Viewing nowRosuvastatin Tablet 10mg (Rosuvastatin Calcium)
Rosuvastatin Calcium 10.4mg
Tablet · Prescription medication
Korea Union Pharmaceutical Co., Ltd.

MFDS item code 201607042 · Approved 2016.12.12 · Insurance code 665506910
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
This medication is used as an adjunct therapy in patients with primary hypercholesterolemia and mixed hyperlipidemia when diet and exercise alone are insufficient. It is also used in conjunction with other therapies for patients with homozygous familial hypercholesterolemia to effectively lower blood cholesterol levels. By controlling total cholesterol and LDL-cholesterol levels to target values, it helps delay the progression of atherosclerosis. It can be safely used in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia when dietary measures are insufficient. Additionally, it is used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. This medication is utilized to reduce the risk of cardiovascular events such as stroke and myocardial infarction in patients with elevated high-sensitivity C-reactive protein levels and cardiovascular disease risk factors. Overall, this medication is effective in improving blood lipid levels and reducing cardiovascular disease risk.
For adult patients with primary hypercholesterolemia, treatment can be administered once daily at any time, regardless of meals. The initial dose is 5mg once daily, while the maintenance dose is generally 10mg once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response, with at least 4 weeks or more intervals between adjustments, and can be increased to a maximum of 20mg per day.
In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage ranges from 5mg to 20mg once daily, doses are adjusted according to individual treatment goals. Adjust dosage
This medication should not be used in individuals who are allergic to any of the components. It should not be administered to patients with active liver disease or unexplained elevated liver enzyme levels. Patients with muscle disease or severe renal impairment should also avoid taking this medication. It should not be given to pregnant or breastfeeding women, or to women of childbearing potential who are not using effective contraception. Patients at high risk of muscle disease, such as those with moderate to severe renal impairment or hypothyroidism, should avoid high doses of this medication. Patients with genetic metabolic disorders such as lactose intolerance should not take this medication. This medication should be used with caution in individuals with a history of liver disease or those who consume excessive alcohol, and regular liver function tests are required. If symptoms of muscle pain or weakness occur, medical attention should be sought immediately for necessary testing. Individuals with reduced renal function or conditions such as hypothyroidism are at a greater risk of muscular adverse reactions, hence careful monitoring is necessary. This medication can rarely cause serious skin reactions, liver dysfunction, or muscle damage. If any adverse reactions occur, discontinue use and consult a healthcare professional immediately. Concomitant use with other drugs may increase blood concentration of this medication, raising the risk of muscle-related side effects. Therefore, any other medications being taken should be disclosed, especially since combination with fibrate drugs poses risks, and there may also be interactions with certain antiviral or antifungal medications. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use appropriate contraception. In case of overdose, there is no specific antidote; symptom-based treatment is required, along with monitoring of liver function and muscle enzyme levels. Dizziness may occur during treatment; therefore, caution is advised when driving or operating machinery.
Allergic reactions including urticaria and angioedema, rash and urticaria, pancreatitis, myopathy (including myositis), rhabdomyolysis, myalgia + CK elevation, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms associated drug reaction syndrome, immune-mediated necrotizing myopathy, hematuria, edema, acute renal failure, severe muscle weakness, ocular muscle weakness, severe skin adverse reactions, severe allergies
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly sealed container to protect it from exposure to air. The recommended storage temperature is between 1°C and 30°C at room temperature. Proper storage will help maintain the medication's efficacy.
Pink round film-coated tablets
30 tablets (15 tablets/PTP × 2)
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.