Medication info
Crovastatin 20mg (Rosuvastatin Calcium)

Crovastatin 20mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Pink round film-coated tablet
Packaging
Domestic: 28 tablets (14 tablets/PTP X 2), Export: 28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 201000980 · Notified 2010.01.28 · Insurance code 671804840

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For adult patients with primary hypercholesterolemia, this drug can be taken at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, which can be adjusted to a maintenance dose as needed. The maintenance dose is usually adjusted to 10 milligrams once daily for most patients, with LDL cholesterol levels and therapeutic goals evaluated after intervals of more than 4 weeks, up to a maximum of 20 milligrams per day.
Child dose
For pediatric patients with mixed familial hypercholesterolemia (ages 10-17), a dose of 5 to 20 milligrams is administered once daily. The dosage should be adjusted individually according to therapeutic goals, and 4.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • mixed familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • stroke
  • myocardial infarction
View approved original text

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia who are not adequately controlled by diet and exercise alone. It is also used with other treatments in patients with homozygous familial hypercholesterolemia to lower cholesterol levels and delay the progression of atherosclerosis. In pediatric patients where mixed familial hypercholesterolemia is not controlled by diet alone, it helps reduce total cholesterol and LDL cholesterol levels. Additionally, it is used in conjunction with diet in patients with primary dysbetalipoproteinemia. Furthermore, in middle-aged and elderly patients with cardiovascular disease risk factors, it is effective in reducing the risk of stroke, myocardial infarction, and arterial revascularization. This medication is used for improving overall blood lipid levels and reducing the risk of cardiovascular disease.

How to take

Adult dose

For adult patients with primary hypercholesterolemia, this drug can be taken at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, which can be adjusted to a maintenance dose as needed. The maintenance dose is usually adjusted to 10 milligrams once daily for most patients, with LDL cholesterol levels and therapeutic goals evaluated after intervals of more than 4 weeks, up to a maximum of 20 milligrams per day.

Child dose

For pediatric patients with mixed familial hypercholesterolemia (ages 10-17), a dose of 5 to 20 milligrams is administered once daily. The dosage should be adjusted individually according to therapeutic goals, and 4.

Precautions

This drug should not be used by certain patients. For example, individuals who are allergic to this drug, those with severe liver dysfunction, muscle disorders, those taking certain medications, individuals with severe kidney impairment, women who are pregnant or breastfeeding, and those with genetic issues such as lactose intolerance should not take this medication. Furthermore, it is important to regularly check liver function tests and muscle status while taking this medication. Those with a history of liver disease or who consume alcohol heavily should take extra caution, and if symptoms of muscle pain or weakness occur, they should consult a doctor immediately. This drug carries a risk of muscle damage, so care should be taken in individuals with decreased kidney function, hypothyroidism, family history, elderly patients, and alcohol abusers. In addition, caution is needed when taking this drug with certain drugs (e.g., fibrates), as the risk of muscle-related side effects may increase. This drug may affect the liver and muscles, so if abnormal symptoms occur, it should be discontinued immediately and medical advice should be sought. Rarely, serious skin reactions, liver dysfunction, and kidney issues can occur, so immediate treatment is necessary if these symptoms appear. Women who are pregnant or may become pregnant must use appropriate contraceptive methods and should not take this drug during pregnancy. Women who are breastfeeding should also not use this medication for safety reasons. This drug can interact with other medications, so inform healthcare providers of any other medications being taken. Particular caution is required when taken with certain antiviral agents, immunosuppressants, antibiotics, and some cardiovascular drugs. In case of overdose, there is no specific antidote, so treatment should be symptomatic, monitoring liver function and muscle enzyme levels. Lastly, this drug is not known to significantly affect driving or operating machinery, but caution should be taken as symptoms like dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

  • Hypersensitivity reactions including hives and angioedema.
  • Severe skin reactions such as Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS).
  • Jaundice, hepatitis, fatal and non-fatal liver failure.
  • Dyspnea, cough, interstitial lung disease.
  • Acute renal failure, oliguria, worsened renal failure.
  • Severe muscle weakness, ophthalmoplegia, rhabdomyolysis, immune-mediated necrotizing myopathy.
  • Acute severe conditions.

Mild side effects

  • Common mild and temporary symptoms include headaches, dizziness, constipation, nausea, abdominal pain, itching, muscle pain, weakness, hematuria, diarrhea, rash, muscle cramps, loss of appetite, abdominal bloating, fatigue, numbness, paresthesia, vomiting, and more.
  • Increases in ALT, AST, CK, thrombocytopenia, elevated serum creatinine, proteinuria, thrombocytopenia, generalized pain, joint pain, erectile dysfunction, depression, sleep disturbances, sexual dysfunction, in women.

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

Storage

This drug should be stored in a tightly sealed container to avoid exposure to air or moisture, preferably at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Domestic: 28 tablets (14 tablets/PTP X 2), Export: 28 tablets (14 tablets/PTP 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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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.