▶ Manufacturer: Ilhwa Co., Ltd.
▶ Sold by: Ilhwa Co., Ltd.
▶ Insurance code : 640902790
▶ Storage : Airtight container, room temperature (1~30℃)
White, elliptical film-coated tablet
atorvastatin calcium trihydrate 21.7mg (20mg Atorvastatin)
1. Reduced risk for the following cardiovascular diseases:
1) In adult patients with no clinical evidence of coronary heart disease but multiple coronary heart disease risk factors (55 year or older, smoker, hypertension, low HDL-C level or family history of early coronary heart disease):
(1) Reduced risk of myocardial infarction
(2) Reduced risk of stroke
(3) Reduced risk from angioplasty and chronic stable angina
2) In type II diabetes patients with no clinical evidence of coronary heart disease but multiple coronary heart disease risk factors (retinopathy, albuminuria, smoking, hypertension, etc.):
(1) Reduced risk of myocardial infarction
(2) Reduced risk of stroke
3) In adult patients with clinical evidence of coronary heart disease :
(1) Reduced risk for nonfatal myocardial infarction
(2) Reduced risk of fatal and nonfatal stroke
(3) Reduced risk from angioplasty
(4) Reduced risk of hospitalization due to congestive heart failure
(5) Reduced risk of angina
2. Hyperlipidemia
1) Supplement to dietary therapy to lower elevated Total-C, LDL-C, Apo-B protein, and triglyceride levels and increase HDL-C levels in patients of primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson Type IIa and IIb)
2) Primary abetalipoproteinemia (Fredrickson Type III) that does not respond to dietary therapy
3) Supplement to dietary therapy for patients with elevated serum triglyceride levels (Fredrickson Type IV)
4) Concomitant use with other lipid-lowering drugs (e.g. LDL-apheresis) to lower Total-C and LDL-C levels in homozygous familial hypercholesterolemia patients, or use when treatment using other lipid-lowering drugs is not possible
1. Hyperlipidemia
Recommended initial dose is 10mg Atorvastatin one a day, but patients requiring further LDL-C level reduction may be started on 20mg or 40mg once a day (Only if reduction of LDL-C level by 45% or more is required). This drug may be administered doses ranging from 10 to 80mg once a day.
The initial dose and maintenance dose of this drug must be individualized for each patient with consideration for treatment objectives and response, etc. Within 2 to 4 weeks after administration begins and/or volumetry, lipid levels must be analyzed and dose must be adjusted accordingly. As the objective of treatment is to lower LDL-C levels, use of LDL-C levels is recommended when beginning treatment and evaluating response to treatment. Provided, that when LDL-C levels are unavailable, Total-C level shall be used for monitoring of response to treatment.
Homozygous familial hypercholesterolemia patients
The administration dose of this drug is 10 to 80mg once a day, concomitantly administered with other lipid-lowering treatments (e.g. LDL apheresis), or administered when such lipid-lower therapies are not possible
2. Pediatric heterozygous familial hypercholesterolemia patients (ages 10 to 17)
Recommended initial dose of this drug is 10mg per day, and the max. recommended dose is 20mg per day (No clinical data of administration of doses higher than 20mg of this drug to pediatric patients). Administration dose shall be adjusted appropriately depending on the recommended treatment objectives for individual patients. Doses shall be adjusted at intervals of at least 4 weeks.White, elliptical film-coated tablet
atorvastatin calcium trihydrate 21.7mg (20mg Atorvastatin)
1. Reduced risk for the following cardiovascular diseases:
1) In adult patients with no clinical evidence of coronary heart disease but multiple coronary heart disease risk factors (55 year or older, smoker, hypertension, low HDL-C level or family history of early coronary heart disease):
(1) Reduced risk of myocardial infarction
(2) Reduced risk of stroke
(3) Reduced risk from angioplasty and chronic stable angina
2) In type II diabetes patients with no clinical evidence of coronary heart disease but multiple coronary heart disease risk factors (retinopathy, albuminuria, smoking, hypertension, etc.):
(1) Reduced risk of myocardial infarction
(2) Reduced risk of stroke
3) In adult patients with clinical evidence of coronary heart disease :
(1) Reduced risk for nonfatal myocardial infarction
(2) Reduced risk of fatal and nonfatal stroke
(3) Reduced risk from angioplasty
(4) Reduced risk of hospitalization due to congestive heart failure
(5) Reduced risk of angina
2. Hyperlipidemia
1) Supplement to dietary therapy to lower elevated Total-C, LDL-C, Apo-B protein, and triglyceride levels and increase HDL-C levels in patients of primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson Type IIa and IIb)
2) Primary abetalipoproteinemia (Fredrickson Type III) that does not respond to dietary therapy
3) Supplement to dietary therapy for patients with elevated serum triglyceride levels (Fredrickson Type IV)
4) Concomitant use with other lipid-lowering drugs (e.g. LDL-apheresis) to lower Total-C and LDL-C levels in homozygous familial hypercholesterolemia patients, or use when treatment using other lipid-lowering drugs is not possible
1. Hyperlipidemia
Recommended initial dose is 10mg Atorvastatin one a day, but patients requiring further LDL-C level reduction may be started on 20mg or 40mg once a day (Only if reduction of LDL-C level by 45% or more is required). This drug may be administered doses ranging from 10 to 80mg once a day.
The initial dose and maintenance dose of this drug must be individualized for each patient with consideration for treatment objectives and response, etc. Within 2 to 4 weeks after administration begins and/or volumetry, lipid levels must be analyzed and dose must be adjusted accordingly. As the objective of treatment is to lower LDL-C levels, use of LDL-C levels is recommended when beginning treatment and evaluating response to treatment. Provided, that when LDL-C levels are unavailable, Total-C level shall be used for monitoring of response to treatment.
Homozygous familial hypercholesterolemia patients
The administration dose of this drug is 10 to 80mg once a day, concomitantly administered with other lipid-lowering treatments (e.g. LDL apheresis), or administered when such lipid-lower therapies are not possible
2. Pediatric heterozygous familial hypercholesterolemia patients (ages 10 to 17)
Recommended initial dose of this drug is 10mg per day, and the max. recommended dose is 20mg per day (No clinical data of administration of doses higher than 20mg of this drug to pediatric patients). Administration dose shall be adjusted appropriately depending on the recommended treatment objectives for individual patients. Doses shall be adjusted at intervals of at least 4 weeks.
