Medication info
Rosuvastatin Tablets 5 mg (Rosuvastatin Calcium)

Rosuvastatin Tablets 5 mg (Rosuvastatin Calcium)

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

MFDS item code 201403910 · Approved 2014.08.22 · Insurance code 641805730

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, administer once daily 5 mg as the initial dose at any time during the day, regardless of meals. If a greater reduction in LDL cholesterol is needed, the maintenance dose is adjusted to 10 mg once daily, which can be increased to a maximum of 20 mg per day at intervals of 4 weeks or more.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is administered once daily in the range of 5 mg to 20 mg, adjusting the dose according to individual patients at intervals of 4 weeks or more.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • early family history of coronary artery disease
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used in patients with various forms of hypercholesterolemia and dyslipidemia when dietary control and exercise alone are insufficient. It is particularly effective as an adjunct to dietary therapy in patients with primary hypercholesterolemia, familial hypercholesterolemia, and mixed dyslipidemia. Additionally, it helps to lower cholesterol levels in pediatric patients aged 10 to 17 years with familial hypercholesterolemia. It reduces total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia to delay the progression of atherosclerosis. In patients at high risk for cardiovascular diseases, it also contributes to the reduction of the risk of stroke, myocardial infarction, and vascular revascularization. Therefore, this medication is effectively used for dyslipidemia and risk reduction of cardiovascular diseases.

How to take

Adult dose

For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, administer once daily 5 mg as the initial dose at any time during the day, regardless of meals. If a greater reduction in LDL cholesterol is needed, the maintenance dose is adjusted to 10 mg once daily, which can be increased to a maximum of 20 mg per day at intervals of 4 weeks or more.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is administered once daily in the range of 5 mg to 20 mg, adjusting the dose according to individual patients at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to its ingredients, severe liver problems, muscle diseases, or severely impaired kidney function may be at risk if they take this medication. Pregnant or breastfeeding women, as well as women of childbearing potential, should consult their doctor and use appropriate contraception. Additionally, patients at high risk for muscle disease should avoid high doses of this medication. As this medication contains lactose, patients with genetic issues such as lactose intolerance should not take it. This medication can affect liver function, so patients with a history of liver disease or excessive alcohol consumption should undergo regular liver function tests before and during treatment. If symptoms such as muscle pain or weakness occur, they should notify their doctor immediately and discontinue treatment if necessary. It is especially safe to stop this medication if muscle-related symptoms are severe or if blood tests show significantly elevated markers of muscle damage. This medication can interact with other drugs, so anyone taking other medications should inform their doctor or pharmacist. Caution is particularly advised when taken with certain antiviral drugs, immunosuppressants, antifungals, and antibiotics. Moreover, high-dose combinations with fibrate-class medications are prohibited. Pregnant or breastfeeding individuals should not take this medication as its safety has not been established, and women planning to become pregnant should use adequate contraceptive methods. There is no specific antidote for overdose, so treatment should be administered based on symptoms, monitoring liver function and muscle damage. This medication may cause dizziness, so caution is needed when driving or operating machinery. Finally, if severe skin reactions or serious liver damage symptoms occur while taking this medication, it should be stopped immediately, and medical advice should be sought.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, severe muscle weakness, ophthalmoplegia, thrombocytopenia, jaundice, hepatitis, increased transaminases, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction (DRESS), immune-mediated necrotizing myopathy, acute kidney failure, oliguria, memory loss, peripheral neuropathy, polyneuropathy, dyspnea

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • chest discomfort
  • diarrhea
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  • loss of appetite
  • abdominal bloating
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • cough

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is best to keep it at room temperature between 1°C and 30°C. This helps to maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets (14 tablets/PTP 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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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.