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
진양제약(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets x 2 PTP), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201000993 · Notified 2010.01.28 · Insurance code 650302680

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dosage is 5 mg once daily, and the maintenance dosage is usually 10 mg once daily, which most patients tolerate well. The dosage may be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum dosage of 20 mg per day allowed. It can be administered at any time of the day, regardless of meals.
Child dose
The usual dosage range for pediatric patients aged 10 to 17 years is 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals, with intervals of 4 weeks or more.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • familial hypercholesterolemia
  • mixed dyslipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
  • vascular revascularization risk
View approved original text

This medication is used as an adjunct when diet and exercise are insufficient for controlling primary hypercholesterolemia and heterozygous familial hypercholesterolemia, as well as for patients with mixed dyslipidemia. It is also used in treatment of homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies, and it helps reduce total cholesterol and LDL cholesterol in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is particularly effective as an adjunct to dietary therapy in pediatric patients aged 10 to 17 years who have heterozygous familial hypercholesterolemia. It also aids in the treatment of patients with type III dysbetalipoproteinemia and contributes to reducing the risk of stroke, myocardial infarction, and vascular revascularization in elderly patients at high risk for cardiovascular disease. Overall, this medication is used for various types of dyslipidemia and reducing the risk of cardiovascular diseases.

How to take

Adult dose

The initial dosage is 5 mg once daily, and the maintenance dosage is usually 10 mg once daily, which most patients tolerate well. The dosage may be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum dosage of 20 mg per day allowed. It can be administered at any time of the day, regardless of meals.

Child dose

The usual dosage range for pediatric patients aged 10 to 17 years is 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals, with intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. First, it must not be administered to individuals allergic to its components or those with severely impaired liver function. Additionally, caution is warranted in individuals with muscle diseases or those taking certain immunosuppressants. Patients with very poor kidney function, pregnant or nursing women, and women of childbearing age who do not use adequate contraception should also avoid this medication. Particularly, patients susceptible to muscle disease should avoid high doses, and those with genetic metabolic disorders like lactose intolerance should not take this medication. Before taking the medication, patients should undergo regular liver function tests and muscle-related tests, and those with a history of significant alcohol consumption or liver disease should exercise additional caution. During treatment, if symptoms like muscle pain, weakness, fatigue, or fever occur, the physician should be notified immediately, and in severe cases, discontinuation of the medication may be required. Also, if an acute severe illness occurs or symptoms of muscle weakness appear, the administration should be stopped. This medication may interact with other drugs, so patients should inform healthcare professionals of any other medications they are taking. Particularly, when taken with certain antiviral drugs, immunosuppressants, antibiotics, or fibrates, the risk of muscle-related adverse effects may increase. Pregnant or nursing women should not take this medication, and women who may become pregnant should ensure appropriate contraception. There is no specific antidote for overdose, so management should be based on symptoms, and monitoring of liver function and muscle enzyme tests should be performed. Finally, this medication may cause side effects like dizziness, so caution is advised when driving or operating machinery. Patients should be well-informed of these precautions when taking this medication and consult healthcare professionals immediately if they experience any unusual symptoms.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe allergic reactions, severe skin reactions, dyspnea, respiratory abnormalities accompanied by cough and fever, severe muscle weakness, ocular myasthenia, rhabdomyolysis, immune-mediated necrotizing myopathy, edema, thrombocytopenia, acute kidney failure, oliguria, liver failure, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • appetite loss
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory deterioration
  • forgetfulness
  • amnesia
  • memory impairment
  • confusion

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

Storage

This medication should be stored in a tightly closed container, protected from air and moisture, at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets x 2 PTP), 30 tablets/bottle, 100 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.