Medication info
Rosuvastatin Calcium 10mg Tablet

Rosuvastatin Calcium 10mg Tablet

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

MFDS item code 201508189 · Approved 2015.12.09 · Insurance code 654701630

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 milligrams once daily at any time of the day, regardless of meals. The maintenance dose is typically adjusted to 10 milligrams once daily for most patients. The maintenance dose should be adjusted as necessary at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.
Children's dosage
For pediatric patients aged 10 to 17 years, the recommended dosage is between 5 milligrams and 20 milligrams once daily. The dosage should be adjusted based on the individual patient's treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
케이엠에스제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • dyslipidemia
  • increased total cholesterol
  • increased LDL cholesterol
  • elevated apolipoprotein B levels
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke risk
View approved original text

This medication is used as an adjunct to diet for the treatment of patients with primary hypercholesterolemia and mixed dyslipidemia who are not adequately controlled with diet and exercise. It is also prescribed as an adjunct to diet in patients with homozygous familial hypercholesterolemia. In patients with hypercholesterolemia, it helps lower total cholesterol and LDL cholesterol levels to target levels, delaying the progression of atherosclerosis. In children, it is used as an adjunct to diet therapy for patients with heterozygous familial hypercholesterolemia that meet specific criteria to reduce cholesterol and apolipoprotein B levels. Additionally, it assists in diet management for patients with primary dysbetalipoproteinemia and has been shown to reduce the risk of stroke, myocardial infarction, and revascularization procedures in high-risk patients with cardiovascular disease. Therefore, this medication is used for various forms of hypercholesterolemia and reduction of cardiovascular disease risk associated with dyslipidemia.

Dosage and Administration

Adult dosage

Administer 5 milligrams once daily at any time of the day, regardless of meals. The maintenance dose is typically adjusted to 10 milligrams once daily for most patients. The maintenance dose should be adjusted as necessary at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.

Children's dosage

For pediatric patients aged 10 to 17 years, the recommended dosage is between 5 milligrams and 20 milligrams once daily. The dosage should be adjusted based on the individual patient's treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any component of this medication, those with severe liver dysfunction, patients with muscle diseases, patients taking specific medications, those with severe kidney impairment, women who are pregnant or breastfeeding, and women of childbearing age who do not use adequate contraception should not be administered this medication. Additionally, patients at high risk for muscle disease should avoid high doses of this medication, and those with certain genetic issues like lactose intolerance should not be administered this medication. During treatment, liver function and muscle status should be regularly monitored, and caution should be exercised in patients who consume excessive alcohol or have a history of liver disease. If symptoms such as muscle pain or weakness occur, patients should promptly inform their healthcare provider, and the medication may need to be discontinued. This medication can affect the liver and muscles; therefore, it is important to monitor liver and muscle enzyme levels before and during treatment with blood tests. Furthermore, this medication may interact with several other drugs, so patients should inform their healthcare provider of any other medications they are taking. In particular, the risk of muscle side effects may increase when taken with certain antiviral medications, immunosuppressants, or fibrate-class drugs. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use effective contraception. In cases of overdose, there is no specific antidote available, so symptomatic treatment and monitoring of liver and muscle function are necessary. Lastly, dizziness may occur while taking this medication, so caution is advised when driving or operating machinery. Patients should immediately consult their healthcare provider if any unusual symptoms arise during treatment, and it is vital to undertake regular check-ups to ensure safe treatment.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver dysfunction, severe edema, acute renal failure, oliguria, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe headache, confusion, visual disturbances, paralysis, severe muscle weakness, ocular muscle weakness, respiratory distress

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • asthenia
  • diarrhea
  • erectile dysfunction
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  • loss of appetite
  • abdominal bloating
  • fatigue
  • numbness
  • paresthesia
  • syncope
  • generalized pain
  • muscle cramps
  • joint pain
  • discomfort in the chest
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • hematuria
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain the storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 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.