Medication info
Rosuvastatin Calcium/Ezetimibe 10/5 mg

Rosuvastatin Calcium/Ezetimibe 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Pink rectangular film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004563 · Approved 2020.06.23 · Insurance code 657308370

Summary

Main use
Reduction of LDL-C and increase of HDL-C to suppress the risk of cardiovascular disease in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. The dose range is 10/5 mg to 10/20 mg once daily, with a recommended starting dose of 10/5 mg. For patients requiring a greater reduction in LDL cholesterol, the dose may be adjusted accordingly. After starting administration or adjusting the dose, check blood lipid levels at intervals of at least four weeks and adjust the dose as necessary, with a maximum dose of 10/20 mg per day.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Reduction of LDL-C and increase of HDL-C to suppress the risk of cardiovascular disease in hypercholesterolemia (primary, mixed) and dyslipidemia

  • 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
View approved original text

This medication helps to lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing levels of good cholesterol (HDL cholesterol). It is particularly effective when used in conjunction with dietary changes, playing a critical role in reducing the risk of cardiovascular disease. Prior to taking this medication, it is essential to confirm that there are no other underlying causes such as diabetes or hypothyroidism, and to treat those issues if necessary. Additionally, it is important to establish appropriate testing and treatment plans for patients with dyslipidemia, enabling timely initiation of treatment after acute cardiovascular events. This medication is used safely and effectively to improve dyslipidemia and promote cardiovascular health.

How to take

Adult dose

This medication is administered once daily regardless of meals. The dose range is 10/5 mg to 10/20 mg once daily, with a recommended starting dose of 10/5 mg. For patients requiring a greater reduction in LDL cholesterol, the dose may be adjusted accordingly. After starting administration or adjusting the dose, check blood lipid levels at intervals of at least four weeks and adjust the dose as necessary, with a maximum dose of 10/20 mg per day.

Precautions

This medication may rarely cause rhabdomyolysis, which can lead to severe muscle damage and acute renal failure, so if serious muscle pain or symptoms of myopathy occur, you should consult a doctor immediately. Patients with hypersensitivity to this medication, active liver disease, muscle disorders, severe renal failure, those who are pregnant or may become pregnant, and nursing mothers should not take this medication. Patients at higher risk of myopathy, such as those with compromised kidney function, hypothyroidism, the elderly, or those with alcohol dependence, should exercise greater caution when receiving this medication and require regular monitoring. Patients with liver dysfunction should avoid using this medication and should have liver function tests performed periodically during treatment. If symptoms of liver damage occur (e.g., jaundice, severe fatigue), medical personnel should be notified immediately. This medication may cause side effects such as muscle pain, headache, dyspepsia, edema, and if symptoms worsen or persist, medical consultation is advisable. This medication may interact with other drugs, so you must inform your doctor of any other medications you are taking, particularly anticoagulants, fibrates, some antibiotics, and antifungals. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use appropriate contraception while on this medication. The safety of this medication in children and adolescents has not been sufficiently established, so its use is generally not recommended except in special cases. In case of overdose, there is no specific antidote, so you should visit a medical institution immediately for appropriate treatment and examination. 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

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

Mild side effects

  • Nasopharyngitis
  • dyspepsia
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • dry mouth
  • elevated liver enzymes
  • muscle pain
Show 19 more
  • weakness
  • pruritus
  • elevated blood sugar
  • increased blood lactate dehydrogenase
  • chest discomfort
  • upper respiratory infections
  • thrombocytopenia
  • dermatitis
  • alopecia
  • cough
  • oropharyngeal pain
  • nasal congestion
  • pelvic pain
  • breast cysts
  • eyelid drooping
  • diabetic retinopathy
  • ear discomfort
  • increased blood cholesterol levels
  • increased blood alkaline phosphatase

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. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink rectangular film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle

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.