Medication info
Rosuvastatin/Ezetimibe Tablet 10/20 mg

Rosuvastatin/Ezetimibe Tablet 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP×3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004594 · Approved 2020.06.23 · Insurance code 663608260

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and dyslipidemia and suppression of the risk of atherosclerotic vascular diseases.
Who takes it
Adults
Adult dose
This medication is taken once daily, regardless of meals. The initial recommended dosage is 10/5 mg once daily. For patients requiring greater LDL cholesterol reduction, the dosage may be adjusted. After starting treatment or adjusting the dosage, blood lipid levels should be checked with an interval of at least 4 weeks, and the dosage can be adjusted accordingly, with a maximum increase to 10/20 mg per day.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and dyslipidemia and suppression of the risk of atherosclerotic vascular diseases.

  • 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 drug is used as an adjuvant to dietary therapy to lower high total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is particularly used in conjunction with appropriate dietary therapy for patients at high risk of atherosclerotic vascular diseases due to hypercholesterolemia, primarily when dietary therapy alone is insufficient. Before treatment, other causes of dyslipidemia should be identified and treated if necessary. Additionally, lipid tests should be used to monitor total cholesterol, LDL, HDL cholesterol, and triglyceride levels, and based on this, treatment directions should be determined. This drug helps to safely and effectively improve lipid levels and reduce the risk of cardiovascular diseases.

How to take

Adult dose

This medication is taken once daily, regardless of meals. The initial recommended dosage is 10/5 mg once daily. For patients requiring greater LDL cholesterol reduction, the dosage may be adjusted. After starting treatment or adjusting the dosage, blood lipid levels should be checked with an interval of at least 4 weeks, and the dosage can be adjusted accordingly, with a maximum increase to 10/20 mg per day.

Precautions

This drug can cause serious muscle problems, so if sudden muscle pain, weakness, or cramps occur, you should immediately inform your doctor. In cases of severe infection, hypotension, major surgery or trauma, or uncontrolled seizures, this medication should be temporarily or permanently discontinued. Patients with allergies to this drug's ingredients, active liver disease, muscle disorders, or severe renal impairment should not take this medication. Women who are pregnant, may become pregnant, or are breastfeeding should also avoid this medication. Moreover, patients at risk of certain myopathies, such as those with hypothyroidism or a family history, patients with alcohol dependence, Asian patients, and those who are taking fibrate drugs should use this medication cautiously. Caution is also required for patients with impaired liver function, heavy alcohol consumption, and the elderly when using this drug. Regular monitoring of liver function tests and muscle-related tests should be conducted while taking this drug, and if liver levels significantly increase or muscle damage indicators rise, usage should be discontinued. Furthermore, this drug may interact with other medications, so if taking other medications, it is essential to inform your doctor or pharmacist. Caution should be exercised as dizziness may occur while driving or operating machinery. Lastly, this drug is not recommended for children, and safety has not been established in children under 10 years old.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

Nasopharyngitis, indigestion, headache, myalgia, edema, dizziness, fatigue, abdominal pain, diarrhea, nausea, pruritus, arthralgia, chest discomfort, asthenia, dry mouth, constipation, elevated blood sugar, elevated blood pressure, thrombocytopenia, tremor, urination abnormalities (including renal failure), elevated serum creatinine, sensory abnormalities, rash, alopecia, nasal congestion, cough, sputum, urticaria, palpitations, congestive heart failure, myocardial ischemia, depression, sleep disorders.

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The storage temperature should be kept at room temperature between 1 degree Celsius and 30 degrees Celsius. This will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×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.