Irostar Tablets (Rosuvastatin Calcium)

Adult dose

This drug can be administered at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, which may be adjusted as necessary for maintenance. The maintenance dose is 10 milligrams once daily, and adjustments should be made based on LDL-cholesterol levels, treatment goals, and patient response, typically at intervals of 4 weeks or more. The maximum daily dose may be increased to 20 milligrams.

Child dose

For pediatric patients aged 10 to 17 years, the typical dosage range is 5 to 20 milligrams once daily. The dosing should be adjusted based on the individual patient's treatment goals, with dosage adjustments made at intervals of 4 weeks or more.

This drug is contraindicated in certain patients. It should not be administered to patients with a history of allergy to this drug, severe hepatic impairment, or muscle disease. Additionally, it should not be used in patients with significantly impaired renal function, pregnant or breastfeeding women, or women of childbearing age who are not using adequate contraception. High-dose administration is prohibited in patients at high risk for muscle disease. This drug contains lactose; therefore, patients with lactose intolerance or certain genetic disorders should avoid it. Caution is particularly necessary for patients with impaired liver function, those who consume a significant amount of alcohol, or those with hypothyroidism. If symptoms such as muscle pain or weakness appear, the doctor must be notified immediately, and blood tests should be conducted to check for muscle damage if necessary. This drug should be discontinued if acute severe illness or severe muscle weakness occurs. Because this drug may affect the liver and kidneys, regular monitoring is necessary, especially with high-dose administration. Asian patients may exhibit higher drug concentrations, requiring dose adjustments. Serious adverse reactions such as severe skin reactions, liver damage, or muscle diseases can occur during treatment; thus, any abnormal symptoms should be reported to healthcare professionals immediately. When taken with other medications, interactions may occur; therefore, patients must inform their healthcare providers about all current medications, and there is an increased risk of muscle disease with certain drug combinations. Pregnant or breastfeeding women should not use this drug, and women of childbearing age should ensure adequate contraception. In cases of overdose, there is no specific antidote; treatment should be symptomatic, and liver and muscle function tests are necessary. This drug does not appear to significantly affect driving or operating machinery, but caution is warranted as dizziness may occur. Lastly, this drug may rarely cause interstitial lung disease with long-term use; therefore, treatment should be discontinued, and healthcare providers should be consulted immediately if any unusual symptoms arise.

Serious side effects

Allergic reactions including rash and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver failure, rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy, severe muscle weakness, ophthalmoplegia, shortness of breath, interstitial lung disease, thrombocytopenia, acute renal failure, oliguria, chest tightness, difficulty breathing

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• muscle pain
• weakness
• rash
• thrombocytopenia

This drug should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance

Pink round film-coated tablets

Package unit

28 tablets/PTP (14 tablets/PTP × 2), 30 tablets/bottle, 100 tablets/bottle