Atorvastatin 10/20 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Adult dosage

This medication is administered once daily without regard to meals. The dosage range is 10/10mg to 10/80mg once a day, with an initial recommended dose of 10/10mg or 10/20mg daily. If greater reduction of LDL cholesterol is needed, a daily dose of 10/40mg is advised. After initiating treatment or adjusting the dosage, the blood lipid levels should be checked at least two weeks apart. For homozygous familial hypercholesterolemia

This drug has a rare side effect that can cause severe damage to muscles called rhabdomyolysis. Particularly, caution is needed as the risk of this side effect is higher in patients with severe infections, hypotension, major surgeries or trauma, or severe metabolic disorders. This medication should not be administered to individuals with allergies to the active ingredient or components, individuals with severe liver dysfunction or persistent unexplained elevation of liver enzymes, muscle diseases, pregnant or potentially pregnant women, breastfeeding women, patients taking certain antiviral drugs, or individuals with lactose intolerance. Patients who are alcoholics, have a history of liver disease, have impaired kidney function, have hypothyroidism, a family history of muscle disorders, or have previously experienced muscle toxicity with statin drugs, individuals over 70 years of age, those taking fibrate medications together, or patients with severe muscle weakness should use this drug cautiously. During treatment, if symptoms such as myalgia, muscle weakness, fatigue, or fever occur, inform a physician immediately, and if necessary, confirm muscle damage through blood tests. If muscle damage is confirmed, the administration of this drug should be discontinued, and the reinstitution should start at a very low dose with careful observation after symptoms have improved. Since liver function abnormalities may occur, liver function tests should be conducted before and during treatment, and if symptoms of hepatitis or jaundice appear, this drug should be discontinued immediately. This drug can raise blood glucose levels, so patients at risk for diabetes should monitor their blood sugar regularly. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraceptive measures while on treatment. The safety and efficacy of this drug have not been confirmed in children; therefore, it is not recommended. Caution should be exercised in elderly patients due to the increased risk of myopathy, but no separate dose adjustment is necessary. This medication should not be administered to patients with active liver disease or persistent unexplained elevation of liver enzymes. Caution should also be taken in patients with impaired kidney function due to the risk of muscle damage. This drug may interact with multiple medications, so patients taking other drugs should inform their physician or pharmacist, especially when combined with CYP3A4 inhibitors, antiviral drugs, fibrate drugs, colchicine, cyclosporine, etc. Caution should be exercised as dizziness may occur while driving or operating machinery. In case of overdose, as there is no specific antidote, treatment must be symptomatic and supportive, with monitoring of liver function and muscle damage. Keep out of reach of children and avoid transferring to other containers.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, mucosal pain in mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

• Myalgia
• abdominal pain
• nausea
• diarrhea
• dizziness
• cough
• musculoskeletal pain
• arthralgia
• muscle weakness
• hyperkalemia

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

White to pale white, double convex, rectangular film-coated tablets

Package unit

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