Medication info
Rosuvastatin Calcium 5 mg Tablet

Rosuvastatin Calcium 5 mg Tablet

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201604058 · Approved 2016.06.29 · Insurance code 073001280

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
This medication 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, which most patients will be titrated to this dose. Dose adjustments should be done at intervals of 4 weeks or more based on serum LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Treatment for improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • hyperlipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • atherosclerosis
  • coronary artery disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke
  • myocardial infarction
View approved original text

This medication is an adjunct therapy used for patients with primary hypercholesterolemia and mixed hyperlipidemia when diet and exercise alone do not achieve adequate control. It is also used as an adjunct to dietary therapy or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. In patients with hypercholesterolemia, it helps lower total cholesterol and LDL-cholesterol levels, thus slowing the progression of atherosclerosis. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Furthermore, it contributes to reducing the risk of stroke, myocardial infarction, and arterial revascularization in men over the age of 50 and women over the age of 60 with high levels of high-sensitivity C-reactive protein. This medicine is effectively used for treating hyperlipidemia and reducing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication 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, which most patients will be titrated to this dose. Dose adjustments should be done at intervals of 4 weeks or more based on serum LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Precautions

This medication should not be administered to certain patients. For example, those who are allergic to this drug, those with severely impaired liver function, those with muscle disorders, and those taking certain medications should not use this drug. Additionally, pregnant or breastfeeding women, or women of childbearing potential who are not using appropriate contraception must consult a physician before taking this medication and consider the risks to the fetus. This medication can affect liver function; therefore, individuals with a history of liver disease or those who consume large amounts of alcohol should have regular liver function tests before and during treatment. If symptoms such as muscle pain, weakness, or related muscle symptoms occur, notify a physician immediately, and in severe cases, the use of this medication may need to be discontinued. Those with reduced kidney function or hypothyroidism should be particularly cautious. This medication may interact with some drugs, increasing serum concentrations, so inform your healthcare provider about any current medications. Avoid using it in combination with certain medications. Pregnant or breastfeeding individuals should not use this drug, and women who might become pregnant should employ appropriate contraception while using this drug. In case of an overdose, there is no specific antidote, so treatment should be symptomatic and liver function and muscle enzyme levels should be monitored. Lastly, caution is advised during driving or operating machinery, as dizziness may occur. Finally, if severe rash, itching, fever, or other symptoms appear during treatment, consult a physician immediately, and discontinuation may be necessary if serious skin reactions are suspected.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, diarrhea, chest discomfort, loss of appetite, abdominal bloating, syncope, myalgia, muscle cramps, gout, erectile dysfunction, fatigue, numbness, paresthesia, arthralgia, hematuria, cough, memory loss, peripheral neuropathy, thrombocytopenia, hepatitis, increased transaminases, eosinophilia, and drug reaction with eosinophilia and systemic symptoms, lupus-like syndrome, immune-mediated

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 or moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

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.