Medication info

Roxifene Tablet (Roxifene Hydrochloride)

Prescription medicationTablet경구Expired
Ingredient · strength
Raloxifene Hydrochloride›60mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
White oval film-coated tablet
Packaging
28 tablets (14 tablets/PTPX2)
Approval status
Expired

MFDS item code 201901763 · Approved 2019.03.25

This product's status changed to Expired on 2024.03.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of postmenopausal osteoporosis
Who takes it
Adults
Adult dose
Administer 60 mg orally once a day as Roxifene Hydrochloride.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Treatment and prevention of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used to prevent and treat osteoporosis that can occur in postmenopausal women. Osteoporosis is a condition where the bones weaken and can fracture easily; thus, this medication can help maintain bone health and prevent bone weakening. By taking it regularly, it can improve bone density and reduce fracture risk, supporting a healthy lifestyle.

How to take

Adult dose

Administer 60 mg orally once a day as Roxifene Hydrochloride.

Precautions

This medication can increase the risk of thromboembolism, which is the formation of blood clots in blood vessels. Therefore, it should be administered cautiously to patients at risk for thrombosis, and if immobility occurs, the medication should be discontinued. Since this medication is primarily metabolized in the liver, patients with impaired liver function should avoid it or use it very cautiously. It is not approved for use in premenopausal women, and pregnant women or those who may become pregnant should not take it. Additionally, breastfeeding women should also avoid taking this medication. It should not be used in patients with cardiovascular diseases or for cardiovascular prevention. This medication is not recommended to be used in conjunction with other systemic estrogen preparations. Careful monitoring of bleeding risks should be done when used with anticoagulants. This medication contains lactose, thus individuals with lactose intolerance should not use it. While taking this medication, symptoms such as facial flushing, leg cramps, peripheral edema, and cold symptoms may appear. If unexpected uterine bleeding occurs, one should seek professional diagnosis immediately. It should be used with caution in patients with a history of breast cancer, and if any abnormal symptoms occur in the breast during treatment, tests should be performed. This medication is strictly for the treatment and prevention of osteoporosis in postmenopausal women and should not be administered to men or children. An overdose may result in leg cramps, dizziness, and other symptoms, so caution is advised. This medication should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Deep vein thrombosis
  • pulmonary embolism
  • retinal vein thrombosis
  • venous thromboembolism
  • superficial venous thrombophlebitis
  • retinal vein occlusion
  • stroke
  • death related to deep vein thrombosis
  • thrombocytopenia
  • hypertension
Show 2 more
  • migraines (including headache)
  • and stroke-related death.

Mild side effects

Vasodilation (flushing), leg cramps, cold symptoms, peripheral edema, slight decrease in platelet count, moderate increase in AST and ALT, gallstones, nausea, vomiting, abdominal pain, indigestion, hypertension, headache, rash, breast symptoms (pain, swelling, tenderness), facial flushing, vaginal bleeding, facial swelling, heartburn, constipation, itching, palpitations, fever, weakness, sweating, myalgia, insomnia, perineal pain, weight gain, arthritis, rheumatic-like symptoms.

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 air infiltration, ideally in a cool place between 15 to 30 degrees Celsius. This way, the effectiveness of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

28 tablets (14 tablets/PTPX2)

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.