Medication info
Rosu Duo Tablet 10/20 mg (Ezetimibe, Rosuvastatin Calcium)

Rosu Duo Tablet 10/20 mg (Ezetimibe, Rosuvastatin Calcium)

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

MFDS item code 202004143 · Approved 2020.05.29 · Insurance code 647304340

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed) and inhibition of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended, and it can be increased to 10/20 mg daily if necessary. Blood lipid levels should be checked at intervals of 4 weeks or more after starting administration or adjusting the dose to modify the dosage.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed) and inhibition 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
View approved original text

This medication mainly helps lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial hypercholesterolemia, as well as mixed dyslipidemia, while raising good HDL cholesterol levels. This medication should be taken as an adjunct to diet, and it is important to use it alongside dietary changes such as limiting saturated fat and cholesterol intake. Additionally, it is necessary to identify and treat possible secondary causes of dyslipidemia, such as diabetes and hypothyroidism, before starting lipid-lowering medications. Hypercholesterolemia may increase the risk of atherosclerotic vascular disease, so treatment plans should consider risk factors thoroughly. Blood lipid tests for patients should include total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, especially for patients with severe dyslipidemia who may require additional testing for accurate measurements. This medication is effectively used in the treatment of dyslipidemia and the prevention of atherosclerotic vascular disease.

How to take

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended, and it can be increased to 10/20 mg daily if necessary. Blood lipid levels should be checked at intervals of 4 weeks or more after starting administration or adjusting the dose to modify the dosage.

Precautions

This medication may cause muscle problems, so if severe muscle pain or weakness occurs, consult a doctor immediately. In particular, in cases of severe infection, hypotension, major surgery or trauma, or metabolic or electrolyte disorders, it may be necessary to temporarily discontinue or stop this medication. It should not be used in patients with allergies to any of the ingredients, liver function issues, muscle diseases, or severe renal impairment. Women who are pregnant or may become pregnant, and breastfeeding women should not take this medication. Patients with a history of alcohol addiction or liver disease should use this medication cautiously, as well as those at high risk for myopathy or rhabdomyolysis. Liver function tests and muscle condition should be regularly checked during treatment, and healthcare providers should be informed immediately if any adverse symptoms occur. Since this medication can interact with other drugs, inform healthcare providers of all medications being taken, as adjustments may be necessary. This medication is not recommended for children and should be used with caution in the elderly or patients with renal impairment. In case of overdose, treatment should be based on the symptoms, and liver function and muscle enzyme tests should be performed. For storage, keep out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Pharyngitis
  • arthralgia
  • headache
  • ALT elevation
  • AST elevation
  • myalgia
  • edema
  • increased bilirubin levels
  • acneiform dermatitis
  • pruritus
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  • dizziness
  • upper respiratory infection
  • cough
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • itching
  • abnormalities in liver function tests
  • fatigue
  • numbness
  • paresthesia
  • appetite loss
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • chest pain
  • chest discomfort
  • asthenia
  • generalized edema
  • tremors
  • vomiting

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. This will help preserve the effectiveness and safety of the medication for a long time.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×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.