Medication info
Rosuvastatin Calcium 20 mg

Rosuvastatin Calcium 20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201405052 · Approved 2014.10.30 · Insurance code 657805480

Summary

Main use
Treatment for hypercholesterolemia and cardiovascular disease risk reduction
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of the day, regardless of meals. The initial dosage is 5 mg once daily, and it is adjusted to a maintenance dose according to treatment goals. The maintenance dose is typically adjusted to 10 mg once daily for most patients. Dosage adjustments should be made every 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, and the maximum dosage can be increased up 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 taken once daily. The dosage may be adjusted according to each individual patient's treatment goals over intervals of 4 weeks or more.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and cardiovascular disease risk reduction

  • 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 early coronary heart disease
View approved original text

This medication is used as an adjunct when diet and exercise alone are insufficiently effective in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunctive therapy along with diet or other lipid-modifying therapies in patients with homozygous familial hypercholesterolemia. Additionally, it helps to lower the total cholesterol and LDL cholesterol levels in hypercholesterolemic patients to target levels, thereby delaying the progression of atherosclerosis. It can be used in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia along with dietary management, as well as being beneficial for patients with primary dysbetalipoproteinemia. Furthermore, in males aged 50 years and older and females aged 60 years and older with cardiovascular risk factors, it aids in reducing the risk of stroke, myocardial infarction, and arterial revascularization. Thus, it is effectively used for various hyperlipidemia and cardiovascular risk conditions.

How to take

Adult dose

This medication can be taken at any time of the day, regardless of meals. The initial dosage is 5 mg once daily, and it is adjusted to a maintenance dose according to treatment goals. The maintenance dose is typically adjusted to 10 mg once daily for most patients. Dosage adjustments should be made every 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, and the maximum dosage can be increased up 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 taken once daily. The dosage may be adjusted according to each individual patient's treatment goals over intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, patients who are allergic to this medication, patients with severely impaired liver function, patients with muscle disorders, patients taking certain immunosuppressants, patients with severe kidney dysfunction, women who are pregnant or breastfeeding, and patients with genetic issues such as lactose intolerance should not take this medication. Moreover, liver function tests and muscle-related tests should be regularly performed before and during treatment with this medication, and if there are any liver diseases or hypothyroidism, those conditions should be treated first. If symptoms of muscle pain or weakness occur, patients should immediately inform their doctor and undergo necessary tests. This medication should be used cautiously in individuals who consume excessive alcohol or have a history of liver disease, as well as in the elderly or patients with reduced kidney function. In addition, the risk of muscle injury may increase when taken with certain medications, so patients should consult with their doctor or pharmacist regarding concomitant medications. During treatment, abnormal symptoms such as liver dysfunction, muscle pain, skin rashes, or allergic reactions may occur, so patients should immediately consult with medical professionals if these symptoms arise. Specifically, although rare, severe skin reactions or liver damage may occur, requiring caution. Women who are pregnant or planning to become pregnant should not take this medication, and if pregnancy is confirmed during treatment, it should be discontinued immediately. It is also safer for breastfeeding women not to take this medication. In the case of overdose, there is no specific antidote, so treatment should be symptomatic and liver function and muscle enzyme tests should be conducted to manage the condition. Lastly, this medication may cause dizziness, so caution is required when driving or operating machinery. It is important to promptly consult with medical professionals regarding any changes in health status or abnormal symptoms during treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, allergic reactions including angioedema, chest tightness, difficulty breathing, respiratory distress, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), acute renal failure, oliguria, thrombocytopenia, severe muscle weakness, ocular myasthenia, immune-mediated necrotizing myopathy, rhabdomyolysis, severe skin abnormal reactions, severe allergic reactions, severe edema, or urination difficulties.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • muscle pain
  • weakness
  • diarrhea
  • itching
  • hematuria
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • appetite loss
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • cough

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its efficacy.

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.