Medication info

Stavaster Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationApproval withdrawn
Ingredient · strength
Rosuvastatin Calcium›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
Brown round film-coated tablet
Packaging
28 tablets/Alu-Alu (7 tablets/Alu-Alu x 4)
Approval status
Approval withdrawn

MFDS item code 201404478 · 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This product's status changed to Approval withdrawn on 2023.06.29.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 and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Without regard to meals, administration begins at a dose of 5 mg once daily. If a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted to generally 10 mg taken once daily. Dosage adjustments should be made at intervals of four weeks or more based on LDL cholesterol levels, therapeutic goals, and patient response. The dose may be increased to a maximum of 20 mg per day.
Children's dosage
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the usual dosage is between 5 mg and 20 mg once daily. The dosage should be adjusted according to the individual therapeutic goals of each patient.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This drug is used as an adjunct treatment when dietary management and exercise alone are insufficient for patients with hypercholesterolemia and mixed hyperlipidemia. It is particularly useful for patients with heterozygous and homozygous familial hypercholesterolemia, lowering total cholesterol and LDL cholesterol levels to delay the progression of atherosclerosis. It is also effective in children over 10 years of age with high LDL cholesterol when used alongside dietary management. Additionally, it aids in the treatment of dysbetalipoproteinemia. In middle-aged men and women who are at high risk for cardiovascular disease, it contributes to reducing the risk of stroke, myocardial infarction, and revascularization procedures. Thus, it is effectively used for improving blood lipid levels and reducing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

Without regard to meals, administration begins at a dose of 5 mg once daily. If a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted to generally 10 mg taken once daily. Dosage adjustments should be made at intervals of four weeks or more based on LDL cholesterol levels, therapeutic goals, and patient response. The dose may be increased to a maximum of 20 mg per day.

Children's dosage

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the usual dosage is between 5 mg and 20 mg once daily. The dosage should be adjusted according to the individual therapeutic goals of each patient.

Precautions

This drug should not be administered to certain patients. For example, individuals who are allergic to any of the components of this drug or have active liver disease should not take it. Patients with muscle disorders or those taking cyclosporine, as well as those with severely impaired kidney function, may also risk complications from using this drug. Pregnant or breastfeeding women, and fertile women who do not use adequate contraception should not use this drug, and women who may become pregnant must consult their doctor. A dosage of 40 mg is particularly contraindicated for patients at high risk of muscle disorders. This drug contains lactose, so those with lactose intolerance or associated genetic disorders should not take it. This drug can affect liver function, so patients with a history of liver disease or those who consume alcohol heavily should use it with caution, and undergo regular liver function tests before and during treatment. If symptoms of muscle pain or weakness occur, inform a doctor immediately. In severe cases, discontinuation of the drug may be necessary. Particular care should be taken in patients with impaired kidney function, hypothyroidism, or a history of genetic muscle disorders regarding signs of muscle distress. This drug can rarely cause side effects such as skin rash, itching, headache, dizziness, indigestion; very rarely, serious skin reactions, liver damage, or muscle rupture have been reported. If abnormal symptoms occur, consult medical personnel promptly. This drug may interact with other medications, so if you are taking any other medications, be sure to inform your doctor, especially when used with certain antivirals, antibiotics, immunosuppressants, or fibrate class drugs. Pregnant or breastfeeding women should not use this drug, and women planning pregnancy should use appropriate contraceptive methods. In the case of overdose, as there is no specific antidote, treatment should be symptomatic, with monitoring of liver function and muscle enzyme levels. Caution is necessary as dizziness may occur when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, severe allergic reactions; Stevens-Johnson syndrome; drug reaction with eosinophilia and systemic symptoms (DRESS); severe cutaneous adverse reactions; cough, shortness of breath, respiratory distress; jaundice and yellowing of skin or eyes (hepatitis), liver impairment; myopathy, rhabdomyolysis, acute kidney failure, oliguria, kidney failure, angioedema, or urinary abnormalities accompanied by elevated blood pressure.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • lupus-like syndrome
  • muscle rupture
  • joint pain
  • immunosuppression.

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

Storage

This drug should be stored in a tightly sealed container to protect it from air and moisture, and it is recommended to keep it at a temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain its efficacy and prevent degradation.

Appearance and packaging

Appearance

Brown round film-coated tablet

Package unit

28 tablets/Alu-Alu (7 tablets/Alu-Alu x 4)

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.

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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.