Medication info
Rosuvastatin Calcium 5mg Tablet

Rosuvastatin Calcium 5mg Tablet

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 201601552 · Approved 2016.03.17 · Insurance code 660702940

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia can take this medication at any time of the day with or without food. The initial dose is 5 milligrams once daily, with a maintenance dose of 10 milligrams once daily. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 years to 17 years), the dosage is between 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually based on the recommended treatment goals.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary 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 primarily used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary therapy and exercise alone do not achieve control. It can also be used in conjunction with other therapies in patients with homozygous familial hypercholesterolemia. It helps to lower cholesterol levels and slow the progression of atherosclerosis. It is especially used to control cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Additionally, it is effective in reducing the risk of stroke, myocardial infarction, and revascularization procedures in middle-aged and older patients at high risk for cardiovascular disease. Thus, this medication is widely used for various dyslipidemias and the prevention of cardiovascular disease.

Dosage and Administration

Adult dosage

Patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia can take this medication at any time of the day with or without food. The initial dose is 5 milligrams once daily, with a maintenance dose of 10 milligrams once daily. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 years to 17 years), the dosage is between 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually based on the recommended treatment goals.

Precautions

This medication should not be used in certain patients. For example, those who are allergic to any of the components of this medication, patients with severely impaired liver function, those with muscle disorders, and women who are pregnant or breastfeeding should not take this medication. Additionally, patients with severely impaired kidney function or those taking certain immunosuppressants should avoid this medication. This medication can affect the muscles, so it's important to notify a physician immediately if symptoms of muscle pain or weakness occur. Particularly, caution is needed when taking high doses as the risk of muscle damage increases. There have been reports of liver function abnormalities or elevated blood sugar levels, thus patients with a history of liver disease or those at risk for diabetes require regular check-ups. Moreover, this medication can interact with certain drugs, so inform healthcare providers if you are taking any other medications. Women who may become pregnant should use appropriate methods to prevent pregnancy before taking this medication, and must stop taking it immediately if they become pregnant. In case of overdose, there is no specific antidote, so treatment should be supportive with monitoring of liver function and muscle enzyme tests. Finally, this medication may cause dizziness or other symptoms, so caution is needed when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe rash, blistering, skin peeling, pain in oral/ocular mucosa, rhabdomyolysis, acute kidney failure, oliguria, high fever, severe edema, headache, thunderclap headache, seizures, altered consciousness, visual disturbances

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • thrombocytopenia
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • decreased appetite
  • abdominal distention
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • hematuria
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication should be stored in a tightly closed container, away from air and moisture. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu x 3]

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.