Rosutin Tablet 5 mg (Rosuvastatin Calcium)

Adult dose

The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, the maintenance dose is adjusted. The maintenance dose is usually 10 mg once daily, and most patients are controlled at this dose. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily increase up to 20 mg.

This medication should not be administered to certain patients. It should not be used by individuals allergic to this medication, those with severe liver dysfunction, those with muscle disorders, those taking certain medications simultaneously, those with severely reduced kidney function, and women who are pregnant or breastfeeding. Women of childbearing potential should confirm that the possibility of being pregnant is low before using this medication and should use appropriate contraceptive methods. Additionally, individuals at high risk for muscle disorders should avoid high doses of this medication; risk factors include decreased kidney function, hypothyroidism, and family history. This medication contains lactose, so individuals with lactose intolerance should not take it. Individuals who consume large amounts of alcohol or have a history of liver disease should undergo periodic liver function tests, and those with hypothyroidism or nephrotic syndrome should treat the underlying conditions first. If symptoms such as myalgia or muscle weakness occur, they should inform healthcare providers immediately, and the medication may be discontinued if necessary. It is advisable to refrain from muscle enzyme tests when muscle damage occurs after exercise or due to other causes. In cases of acute severe illness or suspected severe renal failure, the use of this medication should be discontinued. This medication can rarely induce severe myasthenia gravis or ocular myasthenia; if these symptoms appear, use should be discontinued immediately. This medication may increase the risk of muscle adverse reactions when combined with other medications, especially when taken with fibrates. Kidney function tests may be necessary with high doses. In Asian individuals, increased body exposure to this medication may require dose adjustments. During therapy with this medication, liver function abnormalities, myalgia, headache, gastrointestinal disturbances, and other side effects, mostly mild and transient, may occur. However, serious adverse effects such as severe skin reactions, liver damage, and muscle rupture have also been reported; if symptoms appear, consulting a healthcare provider is essential. This medication should not be taken during pregnancy or while breastfeeding, and women planning pregnancy should use proper contraceptive methods. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzymes should be monitored periodically. Caution is advised as dizziness may occur while driving or operating machinery. This medication does not have any special carcinogenic risks, but it is important to report any abnormal symptoms during use and undertake regular examinations.

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, severe myasthenia gravis, ophthalmoplegia, jaundice, hepatitis, fatal and non-fatal liver failure, acute renal failure, oliguria, thrombocytopenia, severe edema, difficulty breathing, interstitial lung disease, severe allergic reactions

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, hematuria, diarrhea, discomfort in the chest, appetite loss, abdominal bloating, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, fatigue, numbness, paresthesia, chest pain, cough, thrombocytopenia, memory loss, peripheral neuropathy, cough, depression, sleep disorders (including insomnia and nightmares), sexual dysfunction, gynecomastia, cognitive impairment

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and should be stored at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 100 tablets/bottle, Domestic use - 100 tablets/box [(10 tablets/Alu-Alu)x10]