Medication info
Rostorin Tablets 10/20 mg

Rostorin Tablets 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets/box [(10 tablets/blister × 3)]
Approval status
Active

MFDS item code 201601221 · Approved 2016.02.29 · Insurance code 657805780

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and dyslipidemia and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is taken once daily regardless of meals. The dosage range is 10/5mg to 10/20mg per day. The recommended initial dose is 10/5mg per day. For patients requiring a greater reduction in LDL cholesterol, the dose may be adjusted. After initiation of treatment or dosage adjustment, blood lipid levels should be checked at intervals of more than four weeks, and dosage should be adjusted accordingly. The maximum daily dose is 10/20mg.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and dyslipidemia and suppression of the risk of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing good cholesterol HDL levels. It is primarily used in conjunction with diet, as an adjunctive treatment when non-pharmacological therapies that limit saturated fat and cholesterol intake are insufficient. It is also used together with lipid-modifying drugs in patients at increased risk of atherosclerotic vascular disease due to hypercholesterolemia. Before use, it is important to check for secondary causes such as diabetes and hypothyroidism and treat if necessary, and regular monitoring of cholesterol and triglyceride levels during treatment is crucial. In case of acute coronary events, lipid tests are conducted before and after hospitalization to determine the treatment direction. This medication is used effectively to improve dyslipidemia.

How to take

Adult dose

This medication is taken once daily regardless of meals. The dosage range is 10/5mg to 10/20mg per day. The recommended initial dose is 10/5mg per day. For patients requiring a greater reduction in LDL cholesterol, the dose may be adjusted. After initiation of treatment or dosage adjustment, blood lipid levels should be checked at intervals of more than four weeks, and dosage should be adjusted accordingly. The maximum daily dose is 10/20mg.

Precautions

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can result in severe muscle damage. Such muscle damage carries a risk of leading to acute renal failure; therefore, if severe muscle pain or weakness occurs, immediate consultation with a physician is necessary. Additionally, this medication should not be administered to patients with certain diseases, to pregnant women, or nursing mothers, and caution is required for patients with poor liver or kidney function. It is important to check liver and muscle status before taking the medication and to monitor the condition regularly during treatment. If symptoms such as muscle pain, fatigue, or feelings of heat occur while taking this medication, immediate notification to healthcare professionals is required. Because liver function abnormalities may occur, if symptoms of liver damage appear, the medication should be discontinued and a physician consulted. Moreover, this medication may interact with other drugs, so it is essential to inform healthcare providers of any other medications being taken. Women who are pregnant or of childbearing age should use appropriate contraception while taking this medication, and should cease use immediately if pregnancy is confirmed. Special caution is required for children and the elderly, as safety and efficacy in children have not been adequately confirmed. In case of overdose, treatment according to symptoms and monitoring of liver function and muscle enzyme levels is required. Finally, this medication should be stored out of reach of children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in mouth/eyes mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • dizziness
  • upper respiratory infection
  • myalgia
  • constipation
  • nausea
  • abdominal pain
  • acneiform dermatitis
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  • pruritus
  • increased bilirubin in the blood
  • elevated AST
  • elevated ALT
  • asthenia
  • fatigue
  • itching
  • diarrhea
  • vomiting
  • rash
  • urticaria
  • edema
  • chest pain
  • discomfort in the chest
  • paresthesia
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • tremor
  • bronchitis
  • rhinitis
  • cystitis

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Proper storage will ensure the medication's effectiveness is safely preserved.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets/box [(10 tablets/blister × 3)]

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.