Medication info
Rosuvastatin Calcium Tablets 20 mg

Rosuvastatin Calcium Tablets 20 mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201702135 · Approved 2017.04.26 · Insurance code 657307090

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular risk.
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily as an initial dose at any time of the day regardless of meals. If greater LDL cholesterol reduction is needed, maintain with a dosage of 10 mg once daily, adjusting at intervals of 4 weeks or more. A maximum of 20 mg per day may be increased.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years, administer a dose of 5 mg to 20 mg once daily. The dosage should be adjusted at intervals of 4 weeks or more, and for children under 10 years of age, safety and efficacy have not been established.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular risk.

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • and family history of early coronary heart disease.
View approved original text

This medicine is used as an adjunctive therapy for patients with hypercholesterolemia and hyperlipidemia who cannot adequately control their condition through diet and exercise alone. It is particularly effective for patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, and mixed hyperlipidemia, and it can be safely used in children who meet specific criteria. Moreover, it helps slow the progression of atherosclerosis by lowering total cholesterol and LDL cholesterol levels. It can also be used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Furthermore, it contributes to the reduction of the risk of stroke, myocardial infarction, and revascularization procedures in high-risk adult populations with cardiovascular risk factors. Overall, this drug is used to control blood lipid levels and reduce the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

Administer 5 mg once daily as an initial dose at any time of the day regardless of meals. If greater LDL cholesterol reduction is needed, maintain with a dosage of 10 mg once daily, adjusting at intervals of 4 weeks or more. A maximum of 20 mg per day may be increased.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years, administer a dose of 5 mg to 20 mg once daily. The dosage should be adjusted at intervals of 4 weeks or more, and for children under 10 years of age, safety and efficacy have not been established.

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to any component of this medication, those with severely impaired liver function, patients with muscle disorders, those taking certain immunosuppressants, patients with severe kidney dysfunction, pregnant or breastfeeding women, and fertile women who are not using adequate contraception should not be administered this drug. Additionally, patients at high risk for muscle-related disorders or with specific genetic conditions, as well as those sensitive to lactose contained in this drug, should be cautious. This drug can affect liver function, so patients who consume alcohol heavily or have a history of liver disease should undergo regular liver function tests before and during treatment. If symptoms such as muscle pain or weakness occur, the doctor should be informed immediately, and if blood tests show elevated indicators of muscle injury along with these symptoms, discontinuation of the medication may be necessary. It is also advisable to discontinue this medication in cases of severe illness or acute conditions. Rarely, this drug may cause severe skin reactions or liver damage, so if symptoms like skin rash, jaundice, or severe fatigue appear, it is important to stop taking it immediately and consult healthcare personnel. This drug may interact with other medications, so it is essential to inform the doctor or pharmacist of any other medications being taken, particularly when using specific antiviral agents, immunosuppressants, antibiotics, or fibrate drugs. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should employ proper contraceptive methods. There is no specific antidote for overdose, so treatment should be symptom-based, and liver function and muscle injury indicators should be tested. This drug may cause side effects such as dizziness, requiring caution when driving or operating machinery. Finally, Asian patients may demonstrate higher concentrations of this drug in the body, necessitating dose adjustments.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscular weakness, ophthalmoplegia, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, edema, interstitial lung disease, fatal and non-fatal liver failure, severe headache, liver function test abnormalities

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
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture, and keep it at a safe temperature between 1°C and 30°C. This helps maintain the drug's effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle

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.