Medication info
Rosutan 20 Milligrams (Rosuvastatin Calcium)

Rosutan 20 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP*3)
Approval status
Active

MFDS item code 201503865 · Approved 2015.06.12 · Insurance code 653403280

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia, reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer the initial dose of 5 milligrams once daily at any time during the day, regardless of meals. If more reduction in LDL cholesterol is needed, the maintenance dose can be adjusted, with a maintenance dose of 10 milligrams once daily. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more according to LDL cholesterol levels, treatment goals, and the patient's response, up to a maximum of 20 milligrams per day.
Children's dosage
For pediatric patients aged 10 to 17 years, the dosage is administered once daily, ranging from 5 milligrams to 20 milligrams. The dosage should be individually adjusted according to the recommended treatment target, with adjustments made at intervals of 4 weeks or more.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and dyslipidemia, reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of premature coronary artery disease
View approved original text

This medicine is used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia who are not well controlled by diet and exercise. It is particularly used as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This drug lowers total cholesterol and LDL cholesterol levels and has the effect of delaying the progression of atherosclerosis. It can be safely used in pediatric patients aged 10 to 17 years who meet specific criteria for familial hypercholesterolemia. It is also recommended as an adjunct to diet in patients with primary dysbetalipoproteinemia. Finally, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in patients at higher risk for cardiovascular diseases. Therefore, this medicine improves hyperlipidemia and the risk of associated cardiovascular diseases.

Dosage and Administration

Adult dosage

Administer the initial dose of 5 milligrams once daily at any time during the day, regardless of meals. If more reduction in LDL cholesterol is needed, the maintenance dose can be adjusted, with a maintenance dose of 10 milligrams once daily. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more according to LDL cholesterol levels, treatment goals, and the patient's response, up to a maximum of 20 milligrams per day.

Children's dosage

For pediatric patients aged 10 to 17 years, the dosage is administered once daily, ranging from 5 milligrams to 20 milligrams. The dosage should be individually adjusted according to the recommended treatment target, with adjustments made at intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, individuals allergic to the components of this drug, patients with severe liver dysfunction, those with muscle disorders, patients taking certain immunosuppressants, individuals with severe renal impairment, and women who are pregnant or breastfeeding should not take this drug. Also, high-dose use is prohibited in patients at risk of muscle disorders. Risk factors include moderate renal impairment, hypothyroidism, family history of muscle disorders, and alcohol abuse. This drug contains lactose, so it should not be taken by patients with lactose intolerance or related genetic disorders. Patients with a history of liver disease or those who consume large amounts of alcohol should have liver function tests done before taking this drug and periodically during treatment. If symptoms such as muscle pain, muscle weakness, or myopathy appear, notify a doctor immediately and, if necessary, blood tests should be conducted to check for muscle damage. In particular, if muscle enzyme levels increase to more than five times the normal upper limit, the medication should be discontinued. Patients with acute severe conditions or serious metabolic diseases should temporarily stop taking this drug. Use should also be discontinued in case of severe myasthenia gravis or ocular myasthenia. Care should be taken when taking this drug with certain medications (e.g., fibrates, cyclosporine, some antibiotics, and antifungals) as the risk of muscle damage may increase. Renal function tests are necessary during high-dose use, and Asian patients may have higher systemic drug concentrations, which may require dose adjustments. Women who are pregnant or breastfeeding should not take this drug, and women with the potential for pregnancy should use appropriate contraception. In cases of overdose, there are no specific antidotes, so treatment should be based on symptoms with liver function and muscle enzyme tests conducted. Dizziness may occur while taking this medication, so caution is needed when driving or operating machinery. Lastly, this medicine can rarely cause serious skin reactions or liver dysfunction, neurological abnormalities, so any unusual symptoms should be reported to healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, thrombocytopenia, jaundice, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, hematuria, edema, severe muscle weakness, dyspnea, cough, ocular myasthenia, polyneuropathy, amnesia, peripheral neuropathy, fatal and non-fatal liver injury

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • discomfort in the chest
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  • diarrhea
  • loss of appetite
  • abdominal bloating
  • numbness
  • altered sensation
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue

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

Storage

This drug must be stored in a tightly sealed container to avoid exposure to air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This way, the effectiveness of the medicine can be safely maintained for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/PTP*3)

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

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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.