Medication info
DuoRovan Tablets 10/10 mg (Ezetimibe (Unrefined), Rosuvastatin Calcium)

DuoRovan Tablets 10/10 mg (Ezetimibe (Unrefined), Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
White to almost white round film-coated tablets
Packaging
Alu-Alu - 30 tablets/box [(10 tablets/Alu-Alu×3)], Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201601223 · Approved 2016.02.29 · Insurance code 648103750

Summary

Main use
Effectiveness in reducing total cholesterol and LDL-C, increasing HDL-C through treatment of hypercholesterolemia (primary and mixed).
Who takes it
Adults
Adult dose
This medication is administered once a day, regardless of meals. The dosage range is between 10/5 mg and 10/20 mg per day. A starting dose of 10/5 mg once daily is recommended. If further reduction in LDL-cholesterol is necessary, the dosage can be adjusted. Blood lipid levels should be checked at intervals of more than 4 weeks after starting the treatment or adjusting the dosage, and the dose may be increased up to a maximum of 10/20 mg per day.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Effectiveness in reducing total cholesterol and LDL-C, increasing HDL-C through treatment of hypercholesterolemia (primary and mixed).

  • 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 is used as an adjunct to a diet to lower blood levels of total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial, and mixed dyslipidemia. It should be given along with lipid regulating medications to patients at high risk for atherosclerotic vascular disease due to hypercholesterolemia when diet alone is insufficient. It is important to identify and treat secondary causes of dyslipidemia such as diabetes and hypothyroidism before starting this medication, and to regularly check blood lipid levels before and during treatment. By managing in this way, it helps effectively control blood lipids and reduce the risk of cardiovascular disease.

How to take

Adult dose

This medication is administered once a day, regardless of meals. The dosage range is between 10/5 mg and 10/20 mg per day. A starting dose of 10/5 mg once daily is recommended. If further reduction in LDL-cholesterol is necessary, the dosage can be adjusted. Blood lipid levels should be checked at intervals of more than 4 weeks after starting the treatment or adjusting the dosage, and the dose may be increased up to a maximum of 10/20 mg per day.

Precautions

This medication can rarely cause rhabdomyolysis, which can lead to serious muscle damage, so patients should notify their doctor immediately if they experience muscle pain or weakness symptoms. In particular, if there are risk factors such as severe infections, hypotension, major surgery or trauma, severe metabolic disorders, it may be necessary to temporarily discontinue or stop the use of this medication. Individuals allergic to any ingredient of this medication, those with severe liver impairment, those with muscle diseases, those with severe renal impairment, and women who are pregnant or breastfeeding should not take this medication. Additionally, when taken with certain medications, the risk of side effects may increase; therefore, patients taking other medications should consult with healthcare professionals. This drug may affect liver function; thus, individuals with a history of liver disease or who consume alcohol heavily should undergo regular liver function tests, and treatment should be stopped immediately if symptoms of liver damage appear. Elderly patients or those at risk of myopathy need to be especially cautious when taking this medication and should be advised to undergo muscle-related testing before and during use. Women of childbearing potential should practice adequate contraception while taking this medication and should stop taking it immediately if pregnancy is confirmed. Safety in pediatric or adolescent patients has not been sufficiently established; therefore, it is not recommended for pediatric patients. In case of overdose, there is no specific antidote, so treatment should be symptomatic while monitoring liver function and muscle enzyme tests.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, chest tightness, difficulty breathing, cold sweat, paleness, high fever, severe rash, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough+fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and very severe headache, thunderclap headache, seizure, consciousness confusion, visual disturbances, paralysis, significantly decreased urine output.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • muscle pain
  • itching
  • rash
  • pruritus
  • weakness
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  • fatigue
  • joint pain
  • diarrhea
  • upper respiratory infection
  • cough
  • sputum
  • nasal congestion
  • hives
  • hair loss
  • thrombocytopenia
  • depression
  • sensory disturbance
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease.

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, and should be kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

Alu-Alu - 30 tablets/box [(10 tablets/Alu-Alu×3)], Bottle - 30 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.