Irostastatin 5 mg (Rosuvastatin Calcium)

Adult dosage

Administer 5 mg once daily as the initial dose, at any time of the day regardless of meals. If a greater reduction in LDL cholesterol is required, adjust the maintenance dose to 10 mg once daily, modifying the dose at intervals of 4 weeks or more. The maximum daily dose can be increased up to 20 mg.

Children's dosage

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the typical dose is 5 to 20 mg once daily. The dose should be adjusted individually according to the recommended therapeutic goals.

This medication should not be used in certain patients. For example, individuals who are allergic to the ingredients of this medication, those with active liver disease, muscle disorders, those taking cyclosporine, patients with severe renal impairment, and pregnant or nursing women should avoid using this medication. Additionally, individuals at high risk for muscle disorders should avoid high doses. This medication contains lactose, so those with lactose intolerance should also refrain from taking it. Caution is necessary for those with poor liver function or heavy alcohol consumption while taking this medication. It is advisable to monitor liver function by repeating liver enzyme tests before and during treatment. If symptoms of muscle pain or weakness occur, the physician should be notified immediately, and the medication may need to be discontinued if necessary. Particular caution is required for those with impaired kidney function, hypothyroidism, elderly patients, and those with alcohol abuse history who may be more susceptible to muscle disorders. During treatment with this medication, rare side effects such as skin rash, headache, dizziness, gastrointestinal discomfort, and muscle pain may occur. Most are mild and temporary, but if symptoms are severe or persist, medical consultation is required. Additionally, this medication may interact with other drugs, so it is essential to inform the physician or pharmacist if other medications are being taken. Particularly, concomitant use with specific antiviral medications, immunosuppressants, some antibiotics, and fibrate medications may increase the risk of muscle damage. Pregnant or nursing women should not use this medication, and women of childbearing potential should use appropriate contraceptive measures. Caution is necessary because taking this medication during pregnancy could harm the fetus. In the case of overdose, there is no specific antidote, so immediate medical attention should be sought for appropriate treatment, and liver function and muscle enzyme tests should be conducted to assess the condition. Dizziness may occur with this medication, so caution is advised during driving or operation of machinery.

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, chest tightness, difficulty breathing, severe muscle weakness, ophthalmoplegia, rhabdomyolysis.

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• myalgia
• fatigue
• thrombocytopenia
• diarrhea

This medication may be sensitive to air and humidity, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness and safety.

Appearance

Yellow, round, film-coated tablet

Package unit

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