Medication info
Rozekay 10/5 mg Tablet

Rozekay 10/5 mg Tablet

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

MFDS item code 202004560 · Approved 2020.06.23 · Insurance code 641806930

Summary

Main use
Treatment for improving cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring more significant LDL-cholesterol reduction, the dose can be adjusted. After starting administration or adjusting the dose, blood lipid levels should be checked at intervals of more than 4 weeks; dosage adjustments should be made accordingly, with a maximum daily dose of 10/20 mg.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Treatment for improving cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia

  • 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
  • decreased HDL-cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medicine helps reduce total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels, and increase HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It can particularly be used by patients at high risk for atherosclerotic vascular disease along with a diet for lipid control. It is administered as an adjunct when dietary or non-drug therapies are ineffective, and prior to treatment, secondary causes of dyslipidemia such as diabetes and hypothyroidism must be confirmed and treated. Additionally, continuous monitoring of total cholesterol and various lipid levels during treatment is essential. Through safe and systematic management, it effectively helps regulate lipid levels and improve vascular health.

How to take

Adult dose

This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring more significant LDL-cholesterol reduction, the dose can be adjusted. After starting administration or adjusting the dose, blood lipid levels should be checked at intervals of more than 4 weeks; dosage adjustments should be made accordingly, with a maximum daily dose of 10/20 mg.

Precautions

This drug may cause serious muscle damage, especially in patients at risk of weakened kidney function due to acute infections or severe trauma. Patients allergic to the active or inactive ingredients of this drug, patients with severe liver dysfunction, patients with muscle-related diseases, patients taking certain immunosuppressants, patients with severely impaired kidney function, pregnant or potentially pregnant women, and nursing mothers should not take this drug. Patients at risk of muscle diseases, alcoholics or those with a history of liver disease, elderly patients, and patients taking certain medications should use this drug cautiously, and regular testing is recommended if necessary. If muscle pain, muscle weakness, fatigue, or musculoskeletal pain accompany fever occurs during treatment with this drug, inform your doctor immediately and seek testing. Since it can affect liver function, liver function testing should be done before and during use, and drug use should be discontinued if liver enzyme levels significantly rise. Blood glucose levels may rise, so patients at risk for diabetes should manage their blood sugar thoroughly. This drug may interact with several other medications, so if you are taking other medications, be sure to inform your doctor or pharmacist. Pregnant or nursing women should not take this drug, and fertile women should use appropriate contraception during use. Safety for children and adolescents has not been sufficiently established, so use is not recommended. In case of overdose, there is no specific antidote, and treatment should be based on symptoms, along with liver function and muscle-related tests. This drug should be stored out of the reach of children, and should not be transferred 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 accompanied by high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty in breathing, asthmatic attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination changes

Mild side effects

Headache, dizziness, dyspepsia, edema, muscle pain, dry mouth, elevated liver enzymes, abnormal liver function tests, increased blood lactate dehydrogenase levels, pruritus, elevated blood glucose, increased serum creatinine, chest pain, cough, cold sweat, dermatitis, skin burning sensation, skin disorders, alopecia, nausea, abdominal pain, diarrhea, constipation, fatigue, weakness, arthralgia, numbness, sensory abnormalities, chest discomfort, loss of appetite, abdominal bloating, syncope, generalized pain

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

Storage

This medicine must be stored in a tightly sealed container to avoid exposure to air and moisture. It is important to maintain a storage temperature at room temperature between 1 and 30 degrees. This helps retain the medicine's efficacy and safety for a long time.

Appearance and packaging

Appearance

Pink 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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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.