Medication info
Rosuvat 20 mg Tablets (Rosuvastatin Calcium)

Rosuvat 20 mg Tablets (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201906577 · Approved 2019.09.19 · Insurance code 054800360

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
The initial dose is 5 milligrams once daily, and if more reduction in LDL-cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is 10 milligrams once daily, and most patients are managed at this dose. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased 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 used for patients with various forms of dyslipidemia associated with hypercholesterolemia. It effectively aids patients with primary hypercholesterolemia (Type IIa) and mixed hyperlipidemia (Type IIb) that are difficult to manage with diet and exercise. Additionally, it helps lower cholesterol levels in patients with homozygous familial hypercholesterolemia used in conjunction with other lipid-lowering therapies. This drug reduces total cholesterol and LDL-cholesterol, delaying the progression of atherosclerosis and is also used as an adjunct to dietary management in patients with dysbetalipoproteinemia (Type III). Particularly, it reduces the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 years old and women over 60 years old with certain cardiovascular disease risk factors. Thus, it is widely used for the prevention and treatment of cardiovascular diseases.

Dosage and Administration

Adult dosage

The initial dose is 5 milligrams once daily, and if more reduction in LDL-cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is 10 milligrams once daily, and most patients are managed at this dose. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients who are allergic to this medication, have severely impaired liver function, have muscle disorders, have severely impaired kidney function, or are pregnant or breastfeeding. Also, it is important to check liver function and muscle status before taking this medication. Those with a history of liver disease or those who consume alcohol heavily should use this medication with caution, and symptoms like muscle pain or weakness should be reported to a doctor immediately. This medication may increase blood sugar levels in some patients, so individuals at risk for diabetes should regularly monitor their blood sugar levels. Additionally, this medication may interact with other drugs; thus, any other medications being taken should be disclosed to healthcare providers. Caution is especially needed when taken in conjunction with certain antibiotics, antifungals, immunosuppressants, and fibrates, as the risk of muscle damage may increase. Women who may become pregnant should use appropriate contraception while taking this medication and avoid it during pregnancy. It is also advisable not to use this medication while breastfeeding. In the case of overdose, there is no specific antidote; therefore, one should go to the hospital immediately for treatment and undergo liver function and muscle enzyme tests to verify the condition. Lastly, this medication does not significantly affect physical or driving ability but caution should be taken as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, tightness in the chest, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe allergic reactions, severe skin reactions, jaundice, hepatitis, severe muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, acute kidney injury, oliguria, thrombocytopenia, increased serum creatinine, severe liver damage, hyperbilirubinemia, severe skin reactions.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • thrombocytopenia
  • diarrhea
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  • ocular muscle weakness
  • hematuria
  • edema
  • fatigue
  • numbness
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness
  • amnesia
  • memory impairment
  • confusion

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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.