Cholesterol Tablet (Simvastatin)

Adult dose

Patients must adhere to a standard cholesterol-lowering diet before and during treatment with this medication. 1. Risk reduction for cardiovascular diseases Adult patients at high risk for coronary artery disease due to a history of coronary artery disease, diabetes, peripheral arterial disease, stroke, or other cerebrovascular diseases. The recommended initial starting dose is 40 mg of simvastatin once daily. 2. Hyperlipidemia 1) Reduction in risk and improvement of hyperlipidemia in patients with hypercholesterolemia having coronary artery disease. The general initial starting dose is 20 mg of this drug once daily in the evening. In cases of mild to moderate hypercholesterolemia, treatment may begin with this drug at 10 mg. The recommended dosage is 5 to 40 mg once daily in the evening. The dose should be appropriately adjusted based on initial LDL cholesterol levels, treatment goals, and the patient's response to the medication. Cholesterol levels should be measured regularly after starting treatment for 4 weeks and beyond to adjust dosing. If cholesterol levels decrease below the target, the dosage should be reduced. Due to an increased risk of myopathy, especially in the first year of treatment, the use of this drug at a dosage of 80 mg is reserved for patients who have taken this dosage for more than 12 months without evidence of muscular toxicity (see warnings in usage precautions). 2) For patients using fibrate medications (excluding gemfibrozil and fenofibrate), amiodarone, verapamil, diltiazem, and amlodipine, refer to the following considerations for recommended doses (see interactions in usage precautions). (1) Dosage for homozygous familial hypercholesterolemia patients Clinical trial results indicate that homozygous familial hypercholesterolemia patients should receive this drug at a dose of 40 mg in the evening. This medication may be used in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when alternate lipid-lowering therapies are not feasible. (2) In elderly patients, this drug at a dose of 20 mg can achieve maximum cholesterol-lowering effects. (3) For patients treated with verapamil, diltiazem, or dronedarone When co-administering this drug with verapamil, diltiazem, or dronedarone, the total daily dose should not exceed 10 mg. (4) For patients treated with amiodarone, amlodipine, or ranolazine When co-administering this drug with amiodarone, amlodipine, or ranolazine, the total daily dose should not exceed 20 mg. (5) Co-administration with other lipid-lowering agents This drug is effective when used alone or in combination with bile acid sequestrants. If co-administered with fibrate medications (excluding gemfibrozil (refer to usage precautions for contraindications) and fenofibrate), the total dose of this drug should not exceed 10 mg per day. (6) For patients with kidney impairment This drug is not significantly eliminated via the kidneys; therefore, mild to moderate kidney impairment may not necessitate dose adjustment. However, in cases of severe kidney impairment, initial dosing should start at 5 mg once daily with careful monitoring. 3. Dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) The recommended initial dose is 10 mg of this drug once daily in the evening. The recommended dosage range is 10 to 40 mg per day with a maximum recommended dose of 40 mg. Dosage should be adjusted appropriately based on the recommended therapeutic goals for individual patients. Adjustments should be made at intervals of 4 weeks or more.

Child dose

3. Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17): The recommended initial dose is 10 mg once daily in the evening. Recommended dosage range is 10 to 40 mg per day, with a maximum recommended dose.

This medication may cause severe side effects such as myopathy or rhabdomyolysis, so special caution is necessary, particularly in patients taking high doses. Any unexplained muscle pain or weakness during treatment should be reported to a doctor immediately. Furthermore, since this drug is primarily metabolized in the liver, patients with impaired liver function or liver disease should avoid its use and undergo regular liver function tests during treatment. Pregnant or potentially pregnant women and nursing mothers should not take this medication. This drug may interact with certain medications, leading to increased blood concentrations, so it is essential to inform healthcare providers about any other medications taken. There may be an increased risk of myopathy when used in combination with strong CYP3A4 inhibitors, certain antibiotics, immunosuppressants, or calcium channel blockers. Elderly patients, those with impaired kidney function, hypothyroidism patients, and those with a history of muscle diseases should use this drug cautiously and monitor for muscle-related symptoms more closely. It is advisable to avoid grapefruit juice or excessive consumption of grapefruit during treatment. Symptoms such as vomiting or diarrhea may occur with overdose; therefore, the prescribed dosage should be strictly adhered to. Keep out of reach of children and store in the original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweating, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, wheezing or breathing difficulties, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe malaise, sudden and severe headache, thunderclap headache, seizures, consciousness disturbances, vision changes, paralysis, urinary symptoms.

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, dyspepsia, bloating, nausea, headache, upper respiratory infection, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchitis, rhinitis, eczema, urinary tract infection, hair loss, itching, various skin changes, drug rash resembling lichen planus, gynecomastia, decreased libido, sexual dysfunction, cataract progression, ocular muscle paralysis, anemia, thyroid dysfunction, temporary and mild liver function test abnormalities.

This medication should be stored in a tightly sealed container to protect it from air and light, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness and prevents deterioration.

Appearance

Light pink oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle