Medication info
Rosuvastatin Calcium Tablets 20 mg

Rosuvastatin Calcium Tablets 20 mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
맥널티제약(주)
Appearance
Pink, round film-coated tablets
Packaging
30 tablets/box [(15 tablets / Alu Alu × 2)]
Approval status
Active

MFDS item code 202002666 · Approved 2020.04.16 · Insurance code 641502750

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The medication can be taken at any time of day regardless of meals. The initial dose is 5 mg once daily, and for those requiring further LDL-cholesterol reduction, the maintenance dose may be adjusted. The maintenance dose is 10 mg once daily, which can be adjusted according to the treatment goal and patient response at intervals of at least 4 weeks. The maximum daily dose can be increased to 20 mg.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), administer once daily at a dose of 5 mg to 20 mg. The dosage should be adjusted according to the individual therapeutic goals with intervals of at least 4 weeks.

Ingredients

Manufacturer
맥널티제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • elevated total cholesterol levels
  • elevated LDL-cholesterol levels
  • elevated apo-B protein levels
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein levels
  • hypertension
  • low HDL-cholesterol levels
View approved original text

This medication is primarily used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia who are difficult to control with diet and exercise alone. It is also effective as an adjunct to diet in patients with homozygous familial hypercholesterolemia and dysbetalipoproteinemia. This medication lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia and helps delay the progression of atherosclerosis. It can be safely used in adolescents who meet certain criteria for heterozygous familial hypercholesterolemia. Additionally, it is expected to reduce the risk of stroke, myocardial infarction, and risks associated with vascular revascularization in patients at high risk for cardiovascular disease. Thus, this medication is utilized for improving blood lipid levels and preventing cardiovascular diseases.

Dosage and Administration

Adult dosage

The medication can be taken at any time of day regardless of meals. The initial dose is 5 mg once daily, and for those requiring further LDL-cholesterol reduction, the maintenance dose may be adjusted. The maintenance dose is 10 mg once daily, which can be adjusted according to the treatment goal and patient response at intervals of at least 4 weeks. The maximum daily dose can be increased to 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), administer once daily at a dose of 5 mg to 20 mg. The dosage should be adjusted according to the individual therapeutic goals with intervals of at least 4 weeks.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this drug, have severely impaired liver function, have muscle disorders, or are pregnant or breastfeeding should not take this medication. Additionally, this medication may affect liver function, so individuals with a history of liver disease or those who consume alcohol excessively should use it with caution, and it is advisable to perform liver function tests before and during treatment. Symptoms such as muscle pain or weakness may occur; if these symptoms appear, the doctor must be notified immediately, and this medication may need to be discontinued if necessary. This medication can interact with other drugs, so especially in cases of concurrent use with certain antiviral agents, antifungals, immunosuppressants, fibrates, etc., patients should consult with their physician or pharmacist. Women of childbearing potential should use appropriate contraceptive methods to prevent pregnancy while taking this medication, and they should discontinue use immediately if they become pregnant. In case of overdose, there is no specific antidote, and treatment should be symptomatic, and liver function and muscle enzyme levels should be regularly monitored. This medication may rarely cause serious skin reactions, liver damage, or kidney problems; therefore, if skin rash or jaundice symptoms appear, the healthcare provider should be notified immediately. Finally, vigorous exercise should be avoided while on this medication, and if severe muscle pain or weakness occurs, patients should consult with healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, fatal and non-fatal liver failure, severe allergic reactions, severe skin reactions, respiratory issues, liver abnormalities (jaundice), serious neurological symptoms, severe edema or urination abnormalities, myopathy.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • thrombocytopenia
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  • diarrhea
  • ocular muscle weakness
  • memory loss
  • peripheral neuropathy
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment
  • increased ALT
  • increased AST
  • abnormal liver function tests
  • increased CK.

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. The appropriate storage temperature is between 1 to 30 degrees Celsius (room temperature).

Appearance and packaging

Appearance

Pink, round film-coated tablets

Package unit

30 tablets/box [(15 tablets / Alu Alu × 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.