Medication info
Aprogen Rosuvastatin Calcium Tablet 5 Milligrams

Aprogen Rosuvastatin Calcium Tablet 5 Milligrams

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201800813 · Approved 2018.02.13 · Insurance code 645209620

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
For the treatment of primary hypercholesterolemia, mixed dyslipidemia, etc., this medication can be taken at any time during the day without regard to meals. The initial dosage is 5 milligrams once daily, and it can be increased to a maximum of 20 milligrams once daily at intervals of 4 weeks or more as needed. No dose adjustment is required for elderly patients and those with mild to moderate renal impairment. Patients of Asian descent and those prone to myopathy should start with a dose of 5 milligrams.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

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

  • Primary Hypercholesterolemia
  • Mixed Dyslipidemia
  • Homozygous Familial Hypercholesterolemia
  • Hypercholesterolemia
  • Primary Dysbetalipoproteinemia
  • Coronary Heart Disease
  • Stroke
  • Myocardial Infarction
View approved original text

This medication is primarily used in patients with primary hypercholesterolemia and mixed dyslipidemia who are difficult to manage with diet and exercise alone. It is also effective as an adjunct to diet or other treatments in patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. Additionally, it is used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Particularly in patients at risk for cardiovascular diseases, it helps reduce the risk of cardiovascular events such as stroke and myocardial infarction and lowers the risk even after arterial revascularization. Therefore, this drug is used to improve dyslipidemia and reduce the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

For the treatment of primary hypercholesterolemia, mixed dyslipidemia, etc., this medication can be taken at any time during the day without regard to meals. The initial dosage is 5 milligrams once daily, and it can be increased to a maximum of 20 milligrams once daily at intervals of 4 weeks or more as needed. No dose adjustment is required for elderly patients and those with mild to moderate renal impairment. Patients of Asian descent and those prone to myopathy should start with a dose of 5 milligrams.

Precautions

This medication should not be used by patients who are allergic to certain components. Patients with active liver disease or significantly elevated liver enzyme levels should not take this medication. Patients with muscular disorders or severe renal impairment should also avoid this medication. Women who are pregnant or breastfeeding, and women of childbearing age who are not using adequate contraception should not use this medication. Women who may become pregnant should use this medication with caution after consulting a doctor. Patients at high risk of muscle-related side effects should not take high doses of this medication. Patients with genetic lactose intolerance should also refrain from using this medication. Patients who excessively consume alcohol or have a history of liver disease should undergo regular liver function tests when using this medication. If symptoms of muscle pain or weakness occur, medical attention should be sought immediately, and this medication should be discontinued if necessary. Patients in acute serious conditions should discontinue this medication, and it should be stopped if severe muscle weakness develops. This medication may increase the risk of muscle side effects when taken with certain drugs, so it is important to consult with a doctor regarding concurrent medications. Renal function tests may be required with high-dose usage. Asian patients may require dose adjustments due to increased drug exposure. This medication can be used in children and adolescents, but growth and development should be monitored. Rare side effects such as interstitial lung disease, severe liver damage, and severe skin reactions may occur, so any unusual symptoms should be reported to healthcare providers immediately. This medication may interact with other drugs, so it is important to inform the prescribing physician or pharmacist of all medications being taken. Do not use this medication during pregnancy or breastfeeding; women planning to become pregnant should use appropriate contraceptive methods. In case of overdose, as there are no specific antidotes, immediate hospital treatment should be sought. Dizziness may occur while taking this medication, so caution is advised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, hepatitis, jaundice, severe muscle weakness, ocular muscle weakness, immune-mediated necrotizing myopathy, acute renal failure, oliguria, chest tightness, difficulty breathing, interstitial lung disease, fatal and non-fatal liver failure, severe allergic reactions, severe skin adverse reactions

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function test results
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • joint pain
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • depression
  • sleep disorders
  • 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 or moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness safely for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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.