Dabidueo Tablet 10/10 mg (Ezetimibe, Rosuvastatin Calcium)

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended, with dose adjustments possible between 10/5 mg and 10/20 mg per day as needed. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of at least 4 weeks, and the dose may be increased to a maximum of 10/20 mg per day.

This medication may cause serious muscle problems, so it should be temporarily discontinued or stopped if acute serious myopathy appears or there is a risk of kidney dysfunction due to rhabdomyolysis. This medication should not be used in patients with allergies to the active substance or components, patients with liver function issues or active liver disease, patients with muscle disorders, patients taking certain immunosuppressants, patients with severe kidney dysfunction, pregnant women or women who may become pregnant, and nursing mothers. Patients at high risk for myopathy or rhabdomyolysis, patients with liver function impairment, elderly patients, alcoholics, and those taking certain medications should use this medication with caution and require regular testing as per doctor's instructions. While taking this medication, patients should immediately report any symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, fever, etc. to their doctor, and treatment may be stopped in severe cases. Liver function tests should be conducted before and during treatment, as abnormal liver function may occur; if liver enzyme levels remain elevated, dose adjustment or discontinuation may be necessary. This medication can be harmful to the fetus during pregnancy, so women who are pregnant or planning to become pregnant must consult with a doctor and employ appropriate contraception. Safety and efficacy in children and adolescents have not been adequately established, so administration is not recommended. Elderly patients are at higher risk for myopathy, so caution is warranted, but special dose adjustments are generally not necessary. Patients with impaired kidney function should be closely monitored due to the risk of muscle issues. This medication can interact with other drugs, so patients taking anticoagulants, fibrate-class medications, certain antibiotics, and antifungals should inform their physician. In case of overdose, there is no specific antidote; symptomatic treatment and appropriate supportive therapy are required, and monitoring of liver function and muscle enzyme levels should be performed. This medication must be kept out of the reach of children, and transferring to another container is not recommended.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination changes

Mild side effects

• Nasopharyngitis
• joint pain
• headache
• ALT elevation
• AST elevation
• muscle pain
• edema
• elevated blood bilirubin
• acneiform dermatitis
• pruritus

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets/bottle