Rosuvastatin Calcium Tablet 20mg (Rosuvastatin Calcium)

Adult dosage

Administer once daily at any time regardless of meals. The initial dosage is 5 mg once daily; the maintenance dosage may be adjusted to 10 mg once daily based on treatment goals; if necessary, it may be increased to a maximum of 20 mg once daily. Elderly patients and those with mild to moderate renal impairment do not require dose adjustments. The recommended initial dose for Asian patients and those prone to myopathy is

Children's dosage

The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals over a period of 4 weeks.

This medicine should not be administered to certain patients such as those who are allergic to it, those with severely impaired liver function, individuals with muscle diseases, severely impaired renal function patients, and those who are pregnant or breastfeeding. Additionally, it should be administered with caution to patients at high risk of muscle-related side effects or with a history of liver disease, and regular monitoring of liver function and muscle conditions is important during treatment. This medicine may cause musculoskeletal adverse reactions, such as muscle pain, myopathy, and rarely severe muscle destruction known as rhabdomyolysis. If muscle pain or weakness symptoms occur, healthcare providers must be informed immediately. Liver dysfunction, gastrointestinal disturbances, headache, dizziness, skin rash and other side effects have been reported, so caution is needed if these symptoms appear. This medicine may interact with specific drugs, raising blood concentration and increasing the risk of side effects. Therefore, it is crucial to consult a doctor or pharmacist before concomitantly using other medications. Women of childbearing potential should take appropriate contraceptive measures and should not use this medicine during pregnancy. In case of overdose, since there is no specific antidote, treatment according to symptoms along with monitoring of liver function and muscle enzyme levels is necessary. This medicine is not expected to significantly affect the ability to drive or operate machinery; however, due to the possibility of dizziness, caution is advised.

Serious side effects

Allergic reactions including urticaria and angioedema, severe allergic reactions, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular muscle weakness, hepatitis, jaundice, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions, polyneuropathy, severe neurological symptoms, fatal and non-fatal liver failure, acute renal failure, anuria, edema, respiratory issues

Mild side effects

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

This medicine may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to store at room temperature between 1°C and 30°C.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [(15 tablets/PTP x 2)]