Medication info

Hanol Rosuvastatin Calcium Tablet 5 mg

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한올바이오파마(주)
Appearance
Yellow round film-coated tablets
Packaging
28 tablets (14 tablets/PTPX2)
Approval status
Expired

MFDS item code 201404420 · Approved 2014.09.26

This product's status changed to Expired on 2024.09.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia, reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For adults, such as those with primary hypercholesterolemia, the initial dose is 5 mg taken once daily at any time regardless of meals. If more reduction in LDL-cholesterol is necessary, the maintenance dose can be adjusted to 10 mg once daily, with adjustments based on patient response at intervals of 4 weeks or longer. The maximum dose can be increased to 20 mg per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the recommended dosage is once daily between 5 mg and 20 mg, tailored to the individual treatment goals with intervals of 4 weeks or more.

Ingredients

Manufacturer
한올바이오파마(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia, reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • homozygous familial hypercholesterolemia
  • excess LDL-cholesterol
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
View approved original text

This medicine serves as an adjunct treatment for patients with hypercholesterolemia and hyperlipidemia who have difficulty controlling their condition with diet and exercise. It is particularly used in patients with primary hypercholesterolemia and familial hypercholesterolemia, as well as mixed dyslipidemia, and it lowers total cholesterol and LDL-cholesterol levels, slowing the progression of atherosclerosis. Additionally, it is used in pediatric patients with high cholesterol levels due to familial hypercholesterolemia. This drug is effective as an adjunct to dietary control in patients with dysbetalipoproteinemia. Furthermore, it helps in reducing the risk of stroke, myocardial infarction, and revascularization procedures in men over 50 and women over 60 who have elevated high-sensitivity C-reactive protein levels and risk factors for cardiovascular disease. This medicine is used for the reduction of hyperlipidemia and cardiovascular disease risk.

Dosage and Administration

Adult dosage

For adults, such as those with primary hypercholesterolemia, the initial dose is 5 mg taken once daily at any time regardless of meals. If more reduction in LDL-cholesterol is necessary, the maintenance dose can be adjusted to 10 mg once daily, with adjustments based on patient response at intervals of 4 weeks or longer. The maximum dose can be increased to 20 mg per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the recommended dosage is once daily between 5 mg and 20 mg, tailored to the individual treatment goals with intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, it should not be administered to those with allergies to its ingredients, severe liver dysfunction, muscle disorders, those taking specific medications concurrently, severely impaired kidney function, pregnant or breastfeeding women, and fertile women who are not using appropriate contraception. This medication carries a risk of muscle-related side effects, so if symptoms such as muscle pain or weakness occur, the patient should immediately inform their doctor and undergo examination. Particular caution is needed for those with impaired kidney function, hypothyroidism, a family history of, or a previous experience with muscle-toxic medications. Patients with liver dysfunction or those who consume excessive alcohol should have regular liver function tests before and during the use of this medication. Additionally, this drug may slightly increase blood sugar levels, so patients at risk for diabetes should be cautious with blood sugar management. If severe muscle pain, muscle weakness, fatigue, fever, or other symptoms appear while taking this drug, the patient should consult a healthcare professional immediately, as serious skin reactions or liver damage may occur; if symptoms like skin rash or jaundice appear, the medication should be stopped and the patient should go to a hospital. This drug may interact with other medications, so if the patient is currently taking any other medicines, they should inform their doctor or pharmacist, especially when taking specific antiviral agents, immunosuppressants, antibiotics, or fibrate medications. Pregnant women or those planning to become pregnant should not take this drug, and breastfeeding women should also avoid it. If pregnancy is confirmed while taking this medication, it should be immediately discontinued. In cases of overdose, there is no specific antidote, so treatment should be provided according to symptoms, with monitoring of liver function and muscle enzyme levels. Dizziness may occur while driving or operating machinery, so caution is advised. Finally, this drug may show higher blood concentrations in Asians, and dose adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated drug reaction syndrome, jaundice, hepatitis, liver failure, acute renal failure, oliguria, thrombocytopenia, severe skin reactions, rhabdomyolysis, severe muscle weakness, ocular myasthenia gravis, immune-mediated necrotizing myopathy, cough, dyspnea, polyneuropathy, and

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • rash
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • sensory disturbances
  • fatigue
  • numbness
  • fainting
  • joint pain
  • increased blood creatinine
  • elevated ALT
  • elevated AST
  • increased CK

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it should be kept in a cool, dry place, ideally at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets (14 tablets/PTPX2)

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.