Serious side effects

Deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial venous thrombophlebitis, stroke, death related to deep venous thrombosis and pulmonary embolism, thrombocytopenia, arterial thrombosis, retinal vein occlusion, hypertension, including migraine headaches

Mild side effects

  • Vasodilation (flushing)
  • leg cramps
  • cold symptoms
  • peripheral edema
  • slight decrease in platelet count
  • moderate elevation in AST and/or ALT
  • gallstones
  • vaginal bleeding
  • itching
  • palpitations
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  • fever
  • weakness
  • sweating
  • myalgia
  • insomnia
  • perineal pain
  • weight gain
  • arthritis
  • rheumatic-like symptoms
  • pain
  • fatigue
  • discomfort
  • chest tightness
  • skin lesions
  • anxiety
  • weight loss
  • convulsions
  • visual disturbances
  • taste disturbances
  • nausea
  • vomiting
  • abdominal pain
  • indigestion

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

28 tablets (14 tablets PTP x 2)

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.