Medication info
Eurosoto 10 mg (Rosuvastatin Calcium)

Eurosoto 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)유영제약
Appearance
Pink round film-coated tablets
Packaging
28 tablets (14 tablets/PTP (AluAlu) packaging X 2)
Approval status
Active

MFDS item code 201400757 · Approved 2014.02.19 · Insurance code 648203720

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For adult patients with primary hypercholesterolemia, regardless of meals, an initial dose of 5 mg is administered once daily at any time of day. If necessary, the maintenance dose may be adjusted to 10 mg once daily every 4 weeks or more based on LDL cholesterol levels, therapeutic goals, and patient response, with a maximum increase to 20 mg.
Child dose
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) are administered a dose ranging from 5 mg to 20 mg once daily, adjusting every 4 weeks or more according to the individual therapeutic goals.

Ingredients

Manufacturer
(주)유영제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • and family history of early coronary heart disease.
View approved original text

This medication is used as an adjunct to diet and exercise for patients with hypercholesterolemia and hyperlipidemia that cannot be managed by diet and exercise alone. It is effective in lowering total cholesterol and low-density lipoprotein (LDL) cholesterol levels, thus slowing the progression of atherosclerosis in patients with primary hypercholesterolemia, familial hypercholesterolemia, mixed hyperlipidemia, and dysbetalipoproteinemia. It is also used for pediatric patients aged 10 years and older with familial hypercholesterolemia to reduce cholesterol levels. This medication helps lower the risk of stroke, myocardial infarction, and arterial revascularization surgery in patients at high risk for cardiovascular disease. Therefore, it is an important treatment for managing cholesterol levels and cardiovascular disease risk.

How to take

Adult dose

For adult patients with primary hypercholesterolemia, regardless of meals, an initial dose of 5 mg is administered once daily at any time of day. If necessary, the maintenance dose may be adjusted to 10 mg once daily every 4 weeks or more based on LDL cholesterol levels, therapeutic goals, and patient response, with a maximum increase to 20 mg.

Child dose

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) are administered a dose ranging from 5 mg to 20 mg once daily, adjusting every 4 weeks or more according to the individual therapeutic goals.

Precautions

This medication should not be administered to certain patients. For example, patients allergic to any ingredient of this medication, those with liver dysfunction, muscle diseases, severely impaired kidney function, or women who are pregnant or nursing should not use it. Additionally, high doses of this medication are contraindicated for patients who are susceptible to myopathy or rhabdomyolysis or have certain genetic disorders. Patients with lactose intolerance should also be cautious. Patients with a history of liver disease or excessive alcohol consumption should have regular liver function tests while taking this medication, and those with hypothyroidism should treat that condition before beginning treatment. This medication may cause muscle-related side effects such as myalgia or muscle weakness, so if these symptoms occur, patients should consult a physician immediately, and blood tests may be necessary to check for muscle damage. Elderly patients, those with kidney impairment, or those with a history of alcohol misuse require careful monitoring during treatment due to a higher risk of muscle side effects. This medication can also affect liver function. If symptoms of liver damage occur, the medication should be discontinued immediately. Moreover, the concentration in the blood may change depending on other medications taken simultaneously, which may increase the risk of muscle side effects. Therefore, patients must inform healthcare professionals about any concomitant medications and exercise caution. Women of childbearing potential should use adequate contraception and should not use this medication during pregnancy. In cases of overdose, there is no specific antidote; therefore, symptomatic treatment and monitoring of liver function and muscle enzyme levels are necessary. Caution is advised when driving or operating machinery due to potential dizziness.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, jaundice, liver failure, acute kidney failure, oliguria, severe edema, severe allergic reactions, severe skin reactions, dyspnea, dyspnea and cough, severe muscle weakness, ocular muscle weakness, polyneuropathy

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • eosinophilia
  • lichenoid drug rash
  • lupus-like syndrome
  • muscle rupture
  • hematuria
  • edema

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, avoid storing it in extremely hot or cold places, ideally at temperatures between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets/PTP (AluAlu) packaging X 2)

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

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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.