Rosutero Tablet 20mg (Rosuvastatin Calcium)

Adult dose

For patients with primary hypercholesterolemia, mixed hyperlipidemia, or dysbetalipoproteinemia, administer once daily at any time, irrespective of meals. The initial dose is 5mg once daily, which may be adjusted to a maintenance dose of 10mg once daily if necessary. The maintenance dose should be appropriately adjusted at intervals of at least 4 weeks based on LDL cholesterol levels and the patient's response, with a maximum dose of 20mg once daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer 5mg to 20mg once daily. The dosage should be individually adjusted at intervals of at least 4 weeks.

This medication should not be administered to certain patients. For example, it should not be used in patients with allergies to its components, liver function issues, muscle diseases, severe renal impairment, or women who are pregnant or breastfeeding. Additionally, high-dose administration is prohibited in patients at risk for myopathy or rhabdomyolysis. This medication contains lactose, and should not be given to patients with lactose intolerance. Regular monitoring of liver function tests and muscle condition is necessary while using this medication. Special caution is warranted for patients with a history of liver disease or excessive alcohol consumption. If symptoms such as muscle pain, weakness, or cramps occur, medical professionals should be notified immediately, and discontinuation of the medication may be necessary. This medication may interact with other medications, so patients must inform their doctor or pharmacist of any other drugs they are taking. In particular, muscle toxicity risk may increase when used in conjunction with certain antiviral agents, immunosuppressants, and fibrate drugs. Women of childbearing potential should use appropriate contraceptive methods when taking this medication, and should avoid use during pregnancy or lactation. In cases of overdose, there is no specific antidote, so treatment according to symptoms and monitoring of liver and muscle conditions is required. Dizziness may occur when driving or operating machinery, so caution is advised. Lastly, this medication may exhibit higher blood concentrations in Asians, so dose adjustments may be necessary.

Serious side effects

Allergic reactions including urticaria, angioedema, Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), jaundice, hepatitis, liver failure, severe muscle weakness, ocular muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, thrombocytopenia, dyspnea, interstitial lung disease

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash and hives
• myalgia
• weakness
• cough

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle