Ezestat Tablets 10/20

Adult dose

This medication is administered once daily in the evening, irrespective of meals. The dose range for patients with primary hypercholesterolemia is from 10/10mg to 10/40mg daily, with the generally recommended initial dose being 10/20mg per day. Patients who require less reduction in LDL-cholesterol may start at 10/10mg per day. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg once daily in the evening.

This medication can cause serious muscle-related side effects such as myopathy and rhabdomyolysis, so if symptoms of muscle pain or weakness occur, the healthcare provider should be informed immediately. The risk of these side effects may increase, especially when taken in high doses or in combination with certain other medications. Patients allergic to any component of this medication or with severely impaired liver function, as well as women who are pregnant or breastfeeding, should not take this medication. Additionally, this medication should not be used in combination with certain strong CYP3A4 inhibitors or other specific drugs such as certain antifungals, antibiotics, or immunosuppressants. Patients with severe muscle weakness or ocular muscle weakness should also use this medication cautiously, and it should be discontinued immediately if any adverse symptoms appear. This medication should be used with caution in patients with liver dysfunction, and administration should be stopped if elevated liver enzyme levels or symptoms of liver damage occur. Regular blood tests to monitor liver function and muscle enzyme levels are recommended during treatment. Pregnant women or women who may become pregnant should avoid this medication, and if pregnancy is confirmed, administration should be stopped immediately. Breastfeeding women should also discontinue breastfeeding while taking this medication. The safety of this medication has not been fully established in children and adolescents, so it should be used with caution, and elderly patients should be monitored carefully while using it. During the use of this medication, it is important to inform healthcare providers of its use when new medications are prescribed, and it is advisable to avoid certain foods such as grapefruit juice.

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, angioedema, skin mucosal syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), severe cutaneous adverse reactions (SCARs) including erythema multiforme, elevated liver aminotransferase levels, hepatitis, pancreatitis, thrombocytopenia, dyspnea, severe allergic reactions, myopathy, rhabdomyolysis, elevated creatine kinase (CK), acute renal failure, liver

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, myalgia, limb pain, fatigue, abdominal pain, viral infection, pharyngitis, sinusitis, arthralgia, low back pain, cough, weakness, cataract, constipation, dyspepsia, flatulence, nausea, eczema, pruritus, rash, dizziness, sensory disturbances, depression, cholelithiasis, cholecystitis, thrombocytopenia, nausea, pancreatitis, urticaria, rash, angioedema, skin mucosal syndrome (Stevens-Johnson syndrome)

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1°C and 30°C.

Appearance

White to off-white, double convex, rectangular tablet

Package unit

30 tablets (10 tablets/PTPX3)