New Shubatine Tablet 10mg (Rosuvastatin Calcium)

Adult dosage

It can be taken at any time of the day. The initial dose is 5 mg once daily. The maintenance dose is typically 10 mg once daily, which most patients are adjusted to. The maintenance dose may be adequately adjusted based on LDL-cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or longer, and may be increased up to a maximum of 20 mg per day.

Children's dosage

For pediatric patients aged 10 to 17 years, the usual dosage range is once daily 5 mg to 20 mg. The dosing is adjusted individually according to the treatment goals of the patient, and the dosage may be adjusted every 4 weeks or longer.

This drug should not be used in certain patients. For example, it should not be administered to patients with allergies to its components, severely impaired liver function, muscle disorders, severely compromised kidney function, or women who are pregnant or breastfeeding. Additionally, this medication may affect muscle tissue, potentially leading to symptoms such as muscle pain or myopathy; thus, elderly patients or those with a history of muscle disorders or heavy alcohol consumption should use it cautiously. If symptoms such as muscle pain, muscle weakness, or cramps occur during treatment, consultation with a doctor should be sought immediately. Since liver function abnormalities may occur, it is important to perform regular liver function tests before starting and during treatment. If symptoms of liver damage (such as jaundice, severe fatigue, etc.) occur, treatment should be discontinued immediately. This medication may interact with other drugs, so patients taking other medications should inform their doctor or pharmacist. Particularly, combining this medication with specific antiviral agents, immunosuppressants, some antibiotics, and fibrates may increase the risk of muscle disease. Women of childbearing potential should use appropriate contraception while taking this medication and should not use it during pregnancy. It is also advisable to avoid this drug while breastfeeding. There is no specific antidote in cases of overdose; treatment according to symptoms and liver function and muscle enzyme testing is required. Finally, this medication may cause symptoms like dizziness, so caution is advised when driving or operating machinery.

Serious side effects

Hypersensitivity reactions including hives and angioedema, Stevens-Johnson syndrome, respiratory distress, hepatitis, jaundice, fatal and non-fatal liver failure, acute renal failure, oliguria, severe edema, severe myopathy, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), serious neurological symptoms, severe edema or urinary abnormalities.

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and is best kept at room temperature between 1 degree and 30 degrees Celsius. It can be safely used for 36 months from the date of manufacture.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle