Medication info

AhnGuk Raloxifene Hydrochloride Tablet

Prescription medicationExpired
Ingredient · strength
Raloxifene Hydrochloride›Strength being verified
Manufacturer / importer
안국약품(주)
Appearance
White oval film-coated tablet
Packaging
14 tablets (14 tablets/PTP packaging x 1), 28 tablets (14 tablets/PTP packaging x 2)
Approval status
Expired

MFDS item code 201801004 · Approved 2018.02.28

This product's status changed to Expired on 2023.02.28. 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 uses it
Adults
Adult dosage
60 mg is administered orally once daily as Raloxifene Hydrochloride.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Treatment and prevention of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used to treat and prevent osteoporosis in postmenopausal women. Osteoporosis is a condition where bones become weak and more susceptible to fractures, so this medication helps maintain bone health and prevent fractures.

Dosage and Administration

Adult dosage

60 mg is administered orally once daily as Raloxifene Hydrochloride.

Precautions

This medication may increase the risk of blood clots in the bloodstream. It is advised to discontinue the medication if immobility lasts for an extended period and can be resumed once the condition improves. Patients with impaired liver function should consult a physician before taking this medication and should be closely monitored if liver function test results are elevated. This medication has not been approved for use in premenopausal women. Postmenopausal women at high risk of cardiovascular disease should be cautious as this medication may slightly increase the risk of stroke. This medication should not be used for the prevention of cardiovascular disease, and it is not recommended to be taken in conjunction with systemic estrogen. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. It may pose a risk of congenital defects to the fetus and could affect the baby through breast milk. Individuals who have allergic reactions to this medication or have liver dysfunction, unexplained uterine bleeding, suspected endometrial cancer, or those who have prolonged immobility should not take it. Patients with elevated triglycerides or impaired kidney function should exercise caution during use and should have their condition frequently monitored. Common symptoms during the first 6 months of use may include flushing of the face, leg cramps, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, dyspepsia, headache (including migraines), rash, pain, swelling, tenderness, vaginal bleeding, itching, palpitations, fever, weakness, sweating, muscle pain, insomnia, perineal pain, weight gain, arthritis, rheumatic-like symptoms, pain, fatigue, shortness of breath, chest discomfort, skin lesions, anxiety, weight loss, seizures, visual disturbances, dysgeusia, and flushing of the face. This medication has few drug interactions; however, it should not be taken with certain drugs like cholestyramine as it may reduce the absorption of this medication. This medication is used to treat and prevent osteoporosis in postmenopausal women and is not for use in men or children. In the case of overdose, symptoms may include leg cramps and dizziness; however, no life-threatening side effects have been reported.

Side effects and when to seek care immediately

Serious side effects

Deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial thrombophlebitis, thrombocytopenia, elevated blood pressure, arterial thromboembolism, retinal vein occlusion, stroke, death related to deep vein thrombosis and pulmonary embolism, severe edema.

Mild side effects

  • Vasodilation (facial flushing)
  • leg cramps
  • cold symptoms
  • peripheral edema
  • nausea
  • vomiting
  • abdominal pain
  • dyspepsia
  • headache (including migraines)
  • rash
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  • pain
  • swelling
  • tenderness
  • vaginal bleeding
  • itching
  • palpitations
  • fever
  • weakness
  • sweating
  • muscle pain
  • insomnia
  • perineal pain
  • weight gain
  • arthritis
  • rheumatic-like symptoms
  • pain
  • fatigue
  • shortness of breath
  • chest discomfort
  • skin lesions
  • anxiety
  • weight loss
  • seizures
  • visual disturbances
  • dysgeusia
  • and facial flushing.

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 and moisture from entering and should be kept in a cool place between 15 and 30 degrees Celsius. Proper storage helps maintain the efficacy of the medication and prevents deterioration.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

14 tablets (14 tablets/PTP packaging x 1), 28 tablets (14 tablets/PTP packaging 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.