Medication info
Shusta Tablet 5mg (Rosuvastatin Calcium)

Shusta Tablet 5mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
안국약품(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/box [(10 tablets/Alu-Alu × 3)]
Approval status
Active

MFDS item code 201001003 · Approved 2010.01.28 · Insurance code 650203400

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or more, and can be increased to a maximum of 20 mg once daily.
Child dose
The usual dose range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosing should be individually adjusted according to the recommended treatment goals for each patient.

Ingredients

Manufacturer
안국약품(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
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery 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 and exercise do not achieve adequate control. It is also used as an adjunct together with diet or other lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. This medication helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, it is used in addition to diet to decrease total cholesterol, LDL cholesterol, and Apo-B protein levels. Additionally, it is utilized as an adjunct to the dietary therapy for patients with primary dysbetalipoproteinemia. In middle-aged patients at high risk for cardiovascular diseases, the medication can also be expected to reduce the risk of stroke, myocardial infarction, and arterial revascularization. Thus, this medication is usefully applied in various forms of dyslipidemia and for reducing the risk of cardiovascular diseases.

How to take

Adult dose

The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or more, and can be increased to a maximum of 20 mg once daily.

Child dose

The usual dose range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosing should be individually adjusted according to the recommended treatment goals for each patient.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any ingredient of this medication, those with severe liver function impairment, patients with myopathy, those taking certain medications concurrently, patients with severe renal impairment, and women who are pregnant or breastfeeding should not take this medication. Additionally, women who may become pregnant can only take this medication if they are unlikely to become pregnant and fully understand the risks it poses to the fetus. High-dose administration is prohibited in patients who are at high risk for myopathy, and risk factors for this include moderate renal impairment, hypothyroidism, a family history or genetic muscle disease, and alcohol dependence. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients with a history of liver disease or those who consume alcohol in excess need to have regular liver function tests. If symptoms of muscle pain or muscle weakness occur, the doctor should be notified immediately, and in severe cases, the medication should be discontinued. This medication may interact with some drugs, so if other medications are being taken, it is essential to consult a healthcare professional. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant should ensure to use appropriate contraceptive methods. In case of overdose, there is no specific antidote, so treatment based on symptoms and tests for liver function and muscle enzymes may be required. Driving or operating machinery may cause dizziness, so caution is warranted. This medication can rarely cause serious skin reactions, liver damage, or muscle rupture; therefore, if adverse symptoms occur, immediate consultation with healthcare providers is required.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, chest discomfort, difficulty breathing, dyspnea, jaundice, hepatitis, increased transaminases, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, rhabdomyolysis, acute renal failure, oliguria, thrombocytopenia, severe muscle weakness, ocular muscle weakness, severe swelling, severe allergic reactions, severe skin reactions

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
Show 23 more
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • memory disturbance
  • confusion

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly closed container. Additionally, it should be kept in a cool place at or below 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/box [(10 tablets/Alu-Alu × 3)]

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.