Medication info
Rosuzet Tablets 10/20 mg

Rosuzet Tablets 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
This medicine is a pink, oval, film-coated tablet.
Packaging
30 tablets/box [10 tablets/PTP x 3], 100 tablets/bottle
Approval status
Active

MFDS item code 201503660 · Approved 2015.06.08 · Insurance code 643507270

Summary

Main use
Inhibition of the risk of atherosclerotic vascular disease through cholesterol reduction and HDL increase in patients with hypercholesterolemia (primary, mixed) and dyslipidemia.
Who takes it
Adults
Adult dose
This medicine is administered once a day without regard to meals. For primary hypercholesterolemia, an initial dose of 10/5 mg per day is recommended, and the dose may be adjusted as needed. After adjusting the dose, lipid levels should be checked after an interval of at least 4 weeks, and the dose may be increased up to a maximum of 10/20 mg per day.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Inhibition of the risk of atherosclerotic vascular disease through cholesterol reduction and HDL increase in patients with hypercholesterolemia (primary, mixed) and 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 medicine is used as an adjunct to diet to reduce total cholesterol, LDL cholesterol, apo B protein, triglyceride, and non-HDL cholesterol levels, and to increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. In cases where there is a high risk of atherosclerotic vascular disease due to hypercholesterolemia, multiple risk factors should be comprehensively considered when prescribing lipid-modifying drug therapy. This medicine should be used with appropriate dietary measures such as limiting saturated fats and cholesterol and should be administered if dietary changes or non-pharmacological treatments are insufficient. Before administration, it is important to confirm whether there is a secondary cause of dyslipidemia and treat it if necessary. During lipid testing, total cholesterol, LDL, HDL, and triglyceride levels should be measured, and additional tests may be required for accurate LDL values, especially when triglyceride levels are very high. During acute coronary events, early lipid assessment after hospitalization is referenced for treatment planning. This medicine is used to improve dyslipidemia.

How to take

Adult dose

This medicine is administered once a day without regard to meals. For primary hypercholesterolemia, an initial dose of 10/5 mg per day is recommended, and the dose may be adjusted as needed. After adjusting the dose, lipid levels should be checked after an interval of at least 4 weeks, and the dose may be increased up to a maximum of 10/20 mg per day.

Precautions

This medicine can rarely cause serious muscle damage that may lead to kidney problems. Therefore, if severe muscle pain or weakness occurs, you should immediately inform your doctor. This medicine should not be administered to patients with impaired liver function or active liver disease. Patients with a history of muscle disorders or those at high risk for muscle damage should use this medicine with caution. Pregnant women, women of childbearing potential, or breastfeeding mothers should not take this medicine. This medicine should also not be administered to patients with certain genetic lactose intolerance. Patients with alcohol dependence or a history of liver disease should use this medicine cautiously, and regular liver function tests may be necessary. During treatment with this medicine, liver enzyme levels should be tested regularly to check for liver damage. This medicine may interact with other drugs, so you must inform your doctor or pharmacist of any other medications you are taking. This medicine can rarely cause side effects such as headaches, dyspepsia, hypertension, itching, rash, nausea, ALT increase, nasopharyngitis, arthralgia, pruritus, dizziness, cough, diarrhea, fatigue, sensory disturbances, vomiting, abdominal pain, constipation, loss of appetite, abdominal distension, fainting, myalgia, gout, erectile dysfunction, weakness, muscle pain, thrombocytopenia, cholelithiasis, cholecystitis, drowsiness, postural hypotension, migraine, soft tissue inflammation, hepatic steatosis, liver dysfunction, hepatic toxicity.

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 fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanying respiratory distress, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Headache
  • dyspepsia
  • hypertension
  • itching
  • rash
  • nausea
  • ALT increase
  • nasopharyngitis
  • arthralgia
  • pruritus
Show 27 more
  • dizziness
  • cough
  • diarrhea
  • fatigue
  • sensory disturbance
  • vomiting
  • abdominal pain
  • constipation
  • loss of appetite
  • abdominal distension
  • fainting
  • myalgia
  • muscle cramps
  • gout
  • erectile dysfunction
  • weakness
  • muscle pain
  • thrombocytopenia
  • cholelithiasis
  • cholecystitis
  • drowsiness
  • postural hypotension
  • migraine
  • soft tissue inflammation
  • hepatic steatosis
  • liver dysfunction
  • hepatic toxicity.

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

Storage

This medicine should be stored in a tightly closed container to avoid exposure to air or moisture, ideally at room temperature between 1 degree and 30 degrees Celsius. By storing it this way, the efficacy of the medicine can be maintained for a longer period.

Appearance and packaging

Appearance

This medicine is a pink, oval, film-coated tablet.

Package unit

30 tablets/box [10 tablets/PTP x 3], 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.