Medication info
Roxistart Tablet 60 mg (Raloxifene Hydrochloride)

Roxistart Tablet 60 mg (Raloxifene Hydrochloride)

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

MFDS item code 201901789 · Approved 2019.03.26 · Insurance code 657307360

Summary

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

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Treatment and prevention of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

Used to maintain bone health and prevent osteoporosis in women after menopause and to treat osteoporosis that has already occurred.

How to take

Adult dose

60 mg orally once daily as Raloxifene Hydrochloride.

Precautions

This medication may increase the risk of blood clots in the bloodstream; therefore, patients with a history of thrombosis or who are at high risk for thrombosis should consult their doctor thoroughly before using this medication. Since this drug is primarily metabolized in the liver, patients with poor liver function should avoid taking this medication or be monitored carefully. It is not recommended to use this medication in premenopausal women, as safety has not been established. Women after menopause with cardiovascular disease or high risk should use this medication cautiously as it may increase the risk of stroke. This medication should not be used for the prevention of cardiovascular disease and is also not recommended to be used with systemic estrogen. Pregnant women, women who may become pregnant, and women who are breastfeeding should not take this medication as it may harm the fetus or baby. Patients with specific genetic issues such as lactose intolerance should not take this medication. Patients with high triglyceride levels or poor kidney function require careful monitoring by a doctor when taking this medication. During the course of this medication, side effects may arise such as thrombosis, leg cramps, cold symptoms, peripheral edema, facial flushing, etc.; immediate consultation with a doctor should be made if any abnormal symptoms occur. Although this medication does not induce endometrial hyperplasia, if uterine bleeding occurs while taking it, a specialist should be consulted immediately. Patients with a history of breast cancer or those noticing abnormalities in their breasts should consult their doctor before taking this medication. It is advisable to ensure adequate intake of calcium and vitamin D and to improve any smoking or drinking habits. There may be interactions with other medications, so it is necessary to inform the doctor or pharmacist about any other medications being taken. This medication is not to be used in children or men, and while safety and efficacy have been confirmed in the elderly, caution is needed. In case of overdose, symptoms such as leg cramps, dizziness, etc., may occur, so the prescribed dose must be strictly adhered to. This medication should be kept out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

  • Deep vein thrombosis
  • pulmonary embolism
  • retinal vein thrombosis
  • superficial vein thrombophlebitis
  • venous thromboembolism
  • arterial thromboembolism
  • retinal vein occlusion
  • stroke
  • death related to deep vein thrombosis
  • thrombocytopenia
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  • increased mortality rate due to stroke

Mild side effects

Vasodilation (facial flushing), leg cramps, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, indigestion, increased blood pressure, migraine, rash, breast symptoms (pain, swelling, tenderness), vaginal bleeding, facial swelling, heartburn, constipation, itching, palpitations, fever, fatigue, sweating, muscle pain, insomnia, perineal pain, weight gain, arthritis, rheumatism-like symptoms, pain, exhaustion, tightness, chest discomfort, skin lesions, anxiety, weight loss,

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, and it is best kept in a cool place between 15 to 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

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.