Lipoduol Tablet 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Adult dosage

This drug should be administered once daily regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg daily. An initial dose of 10/10 mg or 10/20 mg per day is recommended. For patients requiring greater reduction of LDL-cholesterol, an initial dose of 10/40 mg per day is recommended. After starting therapy or adjusting the dosage, lipid levels in the blood should be assessed at intervals of more than 2 weeks.

This drug can cause myopathy resulting in muscle issues or, in severe cases, rhabdomyolysis. It may be necessary to temporarily cease administration in patients at high risk of renal impairment due to factors such as severe infections, hypotension, major surgery, trauma, metabolic disorders, and uncontrolled seizures. Patients allergic to any components of this drug, those with severe liver dysfunction, muscle disorders, women who are pregnant or breastfeeding, patients taking certain antiviral medications, and those with genetic issues like lactose intolerance should not use this drug. Caution is required for patients with a history of alcoholism, liver disease, impaired renal function, hypothyroidism, history of myopathy, and elderly individuals who are at higher risk of muscle issues. Patients taking fibrates or those with severe myasthenia gravis also need to be careful. Side effects from this drug may include muscle pain, abdominal pain, elevated liver enzymes, and rarely muscle weakness, joint pain, headache, dizziness, cough, diarrhea, hyperkalemia, liver dysfunction, among other abnormal reactions. If symptoms like muscle pain or weakness, fatigue, or fever occur, patients should immediately inform their doctor and check for muscle damage through blood tests. If there is a significant increase in muscle enzyme levels in the blood, this medication should be discontinued. Since it can affect liver function, liver function tests should be conducted before administration, and if symptoms of liver damage arise during treatment, it should be stopped immediately. Continuous elevation of liver enzyme levels may necessitate dosage reduction or cessation. This medication should not be used by women during pregnancy or breastfeeding as it may be harmful to the fetus or baby, and women of childbearing age should use appropriate contraception. Safety in pediatric patients has not been established and is not recommended. Elderly patients should be cautious due to increased risk of muscle issues, but dosage adjustments are usually not necessary. Patients with impaired renal function are also at risk for muscle issues and should be monitored closely. This drug may interact with other medications, especially those metabolized by the liver or affecting muscle, so consultation with a doctor or pharmacist is advised. There is no specific antidote for overdose, so symptomatic treatment and supportive care should be implemented while regular liver function and muscle enzyme tests are conducted. This medication should be kept out of reach of children and should not be transferred to other containers. Dizziness may occur during treatment, so caution should be exercised when driving or operating machinery.

Serious side effects

• Hives
• severe swelling (including angioedema)
• chest tightness
• difficulty breathing
• cold sweat
• pallor
• severe rash with high fever
• blisters
• skin peeling
• painful mucous membranes in mouth/eyes

Mild side effects

• Muscle pain
• abdominal pain
• nausea
• diarrhea
• joint pain
• muscle weakness
• musculoskeletal pain
• hyperkalemia
• bronchitis
• sinusitis

This medication should be stored in a tightly closed container protected from air and moisture. It is recommended to maintain storage temperature between 1° and 30°C.

Appearance

White or light yellow, double convex, capsule-shaped film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu×3]