Rosuvastatin-Ezetimibe Tablet 10/20 mg

Adult dose

This medication is administered once a day regardless of meals. The recommended initial dose for primary hypercholesterolemia is 10/5 mg once daily. Dosing may be adjusted for patients requiring greater LDL-cholesterol reduction. Cholesterol levels should be checked four weeks after initiating treatment or adjusting the dose, and the dose may be increased up to 10/20 mg once daily.

This medication may rarely cause muscle tissue destruction (rhabdomyolysis), which could lead to kidney function issues. Therefore, patients presenting with severe muscle symptoms, severe infections, hypotension, major surgery, trauma, or severe metabolic disorders should temporarily discontinue or cease using this medication. This drug should not be administered to those who have allergic reactions to the active ingredients or components, are suffering from active liver disease, muscle diseases, severe renal impairment, or are pregnant or breastfeeding. Caution should especially be taken with patients who have moderate to severe renal impairment, a history of hypothyroidism, genetic muscle disease, alcohol dependence, or those taking certain other medications that increase the risk of muscle damage. This medication contains lactose, and patients with lactose intolerance should also refrain from its use. Patients with a history of alcohol dependence or liver disease, severe liver dysfunction, or risk factors for myopathy should use this medication cautiously and consult with their physician if necessary. Symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, and fever should be reported to a doctor immediately, and muscle enzyme tests should be performed if necessary. Liver function abnormalities may occur; therefore, liver function tests are recommended before and during treatment. This medication may affect fetal development during pregnancy, so women who are pregnant or may become pregnant must use contraception, and if pregnancy is confirmed, medication should be discontinued immediately. Breastfeeding mothers should also avoid taking this medication. Elderly patients or those with renal impairment may face an increased risk of muscle-related side effects and may require dose adjustments. Caution is necessary with potential drug interactions, and patients should inform their healthcare providers of any other medications they are Taking. Dizziness or headaches may occur when taking this medication, so caution is advised when driving or operating machinery. In case of overdose, treatment should be symptomatic, and liver and muscle function tests are required; there is no specific antidote. Finally, this medication is not recommended for children as its safety and efficacy have not been established.

Serious side effects

• Hives
• severe swelling (edema)
• chest tightness
• difficulty breathing
• cold sweats
• paleness
• severe rash accompanied by high fever
• blisters
• skin peeling
• pain in mouth/eyes

Mild side effects

Nasopharyngitis, dyspepsia, headache, dry mouth, elevated liver enzymes, muscle pain, pruritis, itching, dizziness, drowsiness, cough, diarrhea, elevated blood sugar, increased blood lactate dehydrogenase levels, elevated CPK levels, chest discomfort, constipation, nausea, abdominal pain, rash, alopecia, sweating, dermatitis, burning sensation in the skin, skin disorders, oropharyngeal pain, nasal congestion, pelvic pain, breast cysts, eyelid droop, diabetic retinopathy,

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's efficacy.

Appearance

Pink oval film-coated tablet

Package unit

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