Rosuvael Tablets 10 mg (Rosuvastatin Calcium)

Adult dosage

It can be taken once daily at any time regardless of meals. The initial dose is 5 mg once daily, and maintenance doses can be adjusted to 10 mg once daily based on therapeutic goals, with at least 4-week intervals. A maximum of 20 mg can be increased.

Children's dosage

For pediatric patients aged 10 to 17 years, the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted individually according to therapeutic goals with intervals of not less than 4 weeks. For children under 10 years of age, the

This medication should not be used in patients with certain allergic reactions and is not recommended for patients with severely impaired liver function or muscle disorders. Women who are pregnant or breastfeeding should avoid taking this medication as it may pose risks to the fetus or infant, and women of childbearing age should use appropriate contraception to prevent pregnancy. This medication may cause muscle-related side effects, such as myalgia or muscle weakness; therefore, if unusual symptoms occur in the muscles, immediate consultation with healthcare personnel is necessary. Liver function abnormalities can occur, so liver function tests should be conducted regularly before and during treatment. Patients who consume alcohol excessively or have a history of liver disease should use this medication with caution, and those with hypothyroidism or renal impairment should also be careful. Interactions may occur when taken with other medications; therefore, all medications being taken should be reported to healthcare personnel, and careful monitoring is required for concomitant use. Particularly, the blood concentration of this medication may increase when taken with certain drugs, raising the risk of muscle damage; hence, use with such drugs should be avoided or dosage adjustments may be needed. During the use of this medication, if symptoms such as sudden myalgia, muscle weakness, fever, or fatigue occur, immediate consultation with a physician is essential, and if symptoms are severe, discontinuation of medication may be necessary. In children and adolescents, usage may affect growth and secondary sexual characteristics, requiring close monitoring by healthcare personnel. In case of overdose, there is no specific antidote, so immediate medical attention and proper treatment and examination are required. This medication contains lactose, so patients with lactose intolerance should avoid it. Caution is needed while driving or operating machinery as dizziness may occur. Severe skin reactions may occur; if symptoms such as skin rash, swelling, or difficulty breathing arise, immediate cessation of the medication and consultation with healthcare personnel is necessary.

Serious side effects

Hives, angioedema, rhabdomyolysis, severe allergic reactions, Stevens-Johnson syndrome, increased eosinophils with systemic symptoms drug reaction syndrome, severe skin abnormal reactions, jaundice, hepatitis, liver failure, hyperbilirubinemia, acute kidney injury, anuria, thrombocytopenia, elevated serum creatinine, myopathy (including myositis), immune-mediated necrotizing myopathy, severe muscle weakness, oculomotor weakness, dyspnea, interstitial lung disease

Mild side effects

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature to maintain the drug's efficacy and safety for a longer duration.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/box [(15 tablets / Alu Alu × 2)]