Medication info
Jayba Sujeong 5 mg (Rosuvastatin Calcium)

Jayba Sujeong 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/box [(10 tablets/Alu-Alu X 3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707146 · Approved 2017.09.19

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
It can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to a maintenance dose as needed. The maintenance dose is usually 10 mg once daily, where most patients are adjusted. Dose adjustments should occur at intervals of 4 weeks or more based on LDL cholesterol levels and patient response. The maximum daily dose may be increased up to 20 mg.
Children's dosage
Pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia should be administered 5 mg to 20 mg once daily. The dose should be individually adjusted according to treatment goals, with intervals of 4 weeks or more.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medicine is used as an adjunct when dietary measures and exercise alone do not control primary hypercholesterolemia and mixed dyslipidemia. It also helps lower serum LDL cholesterol levels and delays the progression of atherosclerosis when used with dietary measures or other lipid-lowering therapies in patients with familial hypercholesterolemia. It is particularly effective in pediatric patients aged 10 to 17 who have persistent hypercholesterolemia. In adult patients at high risk for cardiovascular disease, it reduces the risks of stroke, myocardial infarction, and arterial revascularization procedures. Overall, this medication is used to reduce various types of dyslipidemia and the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

It can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to a maintenance dose as needed. The maintenance dose is usually 10 mg once daily, where most patients are adjusted. Dose adjustments should occur at intervals of 4 weeks or more based on LDL cholesterol levels and patient response. The maximum daily dose may be increased up to 20 mg.

Children's dosage

Pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia should be administered 5 mg to 20 mg once daily. The dose should be individually adjusted according to treatment goals, with intervals of 4 weeks or more.

Precautions

This medicine should not be used in certain patients. For instance, it should not be administered to individuals who are allergic to any of its ingredients, those with severely impaired liver function, muscle disorders, severe kidney impairment, pregnant or breastfeeding women, or fertile women who are not using appropriate contraception. Since this medication can affect liver health, caution is advised for patients with liver disease or those who consume alcohol excessively. It is important to have regular liver function tests before and during treatment. Muscle-related side effects such as myalgia or muscle weakness can occur, and rarely, rhabdomyolysis may present with severe muscle damage. If such symptoms occur, notify a doctor immediately, and discontinue medication if necessary. This medication may interact with other drugs, so caution is necessary when taken with specific antibiotics, antifungal medications, immunosuppressants, or fibrates. The risk of muscle-related side effects may increase with concomitant use. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication and utilize appropriate contraceptive methods. Breastfeeding women should also refrain from using this medication for safety. In cases of overdose, no specific antidote exists, and treatment should be symptomatic while monitoring liver function and muscle enzyme levels. When taking this medication, dizziness or headaches may occur, so caution is required when driving or operating machinery. Finally, this medicine contains lactose, so individuals with lactose intolerance or related genetic disorders should not take it.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Steven-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver failure, rhabdomyolysis, severe muscle weakness, ocular myasthenia, acute renal failure, oliguria, thrombocytopenia, severe allergic reactions, severe skin reactions, respiratory distress, breathing difficulties, severe edema or urination abnormalities

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • cough
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  • diarrhea
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • sleep disorders
  • depression
  • 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 closed container to protect it from air and light, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and ensure safe use.

Appearance and packaging

Appearance

Yellow round film-coated tablet

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.