Medication info
Rosuvastatin 20 mg Tablets (Rosuvastatin Calcium)

Rosuvastatin 20 mg Tablets (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
광동제약(주)
Appearance
Pink, round film-coated tablets
Packaging
28 tablets (14 tablets/PTP*2)
Approval status
Active

MFDS item code 201000969 · Approved 2010.01.28 · Insurance code 641804760

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted up to 10 mg once daily as needed. The maintenance dose is adjusted every 4 weeks or more, with a maximum daily increase of up to 20 mg.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosing is 5 mg to 20 mg once daily, with adjustments made individually every 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
  • atherosclerosis
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary heart disease
  • stroke risk
View approved original text

This medication is used as an adjunctive therapy in patients with primary hypercholesterolemia and mixed dyslipidemia who are not adequately controlled with diet and exercise alone. It is also administered in conjunction with other treatments in patients with homozygous familial hypercholesterolemia to enhance efficacy. It lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. In pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, it can also be used alongside dietary modulation. It is utilized as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Lastly, it assists in reducing the risk of myocardial infarction, stroke, and revascularization procedures in patients over middle age who have elevated high-sensitivity C-reactive protein levels and other cardiovascular risk factors. This medication is utilized to improve cardiovascular health.

How to take

Adult dose

This medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted up to 10 mg once daily as needed. The maintenance dose is adjusted every 4 weeks or more, with a maximum daily increase of up to 20 mg.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosing is 5 mg to 20 mg once daily, with adjustments made individually every 4 weeks or more.

Precautions

This medication should not be used in certain patients. For instance, it should not be administered to patients who are allergic to it, have severely impaired liver function, have muscle disorders, are taking certain immunosuppressants, have severe renal impairment, or are pregnant or breastfeeding. In addition, high-dose administration is prohibited in patients at high risk for muscle disorders. This medication contains lactose and should not be given to patients with genetic issues, such as lactose intolerance. Regular liver function tests should be conducted before and during treatment, and caution is needed for those who excessively consume alcohol or have a history of liver disease. If symptoms such as muscle pain, weakness, or cramps occur, the patient should immediately inform a physician and blood tests may be needed to check for muscle damage. If severe muscle damage is suspected, the medication should be discontinued and follow the physician's instructions. This medication may increase blood sugar levels in some patients, hence those at high risk for diabetes should monitor their blood sugar. Interactions with other medications may occur during treatment; therefore, all medications being taken should be discussed with a physician or pharmacist. Women of childbearing potential should employ appropriate contraceptive methods and should not take this medication during pregnancy. In cases of overdose, there is no specific antidote, and treatment should be based on symptoms, with liver function and muscle-related tests conducted. Dizziness and other symptoms may occur, so caution is required when driving or operating machinery. This medication may have increased exposure in Asian individuals, so dosage adjustments may be necessary. If severe rash or allergic reactions occur during treatment, discontinue use immediately and consult medical personnel.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms drug reaction syndrome (DRESS), jaundice, hepatitis, severe allergic reactions, severe skin adverse reactions, severe muscle weakness, ocular muscle weakness, rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy, thrombocytopenia, acute kidney failure, oliguria, increased serum creatinine, dyspnea, cough, interstitial lung disease,

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized aches
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain the storage temperature between 1 degree Celsius and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink, round film-coated tablets

Package unit

28 tablets (14 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.