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

Dulorban Tablet 10/20 mg (Ezetimibe, Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
White to almost white, round film-coated tablets
Packaging
30 tablets (10 tablets/Alu-Alu x 3)
Approval status
Active

MFDS item code 201601224 · Approved 2016.02.29 · Insurance code 648103730

Summary

Main use
Improvement of hypercholesterolemia (primary and mixed) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is between 10/5 mg to 10/20 mg once daily. A starting dose of 10/5 mg once daily is recommended. For patients requiring further reduction in LDL-cholesterol, the dosage may be adjusted. After initiation of therapy or dosage adjustment, lipid levels should be checked after an interval of more than 4 weeks.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary and mixed) 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 apolipoprotein B
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication is primarily used as a lipid-lowering agent in patients with primary hypercholesterolemia, including familial and non-familial hypercholesterolemia, and mixed dyslipidemia. It lowers elevated total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels while increasing levels of HDL-cholesterol, the 'good' cholesterol in the blood. Furthermore, when administered to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, comprehensive consideration of various risk factors is necessary, and co-administration with an appropriate diet can yield the best results. This medication is used as an adjunct when there is inadequate response to dietary measures such as saturated fat and cholesterol restriction and other non-drug interventions. It is essential to identify and appropriately treat other underlying conditions related to dyslipidemia before treatment. This medication helps effectively control lipid levels, thus reducing the risk of cardiovascular diseases.

How to take

Adult dose

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is between 10/5 mg to 10/20 mg once daily. A starting dose of 10/5 mg once daily is recommended. For patients requiring further reduction in LDL-cholesterol, the dosage may be adjusted. After initiation of therapy or dosage adjustment, lipid levels should be checked after an interval of more than 4 weeks.

Precautions

This medication contains two components: rosuvastatin and ezetimibe. Several precautions must be followed while taking this medication. First, this medication can rarely cause severe muscle damage, known as rhabdomyolysis, which may lead to kidney function issues. Therefore, if severe muscle pain or weakness occurs, you should immediately consult a physician. Second, this medication should not be administered to individuals with specific diseases. For instance, individuals allergic to any of its components or those with liver disease, muscle disease, severe kidney dysfunction, or women who are pregnant or breastfeeding should not take this medication. Third, individuals with alcohol dependence, poor liver function, elderly patients, those with hypothyroidism, or those with a history of muscle-related drug side effects should use this medication cautiously and regularly check blood tests and muscle conditions as instructed by their doctors. Fourth, side effects like liver dysfunction, muscle pain, headache, indigestion may occur during the course of taking this medication, so any symptoms should prompt consultation with healthcare providers. Fifth, there may be interactions with other medications, so inform your doctor or pharmacist of any other medications you are taking, especially if you are using anticoagulants, fibrates, or cyclosporine, as caution is needed in these cases. Sixth, pregnant women or those planning to become pregnant should not take this medication, and if pregnancy is confirmed while on this medication, it should be discontinued immediately and consult a doctor. Finally, children, adolescents, elderly patients, and those with impaired liver or kidney function must always consult with a specialist before taking this medication and adhere strictly to the prescribed dosages and regimens. This medication requires regular testing and close monitoring before and during treatment. Therefore, follow your doctor's directions closely and report any unusual symptoms immediately.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Headache
  • nasopharyngitis
  • arthralgia
  • dizziness
  • fatigue
  • abdominal pain
  • diarrhea
  • constipation
  • nausea
  • pruritus
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  • dermatitis
  • acneiform dermatitis
  • itching
  • chest pain
  • cough
  • myalgia
  • asthenia
  • xerostomia
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disturbances
  • upper respiratory infection
  • tremor
  • paresthesia
  • depression
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • chest discomfort
  • edema
  • systemic edema
  • thrombocytopenia
  • increased serum creatinine

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White to almost white, round film-coated tablets

Package unit

30 tablets (10 tablets/Alu-Alu 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.