Medication info
Eurosatin Tablets 10 mg (Rosuvastatin Calcium)

Eurosatin Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)유유제약
Appearance
Pink round film-coated tablets
Packaging
28 tablets/box [14 tablets/Alu-AluX2]
Approval status
Active

MFDS item code 201001000 · Approved 2010.01.28 · Insurance code 644501730

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is usually 5 mg once daily, and if greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, most patients are controlled at this dose. The maintenance dose should be appropriately adjusted every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, and may be increased up to a maximum of 20 mg once daily.
Child dose
In children aged 10 to 17 years with heterozygous familial hypercholesterolemia, the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted individually based on the therapeutic goals.

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • cardiovascular disease
  • coronary heart disease
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
View approved original text

This medication is used as an adjunct when dietary changes and exercise alone are insufficient to control primary hypercholesterolemia, particularly in patients with heterozygous familial hypercholesterolemia and mixed hyperlipidemia. It is also used as an adjunct in patients with homozygous familial hypercholesterolemia along with other lipid-lowering therapies, helping to lower total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. It is effective in children aged 10 to 17 years with heterozygous familial hypercholesterolemia when dietary control is inadequate. It is also used as an adjunct in patients with primary dysbetalipoproteinemia. Moreover, it is useful in reducing the risk of stroke, myocardial infarction, and percutaneous coronary intervention in high-risk adult patients with elevated high-sensitivity C-reactive protein and additional cardiovascular risk factors. In summary, this drug is used to reduce the risk associated with various types of hypercholesterolemia and related cardiovascular diseases, improving blood lipid levels and protecting cardiovascular health.

How to take

Adult dose

The initial dose is usually 5 mg once daily, and if greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, most patients are controlled at this dose. The maintenance dose should be appropriately adjusted every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, and may be increased up to a maximum of 20 mg once daily.

Child dose

In children aged 10 to 17 years with heterozygous familial hypercholesterolemia, the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted individually based on the therapeutic goals.

Precautions

This medication should not be used by patients with known allergies to any of the components. Patients with active liver disease or severe liver dysfunction should not take this medication. It should also not be administered to patients with muscle disease or severe kidney dysfunction. Pregnant or breastfeeding women and women of childbearing potential should consult a physician before taking this medication and use appropriate contraception. This medication can affect muscle tissue, so extra caution is needed for patients at high risk of muscle pain or myopathy, and high doses are contraindicated. It contains lactose; therefore, patients with lactose intolerance or related genetic disorders should not take it. Patients with a history of liver function abnormalities or those consuming alcohol heavily should undergo regular liver function tests, and treatment should be undertaken after addressing hypothyroidism or other conditions. If symptoms such as muscle pain, weakness, or cramps occur, patients should notify their doctor immediately and may need to discontinue the medication. This medication may increase blood levels when taken with certain medications, raising the risk of muscle-related adverse effects, so patients must inform their physician about concomitant medications. Reported side effects from clinical trials and post-marketing include headache, dizziness, gastrointestinal disturbance, skin rash, and muscle pain; in severe cases, myopathy or liver function abnormalities may occur. It should be avoided during pregnancy due to risks to the fetus and is discouraged while breastfeeding as it may pass into breast milk. There is no specific antidote for overdose, and treatment should be symptomatic while monitoring liver function and muscle enzyme levels. Caution is necessary while driving or operating machinery due to possible dizziness. This medication may show higher systemic exposure in Asians, so dose adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanying high fever, blisters, skin peeling, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory complications with cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urinary output changes

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion

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

Storage

Store this medication in a tightly sealed container to prevent air or moisture ingress, ideally at a cool temperature below 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/box [14 tablets/Alu-AluX2]

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.