Medication info
Shubastin Tablet 5mg (Rosuvastatin Calcium)

Shubastin Tablet 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)비보존제약
Appearance
Yellow round film-coated tablets
Packaging
30 tablets (15 tablets/PTP×2)
Approval status
Active

MFDS item code 201607041 · Approved 2016.12.12 · Insurance code 658204730

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily as the initial dose regardless of meals. If a greater reduction in LDL cholesterol is needed, the maintenance dose may be adjusted to 10 mg once daily, and the dosage should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. The maximum daily dose may be increased up to 20 mg.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years, the usual dosage is 5 mg to 20 mg once daily, and the dosage should be adjusted based on the individual patient's treatment goals every 4 weeks.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when not controlled by diet and exercise. It is also prescribed as an adjunct to diet for adolescents aged 10 years and older who have homozygous familial hypercholesterolemia or heterozygous familial hypercholesterolemia. This medication lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis, and it also aids patients with dysbetalipoproteinemia. Specifically, it is effective in reducing the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 years and women over 60 years who have risk factors for cardiovascular disease. Therefore, it is effectively used to control blood lipids and reduce the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

Administer 5 mg once daily as the initial dose regardless of meals. If a greater reduction in LDL cholesterol is needed, the maintenance dose may be adjusted to 10 mg once daily, and the dosage should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. The maximum daily dose may be increased up to 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years, the usual dosage is 5 mg to 20 mg once daily, and the dosage should be adjusted based on the individual patient's treatment goals every 4 weeks.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any ingredient of this drug, those with severely impaired liver function, those with muscle disorders, and those taking certain immunosuppressants should not take this medication. Additionally, patients with significantly impaired renal function and women who are pregnant or breastfeeding should not use this drug. The 40 mg dosage is contraindicated in patients at high risk of muscle disorders. When using this drug, liver function and muscle condition should be periodically checked. Patients who drink large amounts of alcohol or have a history of liver disease should be more cautious, and those with hypothyroidism or nephrotic syndrome should use it only after treating the underlying condition. Symptoms such as muscle pain, muscle weakness, or cramps should be reported immediately to healthcare professionals, and the use of this drug should be discontinued if necessary. This medication contains lactose, so patients with lactose intolerance should be careful. Also, this drug may interact with various medications, so if other medications are being taken, it is essential to consult a doctor or pharmacist. Specifically, when taken with some antiviral drugs, immunosuppressants, and fibrates, the risk of muscle toxicity may increase. Women of childbearing potential should use appropriate contraception before taking this drug, and it should not be taken during pregnancy or when planning to become pregnant. Women who are breastfeeding should also avoid taking this drug and consult a doctor if they need to take it. There is no specific antidote for overdose, so treatment should be based on symptoms and management should include liver function and muscle enzyme testing. This drug is known not to significantly impact driving or machinery operation; however, since dizziness may occur, caution is advised. Finally, this medication may present higher blood levels in Asians, so careful dosage determination is needed.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, jaundice, hepatitis, severe liver damage, liver failure, difficulty breathing or shortness of breath, asthma attacks, severe muscle weakness, ocular myopathy, immune-mediated necrotizing myopathy, myopathy.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
Show 14 more
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • 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 sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps ensure the drug's effectiveness is safely maintained.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets (15 tablets/PTP×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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.