Medication info
Rosuvastatin Calcium/Ezetimibe 10/10 mg

Rosuvastatin Calcium/Ezetimibe 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
White to almost white round film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 202004127 · Approved 2020.05.29 · Insurance code 645210380

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and reduction of atherosclerotic vascular disease risk
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. The dosage range for primary hypercholesterolemia is 10/5 mg to 10/20 mg daily. An initial dose of 10/5 mg daily is recommended. For patients requiring a more significant reduction in LDL cholesterol, the dose may be adjusted. After starting treatment or adjusting the dose, lipid levels should be checked at least 4 weeks apart, and the maximum daily dose may be increased to 10/20 mg.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and reduction of atherosclerotic vascular disease risk

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

This medication helps regulate blood cholesterol and lipid levels in patients with primary hypercholesterolemia, either familial or non-familial, as well as mixed dyslipidemia. Specifically, it reduces total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol while increasing HDL cholesterol, known as good cholesterol. This medication is used in conjunction with a proper diet and is administered when dietary control alone is insufficient. It is particularly important for patients at high risk for atherosclerotic vascular disease due to hypercholesterolemia, and it is recommended to perform diagnostic tests for secondary causes before treatment. Cholesterol and lipid levels should be monitored regularly before and during treatment to confirm effectiveness. This medication is effective for managing dyslipidemia and improving vascular health.

How to take

Adult dose

This medication is administered once daily regardless of meals. The dosage range for primary hypercholesterolemia is 10/5 mg to 10/20 mg daily. An initial dose of 10/5 mg daily is recommended. For patients requiring a more significant reduction in LDL cholesterol, the dose may be adjusted. After starting treatment or adjusting the dose, lipid levels should be checked at least 4 weeks apart, and the maximum daily dose may be increased to 10/20 mg.

Precautions

This medication may rarely cause rhabdomyolysis, leading to severe kidney dysfunction due to muscle damage. Therefore, if severe muscle pain or weakness occurs, it is essential to inform a physician immediately, and the medication should be temporarily stopped if there are specific risk factors. Patients allergic to this medication or with liver or muscle diseases, severe kidney dysfunction, those who are pregnant or nursing, should not take this medication. Furthermore, patients requiring careful observation include those with alcohol dependence, impaired liver function, the elderly, and those with a history of muscle-related diseases. During the use of this medication, liver function tests and muscle-related tests should be conducted regularly, and treatment should be stopped immediately if liver enzyme levels rise significantly or severe muscle pain occurs. Caution is needed as dizziness may occur when driving or operating machinery. This medication can interact with certain drugs, so if taking other medications, it is crucial to inform a physician or pharmacist. Women who may become pregnant should ensure proper contraception while taking this medication and avoid it during pregnancy or breastfeeding. Safety in children and adolescents has not been adequately established; therefore, it is not recommended. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme tests should be performed. Keep out of reach of children and avoid transferring to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucous membranes, breathlessness or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme tiredness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • muscle pain
  • edema
  • increased bilirubin levels
  • acneiform dermatitis
  • itching
Show 26 more
  • nasopharyngitis
  • arthralgia
  • dizziness
  • upper respiratory infection
  • muscle pain
  • fatigue
  • numbness
  • abnormal sensations
  • nausea
  • diarrhea
  • loss of appetite
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • pruritus
  • rash
  • alopecia
  • chest discomfort
  • cough
  • bronchitis
  • rhinitis
  • cystitis
  • skin of fingernails.

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, avoid storing it in excessively hot or cold places, and it is safe to keep it at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 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.