Medication info
Rosuvastatin 20 mg (Rosuvastatin Calcium)

Rosuvastatin 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/PTP [(15 tablets/PTP × 2)]
Approval status
Active

MFDS item code 201607043 · Approved 2016.12.12

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer once daily at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily. The dose can be adjusted at intervals of 4 weeks or more as needed, with a maximum daily dose of 20 mg.
Children's dosage
For pediatric patients aged 10 to 17 years, administer 5 mg to 20 mg once daily, adjusting the dose individually at intervals of 4 weeks or more according to treatment goals. Safety for pediatric patients under 10 years has not been established.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • type IIa heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease risk factors
  • 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 managing blood lipids is insufficient. It is also administered together with diet or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels in individuals with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It can be used safely in pediatric patients aged 10 to 17 years with familial hypercholesterolemia, and it effectively reduces cholesterol levels in high-risk groups. It can also be used as an adjunct to diet in patients with primary dysbetalipoproteinemia. In middle-aged and older patients at high risk for cardiovascular diseases, it contributes to lowering the risks of stroke, myocardial infarction, and vascular reintervention. This medication is effective in improving blood lipid levels and reducing the risk of cardiovascular health problems.

Dosage and Administration

Adult dosage

Administer once daily at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily. The dose can be adjusted at intervals of 4 weeks or more as needed, with a maximum daily dose of 20 mg.

Children's dosage

For pediatric patients aged 10 to 17 years, administer 5 mg to 20 mg once daily, adjusting the dose individually at intervals of 4 weeks or more according to treatment goals. Safety for pediatric patients under 10 years has not been established.

Precautions

This medication should not be used in certain patients. For example, it should not be taken by patients who are allergic to this medication, have severe liver dysfunction, have muscle-related diseases, have severely impaired renal function, or by pregnant or breastfeeding women. Additionally, high-dose use is prohibited in patients at high risk for muscle disorders. This medication contains lactose, so caution is advised in patients with lactose intolerance. Patients who consume large amounts of alcohol or have a history of liver disease should frequently monitor liver function tests before taking this medication. If symptoms of muscle pain or weakness appear, inform the medical staff immediately, and in severe cases, discontinue the medication. Patients with poor kidney function or hypothyroidism should treat these conditions before starting the medication. This medication can rarely cause severe skin reactions or liver damage, so if skin rashes or jaundice occur, it should be discontinued immediately. This medication may interact with other medications, so patients must inform their medical staff of any other drugs they are taking, particularly some antibiotics, antivirals, immunosuppressants, etc. Women who may become pregnant should use appropriate contraceptives and must not take this medication during pregnancy. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle enzyme tests are necessary. While this medication does not significantly impact driving or operating machinery, patients should be cautious as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

  • Hives, angioedema including hypersensitivity reactions → severe allergic reactions
  • Stevens-Johnson syndrome, eosinophilia and systemic symptoms-associated drug reaction syndrome (DRESS) → severe skin adverse reactions
  • Breathing difficulties, cough, and respiratory problems including shortness of breath
  • Skin or eyes turning yellow (jaundice), hepatitis, jaundice → liver dysfunction (jaundice)
  • Sudden, severe headache, seizures, altered consciousness, visual disturbances, paralysis and other severe symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture, at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer duration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/PTP [(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

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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.