Medication info
Bukwang Rosuvastatin Calcium Tablet 10 mg

Bukwang Rosuvastatin Calcium Tablet 10 mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 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 201501710 · Approved 2015.03.31 · Insurance code 642203680

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia, reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
This medication can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and for those requiring greater reductions in LDL cholesterol levels, the maintenance dosage can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, which is sufficient for most patients. Adjustments to the maintenance dose should be made at intervals of 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response.

Ingredients

Manufacturer
부광약품(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia, reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used as an adjunct when dietary therapy and exercise alone do not adequately control primary hypercholesterolemia and mixed hyperlipidemia. It is also used to control cholesterol levels in patients with homozygous familial hypercholesterolemia in combination with diet or other lipid-lowering therapies. It is effective in lowering total cholesterol and LDL cholesterol in patients with hypercholesterolemia, delaying the progression of atherosclerosis. Additionally, it is used as an adjunct for patients with primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in males over 50 years and females over 60 years with elevated high-sensitivity C-reactive protein and additional cardiovascular risk factors. This medication is effective in improving blood lipid levels and reducing cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and for those requiring greater reductions in LDL cholesterol levels, the maintenance dosage can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, which is sufficient for most patients. Adjustments to the maintenance dose should be made at intervals of 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response.

Precautions

This medication should not be used in certain patients. For instance, individuals with allergies to its ingredients, active liver disease, muscle disorders, severe renal impairment, or pregnant or nursing women should not take this medication. Additionally, women of childbearing potential must take measures to reduce the likelihood of pregnancy and may only use this drug if they are fully aware of the risks to the fetus. Patients at high risk of muscle disorders should avoid high-dose use, and caution is required for those with a history of hypothyroidism or genetic muscle disorders. This medication contains lactose, so individuals with lactose intolerance should not take it. Patients who consume alcohol excessively or have a history of liver disease should undergo regular liver function tests before and during treatment with this medication. If symptoms of muscle pain or weakness appear, they should immediately inform their physician and undergo necessary tests. In cases of acute illness or severe conditions such as post-surgery, discontinuation of this medication may be necessary. This medication can interact with other drugs, so caution should be exercised, especially when taken with certain antivirals, immunosuppressants, antibiotics, and fibrate drugs, as concomitant use is contraindicated with some medications. During use, periodic tests of liver function and muscle-related parameters should be conducted, and consultation with healthcare providers is essential if abnormal symptoms arise. This medication should not be used during pregnancy or lactation, and women planning to become pregnant should employ appropriate contraceptive methods. In the case of overdose, there is no specific antidote, and treatment should be symptomatic along with liver function and muscle enzyme testing. This medication can cause dizziness while driving or operating machinery, so caution is advised. Finally, this medication may show higher systemic concentrations in Asians, necessitating potential dose adjustments.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling (edema), chest tightness, difficulty breathing, liver effects (jaundice, hepatitis, liver failure, hyperbilirubinemia), Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions, rhabdomyolysis, severe allergic reactions, severe skin reactions, respiratory issues, liver damage (jaundice), severe neurological symptoms, severe swelling

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • pruritus
  • rash
  • myalgia
  • asthenia
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • arthralgia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • 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 prevent exposure to air and moisture. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature.

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.