Medication info
Raloxifene Tablets (Raloxifene Hydrochloride Hemihydrate)

Raloxifene Tablets (Raloxifene Hydrochloride Hemihydrate)

Prescription medicationTablet경구
Ingredient · strength
Raloxifene Hydrochloride Monohydrate›62.12mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
White, oval film-coated tablets
Packaging
28 tablets/box (7 tablets/PTPX4)
Approval status
Active

MFDS item code 200702691 · Approved 2007.03.05 · Insurance code 643303190

Summary

Main use
Treatment and prevention of postmenopausal osteoporosis
Who takes it
Adults
Adult dose
Raloxifene Hydrochloride should be taken orally once daily at a dose of 60 mg.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Treatment and prevention of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used to treat and prevent osteoporosis that is likely to occur in postmenopausal women. Osteoporosis is a condition where bones become weak and are more likely to fracture, and this medication helps to maintain bone strength and reduce the risk of fractures. Therefore, it is effective in protecting the bone health of postmenopausal women.

How to take

Adult dose

Raloxifene Hydrochloride should be taken orally once daily at a dose of 60 mg.

Precautions

This medication may increase the risk of venous thromboembolism, that is, the formation of blood clots that block blood vessels. Especially, if a state of immobility persists for a long time, this medication should be discontinued, and it can be resumed once symptoms improve and normal mobility is restored. Since this medication is primarily metabolized in the liver, patients with poor liver function should avoid or use it with caution, and liver function tests should be monitored regularly. It is not recommended for premenopausal women. For postmenopausal women with cardiovascular diseases or those at high risk, this medication may affect the risk of myocardial infarction or stroke and should be administered with caution. This medication should not be used for the prevention of cardiovascular diseases, and concurrent use with systemic estrogen is not recommended. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this medication as it may harm the fetus or baby. Patients with a history of thromboembolism or allergies to this medication or its ingredients, liver impairment, and unexplained uterine bleeding should not take this medication. Patients who have experienced elevated triglyceride levels due to oral estrogen therapy should closely monitor their blood triglyceride levels while taking this medication. Common side effects reported in clinical trials include facial flushing, peripheral vasodilation, leg cramps, cold-like symptoms, and peripheral edema, with serious side effects related to thrombosis also reported. If unexpected uterine bleeding occurs during the course of this medication, it is important to receive a diagnosis from a healthcare professional. Breast cancer patients or those with a history of it should thoroughly undergo breast examinations before and after taking this medication. This medication is not for use in males and does not alleviate menopausal symptoms. If there are deficiencies in calcium and vitamin D, supplementation is necessary; it is advisable to improve smoking and drinking habits. When used in conjunction with other medications, it may affect the effectiveness of certain drugs, so especially when taken with anticoagulants, regular monitoring of blood coagulation status is necessary. This medication has not been proven safe and effective in children, so it is not used by them. In the case of overdose, symptoms such as leg cramps and dizziness may occur, and there is no specific antidote. This medication should be stored out of 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, superficial venous thrombophlebitis, arterial thromboembolism, retinal vein occlusion, stroke, death related to deep vein thrombosis and pulmonary embolism, thrombocytopenia, hypertension

Mild side effects

Vasodilation (flushing), leg cramps, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, dyspepsia, headache, rash, breast symptoms (pain, swelling, tenderness), vaginal bleeding, facial swelling, heartburn, constipation, itching, palpitations, 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,

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. In addition, it is recommended to store it at room temperature and not in extremely hot or cold environments.

Appearance and packaging

Appearance

White, oval film-coated tablets

Package unit

28 tablets/box (7 tablets/PTPX4)

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.