Samsung Rosuvastatin 20 mg Tablets (Rosuvastatin Calcium)

Adult dosage

The initial dosage is 5 mg once daily, and for patients requiring greater reductions in LDL cholesterol, the maintenance dose can be adjusted accordingly. The maintenance dose is 10 mg once daily, with most patients being managed at this dose. The maintenance dose should be appropriately adjusted based on the LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Children's dosage

The typical dosage range is 5 mg to 20 mg once daily. The dosage should be individually adjusted according to the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

This drug should not be used by individuals who are allergic to certain ingredients. It should not be administered in the presence of active liver disease or elevated liver enzyme levels. Patients with muscle disorders or problems related to muscle should not take this drug. Patients taking certain immunosuppressants or those with severe kidney dysfunction should also avoid this drug. Women who are pregnant or breastfeeding, and women who could become pregnant should carefully consider the risks when using this drug. High-dose administration is prohibited for patients at high risk of muscle-related disorders, which include those with renal impairment, hypothyroidism, and a history of genetic muscle diseases. Patients with certain hereditary conditions like lactose intolerance should not take this drug. Patients who consume large amounts of alcohol or have a history of liver disease should have regular liver function tests, and treatment of underlying diseases should take precedence in cases of hypothyroidism or nephrotic syndrome. If symptoms such as myalgia, muscle weakness, or cramps occur, inform a doctor immediately and undergo necessary examinations. This drug poses a risk of muscle damage, thus it is important to check muscle enzyme levels before and during treatment. In cases of acute severe conditions, this drug should be discontinued, and immediate cessation is required if symptoms of severe myasthenia gravis or ocular myasthenia occur. The risk of muscle damage may increase when taken with certain other drugs, so caution is needed during concomitant administration. Temporary proteinuria may occur with high doses, so regular kidney function tests should be conducted. Due to the higher systemic concentration in Asian patients, dose adjustment may be necessary. Use in children and adolescents must be cautious as there is limited data on its effects on growth and maturation. While taking this drug, interstitial lung disease, severe liver damage, and severe skin reactions may occur rarely, and treatment should be stopped immediately if symptoms emerge. Blood glucose levels may increase, so patients at high risk of diabetes should regularly check their blood sugar. Drug responses may vary according to genetic characteristics, necessitating potential dose adjustments. If severe skin reactions occur, discontinue the medication and consult a specialist immediately. This drug may interact with other medications, so it is essential to inform the doctor or pharmacist about any other medications being taken. In cases of overdose, as there is no specific antidote, treatment should be symptomatic along with ongoing liver function and muscle enzyme tests. Dizziness may occur while driving or operating machinery, so caution is advised.

Serious side effects

Allergic reactions including urticaria and angioedema, rhabdomyolysis, severe myasthenia gravis, ocular myasthenia, jaundice, severe allergic reactions, severe skin reactions (Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms DRESS), dyspnea, liver failure, acute renal failure, oliguria, thrombocytopenia, fatal liver failure, Stevens-Johnson syndrome, immune-mediated necrotizing myopathy, severe liver

Mild side effects

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

This drug may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should ideally be maintained between 1 and 30 degrees Celsius at room temperature. This will help retain the medication's effectiveness for a longer period.

Appearance

Pink round film-coated tablets

Package unit

30 tablets per bottle