Medication info

Stavaster Tablet 20 mg (Rosuvastatin Calcium)

Prescription medicationApproval withdrawn
Ingredient · strength
Rosuvastatin Calcium›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
Brown round film-coated tablet
Packaging
Manufacturer packaging unit
Approval status
Approval withdrawn

MFDS item code 201404476 · Approved 2014.09.30

This product's status changed to Approval withdrawn on 2023.06.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For adult patients with primary hypercholesterolemia, the medication can be taken at any time during the day, independent of meals. The starting dose is 5 mg once daily, which can be adjusted as needed. The maintenance dose is usually 10 mg once daily, suitable for the majority of patients. Adjustments can be made based on LDL cholesterol levels and patient response at intervals of 4 weeks or longer. The dose can be increased to a maximum of 20 mg per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17), the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted individually based on treatment goals.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • total cholesterol excess
  • LDL cholesterol excess
  • apo-B protein level excess
  • abnormal beta-lipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
View approved original text

This medication is primarily used in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are insufficient. It is particularly used as an adjunct to diet or other therapies in patients with familial hypercholesterolemia to lower total cholesterol and LDL cholesterol levels. This helps delay the progression of atherosclerosis. Additionally, it is used as an adjunct to diet in pediatric patients aged 10 to 17 who meet specific criteria. It is effective in reducing the risk of stroke, myocardial infarction, and vascular interventions in patients at high risk for cardiovascular diseases. This medication is used for major lipid abnormalities and the reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

For adult patients with primary hypercholesterolemia, the medication can be taken at any time during the day, independent of meals. The starting dose is 5 mg once daily, which can be adjusted as needed. The maintenance dose is usually 10 mg once daily, suitable for the majority of patients. Adjustments can be made based on LDL cholesterol levels and patient response at intervals of 4 weeks or longer. The dose can be increased to a maximum of 20 mg per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17), the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted individually based on treatment goals.

Precautions

This medication should not be used in specific patients. For example, it is contraindicated for patients with an allergy to any component of this medication, those with severe liver dysfunction, patients with muscle disorders, those taking certain immunosuppressants, patients with severely reduced kidney function, pregnant or breastfeeding women, and fertile women not using appropriate contraception. Additionally, high-dose use is prohibited in patients with a high risk of muscle disorders. This medication contains lactose, so it should not be used by patients with lactose intolerance or specific genetic metabolic disorders. Caution should be exercised in patients with liver dysfunction or excessive alcohol consumption, and it is important to regularly check liver function before and during treatment. Symptoms such as muscle pain, weakness, and damage may occur; if these symptoms appear, medical personnel should be informed immediately. Particularly, patients at high risk of muscle damage should have muscle enzyme levels checked before starting treatment, and routine monitoring through symptoms and tests is necessary during treatment. In cases of acute renal failure or severe systemic diseases, use of this medication should be discontinued. This medication may increase the risk of muscle damage when used in conjunction with other specific drugs, so if any medications are being taken concurrently, this must be disclosed to medical personnel. Using high doses of this medication may cause transient proteinuria, necessitating kidney function tests. For Asians, the drug may accumulate more in the body, so dose adjustment may be necessary. In pediatric patients aged 10 to 17, the impact on growth and secondary sexual characteristics is limited, requiring caution. During the use of this medication, rare side effects such as interstitial lung disease, severe liver damage, and severe skin reactions may occur; if symptoms appear, treatment should be discontinued immediately, and advice from medical personnel should be sought. Furthermore, this medication can raise blood sugar levels, so patients at high risk for diabetes require regular blood sugar checks. This medication can interact with many drugs, so if other medications are being taken, this should be disclosed to medical personnel, especially with particular antiviral agents, immunosuppressants, and fibrate class medications. It should be avoided during pregnancy or breastfeeding, and women who may become pregnant should use appropriate birth control methods. In case of overdose, there are no specific antidotes, and treatment should be symptomatic while monitoring liver function and muscle enzyme levels. Finally, this medication may cause dizziness, so precautions should be taken while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, thrombocytopenia, jaundice, hepatitis, transaminase elevation, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute kidney failure, oliguria, chest tightness, dyspnea, respiratory distress, severe edema, severe allergic reactions, severe skin reactions.

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 bloating
  • 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 may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, it is best to store it at room temperature between 1°C and 30°C, avoiding extremely hot or cold places.

Appearance and packaging

Appearance

Brown round film-coated tablet

Package unit

Manufacturer packaging unit

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.