Rosuvastatin Calcium 10mg Tablets
Rosuvastatin Calcium 10.4mg
Tablet · Prescription medication
Kyungbang Pharmaceutical Co., Ltd.
MFDS item code 202000659 · Approved 2020.02.05
This product's status changed to Expired on 2025.02.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk
This medication is used as an adjunct when dietary changes and exercise alone are not sufficient for patients with primary hypercholesterolemia and mixed hyperlipidemia. It is also utilized as an adjunct to dietary therapy or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. This medicine helps to lower total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It is also used as an adjunct to dietary therapy for patients with primary dysbetalipoproteinemia. Furthermore, it is effective for reducing the risk of stroke, myocardial infarction, and arterial revascularization in men aged 50 years and older and women aged 60 years and older who have elevated high-sensitivity C-reactive protein levels and additional cardiovascular risk factors. This medication contributes to lowering the risk of hyperlipidemia and cardiovascular disease.
This medication may be taken at any time during the day without regard to meals. The initial dose is 5 mg once daily and may be adjusted to the maintenance dose if greater LDL-cholesterol reduction is required. The maintenance dose is mostly at 10 mg once daily for most patients. The maintenance dose should be adjusted as appropriate according to LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer.
This medication should not be used in certain patients. It should not be administered to individuals with allergies to its components, severe liver dysfunction, muscle disorders, those taking certain immunosuppressants, severe renal impairment, pregnant or breastfeeding women, or fertile women not using proper contraception. In particular, high dose usage is prohibited in patients at high risk for muscle disorders. Patients with genetic metabolic disorders such as lactose intolerance should also avoid this medication. Since this medication can affect liver function, patients with a history of liver disease or those who consume alcohol excessively should undergo liver function tests before and during treatment. Muscle-related side effects such as myalgia, muscle weakness, and muscle damage may occur; if any of these symptoms arise, medical personnel should be notified immediately. Patients at high risk for muscle damage should check muscle enzyme levels before treatment and be monitored periodically during treatment. If severe muscle damage or rhabdomyolysis occurs, discontinuation of the medication is necessary, and re-administration will be determined based on symptoms. This medication may raise blood sugar levels in some patients, so those at risk for diabetes should take care to manage their blood glucose. Special caution is needed for the elderly, patients with reduced renal function, and those with hypothyroidism. Furthermore, this medication can interact with various drugs, so it is essential to consult with medical personnel if taking other medications. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential should use appropriate contraception. In cases of overdose, as there is no specific antidote, immediate medical attention should be sought, and liver function and muscle enzyme levels should be monitored. This medication does not significantly impact driving or machine operation, but caution is advised as dizziness and similar symptoms may occur. Lastly, while serious side effects like severe skin reactions are rare, if symptoms such as rashes or swelling appear, discontinuation should occur immediately, and consultation with medical personnel is advised.
Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, severe edema, chest tightness, difficulty breathing, severe allergic reactions, severe skin abnormalities, respiratory issues, liver abnormalities (jaundice), severe neurological symptoms
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a sealed container to protect it from air or moisture and is best kept at room temperature between 1°C and 30°C.
Pink round film-coated tablets
28 tablets per box [14 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.