Rosuvastatin/Ezetimibe 10/5 mg

Adult dose

This medication is administered once daily, regardless of meals. For the treatment of primary hypercholesterolemia, an initial dose of 10/5mg once daily is recommended. For patients needing greater reductions in LDL cholesterol, the dosage can be adjusted. When adjusting the dosage, blood lipid levels should be checked at intervals of more than 4 weeks, and the dosage can be increased up to a maximum of 10/20mg per day.

This medication may cause a rare side effect called rhabdomyolysis, which can lead to serious muscle problems. Patients with acute infections, hypotension, major surgeries or trauma, metabolic abnormalities, endocrine diseases, electrolyte imbalances, uncontrolled seizures, etc. should temporarily stop or discontinue this medication. It should not be used in patients with known allergies to any of the active ingredients or components, those with active liver disease, or persistent unexplained increases in liver enzyme levels, muscle disease patients, patients taking cyclosporine, patients with severe kidney failure, pregnant women or women who may become pregnant, and nursing mothers. Additionally, patients with reduced kidney function or hypothyroidism, those with a family history of muscle diseases or a history of myopathy with other statins or fibrates, alcoholics, and Asian patients who are at higher risk of myopathy should use this medication with caution. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic disorders. Liver function tests should be performed before and during treatment, as it may affect liver function, and the medication should be discontinued immediately if there are significant increases in liver enzyme levels or signs of liver damage. During the use of this medication, if symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, fever, etc. occur, contact a doctor immediately and check for muscle damage through blood tests. This medication may slightly raise blood sugar levels, so patients at high risk for diabetes should closely monitor their blood sugar levels. There may be interactions with other medications, and especially patients taking anticoagulants, fibrates, certain antibiotics, antifungals, and immunosuppressants should consult with their physician. Pregnant or nursing women should not take this medication, and women of childbearing age should use appropriate contraception while on it. The safety for children and adolescents has not been sufficiently established and therefore is not recommended. Elderly patients may be at increased risk of myopathy and should use it with caution. In case of overdose, there is no specific antidote, so symptomatic treatment and supportive care should be provided while monitoring liver function and muscle damage.

Serious side effects

Urticaria, edema, chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly decreased urine output

Mild side effects

• Nasopharyngitis
• arthralgia
• headache
• dizziness
• upper respiratory tract infections
• myalgia
• fatigue
• weakness
• pruritus
• itching

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

White to almost white round film-coated tablet

Package unit

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