NewStatin Tablet 10mg (Rosuvastatin Calcium)

Adult dose

Administer once daily at any time of the day, regardless of meals. The initial dose is 5mg once daily and can be adjusted to a maintenance dose as needed. Most patients will adjust to the maintenance dose of 10mg once daily. Adjustments based on LDL-cholesterol levels and patient response should occur at intervals of 4 weeks or more, with a maximum dose of 20mg once daily.

Child dose

For pediatric patients aged 10 to 17 years, administer a dose of 5mg to 20mg once daily. The dose should be adjusted individually according to treatment goals, with adjustments made at intervals of 4 weeks or more.

This medication should not be used in certain patients. Do not take if you have allergies to any components of this medication or have active liver disease. Patients with myopathy or those taking cyclosporine and individuals with severe renal impairment should not use this medication. Pregnant or nursing women, and women of childbearing age who are not using adequate contraception must consult a physician prior to taking this medication. Patients at high risk for muscle disease are prohibited from using high doses, and special caution is needed for those with these risk factors when using this medication. This medication contains lactose, therefore patients with lactose intolerance or related genetic disorders should avoid it. Patients who consume alcohol excessively or have a history of liver disease should have regular liver function tests before and during taking this medication. If symptoms such as muscle pain, weakness, or cramps occur, inform healthcare professionals immediately and get tested. If clinical muscle damage is suspected, this medication may be discontinued, and the decision to re-administer depends upon physician discretion after symptom improvement. This drug may interact with other medications, therefore it is essential to inform healthcare professionals of any other medications being taken. Particularly, caution should be taken as the risk of muscle-related side effects increases when used in conjunction with fibrates. During pregnancy, this medication can pose risks to the fetus, hence it should be avoided if planning to conceive or if pregnant. There is no specific antidote for overdose, and appropriate treatment along with liver function and muscle enzyme tests are necessary based on symptoms. Dizziness may occur when taking this medication; therefore, caution should be exercised when driving or operating machinery. Rarely, various side effects such as skin rash, headache, dyspepsia, liver dysfunction, etc., have been reported, and consultation with healthcare professionals should occur immediately if unusual symptoms arise. It can also be used in children and adolescents, but careful monitoring of its effects on growth and development is necessary.

Serious side effects

Urticaria, angioedema, chest discomfort, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, severe muscle weakness, ophthalmoplegia, acute kidney failure, oliguria, thrombocytopenia, fatal and non-fatal liver failure, acute severe conditions (sepsis, hypotension, severe metabolic/endocrine/electrolyte disorders, uncontrolled seizures, etc.), severe allergic reactions.

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash
• myalgia
• weakness
• diarrhea

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. Proper storage can help safely maintain the medication's effectiveness.

Appearance

Pink, round film-coated tablets

Package unit

Domestic use - 30 tablets/box [10 tablets/PTP*3], Domestic use - 100 tablets/bottle, Export use - 28 tablets/box [14 tablets/PTP*2]