Medication info
Erosuva Tablet 20 mg (Rosuvastatin Calcium (Unrefined))

Erosuva Tablet 20 mg (Rosuvastatin Calcium (Unrefined))

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›20.8mg / 1 tablet
Manufacturer / importer
(주)중헌제약
Appearance
Pink round film-coated tablet
Packaging
Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201400401 · Approved 2014.01.29 · Insurance code 053300630

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer once daily at any time regardless of meals. The initial dose is 5 mg, and the maintenance dose is 10 mg, which most patients are adjusted to at this dosage. The maintenance dose may be adjusted appropriately depending on LDL cholesterol levels and patient response, with an increase up to a maximum of 20 mg possible at intervals of 4 weeks or more.
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage is 5 mg to 20 mg once daily. There is no clinical data for doses exceeding 20 mg.

Ingredients

Manufacturer
(주)중헌제약

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dyslipidemic familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is very useful for patients with hypercholesterolemia and hyperlipidemia. It is used primarily for primary hypercholesterolemia or familial hypercholesterolemia that is not controlled by diet and exercise, as well as combined hyperlipidemia. Additionally, it is used as an adjunct when patients with homozygous familial hypercholesterolemia are on dietary or other treatments. This medicine helps lower total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. It also assists in dietary management for young patients with high LDL cholesterol levels or cardiovascular disease risk factors. Furthermore, it is used in treating primary dysbetalipoproteinemia and is effective in reducing the risk of stroke, myocardial infarction, and revascularization in high-risk patients. This medication is used for cholesterol management and reducing cardiovascular disease risk.

How to take

Adult dose

Administer once daily at any time regardless of meals. The initial dose is 5 mg, and the maintenance dose is 10 mg, which most patients are adjusted to at this dosage. The maintenance dose may be adjusted appropriately depending on LDL cholesterol levels and patient response, with an increase up to a maximum of 20 mg possible at intervals of 4 weeks or more.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage is 5 mg to 20 mg once daily. There is no clinical data for doses exceeding 20 mg.

Precautions

This medication should not be used in certain patients. For instance, it is contraindicated in patients with allergies to the components of this drug, severely impaired liver function, muscular diseases, severely reduced kidney function, and in women who are pregnant or breastfeeding. Additionally, high-dose administration is prohibited in patients at risk of myopathy. This medication contains lactose, so caution is needed for patients with lactose intolerance. Patients with a history of liver disease or those who consume alcohol heavily should have liver function tests performed periodically while using this medication. If symptoms of myalgia or muscle weakness appear, the doctor should be informed immediately, and the medication may be discontinued if necessary. Caution is especially advised for patients with kidney disease, a history of hypothyroidism, or genetic muscle disorders due to a higher risk of muscle problems. Women who may become pregnant should use adequate contraception to avoid pregnancy, and they should discontinue use immediately if pregnancy occurs. This medication may interact with other drugs, so patients must inform their healthcare provider about any concurrent medications. There is no specific antidote for overdose, so treatment should be symptomatic, monitoring liver function and muscle enzyme levels. This medication may cause side effects such as dizziness, requiring caution when driving or operating machinery. While taking this drug, adverse reactions such as headaches, dizziness, myalgia, dyspepsia, and skin rash may occur, and patients should consult healthcare providers if symptoms worsen. Overall, this medication should be used with careful observation of liver and muscle health, and regular examinations to confirm safety are important.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver failure, acute renal failure, oliguria, severe muscular weakness, ophthalmoplegia, rhabdomyolysis, immune-mediated necrotizing myopathy, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms, severe

Mild side effects

  • Headaches
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • thrombocytopenia
  • diarrhea
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  • hematuria
  • fatigue
  • numbness
  • sensory abnormalities
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture ingress. The storage temperature should be maintained at room temperature between 1 degree Celsius and 30 degrees Celsius. Doing so will ensure the medication's efficacy is preserved.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Bottle - 30 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

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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.