▶ Manufacturer: Ilhwa Co., Ltd.
▶ Sold by: Ilhwa Co., Ltd.
▶ Insurance code : 640902920
▶ Storage : Airtight container, room temperature (1~30℃)
Pink, circular film-coated tablet
Rosuvastatin calcium 20.8mg (20mg as Rosuvastatin)
1. Primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia), mixed hyperlipidemia (type IIb), primary abetalipoproteinemia (type III) and homozygous familial hypercholesterolemia
Patients being administered and prior to administration of this drug must be on a standard lowered cholesterol diet, which must be sustained throughout the treatment period. This drug may be administered at any time of the day regardless of meals. The initial dose is 5mg once a day, and the maintenance dose may be adjusted if further lowering of LDL-c levels is necessary. Maintenance dose is 10mg once a day, and drug is effective in most patients at this dose. Maintenance dose must be adjusted appropriately at intervals of 4 weeks or longer according to LDL-c levels, treatment objectives and patient response, and may not exceed 20mg per day.
2. Pediatric heterozygous familial hypercholesterolemia patients (10 to 17 years of age)
The ordinary dose range is 5mg to 20mg once a day. (No clinical data on administration of doses exceeding 20mg in pediatric patients.) Administration dose to be adjusted individually for patients depending on recommended treatment objectives. Dose must be adjusted at intervals of 4 weeks or longer. Safety and efficacy is not established for children less than 10 years old.
3. Elderly patients: No need for dose adjustment.
4. Patients with renal failure: No need to adjust dose for mild to moderately severe renal failure patients. Do not administer to patients with severe renal failure. Administration of 20mg of this drug to a moderately severe renal failure patient requires special caution.
1. Primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia), mixed hyperlipidemia (type IIb) : Supplement to dietary therapy if not regulated through diet and exercise
2. Supplement to dietary therapy or other lipid-lowering treatment (e.g. LDL apheresis) for homozygous familial hypercholesterolemia
3. Lowers Total-c and LDL-c in hypercholesterolemia patients to target levels to slow the progression of atherosclerosis
4. Supplement to dietary therapy to reduce Total-C, LDL-C, and Apo-B levels in pediatric patients ages 10 to 17 (for females, patients at least 1 year past menarche) who, despite dietary therapy, still have heterozygous familial hypercholesterolemia meeting the following criteria:
ㆍLDL-C still exceeds 190mg/dL (LDL-C > 190mg/dL)
ㆍLDL-C still exceeds 160mg/dL (LDL-C > 160mg/dL), with a family history of early cardiovascular disease or at least two cardiovascular disease risk factors
5. Supplement to dietary therapy for primary abetalipoproteinemia (type III) patientsPink, circular film-coated tablet
Rosuvastatin calcium 20.8mg (20mg as Rosuvastatin)
1. Primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia), mixed hyperlipidemia (type IIb), primary abetalipoproteinemia (type III) and homozygous familial hypercholesterolemia
Patients being administered and prior to administration of this drug must be on a standard lowered cholesterol diet, which must be sustained throughout the treatment period. This drug may be administered at any time of the day regardless of meals. The initial dose is 5mg once a day, and the maintenance dose may be adjusted if further lowering of LDL-c levels is necessary. Maintenance dose is 10mg once a day, and drug is effective in most patients at this dose. Maintenance dose must be adjusted appropriately at intervals of 4 weeks or longer according to LDL-c levels, treatment objectives and patient response, and may not exceed 20mg per day.
2. Pediatric heterozygous familial hypercholesterolemia patients (10 to 17 years of age)
The ordinary dose range is 5mg to 20mg once a day. (No clinical data on administration of doses exceeding 20mg in pediatric patients.) Administration dose to be adjusted individually for patients depending on recommended treatment objectives. Dose must be adjusted at intervals of 4 weeks or longer. Safety and efficacy is not established for children less than 10 years old.
3. Elderly patients: No need for dose adjustment.
4. Patients with renal failure: No need to adjust dose for mild to moderately severe renal failure patients. Do not administer to patients with severe renal failure. Administration of 20mg of this drug to a moderately severe renal failure patient requires special caution.
1. Primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia), mixed hyperlipidemia (type IIb) : Supplement to dietary therapy if not regulated through diet and exercise
2. Supplement to dietary therapy or other lipid-lowering treatment (e.g. LDL apheresis) for homozygous familial hypercholesterolemia
3. Lowers Total-c and LDL-c in hypercholesterolemia patients to target levels to slow the progression of atherosclerosis
4. Supplement to dietary therapy to reduce Total-C, LDL-C, and Apo-B levels in pediatric patients ages 10 to 17 (for females, patients at least 1 year past menarche) who, despite dietary therapy, still have heterozygous familial hypercholesterolemia meeting the following criteria:
ㆍLDL-C still exceeds 190mg/dL (LDL-C > 190mg/dL)
ㆍLDL-C still exceeds 160mg/dL (LDL-C > 160mg/dL), with a family history of early cardiovascular disease or at least two cardiovascular disease risk factors
5. Supplement to dietary therapy for primary abetalipoproteinemia (type III) patients
