Medication info
Rosuvastatin Calcium Tablets 20mg

Rosuvastatin Calcium Tablets 20mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
Pink round film-coated tablets
Packaging
28 tablets/Alu-Alu, 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201800670 · Approved 2018.02.02 · Insurance code 628900990

Summary

Main use
Treatment to reduce high cholesterol and cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dosage is 5mg once daily, which can be adjusted to a maintenance dose if greater reduction in LDL-cholesterol is needed. The maintenance dose is usually 10mg once daily, which is where most patients are adjusted. This dose should be adjusted considering LDL-cholesterol levels, treatment targets, and patient response at intervals of 4 weeks or longer, with a maximum daily dose of 20mg.
Children's dosage
The usual dosage range is 5mg to 20mg once daily. Dosing must be adjusted individually based on the recommended treatment goals for each patient. Adjustments should be made at intervals of 4 weeks or longer.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Treatment to reduce high cholesterol and cardiovascular disease risk

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

This medication is used as an adjunct to diet and exercise in patients with primary hypercholesterolemia and mixed dyslipidemia when diet alone is inadequate. It also helps lower total cholesterol and LDL-cholesterol levels in adolescents aged 10 and older with homozygous familial hypercholesterolemia or heterozygous familial hypercholesterolemia. This helps to delay the progression of atherosclerosis and reduce the risk of cardiovascular disease. It is particularly used to reduce the risk of stroke, myocardial infarction, and vascular revascularization in men over 50 and women over 60 who have elevated high-sensitivity C-reactive protein and cardiovascular risk factors. This medication improves cardiovascular health and effectively treats high cholesterol.

Dosage and Administration

Adult dosage

The initial dosage is 5mg once daily, which can be adjusted to a maintenance dose if greater reduction in LDL-cholesterol is needed. The maintenance dose is usually 10mg once daily, which is where most patients are adjusted. This dose should be adjusted considering LDL-cholesterol levels, treatment targets, and patient response at intervals of 4 weeks or longer, with a maximum daily dose of 20mg.

Children's dosage

The usual dosage range is 5mg to 20mg once daily. Dosing must be adjusted individually based on the recommended treatment goals for each patient. Adjustments should be made at intervals of 4 weeks or longer.

Precautions

This medication should not be used in patients with known allergies to any of its components. Patients with active liver disease or markedly elevated liver enzyme levels should not take this medication. Patients with muscle diseases or those at risk for muscle damage should avoid this medication. Caution is required if used in conjunction with certain immunosuppressants due to potential risks. Patients with severely impaired kidney function, pregnant or breastfeeding women, and fertile women without adequate contraception should not take this medication. High-dose administration of 40mg or more is contraindicated in patients at higher risk for muscle-related side effects. Patients with lactose intolerance should not take this medication. Those who consume excessive alcohol or have a history of liver disease should undergo liver function tests before using this medication, and periodically during treatment. If muscle pain or weakness occurs, it is essential to inform a doctor immediately and undergo necessary testing. In severe cases, discontinuation of the medication may be required. Caution is also necessary for patients in acute severe conditions or those showing symptoms of myasthenia. There are multiple drugs that interact with this medication, so it is critical to inform a doctor or pharmacist about any other medications being taken. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential should use appropriate contraception. There is no specific antidote for overdose, so treatment should be symptomatic, along with liver function and muscle enzyme tests. This medication does not greatly affect driving or machine operation abilities, but caution should be observed as dizziness may occur. While taking this medication, signs of liver dysfunction, muscle pain, allergic reactions, or other abnormal symptoms may occur, and any such symptoms should be reported to a healthcare professional immediately.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, severe allergic reactions (hives, severe swelling), serious skin reactions (Stevens-Johnson syndrome, eosinophilia and systemic symptom drug reaction syndrome), respiratory issues (cough, dyspnea), jaundice, hepatitis, severe myasthenia, ocular myasthenia, thrombocytopenia, immune-mediated necrotizing myopathy, acute kidney failure, etc.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • increased ALT
  • hives
Show 16 more
  • rash
  • hematuria
  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • 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 prevent exposure to air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/Alu-Alu, 30 tablets/bottle, 300 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.