Medication info
Rozduo Tablet 10/2.5 mg (Ezetimibe, Rosuvastatin Calcium)

Rozduo Tablet 10/2.5 mg (Ezetimibe, Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›2.6mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Yellow rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP X 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202300828 · Approved 2023.03.10 · Insurance code 645406310

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is between 10/2.5 mg to 10/20 mg daily. A starting dose of 10/2.5 mg or 10/5 mg per day is recommended. For patients requiring more reduction in LDL-cholesterol, the dosage may be adjusted. After administration, check blood lipid levels at intervals of 4 weeks or more.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed) and treatment of 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 control blood lipid levels in patients with primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia, as well as mixed dyslipidemia. It effectively lowers total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels while increasing good HDL-cholesterol levels. This medication is used as an adjunct to dietary therapy and plays an important role in improving the balance of blood lipids to reduce the risk of cardiovascular diseases. Therefore, this medication is very useful for treating hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is between 10/2.5 mg to 10/20 mg daily. A starting dose of 10/2.5 mg or 10/5 mg per day is recommended. For patients requiring more reduction in LDL-cholesterol, the dosage may be adjusted. After administration, check blood lipid levels at intervals of 4 weeks or more.

Precautions

This medication may pose a risk of serious muscle problems; therefore, patients who exhibit symptoms of acute severe myopathy or are at risk of renal impairment due to rhabdomyolysis should temporarily suspend or discontinue the medication. This medication should not be administered to certain patients. For example, patients who are allergic to any component of this medication or have active liver disease or muscle disorders, patients with severely impaired renal function, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Patients at high risk of myopathy or rhabdomyolysis, those with impaired liver function, elderly patients, alcoholics, and those taking certain medications should use this medication carefully under strict medical supervision. Various side effects, including constipation, dyspepsia, muscle pain, headache, dizziness, increased liver enzymes, may occur; therefore, if symptoms arise, patients should consult a doctor immediately. Before taking this medication and during treatment, liver function and muscle enzyme levels should be regularly checked, and if abnormalities are found, the treatment should be suspended or adjusted. This medication should not be administered to pregnant or nursing women; fertile women should practice adequate contraception while taking this medication. Safety and efficacy have not been established in children, so this medication is not recommended for them. Elderly patients are at higher risk for myopathy, so caution should be exercised; however, dosage adjustments are not necessary. This medication may interact with other drugs, so if patients are taking other medications, they must inform their doctor or pharmacist, particularly when combined with cyclosporine, fenofibrate, warfarin, etc. There is no specific antidote for overdose; therefore, appropriate treatment and supportive therapy should be administered based on symptoms, and liver function and muscle enzyme levels should be monitored. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), severe allergic reactions, chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties with cough + fever, skin or eyes turning yellow (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Constipation
  • dyspepsia
  • increased CPK
  • colon polyps
  • diverticulosis
  • COVID-19
  • arthralgia
  • contusion
  • hematoma
  • iron deficiency anemia
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  • nasopharyngitis
  • muscle pain
  • headache
  • dizziness
  • edema
  • fatigue
  • chest pain
  • chest discomfort
  • weakness
  • generalized edema
  • diabetes
  • depression
  • itching
  • rash
  • dermatitis
  • skin burning sensation
  • skin disorders
  • alopecia
  • oropharyngeal pain
  • nasal congestion
  • pelvic pain
  • breast cysts
  • drooping eyelids

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius. Storing it this way will help safely preserve the medication's efficacy.

Appearance and packaging

Appearance

Yellow rectangular 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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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.