Medication info
Rosuvastatin Calcium 20mg Tablets

Rosuvastatin Calcium 20mg Tablets

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

MFDS item code 202003604 · Approved 2020.05.18 · Insurance code 661605270

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For adult patients with primary hypercholesterolemia, start with a dose of 5mg once daily; maintain at 10mg after adjusting based on LDL-cholesterol levels and patient response at intervals of 4 weeks or more, up to a maximum of 20mg if needed. It can be administered at any time of the day regardless of meals.
Children's dosage
In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose of 5mg to 20mg once daily, adjusting according to individual treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)알피바이오

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct in patients with primary hypercholesterolemia, mixed dyslipidemia, and familial hypercholesterolemia when dietary control and exercise are inadequate. It is also used in patients with homozygous familial hypercholesterolemia in conjunction with other lipid-lowering therapies and plays a role in lowering cholesterol levels to delay the progression of atherosclerosis. It is recommended for pediatric patients aged 10 years and older who meet specific criteria for hypercholesterolemia. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in patients at high risk for cardiovascular disease. This drug effectively improves cholesterol levels and cardiovascular disease risk.

Dosage and Administration

Adult dosage

For adult patients with primary hypercholesterolemia, start with a dose of 5mg once daily; maintain at 10mg after adjusting based on LDL-cholesterol levels and patient response at intervals of 4 weeks or more, up to a maximum of 20mg if needed. It can be administered at any time of the day regardless of meals.

Children's dosage

In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose of 5mg to 20mg once daily, adjusting according to individual treatment goals at intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, it should not be administered to patients who are allergic to it, have severe liver problems, have myopathy, are taking cyclosporine, have severely impaired kidney function, are pregnant or breastfeeding, and women of childbearing age who are not using adequate contraception. Additionally, high-dose (40mg) administration is contraindicated in patients with a high risk of myopathy or rhabdomyolysis. Risk factors for this include moderate renal impairment, hypothyroidism, a personal or family history of muscular disorders, alcohol addiction, and concomitant use of certain medications. This drug contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients should have regular liver function tests and muscle-related tests before and during treatment, especially if consuming alcohol heavily or having a history of liver disease. If muscle pain, weakness, or cramps occur, contact a doctor immediately for testing, and in severe cases, discontinue the medication. This drug may elevate blood sugar levels in some patients, so those at risk for diabetes should consistently monitor their blood sugar levels. This drug may interact with other medications, so inform your doctor or pharmacist of any other drugs you are taking, especially when combined with certain antivirals, immunosuppressants, some antibiotics, and fibrates. Women who are pregnant or planning to become pregnant must use adequate contraception and discontinue this medication immediately if pregnancy is confirmed. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and monitoring of liver function and muscle enzymes should be done. This drug may cause side effects such as dizziness, necessitating caution when driving or operating machinery. Lastly, rare but serious skin reactions, liver damage, and severe muscle-related adverse reactions may occur, so consult healthcare professionals immediately if these symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, chest tightness, difficulty breathing, jaundice, severe skin reactions (Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms), severe allergic reaction, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular muscle weakness, acute renal failure, oliguria, severe edema associated with increased blood pressure, polyneuropathy

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • diabetes
  • itching
  • muscle pain
  • weakness
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to store the medication at room temperature between 1 to 30 degrees Celsius, not in excessively hot or cold places.

Appearance and packaging

Appearance

Pink round film-coated tablet

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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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.