Medication info
Rosuvastatin Calcium Tablet 10 mg (Rosuvastatin Calcium)

Rosuvastatin Calcium Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)한독
Appearance
Pink round film-coated tablets
Packaging
28 tablets (14 tablets/PTP packaging × 2)
Approval status
Active

MFDS item code 201400389 · Approved 2014.01.28 · Insurance code 652104660

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is usually 10 mg once daily, with most patients adjusted to this dose. The dose should be appropriately adjusted every 4 weeks or longer based on LDL cholesterol levels, therapeutic goals, and patient response.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dose range is 5 mg to 20 mg once daily. The dosing should be adjusted according to individual therapeutic goals.

Ingredients

Manufacturer
(주)한독

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used to treat hypercholesterolemia and various forms of dyslipidemia. It is particularly effective as an adjunct therapy in primary hypercholesterolemia and mixed dyslipidemia when diet and exercise are insufficient. It also lowers cholesterol levels and delays the progression of atherosclerosis when used in conjunction with diet or other therapies for patients with familial hypercholesterolemia. In some pediatric patients, it is also used as an adjunct to reduce total cholesterol and LDL cholesterol. Additionally, this medication helps reduce the risk of cardiovascular diseases, contributing to lower risks of stroke, myocardial infarction, and arterial revascularization. Overall, it is used to improve cholesterol management and enhance cardiovascular health.

How to take

Adult dose

This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is usually 10 mg once daily, with most patients adjusted to this dose. The dose should be appropriately adjusted every 4 weeks or longer based on LDL cholesterol levels, therapeutic goals, and patient response.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dose range is 5 mg to 20 mg once daily. The dosing should be adjusted according to individual therapeutic goals.

Precautions

This medication should not be administered to certain patients. For example, individuals who are allergic to this medication, those with severely impaired liver function, patients with muscle disorders, and women who are pregnant or breastfeeding should not use this medication. Additionally, caution is advised when used by individuals with compromised liver function or those who consume excessive alcohol. Regular liver function tests should be conducted during treatment, and any symptoms of muscle pain or weakness should be reported to a healthcare professional immediately. This medication may affect the muscles, so patients at higher risk for muscle pain or myopathy should be closely monitored for muscle condition before and during treatment. If muscle enzyme levels rise significantly, discontinuation of the medication may be necessary. Since this medication contains lactose, patients with lactose intolerance or certain genetic metabolic disorders should not take it. This medication can interact with other drugs, so it is important to consult a doctor, especially if taking certain antiviral agents, immunosuppressants, antibiotics, and fibrate medications. Taking it with some medications may increase its blood concentration and raise the risk of muscle side effects. Women who are pregnant or may become pregnant should ensure proper contraception is used, and if pregnancy is confirmed, the medication should be stopped immediately. This medication can also be passed into breast milk, so it is safest for breastfeeding women to avoid taking it. In case of overdose, as there is no specific antidote, symptomatic treatment along with monitoring liver function and muscle enzymes is required. While taking this medication, dizziness may occur, so caution should be exercised when driving or operating machinery. Lastly, this medication can rarely cause severe skin reactions or liver dysfunction, so any unusual skin symptoms or jaundice should be reported to medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, fatal and non-fatal hepatic failure, acute renal failure, anuria, thrombocytopenia, increased serum creatinine, interstitial lung disease, severe allergic reactions, severe skin abnormalities

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • myalgia
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion

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 moisture. It is best to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets/PTP packaging × 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.