Medication info

Yturosuvastatin 5 mg (Rosuvastatin Calcium) Tablet

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
성이바이오제약주식회사
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 30 tablets/box [15 tablets/PTP (Alu-Alu) x 2]
Approval status
Active

MFDS item code 202106979 · Approved 2021.10.18

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily as the initial dose, irrespective of meals. If a greater reduction in LDL cholesterol is required, it can be adjusted to 10 mg as a maintenance dose once daily. The dose should be appropriately adjusted based on LDL cholesterol levels, therapeutic goals, and patient response, with a minimum interval of 4 weeks. The maximum daily dose is 20 mg.
Children's dosage
Pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) should be administered a dose between 5 mg and 20 mg once daily. The dosage should be individually adjusted according to the therapeutic goals for each patient.

Ingredients

Manufacturer
성이바이오제약주식회사

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol level
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used in patients with primary hypercholesterolemia and mixed dyslipidemia who are not adequately controlled with diet and exercise, and it helps slow the progression of atherosclerosis due to hypercholesterolemia. It is also used as an adjunct to diet for patients with homozygous familial hypercholesterolemia. This medication is particularly utilized as an adjunct to diet in pediatric patients aged 10 to 17 years who exceed specific LDL cholesterol criteria. It is also beneficial for patients with primary dysbetalipoproteinemia, and in men over 50 years and women over 60 years with cardiovascular risk factors, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization. Overall, this medication is effectively used in the management of dyslipidemic disorders and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

Administer 5 mg once daily as the initial dose, irrespective of meals. If a greater reduction in LDL cholesterol is required, it can be adjusted to 10 mg as a maintenance dose once daily. The dose should be appropriately adjusted based on LDL cholesterol levels, therapeutic goals, and patient response, with a minimum interval of 4 weeks. The maximum daily dose is 20 mg.

Children's dosage

Pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) should be administered a dose between 5 mg and 20 mg once daily. The dosage should be individually adjusted according to the therapeutic goals for each patient.

Precautions

This medication should not be used in certain patients. For example, individuals allergic to the components of this medication, those with severely impaired liver function, muscle disorders, those taking certain immunosuppressants, individuals with severe renal impairment, pregnant or breastfeeding women, and individuals with specific genetic diseases should not take this medication. Moreover, before taking this medication, it is essential to inform if there is a history of liver or kidney disease, thyroid dysfunction, or muscle disorders, as these patients should use this medication cautiously. This medication can cause muscle pain, weakness, and, rarely, severe muscle damage; therefore, if any unusual muscle symptoms occur, the physician should be informed immediately. It is important to receive regular liver function tests and muscle enzyme tests, especially when taking high doses. Caution is also necessary for those who consume alcohol heavily or have a history of liver disease. This medication can interact with other drugs, so it is crucial to inform healthcare providers of any other medications being taken. Particularly, muscle damage risk may increase when taken with certain antiviral agents, immunosuppressants, and fibrate medications. Women who are pregnant or may become pregnant must not use this medication and should implement appropriate contraception methods. Breastfeeding women should also avoid taking this medication. In the case of overdose, there is no specific antidote, so it is imperative to visit a medical facility immediately for treatment based on symptoms and to monitor liver function and muscle enzyme levels. This medication is not known to significantly affect driving or machine operation abilities; however, caution is warranted as dizziness may occur after intake. Lastly, if severe skin rashes or allergic reactions occur during treatment, it is essential to discontinue use immediately and consult a healthcare professional.

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), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myasthenia gravis, respiratory distress, hepatitis, jaundice, acute renal failure, thrombocytopenia, fatal and non-fatal liver failure, severe skin reactions, neurological effects (including polyneuropathy, severe muscle weakness)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • increased serum creatinine
  • elevated ALT
  • elevated AST
  • increased CK
  • arthralgia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is essential to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. This helps maintain the effectiveness of the medication and ensures safe use.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 30 tablets/box [15 tablets/PTP (Alu-Alu) x 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

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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.