Medication info
Rosuvastatin 5mg Tablet (Rosuvastatin Calcium)

Rosuvastatin 5mg Tablet (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Yellow round film-coated tablet
Packaging
28 tablets / PTP [(14 tablets/PTP x 2 packs)]
Approval status
Active

MFDS item code 201904445 · Approved 2019.06.28 · Insurance code 649702250

Summary

Main use
Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Regardless of meals, the initial dose of 5 mg should be administered once daily at any time during the day. If further reduction of LDL cholesterol levels is needed, the maintenance dose can be adjusted to 10 mg once daily, and dosage should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. The dosage may be increased to a maximum of 20 mg per day.
Children's dosage
For pediatric patients aged 10 to 17 years, a dose of 5 mg to 20 mg is administered once daily. The dosage should be adjusted based on individual patient treatment goals and should be evaluated with intervals of 4 weeks or more.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • hyperlipidemia
  • familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • risk factors for coronary heart disease
  • stroke risk
  • myocardial infarction risk
  • risk of endovascular intervention
View approved original text

This medication is used as an adjunct when primary hypercholesterolemia and mixed hyperlipidemia are not controlled by diet and exercise. It reduces LDL cholesterol and total cholesterol levels in pediatric patients with homozygous familial hypercholesterolemia and heterozygous familial hypercholesterolemia in conjunction with dietary therapy, enhancing treatment effectiveness. It is also utilized as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. This drug lowers total cholesterol and LDL cholesterol levels, slowing the progression of atherosclerosis and reducing the risks of stroke, myocardial infarction, and endovascular interventions in patients at risk for cardiovascular disease. Overall, it is effective in improving cardiovascular health.

Dosage and Administration

Adult dosage

Regardless of meals, the initial dose of 5 mg should be administered once daily at any time during the day. If further reduction of LDL cholesterol levels is needed, the maintenance dose can be adjusted to 10 mg once daily, and dosage should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. The dosage may be increased to a maximum of 20 mg per day.

Children's dosage

For pediatric patients aged 10 to 17 years, a dose of 5 mg to 20 mg is administered once daily. The dosage should be adjusted based on individual patient treatment goals and should be evaluated with intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, patients with allergies to this drug, severely impaired liver function, muscle diseases, and those taking certain medications should not take this medication. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraception to prevent pregnancy. Additionally, patients at high risk for muscle disease should avoid high doses. Regular monitoring of liver function tests and muscle-related tests is required. Caution is especially needed for individuals with a history of liver disease or those who consume alcohol heavily. If symptoms such as muscle pain, muscle weakness, or sudden fatigue occur, they should contact a doctor immediately. This drug may interact with certain medications, so anyone taking other medications must inform their healthcare provider, and dosage adjustments or discontinuation may be necessary if taken with specific drugs. Liver or kidney function issues may arise while taking this medication, making regular check-ups necessary, and medical consultation should be sought upon any abnormal symptoms. Dizziness may occur while driving or operating machinery, so caution is warranted. In cases of overdose, there is no specific antidote, so immediate medical attention should be sought for appropriate treatment and examination.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe allergic reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosa pain, severe skin adverse reactions, rhabdomyolysis, immune-mediated necrotizing myopathy, severe neurological symptoms, jaundice.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
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  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • sleep disturbance
  • depression
  • memory loss
  • cognitive impairment
  • confusion
  • cough
  • sexual dysfunction
  • gynecomastia

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. The appropriate storage temperature is recommended to be kept at room temperature between 1 degree and 30 degrees. This helps maintain the drug's efficacy over time and ensures safe usage.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets / PTP [(14 tablets/PTP x 2 packs)]

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

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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.