Viewing nowRostastatin 10 mg (Rosuvastatin Calcium)
Rosuvastatin Calcium 10.4mg
Tablet · Prescription medication
R.P. Bio Co., Ltd.

MFDS item code 201603489 · Approved 2016.06.15 · Insurance code 661604760
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
This medicine is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone do not control the condition. It is also beneficial in patients with homozygous familial hypercholesterolemia when used alongside diet or other lipid-lowering treatments. This drug reduces total cholesterol and LDL-cholesterol levels, effectively slowing the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 years who meet specific criteria for heterozygous familial hypercholesterolemia. In patients with primary dysbetalipoproteinemia, it also acts as an adjunct to diet and contributes to reducing the risks of stroke, myocardial infarction, and arterial revascularization in adult patients at high risk for cardiovascular disease. Overall, this drug is used to effectively improve cholesterol levels and lower the risk of cardiovascular disease.
Administer 5 milligrams once daily at any time of day, regardless of meals. If a greater reduction in LDL cholesterol is needed, adjust to a maintenance dose of 10 milligrams once daily, with a maximum increase to 20 milligrams per day. Dose adjustments should occur with intervals of 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response.
In pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer 5 milligrams to 20 milligrams once daily. The dose should be adjusted individually with intervals of 4 weeks or longer.
This drug should not be used in certain patients. For example, patients who are allergic to this drug, those with severely impaired liver function, patients with muscular diseases, those with severe renal impairment, women who are pregnant or breastfeeding, and women of childbearing age who do not use appropriate contraception should not take this drug. Additionally, caution is especially warranted in patients at high risk of muscle ailments, and high-dose administration is contraindicated. This drug contains lactose; thus, patients with lactose intolerance should not take it. Before taking this drug, regular liver function tests and muscle-related tests should be conducted, and patients with a history of liver disease or excessive alcohol consumption should be particularly cautious. If symptoms such as muscle pain, muscle weakness, or cramps occur, immediate notification to a healthcare provider is necessary, and in severe cases, discontinuation of treatment should happen. This drug can rarely cause serious skin reactions or liver damage; therefore, if symptoms such as skin rash, jaundice, or severe fatigue appear, it is essential to stop taking the medication immediately and consult with healthcare personnel. Moreover, this drug may interact with other medications, so if other medications are being taken, patients must inform their doctor or pharmacist. Caution is required when co-administered with specific medications, as this may increase the concentration of this drug and elevate the risk of muscle side effects. Women who are pregnant or planning to become pregnant should not take this drug, and if pregnancy is confirmed during treatment, discontinuation should occur immediately. Breastfeeding women are also advised to avoid this medication. In the event of an overdose, there is no specific antidote, and treatment should be symptomatic, with monitoring of liver function and muscle enzyme levels. Caution is necessary while driving or operating machinery due to potential dizziness.
Hives, hypersensitivity reactions including angioedema, chest tightness, breathing difficulties, pallor, severe allergic reactions, severe rash accompanied by fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe adverse skin reactions, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice), sudden and severe symptoms.
Not everyone experiences these, and they can vary from person to person.
This medicine should be stored in a tightly closed container to protect it from air or moisture and is best kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medicine's effectiveness.
Pink round film-coated tablet
30 tablets/bottle
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.