▶ Manufacturer: Ilhwa Co., Ltd.
▶ Sold by: Ilhwa Co., Ltd.
▶ Insurance code : 6640903280
▶ Storage : Airtight container, room temperature (1~30℃)
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Oblong white or light yellow tablet with convex faces
Ezetimibe 10mg, Simvastatin 20mg
Primary hypercholesterolemia
This drug administered to reduce elevated total-c, LDL-C, Apo B and TG and elevate HDL-C in primary hypercholesterolemia (heterozygous familial and non-familial) patients and mixed hyperlipidemia patients.
Heterozygous familial hypercholesterolemia (HoFH)
A supplement for other lipid-lowering treatments (e.g. LDL Apheresis) to reduce elevated total-c and LDL-C in heterozygous familial hypercholesterolemia (HoFH) patients. This drug is administered when other lipid-lowering treatments are ineffective.
When administering lipid modifying agents to patients with increased risk of atherosclerotic arterial disease due to hypercholesterolemia, a variety of risk factors needs to be considered. Lipid modifying agents must be used with appropriate dietary restrictions (including restriction of saturated fats and cholesterol), and when response to dietary therapy and other non-pharmaceutical measures is insufficient (See Precautions for Use, 12. Miscellaneous, Guidelines on Management of Hyperlipidemia (Summarized table of NCEP ATP III Guideline).
Prior to administering this drug, check for other secondary causes of dyslipidemia (e.g. diabetes, hypothyroidism, obstructive liver disease, chronic renal failure, drugs that increase LDL-cholesterol and drugs that reduce HDL-cholesterol (progestin, anabolic steroids, and corticosteroids). If needed, the secondary cause must be treated. A lipid test must include total cholesterol, LDL-c, HDL-c and triglycerides. If the triglyceride level is 400mg/dL (4.5 mmol/L) or higher, the LDL-c concentration must be measured using a superspeed centrifuge. If a patient is hospitalized due to acute coronary artery injury, lipids must be measured at the time of hospitalization or within 24 hours thereof. The measurement taken at this time may be used as a reference for starting LDL lipid-lowering treatment prior to or upon discharge of the patient.
Primary hypercholesterolemia patients
The dosage range for this drug is 10/10mg to 10/40mg per day. The generally recommended first dosage is 10/20mg per day. If the patient has a low need for reduction of LDL-c, such patient may begin with 10/10mg per day. After beginning administration of this drug or after volumetry, check blood lipid levels at an interval of at least 4 weeks before adjusting dosage.
Due to the increased risk of muscle disease including rhabdomyolysis, especially during the first year of treatment, doses of 10/80mg of this drug may only be administered to patients having taken 10/80mg of this drug for at least 12 months without evidence of muscle toxicity (See Precautions for Use, 1. Warnings)
Heterozygous familial hypercholesterolemia patients
Recommended dosage for heterozygous familial hypercholesterolemia patients is 10/40mg per day, administered once a day in the evening. This drug is a supplement to other lipid-lowering treatments (e.g. LDL Apheresis), and is administered if other lipid-lowering treatments are not effective.
Administration to patients with liver impairment
No need to adjust dosage for mild liver impairment, but administration of this drug is not recommended for moderately severe or severe liver impairment (See Precautions for Use, 4. General precautions, paragraph on patients with liver function impairment).
Administration to patients with renal impairment and chronic renal disease
No need to adjust dosage for patients with mild renal impairment (Estimated Glomerular filtration rate (GFR) ≥ 60mL/min/1.73m2). For patients with chronic renal disease and a glomerular filtration rate < 60mL/min/1.73m2, administer 10/20mg of this drug once a day in the evening. When administering this drug in higher doses to such patients, administer carefully, and closely monitor (See Precautions for Use, 4. General precautions).
Administration to the elderly
No need to adjust dosage when administering to the elderly.Oblong white or light yellow tablet with convex faces
Ezetimibe 10mg, Simvastatin 20mg
Primary hypercholesterolemia
This drug administered to reduce elevated total-c, LDL-C, Apo B and TG and elevate HDL-C in primary hypercholesterolemia (heterozygous familial and non-familial) patients and mixed hyperlipidemia patients.
Heterozygous familial hypercholesterolemia (HoFH)
A supplement for other lipid-lowering treatments (e.g. LDL Apheresis) to reduce elevated total-c and LDL-C in heterozygous familial hypercholesterolemia (HoFH) patients. This drug is administered when other lipid-lowering treatments are ineffective.
When administering lipid modifying agents to patients with increased risk of atherosclerotic arterial disease due to hypercholesterolemia, a variety of risk factors needs to be considered. Lipid modifying agents must be used with appropriate dietary restrictions (including restriction of saturated fats and cholesterol), and when response to dietary therapy and other non-pharmaceutical measures is insufficient (See Precautions for Use, 12. Miscellaneous, Guidelines on Management of Hyperlipidemia (Summarized table of NCEP ATP III Guideline).
Prior to administering this drug, check for other secondary causes of dyslipidemia (e.g. diabetes, hypothyroidism, obstructive liver disease, chronic renal failure, drugs that increase LDL-cholesterol and drugs that reduce HDL-cholesterol (progestin, anabolic steroids, and corticosteroids). If needed, the secondary cause must be treated. A lipid test must include total cholesterol, LDL-c, HDL-c and triglycerides. If the triglyceride level is 400mg/dL (4.5 mmol/L) or higher, the LDL-c concentration must be measured using a superspeed centrifuge. If a patient is hospitalized due to acute coronary artery injury, lipids must be measured at the time of hospitalization or within 24 hours thereof. The measurement taken at this time may be used as a reference for starting LDL lipid-lowering treatment prior to or upon discharge of the patient.
Primary hypercholesterolemia patients
The dosage range for this drug is 10/10mg to 10/40mg per day. The generally recommended first dosage is 10/20mg per day. If the patient has a low need for reduction of LDL-c, such patient may begin with 10/10mg per day. After beginning administration of this drug or after volumetry, check blood lipid levels at an interval of at least 4 weeks before adjusting dosage.
Due to the increased risk of muscle disease including rhabdomyolysis, especially during the first year of treatment, doses of 10/80mg of this drug may only be administered to patients having taken 10/80mg of this drug for at least 12 months without evidence of muscle toxicity (See Precautions for Use, 1. Warnings)
Heterozygous familial hypercholesterolemia patients
Recommended dosage for heterozygous familial hypercholesterolemia patients is 10/40mg per day, administered once a day in the evening. This drug is a supplement to other lipid-lowering treatments (e.g. LDL Apheresis), and is administered if other lipid-lowering treatments are not effective.
Administration to patients with liver impairment
No need to adjust dosage for mild liver impairment, but administration of this drug is not recommended for moderately severe or severe liver impairment (See Precautions for Use, 4. General precautions, paragraph on patients with liver function impairment).
Administration to patients with renal impairment and chronic renal disease
No need to adjust dosage for patients with mild renal impairment (Estimated Glomerular filtration rate (GFR) ≥ 60mL/min/1.73m2). For patients with chronic renal disease and a glomerular filtration rate < 60mL/min/1.73m2, administer 10/20mg of this drug once a day in the evening. When administering this drug in higher doses to such patients, administer carefully, and closely monitor (See Precautions for Use, 4. General precautions).
Administration to the elderly
No need to adjust dosage when administering to the elderly.