Ezisan Tablet 10/2.5 mg (Ezetimibe, Rosuvastatin)

Adult dose

This medication is administered once daily regardless of meals. The dosage range is from 10/2.5 mg to 10/20 mg daily. The recommended initial dosage is 10/2.5 mg or 10/5 mg daily. In patients requiring a greater reduction in LDL cholesterol, the dosage can be adjusted. Blood lipid levels should be monitored at least 4 weeks after starting treatment or adjusting the dose, and the dosage should be adjusted accordingly. The maximum daily dose is

This medication may cause serious problems with muscles, so it should be discontinued immediately if acute myopathy or rhabdomyolysis is suspected. Patients should not use this medication if they have allergies to its ingredients or have liver disease, muscle disease, or significantly impaired renal function, and should not use it if pregnant or breastfeeding. Particular caution is needed in patients with moderate to severe renal impairment, hypothyroidism, a family history or history of muscle toxicity, alcohol abusers, Asian patients, and those taking fibrate-class drugs concomitantly. This medication contains lactose and should not be administered to patients with lactose intolerance or associated genetic disorders. Patients with a history of alcohol abuse or liver disease and those at risk of myopathy should use this medication cautiously and undergo regular muscle and liver function tests. If symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, and fever occur during treatment, consult a doctor immediately, and blood tests may be needed to check for muscle damage. As liver function abnormalities may occur, liver function tests should be conducted before and during treatment, and if liver enzyme levels become abnormally high, dose adjustments or cessation may be necessary. This medication may interact with other drugs; therefore, consultation with a doctor or pharmacist is required, especially when taken with other lipid-lowering agents, anticoagulants, antifungals, and antibiotics. Women who are pregnant or may become pregnant should use appropriate contraception while taking this medication, and should discontinue use immediately if pregnancy is confirmed. This medication is not recommended for children and adolescents due to insufficient evidence of safety and efficacy, and elderly patients should take it cautiously due to an increased risk of myopathy. In case of overdose, there is no specific antidote, and treatment and supportive therapy should be provided according to symptoms, monitoring liver function and muscle damage.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, mucosal pain in mouth/eyes, difficulty breathing or wheezing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urine changes

Mild side effects

• Nasopharyngitis
• headache
• sensory impairment
• aphthous ulcer
• chronic gastritis
• myalgia
• gout
• elevated C-reactive protein
• arthralgia
• headache

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it should be stored at room temperature, ideally between 1 to 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

White oval film-coated tablet

Package unit

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