Rosuvastatin Calcium/Ezetimibe 10/5 mg

Adult dose

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dosage can be adjusted. Blood lipid levels should be checked at intervals of more than 4 weeks after treatment initiation or dosage adjustment, and dosage should be adjusted accordingly. The maximum daily dose may be increased up to 10/20 mg.

This medication can cause a rare side effect known as rhabdomyolysis, which can cause severe muscle damage, so if severe muscle pain or weakness occurs, the doctor should be notified immediately. The use of this drug should be temporarily suspended or stopped in the presence of risk factors such as acute infections, hypotension, major surgeries or trauma, metabolic and electrolyte abnormalities, and uncontrolled seizures. Individuals with allergies to the active ingredients or components, active liver diseases, unexplained elevated liver enzyme levels, muscle diseases, severe kidney function impairment, pregnant women or those who may become pregnant, and nursing mothers should not use this medication. Additionally, care should be taken in patients taking certain medications, those with impaired kidney or thyroid function, the elderly, and alcoholics; they should use this medication cautiously and observe for potential side effects such as muscle pain or liver function abnormalities. Since this drug can affect liver function, liver function tests should be conducted before and during treatment, and if symptoms of liver damage arise, the doctor should be consulted immediately. If muscle-related abnormalities occur, serum creatine kinase levels should be measured, and in severe cases, the administration of this drug should be discontinued. This medication is not recommended for use in pregnant or nursing women due to potential risks to the fetus or baby; women of childbearing potential should use appropriate contraception during treatment. Safety and efficacy in children and adolescents have not been adequately established, so it is not recommended. Dizziness may occur during treatment, so caution is required when driving or operating machinery. This medication may interact with other drugs, so it is essential to inform the doctor or pharmacist about any other medications being taken, particularly when used alongside anticoagulants, fibrates, and certain antibiotics or antifungals. In the case of overdose, there is no specific antidote, so treatment and supportive therapy based on symptoms are needed, and liver function and muscle condition should be monitored. This drug should be stored out of reach of children and should not be transferred to other containers.

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash, blisters, skin peeling, painful mucous membranes in the mouth/eyes, severe skin reactions, respiratory distress, asthma attacks, respiratory abnormalities accompanied by coughing and fever, jaundice of the skin or eyes, extreme lethargy throughout the body, liver anomalies, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness

Mild side effects

• Nasopharyngitis
• dyspepsia
• headache
• myalgia
• dry mouth
• elevated liver enzymes
• abnormal liver function tests
• increased serum lactate dehydrogenase
• pruritus
• dizziness

This medication may be sensitive to air or humidity, so it must be stored in a tightly closed container. The storage temperature should maintain room temperature between 1 and 30 degrees Celsius to preserve its effectiveness and safety over time.

Appearance

Pink, rectangular film-coated tablet

Package unit

30 tablets/PTP [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle