Medication info
J Rosuvastatin 20 mg (Rosuvastatin Calcium)

J Rosuvastatin 20 mg (Rosuvastatin Calcium)

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

MFDS item code 201702526 · Approved 2017.05.23 · Insurance code 645405220

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be administered at any time during the day, regardless of meals. The initial dosage is 5 mg once daily, with a maintenance dosage typically being 10 mg once daily. The dosage should be adjusted every 4 weeks or more based on LDL cholesterol levels, treatment goals, and the patient’s response, with a maximum increase up to 20 mg per day.
Children's dosage
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 according to the individual patient's therapeutic goal, with an interval of 4 weeks or more.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary artery disease
  • stroke risk
View approved original text

This medication is primarily used for various types of dyslipidemia associated with hypercholesterolemia. It is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary management and exercise are insufficient. It is also used concurrently with other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia and helps to reduce total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. Additionally, it is prescribed as an adjunct to diet in pediatric patients aged 10 to 17 years who meet certain criteria. It also aids patients with primary dysbetalipoproteinemia, particularly in middle-aged and older adults at high risk for cardiovascular diseases, as it reduces the risk of stroke, myocardial infarction, and arterial revascularization. Thus, this drug is used to improve dyslipidemia and lower cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be administered at any time during the day, regardless of meals. The initial dosage is 5 mg once daily, with a maintenance dosage typically being 10 mg once daily. The dosage should be adjusted every 4 weeks or more based on LDL cholesterol levels, treatment goals, and the patient’s response, with a maximum increase up to 20 mg per day.

Children's dosage

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 according to the individual patient's therapeutic goal, with an interval of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this drug, have severely impaired liver function, have muscular disorders, have significantly reduced kidney function, or are pregnant or nursing should not take this medication. Additionally, patients at high risk for muscle-related disorders should exercise caution while taking this medication and report any symptoms of muscle pain or weakness to their doctor immediately. Regular monitoring is also required if there are liver function abnormalities. This drug may increase blood concentration when taken with certain medications, raising the risk of muscle damage, so patients taking other medications must consult with their doctor or pharmacist. Women of childbearing potential should practice appropriate contraception and must not take this medication during pregnancy. Additionally, since this drug can be excreted in breast milk, nursing mothers should avoid taking it. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored regularly. During the use of this medication, symptoms such as dizziness or muscle pain may occur, so caution is required when driving or operating machinery. Finally, it may be necessary to adjust the dose as this drug may show higher blood concentrations in certain genetic factors or among individuals of Asian descent.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular myasthenia, immune-mediated necrotizing myopathy, rhabdomyolysis, acute kidney failure, oliguria, severe edema, chest tightness, difficulty breathing, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), serious neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal distention
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • arthralgia
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment
  • elevated serum creatinine

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, and it is advisable to keep it at a temperature between 1 degree and 30 degrees Celsius. Proper storage will maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

100 tablets/bottle, 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.