Medication info
Rosuvastatin Calcium 10 mg Tablet

Rosuvastatin Calcium 10 mg Tablet

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
주식회사케이에스제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201908153 · Approved 2019.11.28 · Insurance code 059000070

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, it can be dosed at any time of day, with or without food. The initial dosage is 5 mg once daily, and if necessary, maintenance doses are adjusted. The maintenance dose is generally 10 mg once daily, adjusted based on LDL-cholesterol levels and patient response at intervals of 4 weeks or more.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the standard dosage is 5 mg to 20 mg once daily. The dose is to be adjusted according to the individual treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medicine is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise are insufficient. It also helps patients with homozygous familial hypercholesterolemia as an adjunct to diet or other lipid-lowering treatments. It lowers total cholesterol and LDL-cholesterol in patients with hypercholesterolemia, effectively slowing the progression of atherosclerosis. It also serves as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. Additionally, it is used as an adjunct to diet for patients with primary dysbetalipoproteinemia. Finally, for high-risk patients with elevated high-sensitivity C-reactive protein and other cardiovascular risk factors, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization. This medicine is used to manage dyslipidemia and reduce cardiovascular disease risk.

Dosage and Administration

Adult dosage

For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, it can be dosed at any time of day, with or without food. The initial dosage is 5 mg once daily, and if necessary, maintenance doses are adjusted. The maintenance dose is generally 10 mg once daily, adjusted based on LDL-cholesterol levels and patient response at intervals of 4 weeks or more.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the standard dosage is 5 mg to 20 mg once daily. The dose is to be adjusted according to the individual treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. It should not be used in patients allergic to its components, patients with severe liver dysfunction, patients with muscle disorders, patients taking specific medications, patients with very impaired kidney function, pregnant or breastfeeding women, and patients with certain genetic issues. This medication should be used with caution in patients with a history of liver disease or those consuming excessive alcohol, and regular liver function tests should be conducted. Additionally, if symptoms such as muscle pain or weakness appear, healthcare professionals should be notified immediately. Particular caution should be exercised in patients at high risk for muscle-related problems, such as those with impaired kidney function, hypothyroidism, or a history of genetic muscle disorders. This medication may affect the liver and kidneys, necessitating regular testing and monitoring. Rare but serious skin reactions or muscle diseases may occur, so if any unusual symptoms arise, the medication should be discontinued immediately, and consultation with a healthcare professional is advised. Because this medication can interact with other drugs, if patients are taking other medications, they must inform their healthcare provider. Special caution is necessary when used in combination with specific antiviral medications, immunosuppressants, antibiotics, and fibrate-class drugs. Women who are pregnant or breastfeeding should not use this medication, and women who may become pregnant should use appropriate contraception. In cases of overdose, there is no specific antidote; symptomatic treatment and liver and muscle function tests are required. This medication does not significantly affect the ability to drive or operate machinery, but caution is advised due to the possibility of dizziness. Finally, the drug concentration may be higher in Asians, so dose adjustment may be needed.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, severe allergic reactions, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated drug reaction syndrome (DRESS), jaundice, hepatitis, severe muscle weakness, ophthalmoplegia, thrombocytopenia, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, severe skin adverse reactions, dyspnea, severe edema, severe bruising.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • sensory abnormalities
  • cough.

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 humidity, and it should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medicine for a longer period.

Appearance and packaging

Appearance

Pink 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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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.