Megalosuvastatin 10 mg (Rosuvastatin Calcium)

Adult dosage

It can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily, which is what most patients will be adjusted to. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum dose of 20 mg per day.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is once daily 5 mg to 20 mg. The dosage adjustment should be made individually according to the recommended treatment goals.

This drug should not be used in certain patients. For example, it should not be administered to patients who are allergic to any components of this drug, patients with severe liver dysfunction, those with muscle diseases, or patients with significantly impaired kidney function. Women who are pregnant or breastfeeding, as well as fertile women who do not use adequate contraception, should not use this drug. Furthermore, high doses are prohibited in patients at high risk of muscle disease. This drug should be used cautiously in patients who consume alcohol excessively or have a history of liver disease, and it is advisable to repeat liver function tests before and during treatment. If symptoms such as muscle pain or weakness occur, patients should immediately inform their doctor and undergo necessary examinations. In particular, if muscle enzyme levels rise significantly, the drug should be discontinued, and it may be reconsidered for re-administration at an appropriate dose once symptoms improve. This drug may elevate blood glucose levels in some patients; therefore, patients at risk of diabetes should vigilantly manage their blood sugar. Additionally, this drug contains lactose, and patients with lactose intolerance should not take it. There may be interactions with this drug and other medications, so if there are any currently taken medications, patients must inform their doctor or pharmacist. In particular, co-administration with certain antiviral drugs, immunosuppressants, and fibrate drugs may increase the risk of muscle-related side effects. Pregnant or breastfeeding women should not use this drug, and women who may become pregnant should use appropriate contraception. Caution is necessary as this drug may pose a risk to the fetus during pregnancy. In case of overdose, there is no specific antidote, so symptomatic management should be provided while monitoring liver function and muscle enzyme levels. This drug may cause symptoms such as dizziness; therefore, caution is needed when driving or operating machinery. Finally, if severe skin rashes or allergic reactions occur while using this drug, it should be promptly discontinued and medical consultation sought.

Serious side effects

Hives, hypersensitivity reactions including angioedema, pancreatitis, myopathy, rhabdomyolysis, polyneuropathy, severe muscle weakness, dyspnea, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe skin reactions, acute renal failure, oliguria, chest tightness, severe swelling (edema), severe allergic reactions, severe edema or urinary abnormalities, severe fatigue

Mild side effects

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

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. The storage temperature should ideally be maintained at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

30 tablets per bottle