Medication info
Rosuvastatin Calcium 20 mg Tablet

Rosuvastatin Calcium 20 mg Tablet

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201604060 · Approved 2016.06.29 · Insurance code 073001300

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and dyslipidemia, risk reduction of cardiovascular disease
Who uses it
Adults
Adult dosage
The initial dose is 5 mg once daily, and if greater reduction of LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is usually 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted adequately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dosage of 20 mg.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke
  • myocardial infarction
View approved original text

This medication is used as an adjunct for patients with primary hypercholesterolemia and mixed dyslipidemia who are inadequately controlled by diet and exercise. It is also used in conjunction with dietary changes or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia to enhance effectiveness. It helps to lower total cholesterol and LDL-cholesterol levels to target levels, slowing the progression of atherosclerosis. It is also utilized as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Additionally, this drug reduces the risk of cardiovascular diseases associated with stroke, myocardial infarction, and arterial revascularization in high-risk patients with elevated high-sensitivity C-reactive protein levels. Overall, it is used to improve cardiovascular health.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if greater reduction of LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is usually 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted adequately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dosage of 20 mg.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this medication, those with active liver disease, muscle disorders, and patients with severe renal impairment should not take this drug. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing potential should use appropriate contraceptive methods to minimize the possibility of pregnancy. Moreover, patients at high risk for muscle disorders should avoid high doses. This drug contains lactose, so caution is required for patients with lactose intolerance. Patients with poor liver function or excessive alcohol intake should have regular liver function tests before and during treatment with this medication. Those with thyroid dysfunction or nephrotic syndrome should treat their underlying conditions before taking this drug. Muscle-related side effects such as myalgia, myopathy, and rhabdomyolysis have been reported; thus, if there are any unusual muscle symptoms, immediate medical consultation is necessary. Particularly, if muscle pain, weakness, or cramps occur, blood tests should be performed to check for muscle damage, and discontinuation of the medication may be warranted if necessary. This medication can interact with certain drugs; therefore, if other drugs are being taken, healthcare providers should be informed. Particularly, co-administration with drugs that affect hepatic metabolism may increase the blood concentration of this drug, raising the risk of side effects. The safety of this medication has not been established in pregnant or breastfeeding women; hence, its use should be avoided, and women planning to become pregnant should consult their healthcare provider prior to use. There is no specific antidote for overdose; management should focus on symptomatic treatment along with liver function and muscle enzyme tests. This medication is known not to significantly affect the ability to drive or operate machinery, but caution is required as symptoms such as dizziness may occur. Finally, if severe skin reactions or allergic symptoms appear during treatment with this medication, it should be discontinued immediately and healthcare providers should be consulted.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, amnesia, peripheral neuropathy, severe muscle weakness, dyspnea, ophthalmoplegia, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia, and systemic symptom accompanied drug reaction syndrome (DRESS), immune-mediated necrotizing myopathy, acute kidney injury, oliguria, increased serum creatinine levels.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and light, and it is best stored at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 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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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.