New Shubatine 20mg (Rosuvastatin Calcium)
Rosuvastatin Calcium
Prescription medication
Anguk New Pharm Co., Ltd.
MFDS item code 201802675 · Approved 2018.06.27
This product's status changed to Expired on 2023.06.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
This medicine is used as an adjunct in cases of primary hypercholesterolemia, heterozygous familial hypercholesterolemia, and combined hyperlipidemia where diet and exercise alone are insufficient to control levels. It is also used in combination with other treatments for patients with homozygous familial hypercholesterolemia to enhance effectiveness. It lowers total cholesterol and LDL cholesterol levels, slows the progression of atherosclerosis, and helps improve hypercholesterolemic conditions in some pediatric patients. It is also used as an adjunct to dietary measures for patients with primary dysbetalipoproteinemia. Furthermore, it contributes to a decrease in the risk of stroke, myocardial infarction, and arterial revascularization procedures in patients at high risk for cardiovascular disease. This medicine effectively improves hyperlipidemia and the risk of cardiovascular diseases.
For patients with primary hypercholesterolemia, combined hyperlipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, it can be administered at any time of day without regard to meals. The initial dose is 5 mg once daily and can be adjusted to a maintenance dose as needed. The maintenance dose is 10 mg once daily, and LDL-cholesterol levels and treatment goals should be assessed at intervals of 4 weeks or more.
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The dose may be adjusted according to the treatment goals for each individual patient over intervals of 4 weeks or longer.
This medication should not be used in certain patients. For example, individuals allergic to any components of this drug, those with severe liver dysfunction, individuals with muscle disorders, and women who are pregnant or breastfeeding should not take this drug. This medication can affect liver health; thus, individuals with a history of liver disease or those who consume alcohol excessively should undergo regular liver function tests before and during treatment. Patients with specific conditions such as hypothyroidism or nephrotic syndrome should treat those conditions prior to taking this medication. Muscle-related symptoms may occur, so if symptoms such as myalgia, muscle weakness, or cramps arise, immediate consultation with a doctor is necessary. Caution is especially required in the elderly, those with impaired kidney function, or individuals who abuse alcohol, as they have a higher risk of muscle adverse reactions. This medication can interact with other drugs, increasing blood concentration and the risk of side effects; therefore, it is essential to consult a doctor or pharmacist when taking other medications, especially certain antivirals, immunosuppressants, antifungals, some antibiotics, and fibrate-class medications. Women of childbearing age should use appropriate contraception while taking this drug, and if pregnancy occurs, they must stop taking it immediately. Additionally, this medication may be excreted in breast milk, so it's advisable not to use it while breastfeeding. In the case of overdose, there is no specific antidote; hence, treatment according to symptoms and tests for liver and muscle function may be required. Finally, dizziness may occur during the usage of this drug, so caution should be exercised when driving or operating machinery. It is important to consult medical personnel immediately if abnormal reactions occur during the use of this drug.
Allergic reactions including hives, angioedema, severe swelling, tightness in the chest, difficulty breathing, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, Stevens-Johnson syndrome, dyspnea, jaundice, hepatitis, severe liver damage, fatal and non-fatal liver failure, sudden and severe headache, lightning headache, seizures, confusion, vision disturbances, paralysis, myopathy, rhabdomyolysis, severe edema
Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, hematuria, cough, diarrhea, thrombocytopenia, increase in transaminases, eosinophilia, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), lupus-like syndrome, arthralgia, fatigue, numbness, paresthesia, chest discomfort, anorexia, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disturbances, sexual dysfunction,
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly sealed container to prevent air and moisture from entering and kept in a cool place below 30 degrees Celsius. Proper storage can help maintain effectiveness over time and prevent deterioration.
Pink round film-coated tablet
30 tablets (10 tablets/Alu-Alu x 3)
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.