Medication info
J-Basujeong 20mg (Rosuvastatin Calcium)

J-Basujeong 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/box [(10 tablets/Alu-Alu X 3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707147 · Approved 2017.09.19

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol is needed, the maintenance dose may be adjusted accordingly. The maintenance dose is often 10 mg once daily, and most patients are adjusted to this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient responses, with a maximum daily dose of 20 mg.
Children's dosage
The usual dose range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17 years) is 5 mg to 20 mg once daily. The dosing should be individually adjusted based on the recommended treatment goals for each patient.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

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

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

This medication helps patients with primary hypercholesterolemia or mixed dyslipidemia, and familial hypercholesterolemia who cannot control their conditions through diet and exercise. It lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia and slows the progression of atherosclerosis. It is also used in children aged 10 to 17 years with severe hypercholesterolemia to manage blood lipid levels. Additionally, it serves as an adjunct to diet in patients with primary dysbetalipoproteinemia. In middle-aged patients with elevated high-sensitivity C-reactive protein and risk factors for cardiovascular disease, it helps reduce risks associated with stroke, myocardial infarction, and vascular interventions. Overall, this medication effectively improves the management of dyslipidemia and cardiovascular disease risk.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol is needed, the maintenance dose may be adjusted accordingly. The maintenance dose is often 10 mg once daily, and most patients are adjusted to this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient responses, with a maximum daily dose of 20 mg.

Children's dosage

The usual dose range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17 years) is 5 mg to 20 mg once daily. The dosing should be individually adjusted based on the recommended treatment goals for each patient.

Precautions

This medication should not be used in certain patients. For example, individuals with allergies to any ingredient of this medication, severely impaired liver function, muscle disorders, and women who are pregnant or breastfeeding should not take this medication. Additionally, patients with severely impaired kidney function or those taking specific medications need to use caution. This medication can affect liver health, so individuals with a history of liver disease or those who consume alcohol heavily should have liver function tests done before and during treatment. If symptoms such as muscle pain or weakness occur, the doctor should be informed immediately, and in severe cases, the medication might need to be discontinued. This medication may increase blood sugar levels in some patients, so those at risk for diabetes should strictly manage their blood sugar levels. Furthermore, there may be interactions when taken with other medications, especially certain antivirals, immunosuppressants, or lipid-lowering agents. Women who are pregnant or may become pregnant must use appropriate contraception and should discontinue the medication immediately if pregnancy is confirmed. In the case of overdose, since there is no specific antidote, symptomatic treatment should be provided, and liver function and muscle enzyme levels should be monitored. Lastly, this medication can rarely cause serious skin reactions, liver damage, or muscle disorders, so any unusual symptoms should prompt immediate consultation with medical personnel.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, severe muscle weakness, ocular muscle weakness, rhabdomyolysis, acute kidney failure, anuria, thrombocytopenia, increased serum creatinine, severe allergic reactions, severe skin reactions, respiratory issues, liver abnormalities (jaundice), severe neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • fatigue
  • numbness
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  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • diarrhea
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hematuria
  • cough

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. It should also be stored at a temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/box [(10 tablets/Alu-Alu X 3)], 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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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.