Medication info
Irostar 20 mg Tablets (Rosuvastatin Calcium)

Irostar 20 mg Tablets (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (10 tablets/Alu-Alu × 3)
Approval status
Active

MFDS item code 201405101 · Approved 2014.10.31 · Insurance code 658603120

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Regardless of meals, the initial dose is 5 mg taken once daily at any time of the day. Depending on the need, the maintenance dose can be adjusted to 10 mg taken once daily, with adjustments made every 4 weeks or more based on the patient's response, up to a maximum of 20 mg per day.
Child dose
For pediatric patients aged 10 to 17 years, the recommended dose is 5 mg to 20 mg taken once daily. The dose should be adjusted individually according to the treatment goals and modified at intervals of 4 weeks or more.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medicine is used as an adjunct for patients with primary hypercholesterolemia, particularly heterozygous familial hypercholesterolemia and combined hyperlipidemia, when diet and exercise alone do not control the condition. It is also used in conjunction with diet in patients with homozygous familial hypercholesterolemia to enhance effectiveness. It helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. Additionally, it is used as an adjunct therapy for certain pediatric patients aged 10 to 17 years with familial hypercholesterolemia. Moreover, it can be used as an adjunct for patients with dysbetalipoproteinemia and is effective in reducing cardiovascular disease risks, helping to lower the risk of stroke, myocardial infarction, and vasculopathy after coronary artery surgery. In summary, this medication is used to improve various conditions related to hypercholesterolemia and to reduce the risk of cardiovascular disease.

How to take

Adult dose

Regardless of meals, the initial dose is 5 mg taken once daily at any time of the day. Depending on the need, the maintenance dose can be adjusted to 10 mg taken once daily, with adjustments made every 4 weeks or more based on the patient's response, up to a maximum of 20 mg per day.

Child dose

For pediatric patients aged 10 to 17 years, the recommended dose is 5 mg to 20 mg taken once daily. The dose should be adjusted individually according to the treatment goals and modified at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medicine, have severe liver dysfunction, have muscular diseases, or are taking certain medications should not take this drug. Women who are pregnant or breastfeeding, as well as women who may become pregnant, should consult their doctor before taking this medication. This medicine may affect liver function, so caution is needed for patients with a history of liver disease or heavy alcohol consumption. Symptoms such as muscle pain or weakness may occur; if these symptoms appear, healthcare professionals should be notified immediately. This medication can interact with other drugs, so it is important to inform healthcare professionals about any currently used medications, especially when used in conjunction with certain antibiotics, antifungals, and immunosuppressants. Regular blood tests are recommended as liver enzymes or muscle-related levels may rise during clinical evaluations. This medication should be avoided during pregnancy as it may pose risks to the fetus, and caution is required when breastfeeding as this drug may pass into breast milk. There is no specific antidote for overdose, so treatment should be symptomatic; patients might experience dizziness while on this medication, necessitating caution when driving or operating machinery. Finally, this drug contains lactose, so patients with lactose intolerance should consult before taking it.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, severe swelling (edema), chest tightness, dyspnea, cold sweats, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), shortness of breath or respiratory distress, asthma attacks, breathing abnormalities accompanied by cough and fever, yellowing of the skin or eyes

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness

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. Additionally, it is important to store it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets (10 tablets/Alu-Alu × 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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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.