Rosustine Tablets 5 mg (Rosuvastatin Calcium)

Adult dosage

Administration can be taken at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is 10 milligrams once daily, with most patients adjusting at this dosage. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum increase to 20 milligrams once daily.

Children's dosage

Pediatric patients aged 10 to 17 years receive a dose of 5 milligrams to 20 milligrams once daily. The administration dose is adjusted according to each patient's treatment objectives at intervals of 4 weeks or more.

This medication should not be given to certain patients. First, persons who have had allergic reactions to this medication must not use it. Patients with active liver disease or significantly elevated liver enzyme levels should not take this drug. Patients with muscle disorders or severely impaired kidney function should also refrain from using this medication. Women who are pregnant, nursing, or capable of becoming pregnant must use appropriate contraceptive methods and only take it if they understand the potential risks to the fetus. Additionally, patients at high risk for muscle disorders should avoid high doses. This medication contains lactose, so patients with lactose intolerance should not take it. Caution is needed when consuming alcohol or if there is a history of liver disease. Regular liver function tests must be conducted, and existing conditions such as hypothyroidism or nephrotic syndrome must be treated first. If symptoms such as muscle pain or weakness occur, medical assistance should be sought immediately, and blood tests should be conducted to assess muscle damage. Extra caution is recommended for patients with renal impairment, elderly patients, or those with a history of alcohol abuse. This medication can rarely cause serious side effects such as liver damage, myositis, or rhabdomyolysis; if any symptoms appear, the medication should be stopped immediately, and a doctor consulted. Furthermore, if a serious rash or allergic reaction occurs, usage must be stopped immediately. This medication may interact with other drugs, so if you are currently taking any medication, you must inform your doctor or pharmacist. In particular, muscle damage risk may increase when taken with certain antiviral agents, immunosuppressants, antifungals, some antibiotics, and fibric acid derivatives. Safety has not been established for use during pregnancy or breastfeeding, so it should not be taken under these conditions and women capable of becoming pregnant must use proper contraception. In cases of overdose, there is no specific antidote, and treatment should be based on symptoms with liver function and muscle enzyme tests performed. This medication is unlikely to affect driving or operating machinery, but caution should be taken as dizziness may occur.

Serious side effects

Hypersensitivity reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, jaundice, hepatitis, acute renal failure, oliguria, worsening of acute renal failure due to severe conditions, severe allergic reactions, severe skin reactions, dyspnea, liver abnormalities (jaundice), severe skin adverse reactions, fatal and non-fatal liver failure, serious neurological symptoms,

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash and hives
• myalgia
• weakness
• myopathy (including myositis)

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safest to keep it at room temperature between 1°C and 30°C. Therefore, to maintain the medication's effectiveness, it is advisable to store it in a cool, dry place away from direct sunlight.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets (15 tablets/PTP × 2 packs)