Medication info

Raloxifene Tablets (Raloxifene Hydrochloride)

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

MFDS item code 201905438 · Approved 2019.07.31

This product's status changed to Expired on 2024.07.31. 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 Raloxifene Hydrochloride.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Treatment and prevention of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

Used for the treatment and prevention of osteoporosis in postmenopausal women.

How to take

Adult dose

Administer 60 mg orally once a day as Raloxifene Hydrochloride.

Precautions

This medication may increase the risk of venous thromboembolism, which is the formation of blood clots in blood vessels. Therefore, patients at risk of thrombosis should consult with a physician before taking this medication. Especially if there is a prolonged state of immobility, the use of this medication should be discontinued and can be restarted after symptoms improve. Since this medication is primarily metabolized in the liver, patients with poor liver function should avoid taking it. If liver enzymes become abnormally elevated, careful monitoring is needed during treatment. The safety and efficacy of this medication have not been established in premenopausal women; therefore, it is recommended not to use it. For postmenopausal women at high risk of cardiovascular disease, this medication may affect the risk of myocardial infarction or stroke; therefore, it should be used cautiously, especially if there is a history of stroke. This medication should not be used for the purpose of preventing cardiovascular diseases, and it is also not recommended to be used in combination with systemic estrogens. Women who are pregnant or may become pregnant, and nursing mothers should not take this medication as it may cause congenital defects in the fetus and may also affect the nursing infant. Patients with a history of thrombosis, liver disease, uterine bleeding, endometrial cancer, prolonged immobility, antiphospholipid syndrome, etc., should not take this medication. Patients with high triglyceride levels or severe renal impairment should be cautious when taking this medication. During the use of this medication, side effects such as flushing, leg cramps, cold symptoms, peripheral edema may occur. These symptoms are most commonly seen during the first 6 months of treatment. This medication can interact with other medications, so if taken with anticoagulants such as warfarin, it is essential to inform the physician or pharmacist and to undergo regular blood tests. Calcium and vitamin D supplements should be taken if there is a deficiency, and improving smoking and drinking habits may be beneficial. This drug is intended solely for the treatment and prevention of osteoporosis in postmenopausal women and should not be used in children or men. Overdosage may result in leg cramps or dizziness; therefore, the dosage should be strictly adhered to, and if an overdose is suspected, medical attention should be sought immediately. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Venous thromboembolism including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, arterial thromboembolism, retinal vein occlusion, stroke, death related to venous thromboembolism, thrombocytopenia, increased blood pressure, and headaches including migraines

Mild side effects

Vasodilation (flushing), leg cramps, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, dyspepsia, 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, arthralgia, rheumatism-like symptoms, pain, fatigue, tightness, chest discomfort, skin lesions, anxiety, weight loss, seizures,

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 intrusion. The storage temperature should be maintained between 15 to 30 degrees Celsius. This helps to preserve the drug's efficacy and safety for an extended period.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

14 tablets/box [14 tablets/PTP pack x 1], 28 tablets/box [14 tablets/PTP pack 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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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.