Medication info
Rosuejeong 10/5 mg (Ezetimibe, Rosuvastatin Calcium)

Rosuejeong 10/5 mg (Ezetimibe, Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
This medication is a yellow, rectangular film-coated tablet.
Packaging
30 tablets / box [10 tablets / PTP × 3]
Approval status
Active

MFDS item code 202004135 · Approved 2020.05.29 · Insurance code 646005120

Summary

Main use
Improvement of hypercholesterolemia (primary and mixed types) and suppression 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, it is administered at doses ranging from 10/5 mg to 10/20 mg daily, with a recommended initial dose of 10/5 mg daily. If further LDL cholesterol reduction is required, the dose can be adjusted, and increased up to a maximum of 10/20 mg daily. After initiation of therapy or dose adjustment, blood lipid levels should be monitored at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement of hypercholesterolemia (primary and mixed types) and suppression of the risk of atherosclerotic vascular disease

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

This medication helps to lower blood cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases HDL cholesterol. It is mainly used in conjunction with a dietary regimen to control cholesterol levels and reduce the risk of atherosclerotic vascular disease caused by hypercholesterolemia. Before using this medication, it is important to identify and treat any other causes of dyslipidemia if necessary. Regular lipid tests are conducted to assess treatment efficacy, and for patients with acute coronary syndrome, early lipid tests are carried out upon hospitalization. Through this process, lipid conditions can be improved safely and effectively. Therefore, this medication is used for the treatment of hypercholesterolemia and dyslipidemia.

How to take

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, it is administered at doses ranging from 10/5 mg to 10/20 mg daily, with a recommended initial dose of 10/5 mg daily. If further LDL cholesterol reduction is required, the dose can be adjusted, and increased up to a maximum of 10/20 mg daily. After initiation of therapy or dose adjustment, blood lipid levels should be monitored at intervals of 4 weeks or more.

Precautions

This medication may pose a risk of muscle problems; therefore, if severe muscle pain or weakness occurs, consult a physician immediately. In particular, patients in states such as serious infections, hypotension, major surgery, or trauma may need to temporarily halt or discontinue treatment with this medication. Individuals with allergies to this medication's active ingredients or components, those with active liver disease or persistently elevated liver enzymes, muscle disease patients, patients with severely impaired kidney function, women who are pregnant or may become pregnant, and breastfeeding women should not use this medication. Additionally, those with a history of muscle disease or those taking specific medications should use this medication with caution, and regular blood tests should be conducted as directed by a physician. This medication may affect liver function; therefore, if there are symptoms of liver dysfunction, inform your doctor immediately, and periodic liver function tests should be performed. While taking this medication, if symptoms such as muscle pain, weakness, fatigue, fever, etc., appear, inform a healthcare professional immediately, and if necessary, check muscle enzyme levels. Women who are pregnant or planning to become pregnant should avoid taking this medication, and if pregnancy occurs during the usage, they should discontinue and consult a physician immediately. It is advisable to avoid or limit alcohol consumption during the course of this medication, and inform healthcare professionals of all medications being taken due to the possibility of drug interactions. Special caution is required when prescribed to children and the elderly, particularly the elderly who may be more susceptible to muscle side effects, and they should closely follow a physician's instructions. This medication should be kept out of the reach of children and it is safer not to transfer it to another container.

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, blistering, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory irregularities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy throughout the body, sudden and extremely severe headache, lightning headache, seizures, confusion, vision abnormalities, paralysis, loss of sensation

Mild side effects

  • Nasopharyngitis
  • joint pain
  • headache
  • dizziness
  • upper respiratory infection
  • muscle pain
  • itching
  • rash
  • constipation
  • nausea
Show 28 more
  • abdominal pain
  • diarrhea
  • fatigue
  • weakness
  • chest pain
  • discomfort in the chest
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • cough
  • sputum
  • runny nose
  • limb pain
  • sensory disturbances
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • vomiting
  • gastritis
  • dry mouth
  • epigastric discomfort
  • belching
  • gastrointestinal symptoms

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. The storage temperature should be maintained between 1°C to 30°C at room temperature, to prolong the medication's effectiveness.

Appearance and packaging

Appearance

This medication is a yellow, rectangular film-coated tablet.

Package unit

30 tablets / box [10 tablets / PTP × 3]

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.