Medication info
Rosutin Tablets 10 mg (Rosuvastatin Calcium)

Rosutin Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Pink round film-coated tablet
Packaging
100 tablets/box [10 tablets/Alu-Alu*10], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201001002 · Approved 2010.01.28 · Insurance code 651203240

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
Can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily, and if more reduction in LDL cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily for most patients, who are typically controlled at this dosage. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and the patient's response, at intervals of 4 weeks or more.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Treatment for improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • hyperlipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke
  • myocardial infarction
View approved original text

This medication is used as an adjunct to diet and exercise in patients with primary hypercholesterolemia and mixed dyslipidemia when those alone are insufficient to achieve target levels. It is also used as an adjunct in conjunction with other treatments in patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. Additionally, it assists with the dietary management of patients with dysbetalipoproteinemia. In older patients at high risk for cardiovascular disease, it may also reduce risks associated with stroke, myocardial infarction, and arterial revascularization. Overall, it is effectively used for cholesterol management and reduction of cardiovascular disease risk.

How to take

Adult dose

Can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily, and if more reduction in LDL cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily for most patients, who are typically controlled at this dosage. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and the patient's response, at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to this medication's components, patients with severe liver dysfunction, those with muscle diseases, those with severe kidney impairment, and pregnant or nursing women. Additionally, caution should be exercised in patients at higher risk for myopathy, such as those with moderate renal impairment, hypothyroidism, or family history of muscle disease. Monitoring of liver function and muscular symptoms is crucial while using this medication. If muscle pain, weakness, or cramps occur, the physician should be informed immediately, and in severe cases, discontinuation of the drug may be necessary. This medication can also temporarily elevate liver enzyme levels, so regular testing is required. Drug interactions may occur, so inform your doctor or pharmacist of any other medications you are taking. Particularly, the risk of muscle-related side effects may be increased when taken with certain antibiotics, antifungals, immunosuppressants, or fibrates. Women who are pregnant or planning to become pregnant should not take this medication and should use appropriate contraceptive methods. Its use is also not recommended during breastfeeding. There is no specific antidote for overdose, and treatment should be symptomatic with monitoring of liver function and muscle enzyme levels. Lastly, this medication can rarely cause severe side effects such as skin rashes, urticaria, and serious skin reactions, so consult healthcare professionals immediately if any unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, amnesia, peripheral neuropathy, severe muscle weakness, respiratory distress, ophthalmoplegia, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction (DRESS), immune-mediated necrotizing myopathy, acute kidney failure, oliguria

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • urticaria
  • muscle pain
  • weakness
Show 15 more
  • hematuria
  • diarrhea
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • joint pain

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This ensures the safe retention of the medication's efficacy.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

100 tablets/box [10 tablets/Alu-Alu*10], 30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.