RosuDuo Tablet 10/5 mg (Ezetimibe, Rosuvastatin Calcium)

Adult dose

This medicine is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended. For patients needing more significant LDL-cholesterol reduction, the dosage may be adjusted, and blood lipid levels should be monitored after intervals of at least 4 weeks prior to dosage adjustment. The dosage can be increased up to a maximum of 10/20 mg daily.

This medicine could cause rhabdomyolysis, a rare side effect that may result in serious muscle problems. It should be temporarily discontinued or stopped in patients at risk of acute renal failure or those with severe infections, hypotension, major surgery, or trauma. Patients allergic to any ingredients of this drug, those with liver disease or persistently elevated serum liver enzyme levels without known cause, those with muscle disorders, those taking the immunosuppressant cyclosporine, those with severe kidney dysfunction, pregnant women or women who may become pregnant, and breastfeeding women should not take this medicine. Individuals at high risk for myopathy or rhabdomyolysis should consult with a physician before taking this medicine, and should immediately inform their doctor if symptoms such as muscle pain, muscle cramps, or muscle weakness occur during treatment. This medicine may affect liver function, so liver function tests should be performed prior to use, and if abnormal liver function symptoms occur during treatment, the tests should be repeated. If liver enzyme levels significantly increase, this medicine may be discontinued. Patients with a history of alcoholism or liver disease should use this medicine cautiously, and elderly patients are also at higher risk for myopathy and should be careful. This drug may interact with other medications, so it is essential to inform the doctor or pharmacist of any current medications. Particular caution should be taken when used with fibrates, anticoagulants, certain antifungals, antivirals, or specific antibiotics. Pregnant or breastfeeding women should not use this medicine, and women of childbearing age should ensure appropriate contraception while taking this drug. Safety and efficacy in children and adolescents have not been sufficiently established, therefore it is not recommended. In case of overdose, there is no specific antidote, and treatment should be provided based on symptoms, along with liver and muscle-related testing. This medicine should be kept out of reach of children, and care should be taken as transferring it to another container may degrade its quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, difficulty breathing or wheezing, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbance, paralysis, urination

Mild side effects

• Nasopharyngitis
• arthralgia
• headache
• increased ALT
• increased AST
• myalgia
• elevated bilirubin levels
• acneiform dermatitis
• pruritus
• dizziness

This medicine should be stored in a tightly closed container to prevent air or moisture ingress, at room temperature between 1°C and 30°C. By storing it this way, the efficacy of the medicine can be safely maintained.

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×3]