Medication info

Rosuvastatin/Ezetimibe Combination 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004564 · Approved 2020.06.23

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This drug is administered once daily regardless of meals. For primary hypercholesterolemia, a starting dose of 10/5 mg once daily is recommended. In patients requiring greater reduction of LDL cholesterol, adjustments to the dosage can be made. After appropriate dosing, the serum lipid levels should be checked at intervals of at least four weeks, and dosing can be adjusted accordingly, up to a maximum of 10/20 mg once daily.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia

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

This drug effectively lowers cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and helps to increase the good cholesterol, HDL levels. It is primarily used in patients at high risk of atherosclerotic vascular disease, in conjunction with dietary adjustments. This drug is administered when improvement is difficult despite adequate implementation of non-pharmacological therapies, such as restriction of saturated fats and cholesterol intake. Before administering, it is essential to check for and treat secondary causes, such as diabetes and hypothyroidism. During treatment, monitoring of total cholesterol, LDL, HDL, and triglyceride levels is necessary to make appropriate adjustments. This drug is used to reduce the risks associated with hypercholesterolemia and improve blood lipid levels.

How to take

Adult dose

This drug is administered once daily regardless of meals. For primary hypercholesterolemia, a starting dose of 10/5 mg once daily is recommended. In patients requiring greater reduction of LDL cholesterol, adjustments to the dosage can be made. After appropriate dosing, the serum lipid levels should be checked at intervals of at least four weeks, and dosing can be adjusted accordingly, up to a maximum of 10/20 mg once daily.

Precautions

This drug has been reported to cause a rare side effect called rhabdomyolysis, which can result in serious muscle damage. Therefore, if severe muscle pain or weakness occurs, it is important to consult a doctor immediately. This drug should not be used in patients with impaired liver function or patients with active liver disease. Patients with severely reduced kidney function, those with muscular diseases, women who are pregnant or may become pregnant, and nursing mothers should not take this drug. In cases with a high risk of myopathy, such as alcoholics or patients with a history of liver disease, the elderly, and patients with hypothyroidism, this drug should be used with caution and regular testing is required. This drug can interact with other medications; therefore, if other drugs are currently being taken, it is crucial to inform the doctor or pharmacist. Special caution is needed when used in conjunction with anticoagulants, certain antibiotics, or medications that affect liver function. While taking this drug, regular liver function tests and muscle-related tests should be carried out, and any unusual symptoms should be reported to healthcare professionals immediately. Use of this drug is contraindicated during pregnancy and breastfeeding due to risks to the fetus and newborn, and women of childbearing potential should use appropriate contraception. Safety in children or adolescents has not been sufficiently established; therefore, it is not recommended for pediatric use. In case of overdose, there is no specific antidote available, and appropriate treatment should be taken according to symptoms, monitoring liver and muscle function tests.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, acute renal failure, thrombocytopenia, jaundice, hepatitis, toxic hepatitis, acute hepatitis, renal impairment, renal failure, chest pain, breathing difficulties, difficulty in breathing, chest tightness, seizure, severe edema, severe allergic reactions, severe skin reactions, severe neurological symptoms, high fever accompanied by

Mild side effects

  • Headache
  • dizziness
  • dyspepsia
  • ALT elevation
  • AST elevation
  • edema
  • myalgia
  • dry mouth
  • abnormal liver function tests
  • increased serum lactate dehydrogenase
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  • pruritus
  • cough
  • diarrhea
  • increased blood sugar
  • chest discomfort
  • chest pain
  • fatigue
  • weakness
  • arthralgia
  • paresthesia
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • urticaria
  • rash
  • itching
  • cold sweat
  • dermatitis

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

Storage

This drug should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Storing it this way can help retain the drug's efficacy for a longer duration.

Appearance and packaging

Appearance

Pink oval film-coated tablet

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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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.