Rosustine 20 mg (Rosuvastatin Calcium)

Adult dosage

Patients with primary hypercholesterolemia, mixed hyperlipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia should take an initial dose of 5 mg once daily, regardless of meals. If greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted, typically 10 mg once daily. The dose should be adjusted every 4 weeks based on LDL cholesterol levels and treatment goals.

Children's dosage

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) should be administered a dose of 5 to 20 mg once daily. The dose should be adjusted individually based on therapeutic goals over a period of 4 weeks.

This medication should not be taken by certain patients. For example, patients with an allergy to any components of this drug, those with severe liver dysfunction, those with muscle diseases, and those with significantly impaired kidney function should not take this medication. Additionally, it should not be used by pregnant or nursing women, or women of childbearing potential not using appropriate contraception, and women of reproductive age should only take it after fully understanding the risks to the fetus if pregnancy is possible. This drug should be used with particular caution in patients at higher risk of muscle-related side effects. Patients with moderate to severe kidney impairment, hypothyroidism, a family history of muscle diseases, or a history of muscle toxicity, alcohol dependence, and Asian race should exercise more caution while taking this medication, and if symptoms like muscle pain or weakness occur, they should consult their physician immediately. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Regular monitoring of liver function and muscle condition while taking this medication is important. If significantly elevated liver enzyme levels or symptoms such as muscle pain, muscle weakness, or muscle cramps occur, medical staff should be informed immediately. Since CK levels may increase after exercise or other causes, the timing and condition of tests should be considered. This medication can interact with other drugs, so patients currently taking other medications should definitely inform their medical staff. In particular, caution is needed when used with cyclosporine, fibrates, certain antibiotics, antifungals, antivirals, etc., as this can increase the risk of muscle side effects. Pregnant or nursing women should not take this medication, and women of childbearing potential must use appropriate contraceptive methods. There are no specific antidotes for overdose, so management should be based on symptoms and monitoring of liver function and muscle enzyme levels. This medication may cause dizziness and should be used with caution when driving or operating machinery. Rarely, serious allergic skin reactions or liver dysfunction may occur while taking this medication, so if symptoms such as rash, jaundice, or severe fatigue appear, medical staff should be informed immediately.

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, jaundice, liver failure, acute renal failure, oliguria, chest tightness, difficulty breathing, severe swelling

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash
• myalgia
• asthenia
• hematuria

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain room temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP × 2 packs)