Medication info
Roget Tablet 10/2.5mg (Ezetimibe, Rosuvastatin)

Roget Tablet 10/2.5mg (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›2.6mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 30 tablets/box [(10 tablets/PTP x 3, Alu-Alu)]
Approval status
Active

MFDS item code 202501472 · Approved 2025.06.17 · Insurance code 649808350

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed type) and treatment of dyslipidemia
Who takes it
Adults
Adult dose
This drug is administered once daily, regardless of meals. The dosage range is 10/2.5mg to 10/20mg per day. The recommended initial dose is 10/2.5mg or 10/5mg per day. For patients requiring more substantial reduction of LDL cholesterol, the dosage may be adjusted accordingly. After initiation of treatment or adjustment of dosage, blood lipid levels should be checked at intervals of at least 4 weeks and adjusted as needed.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed type) and treatment of 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 drug is used together with diet to lower elevated total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol, the 'good' cholesterol. This helps improve blood lipid profiles and reduces the risk of cardiovascular disease. Therefore, this drug is effectively used in the treatment of hyperlipidemia.

How to take

Adult dose

This drug is administered once daily, regardless of meals. The dosage range is 10/2.5mg to 10/20mg per day. The recommended initial dose is 10/2.5mg or 10/5mg per day. For patients requiring more substantial reduction of LDL cholesterol, the dosage may be adjusted accordingly. After initiation of treatment or adjustment of dosage, blood lipid levels should be checked at intervals of at least 4 weeks and adjusted as needed.

Precautions

This drug has been reported to cause a rare side effect called rhabdomyolysis, which can lead to serious muscle abnormalities. Therefore, if severe muscle pain or weakness occurs, immediate consultation with a physician is needed. This drug should not be administered to patients with poor liver function, severely impaired kidney function, muscle diseases, or to women who are pregnant or breastfeeding. Care is particularly necessary when co-administering with certain medications in patients with severe renal impairment. Patients with a history of alcoholism or liver disease should also be cautious when using this drug. This drug may elevate liver enzyme levels, so regular liver function tests should be performed before and during treatment. If symptoms of muscle pain, cramps, weakness, fatigue, fever, etc. appear during treatment, inform a physician immediately for examination. This drug may increase blood glucose levels, but since the cardiovascular disease prevention effect is greater, appropriate diabetes management may be necessary when needed. This drug may interact with other medications, so if you are taking other drugs, you must inform your physician or pharmacist. Women who may become pregnant should use appropriate contraception while taking this drug and discontinue use immediately if pregnancy occurs. Safety in children and adolescents has not been sufficiently established, so use is not recommended. Caution should be taken when using this drug in the elderly due to a higher risk of muscle abnormalities. In case of overdose, as there is no specific antidote, appropriate treatment and support therapy according to the symptoms are necessary, and liver function and muscle enzyme tests should be performed. This drug contains lactose and should not be taken by patients with lactose intolerance. During the use of this drug, dietary measures and lifestyle improvements should be continued, and regular blood lipid tests should be conducted to monitor treatment effects and side effects.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizure, altered consciousness, visual disturbances, paralysis, urination issues.

Mild side effects

  • Headache
  • migraine
  • sensory loss
  • aphthous ulcer
  • chronic gastritis
  • muscle pain
  • gout
  • increased C-reactive protein
  • nasopharyngitis
  • arthralgia
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  • dizziness
  • fatigue
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • pruritus
  • acne-like dermatitis
  • vomiting
  • gastritis
  • bloating
  • nausea
  • upper respiratory tract infection
  • low back pain
  • muscle pain
  • rash
  • itching
  • hives
  • chest pain
  • discomfort in the chest
  • weakness
  • systemic edema
  • trembling
  • bronchitis
  • rhinitis
  • and others.

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

Storage

This drug should be stored in a tightly sealed container to prevent air or moisture from entering. It is advisable to store it at room temperature, between 1 to 30 degrees Celsius. Proper storage helps maintain the drug's efficacy.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 30 tablets/box [(10 tablets/PTP x 3, Alu-Alu)]

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.