Robatarn 20 mg (Rosuvastatin Calcium)

Adult dosage

For patients with primary hypercholesterolemia, mixed dyslipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, administer 1 dose daily at any time of the day, with or without meals. The initial dose is 5 mg once daily, and the maintenance dose can be adjusted to 10 mg once daily as needed. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels and patient response at intervals of 4 weeks or more.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), administer a daily dose of 5 mg to 20 mg, adjusting the dosage at intervals of at least 4 weeks according to treatment goals.

This medication should not be used in certain patients. For instance, patients who are allergic to any components of this medication, those with active liver disease, patients with muscle disorders, those with severe renal impairment, and women who are pregnant or breastfeeding should not take this medication. Moreover, high-dose administration is prohibited for patients at high risk of muscle-related disorders, which include moderate renal impairment, hypothyroidism, a history of genetic muscle diseases, and alcohol dependence. This medication contains lactose, so patients with lactose intolerance should be cautious. Since it can affect liver function, patients with a history of liver disease or those consuming excessive alcohol should have regular liver enzyme tests. If symptoms such as muscle pain, muscle weakness, or muscle cramps occur, immediate consultation with a healthcare provider is necessary, and drug administration may need to be stopped in severe cases. Severe skin reactions may occur, so if symptoms like skin rash, itching, or swelling arise, administration should be discontinued immediately, and a doctor should be consulted. This medication may interact with other drugs; therefore, patients taking specific antivirals, immunosuppressants, antibiotics, or fibrate-class drugs should consult with a specialist. Women who could become pregnant should use appropriate contraceptive methods and avoid taking this medication during pregnancy. Since there is no specific antidote for overdose, treatment should be symptom-based, with liver function and muscle enzyme tests as needed. This medication may cause dizziness while driving or operating machinery, so caution is advised. Lastly, this medication may have higher blood concentrations in Asians, so dosage adjustment may be necessary.

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, severe muscle weakness, ocular muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, peripheral neuropathy, memory loss, peripheral neuropathy, interstitial lung disease

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash
• muscle pain
• weakness
• hematuria

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

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP x 2 units)