Rosutan Tablet 10 mg (Rosuvastatin Calcium)

Adult dose

The initial dose of 5 mg is administered once daily at any time of day, regardless of meals. In cases requiring further reduction of LDL cholesterol, the maintenance dose is adjusted, typically using 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, with a maximum increase of up to 20 mg per day.

Child dose

Children aged 10 to 17 with heterozygous familial hypercholesterolemia are administered 5 mg to 20 mg once daily. The dosage should be adjusted individually according to the recommended treatment target.

This medication should not be administered to certain patients. For example, patients allergic to any component of this medication, those with liver problems, muscle diseases, severe renal impairment, or women who are pregnant or breastfeeding should not use this product. Additionally, high-dose administration is prohibited in patients with a high risk of muscle-related disorders. This medication contains lactose, so patients with lactose intolerance should avoid taking it. This medication can affect liver function, so patients with a history of liver disease or those who consume alcohol heavily should have liver function tests before use and continue to have regular liver enzyme tests during treatment. If symptoms such as myalgia or muscle weakness occur, the healthcare provider should be notified immediately, and discontinuation of the medication may be necessary. This medication may interact with other drugs, so caution is advised when taken with certain antiviral drugs, immunosuppressants, antifungals, antibiotics, and fibrates. Women who are pregnant or planning to become pregnant must use appropriate contraception, and if pregnancy occurs, they should stop taking this medication immediately. In case of overdose, since there is no specific antidote, management should be based on symptoms, along with liver function and muscle enzyme tests. Caution is necessary for activities requiring alertness, such as driving or operating machinery, as dizziness may occur. Finally, this medication may present higher drug concentrations in Asians, which may require dose adjustments.

Serious side effects

Allergic reactions including hives and angioedema, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction syndrome (DRESS), jaundice, hepatitis, hyperbilirubinemia, severe liver damage, difficulty breathing, respiratory distress, severe muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, myopathy, sudden and severe headache, seizures, altered consciousness, visual disturbances, paralysis, oliguria, elevated blood pressure.

Mild side effects

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius. This will help preserve the efficacy and safety of the medication.

Appearance

Pink round film-coated tablets

Package unit

30 tablets (10 tablets x 3)/PTP