Medication info
Rozduo Tablet 10/20 Milligrams

Rozduo Tablet 10/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Pink egg-shaped film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTPX3)], 30 tablets/bottle
Approval status
Active

MFDS item code 201506796 · Approved 2015.09.24 · Insurance code 645404540

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and reduction 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, the dosage range is 10/5mg to 10/20mg per day. A starting dose of 10/5mg daily is recommended. For patients requiring greater LDL cholesterol reduction, the dosage can be adjusted accordingly. After starting treatment or adjusting the dose, serum lipid levels should be checked at intervals of more than 4 weeks, with a maximum daily dose of

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and reduction 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 used to lower total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, especially those with heterozygous familial and non-familial hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It is prescribed as an adjunct to a proper diet to limit saturated fat and cholesterol intake, particularly in cases where dietary management alone is insufficient. Additionally, it is administered to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia to help improve cardiovascular disease risk. Before use, it is necessary to identify secondary factors causing dyslipidemia and to treat them if necessary. This medication effectively improves the patient's lipid profile and enhances cardiovascular health.

How to take

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/5mg to 10/20mg per day. A starting dose of 10/5mg daily is recommended. For patients requiring greater LDL cholesterol reduction, the dosage can be adjusted accordingly. After starting treatment or adjusting the dose, serum lipid levels should be checked at intervals of more than 4 weeks, with a maximum daily dose of

Precautions

This medication can rarely cause serious side effects such as rhabdomyolysis, which may result in muscle abnormalities; therefore, patients should immediately inform a physician if they experience sudden muscle pain or weakness. This medication may affect liver function; hence, it should not be used in patients with liver disease or those with abnormally elevated liver enzyme levels. Patients with muscle diseases or at high risk for adverse muscle reactions, such as those with severe infections, hypotension, or after major surgery or trauma, must be carefully monitored when using this medication, and discontinuation may be necessary. This medication should not be administered to individuals with certain genetic conditions or lactose intolerance. Pregnant women, women who may become pregnant, and nursing mothers should not use this medication, and women of childbearing potential should use appropriate contraception during treatment. This medication may interact with other drugs, so it is essential to consult a physician, especially if taking medications that affect drug metabolism in the liver. Elderly patients or those with impaired renal function are also at higher risk for adverse muscle reactions and should be monitored closely. Regular liver function and muscle enzyme tests should be performed during treatment to detect any abnormalities early. Caution is needed when driving or operating machinery due to the possibility of dizziness.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), severe lethargy, sudden and very severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

Nasopharyngitis, dyspepsia, headache, dizziness, constipation, nausea, abdominal pain, dry mouth, elevated liver enzymes, abnormal liver function tests, increased serum lactate dehydrogenase levels, pruritus, itching, rash, myalgia, weakness, fatigue, arthralgia, sensory disturbances, chest discomfort, diarrhea, decreased appetite, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, tremor, oropharyngeal pain, nasal congestion, cough, increased serum creatinine, blood

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 exposure to air or moisture. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink egg-shaped film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTPX3)], 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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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.