Medication info
Rosuvastatin Calcium 5 mg (Rosuvastatin Calcium Tablet)

Rosuvastatin Calcium 5 mg (Rosuvastatin Calcium Tablet)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/PTP [(10 tablets/PTP x 3)], 30 tablets/bottle
Approval status
Active

MFDS item code 201000982 · Approved 2010.01.28 · Insurance code 643305640

Summary

Main use
Treatment for hyperlipidemia 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 the maintenance dose is usually 10 mg once daily, which is effective for the majority of patients. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and patient response after at least a 4-week interval, with a maximum increase to 20 mg once daily.
Child dose
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 mg to 20 mg once daily. The administered dose should be adjusted according to the recommended therapeutic target for individual patients.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Treatment for hyperlipidemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of early coronary heart disease
  • risk of stroke
View approved original text

This medication serves as an adjunct to diet in the management of primary hyperlipidemia and mixed dyslipidemia in patients whose conditions are not adequately controlled by diet and exercise alone. It is also used in conjunction with other lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. By lowering total cholesterol and LDL cholesterol levels, it delays the progression of atherosclerosis and is also helpful in treating familial hypercholesterolemia in children and adolescents. Additionally, it aids as an adjunct to diet in patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and revascularization in high-risk cardiovascular patients with elevated high-sensitivity C-reactive protein levels. Thus, it is effectively used in treating patients with various forms of dyslipidemia and cardiovascular risk factors.

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 the maintenance dose is usually 10 mg once daily, which is effective for the majority of patients. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and patient response after at least a 4-week interval, with a maximum increase to 20 mg once daily.

Child dose

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 mg to 20 mg once daily. The administered dose should be adjusted according to the recommended therapeutic target for individual patients.

Precautions

This drug should not be used in certain patients. It must not be administered to those with allergies to its components, severe liver impairment, muscle disorders, patients taking specific medications, severely impaired renal function, women who are pregnant or breastfeeding, and those at high risk of myopathy. Before taking this medication, patients must check for other conditions such as liver disease or hypothyroidism. Symptoms such as muscle pain or weakness may occur; if these are experienced, the doctor should be informed immediately. Additionally, this medication may elevate blood sugar in some patients, so those at risk of diabetes should have their blood sugar levels monitored regularly. It can affect the liver and kidneys, so regular tests of liver function and kidney function are important. Drug efficacy or side effects may vary according to specific genetic factors, so dose adjustments may be necessary. Certain drugs that may interact with this medication must be reported to the doctor or pharmacist. Women who are pregnant or planning pregnancy should not take this medication and should use appropriate contraception, and breastfeeding women should avoid using this medication. In cases of overdose, there is no specific antidote, so appropriate treatment should be conducted based on symptoms, while monitoring liver function and muscle enzyme levels. Lastly, while this medication is unlikely to impair driving or machine operation, caution should be exercised as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms drug reaction (DRESS), jaundice, hepatitis, severe malaise, acute renal failure, oliguria, thrombocytopenia, polyneuropathy, severe muscle weakness, dyspnea, oculomotor weakness, severe skin reactions, severe skin adverse effects, significant

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • muscle pain
  • weakness
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory disturbances
  • hematuria
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • increased blood creatinine
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air and humidity, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the medication's efficacy for a long time.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP x 3)], 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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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.