Medication info
Shubastatin 5 mg (Rosuvastatin Calcium)

Shubastatin 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
조아제약(주)
Appearance
Yellow round film-coated tablets
Packaging
28 T / PTP
Approval status
Active

MFDS item code 201500672 · Approved 2015.02.10 · Insurance code 644603040

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For adults, 5 milligrams should be administered once daily at any time of the day, regardless of meals, as an initial dose. If a greater reduction in LDL cholesterol is necessary, the maintenance dose can be adjusted, with the maintenance dose being 10 milligrams once daily. Maintenance doses should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.
Child dose
Pediatric patients aged 10 years to 17 years with heterozygous familial hypercholesterolemia are administered between 5 milligrams and 20 milligrams once daily. The dosage is adjusted according to each patient's treatment goals over intervals of 4 weeks or more.

Ingredients

Manufacturer
조아제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • hyperlipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of premature coronary artery disease
  • risk of stroke
  • risk of myocardial infarction
  • risk of arterial revascularization
View approved original text

This medication is used as an adjunctive therapy in patients with primary hypercholesterolemia and mixed dyslipidemia when not adequately controlled by diet and exercise. It is also effective as an adjunctive therapy for patients with homozygous familial hypercholesterolemia. This drug is used to lower total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It can also be used as an adjunct to diet in pediatric patients aged 10 to 17 years with specific criteria of heterozygous familial hypercholesterolemia. Additionally, it is used as an adjunctive treatment for patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and revascularization procedures in middle-aged and older patients at high risk for cardiovascular disease. Based on these efficacies, it is used to improve cholesterol levels and reduce the risk of cardiovascular disease.

How to take

Adult dose

For adults, 5 milligrams should be administered once daily at any time of the day, regardless of meals, as an initial dose. If a greater reduction in LDL cholesterol is necessary, the maintenance dose can be adjusted, with the maintenance dose being 10 milligrams once daily. Maintenance doses should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.

Child dose

Pediatric patients aged 10 years to 17 years with heterozygous familial hypercholesterolemia are administered between 5 milligrams and 20 milligrams once daily. The dosage is adjusted according to each patient's treatment goals over intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, individuals allergic to this drug, those with liver problems, and patients with muscle diseases should avoid taking it. In addition, patients with severely impaired kidney function, as well as pregnant or nursing women, should not use this drug. High-dose use is prohibited in patients at high risk for muscle disease. This drug contains lactose and caution is required for patients with lactose intolerance. It is important to regularly monitor liver function and muscle status while taking this medication. Those who drink alcohol heavily or have a history of liver disease should be particularly careful. Symptoms such as muscle pain or weakness should be reported to a doctor immediately, and the drug should be discontinued if necessary. This drug may interact with other medications, so consult a doctor or pharmacist if you are taking other medications. The risk of muscle damage may increase when used in combination with certain antiviral agents, immunosuppressants, antifungals, etc. Women who could become pregnant should employ appropriate contraceptive methods, and pregnant women should not use this drug. Nursing mothers should also avoid using this medication for safety. There is no specific antidote in case of overdose, so treatment should be based on symptoms while monitoring liver function and muscle enzyme levels. While taking this medication, dizziness or headaches may occur, so caution is needed when driving or operating machinery. Finally, this drug may show higher blood concentration levels in Asians, so dosage adjustments may be necessary. Therefore, it is extremely important to take it as directed by a physician.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, chest tightness, breathing difficulties, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe liver damage, severe muscle weakness, ocular myasthenia, immune-mediated necrotizing myopathy, rhabdomyolysis, severe edema associated with increased blood pressure, acute renal failure, oliguria, severe allergic reactions, severe skin reactions

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory abnormalities
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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 or moisture, and should be kept at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 T / PTP

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.