Atorvastatin and Ezetimibe Tablets 10/20 mg

Adult dosage

This drug is administered once daily regardless of meals. For the treatment of primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg per day is recommended. For patients requiring a greater reduction in LDL cholesterol (over 55%), an initial dose of 10/40 mg per day is recommended. The interval for checking blood lipid levels after starting treatment or adjusting the dose should be at least 2 weeks.

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can lead to serious muscle damage. If severe muscle pain or weakness occurs, immediate medical attention should be sought. This medication should not be used in people with an allergy to the active ingredient or any of its components, those with active liver disease or persistent unexplained elevation of liver enzymes, individuals with muscle disorders, pregnant or potentially pregnant women, breastfeeding mothers, individuals taking certain antiviral drugs, and those with lactose intolerance. Caution is especially needed for individuals with a history of alcoholism or liver disease, reduced kidney function, hypothyroidism, elderly patients, and those on specific medications. During the course of treatment, side effects such as muscle pain, joint pain, abdominal pain, and liver function abnormalities may arise, and if these symptoms worsen or persist, a healthcare professional should be consulted. As this medication may affect liver function, liver function tests should be conducted before initiating treatment, and regular assessments should be done during therapy. If symptoms of liver damage occur, the drug should be discontinued immediately. This drug should not be administered to pregnant or breastfeeding women, and women of childbearing age should use appropriate contraceptive methods while taking this medication. Safety and efficacy have not been established in children, so it is not recommended for use in this population. Elderly patients may have an increased risk of myopathy, but dosage adjustment is generally not needed. This medication may interact with other drugs; thus, it is essential to inform the healthcare provider or pharmacist of all medications being taken, especially when using drugs that affect liver metabolism. In case of overdose, since no specific antidote exists, symptomatic treatment and supportive care are required, with monitoring of liver function and muscle enzyme levels. This medication should be stored out of the reach of children and should not be transferred to another container. If dizziness or muscle pain occurs during treatment, caution should be exercised regarding driving or operating machinery.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash accompanied by high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues.

Mild side effects

• Muscle pain
• abdominal pain
• elevation of liver enzymes
• dizziness
• cough
• nausea
• diarrhea
• joint pain
• muscle weakness
• musculoskeletal pain

This drug may be sensitive to air and moisture; therefore, it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1°C and 30°C. Proper storage will help preserve the drug's effectiveness.

Appearance

White oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP*3)], 30 tablets/bottle