Rosuvastatin Tablets 10/2.5 mg (Ezetimibe, Rosuvastatin Calcium)

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/2.5 mg to 10/20 mg per day, with an initial recommended dose of 10/2.5 mg or 10/5 mg per day. Patients requiring a larger reduction in LDL cholesterol may have their dosage adjusted. Blood lipid levels should be checked at intervals of at least 4 weeks after initiating therapy or adjusting the dosage.

This medication is associated with the rare side effect known as rhabdomyolysis, which can cause severe muscle damage. Therefore, if severe muscle pain or weakness occurs, immediate consultation with a physician is advised. The use of this medication may need to be temporarily stopped or discontinued in patients with risk factors such as severe acute infections, hypotension, after major surgery, severe trauma, metabolic abnormalities, or uncontrolled seizures. The use of this medication is contraindicated in certain patients. For example, it should not be used in patients who are allergic to any component of this medication, those with active liver disease, patients with persistent unexplained elevations in liver enzymes, individuals with muscle disorders, severe renal failure patients, and women who are pregnant or breastfeeding. Additionally, the use of high doses in patients at higher risk for muscle myopathy is also prohibited. Patients with a history of alcoholism or liver disease, decreased renal function, hypothyroidism, elderly patients, or those using other medications concurrently should use this medication with caution. This medication may affect liver function, thus regular liver function tests should be performed before and during treatment. If liver enzymes rise significantly or symptoms of liver damage appear, the physician should be notified immediately. If symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, or fever occur during the use of this medication, consultation with healthcare professionals should be sought immediately, and blood tests should be conducted to check for muscle damage. This medication should not be used during pregnancy or breastfeeding, and women of childbearing age should use appropriate contraception while taking it. Safety and efficacy in children have not been established, therefore it is not recommended for them. In the elderly, caution should also be exercised due to the risk of myopathy, though dosage adjustment is usually not necessary. There may be interactions with other medications, particularly if the patient is taking cyclosporine, fibrates, anticoagulants, etc., and the physician should be informed. There is no specific antidote for overdose, therefore treatment should be based on symptoms, and liver function and muscle enzyme levels should be monitored.

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, reduced urine output

Mild side effects

• Constipation
• indigestion
• COVID-19
• arthralgia
• contusions
• increased CPK
• hematoma
• iron deficiency anemia
• nasopharyngitis
• headache

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is best to keep it at room temperature between 1°C and 30°C, away from extremes of heat or cold.

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 3], 100 tablets/bottle, 30 tablets/bottle