Medication info
Rosuvastatin Calcium/Ezetimibe Tablet 10/5 mg

Rosuvastatin Calcium/Ezetimibe Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Pink oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004587 · Approved 2020.06.23 · Insurance code 648604100

Summary

Main use
Control of lipid levels in hypercholesterolemia (primary, mixed) and reduction of atherosclerotic vascular disease risk
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended. The dose range is from 10/5 mg to 10/20 mg per day, adjustable according to the patient's LDL cholesterol reduction needs. After administration or dose adjustment, lipid levels should be checked at least 4 weeks apart to adjust the dosage accordingly, with a maximum dose of 10/20 mg per day.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Control of lipid levels in hypercholesterolemia (primary, mixed) and reduction of atherosclerotic vascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps lower high levels of total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing levels of HDL cholesterol (the 'good' cholesterol). It is primarily used as an adjunct to dietary changes, and effectiveness is enhanced when used in conjunction with a proper diet, including limiting saturated fat and cholesterol intake. This medication is prescribed after identifying and treating other secondary causes of dyslipidemia, and when dietary and non-drug therapies have not sufficiently responded. It is also applicable to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, where lipid levels would be monitored closely before and after treatment. In cases of acute coronary events, initial lipid testing upon hospitalization can also guide treatment plans. This medication is used to improve blood lipid levels and reduce the risk of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended. The dose range is from 10/5 mg to 10/20 mg per day, adjustable according to the patient's LDL cholesterol reduction needs. After administration or dose adjustment, lipid levels should be checked at least 4 weeks apart to adjust the dosage accordingly, with a maximum dose of 10/20 mg per day.

Precautions

This medication has the rare side effect of rhabdomyolysis, which can cause serious muscle damage. If sudden severe muscle pain or weakness occurs, immediate consultation with a physician is necessary. It can also affect the liver, thus liver function tests should be performed before initiating treatment, and liver function should be regularly monitored during treatment. Patients with liver disease or abnormally high liver enzyme levels should avoid using this medication. Patients with severely impaired kidney function or muscle disorders should not take this medication, while those with mildly impaired kidney function should use it cautiously under medical advice. This medication should not be taken by pregnant women, those who may become pregnant, or nursing mothers, and appropriate contraception should be used if planning to conceive. Patients with a history of significant alcohol consumption or liver disease should exercise caution when using this medication. This medication may interact with other drugs; therefore, it is essential to inform the physician or pharmacist about any currently taken medications. Particularly, the risk of muscle damage may increase when taken with certain antibiotics, antifungals, immunosuppressants, antivirals, and fibrate-class drugs. Since this medication contains lactose, patients with lactose intolerance should use it with caution. Dizziness and headaches may occur, so be careful when driving or operating machinery. The safety and efficacy of this medication have not been adequately established for children and the elderly, thus a physician's judgment is necessary when using it. It is essential to consult a doctor immediately if any unusual symptoms or discomfort occur while taking this medication.

Side effects and when to seek care immediately

Serious side effects

  • Hives, swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions
  • Severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin abnormal reactions
  • Difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever
  • Jaundice of the skin or eyes, extreme lethargy, liver dysfunction (jaundice)
  • Sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision problems

Mild side effects

  • Pharyngitis
  • dyspepsia
  • headache
  • dizziness
  • pruritus
  • rash
  • myalgia
  • weakness
  • fatigue
  • arthralgia
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  • abdominal pain
  • diarrhea
  • nausea
  • loss of appetite
  • abdominal bloating
  • dry mouth
  • palpitations
  • flushing
  • cough
  • sputum
  • nasal congestion
  • facial swelling
  • unusual sensations
  • medication intolerance
  • dizziness
  • drowsiness
  • neurodegenerative disorders
  • postural dizziness
  • migraine
  • cough
  • sensory disturbance
  • depression
  • tremors
  • chest pain
  • musculoskeletal stiffness
  • musculoskeletal discomfort

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

Storage

Store this medication in a tightly sealed container to prevent air or moisture from entering and keep it at a temperature between 1 and 30 degrees Celsius (room temperature). This helps maintain the medication's effectiveness and ensures safe use.

Appearance and packaging

Appearance

Pink oblong 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.