Medication info
Bugang Rosuvastatin Calcium Tablet 20mg

Bugang Rosuvastatin Calcium Tablet 20mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
부광약품(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201501709 · Approved 2015.03.31 · Insurance code 642203670

Summary

Main use
Treatment for hypercholesterolemia (primary, mixed) and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is usually 10 mg once daily, which is sufficient for most patients. The maintenance dose should be appropriately adjusted every 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily increase of up to 20 mg.

Ingredients

Manufacturer
부광약품(주)

Efficacy & effects

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

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

This medication is used as an adjunct to diet for patients with primary hypercholesterolemia and mixed dyslipidemia who have difficulty controlling cholesterol levels with diet and exercise. Additionally, patients with homozygous familial hypercholesterolemia may use this medication alongside dietary therapy or other lipid-lowering treatments. This medication helps lower total cholesterol and LDL cholesterol levels to target levels, thereby slowing the progression of atherosclerosis. It is also utilized as an adjunct to therapy for patients with primary dysbetalipoproteinemia. Furthermore, in middle-aged individuals with elevated high-sensitivity C-reactive protein levels and additional cardiovascular risk factors, this medication is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization. Therefore, this medicine is effectively used for various types of hypercholesterolemia and cardiovascular disease risk reduction.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is usually 10 mg once daily, which is sufficient for most patients. The maintenance dose should be appropriately adjusted every 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily increase of up to 20 mg.

Precautions

This medication may not be used in certain patients. For example, it should not be administered to patients with allergies to this medication, patients with severe liver dysfunction, patients with muscle disorders, patients taking certain medications concurrently, and patients with severely impaired kidney function. Moreover, women who are pregnant, nursing, or may become pregnant should consult a doctor and use appropriate contraceptive methods before taking this medication. This medication can affect muscles, leading to muscle pain or damage, so any muscle-related symptoms should be reported to healthcare professionals immediately. Since liver function may be affected, liver function tests should be conducted regularly while on this medication, and it should be discontinued immediately if symptoms of liver damage occur. Patients who consume large amounts of alcohol or have a history of liver disease should use this medication with particular caution and should have liver function tests as per a doctor's instructions. Additionally, this medication may interact with certain drugs, so if other medications are being taken, healthcare professionals should be informed. In particular, caution is needed when taken with drugs that have a high risk of muscle toxicity, as the risk of muscle damage may increase. Rarely, this medication can cause severe allergic reactions on the skin; if symptoms such as rash, itching, or difficulty breathing occur, the medication should be stopped immediately and medical attention sought. Pregnant or nursing women should not take this medication, and women planning pregnancy should consult a doctor before starting it. In case of overdose, since there is no specific antidote, immediate medical attention should be sought, and liver and muscle function tests should be performed. Caution is advised while driving or operating machinery, as dizziness may occur. This medication may have higher blood concentrations in Asian individuals; thus, dosage adjustments may be necessary. When used in children and adolescents, it should be used under a doctor's guidance, as it may affect growth and development.

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, eosinophilia and systemic symptoms associated drug reaction syndrome (DRESS), jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, severe muscle weakness, ocular myasthenia, rhabdomyolysis, immune-mediated necrotizing myopathy, fatal and non-fatal liver failure, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
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  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function test
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • memory loss
  • peripheral neuropathy
  • hematuria
  • depression
  • sleep disorders
  • 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 sealed container to prevent exposure to air or moisture. It is also advisable to avoid storing it in excessively hot or cold places, ideally keeping it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 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.