Shubajet Tablet 10/5 mg (Ezetimibe, Rosuvastatin)

Adult dose

This medication is administered once daily, regardless of meals. For the treatment of primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg daily, with an initial recommended dose of 10/5 mg. In patients requiring more significant LDL-cholesterol reduction, the dosage can be adjusted. Blood lipid levels should be checked at least 4 weeks after initiating treatment or adjusting the dose, and dosages can be adjusted accordingly.

This medication may pose a risk of muscle abnormalities; therefore, if symptoms such as muscle pain, muscle cramps, or muscle weakness occur, consult a physician immediately. Special caution is needed if severe myopathy or rhabdomyolysis develops, as this may cause kidney function issues. This medication may affect liver function, so liver function tests should be conducted before administration, and if any signs of liver dysfunction occur during treatment, repeat testing is necessary. If liver enzyme levels rise above a certain threshold, discontinuation or dose adjustment of the medication may be required. This medication is not to be used in patients with certain liver diseases or persistently elevated liver enzymes. Additionally, it is not safe for patients with severely impaired kidney function or muscle disorders. Pregnant women, women of childbearing potential, and nursing mothers should not take this medication; fertile women should use appropriate contraceptive methods. Patients with a history of alcohol dependence or liver disease, elderly patients, and those with hypothyroidism require closer monitoring while taking this medication. Interactions may occur when taken with other drugs, so disclose any medications being taken to a physician or pharmacist. This medicine contains lactose, so patients with lactose intolerance should not take it. Caution is needed as dizziness and other symptoms may occur while driving or operating machinery. If severe rashes, hives, or swelling appear while taking this medication, discontinue use immediately and consult a physician. Safety for pediatric and adolescent use has not been sufficiently confirmed; therefore, it is advisable not to administer it except in special cases. In the case of overdose, there is no specific antidote; treatment and supportive care based on symptoms are required, along with liver function and muscle-related tests.

Serious side effects

Hives, edema (severe swelling), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/conjunctival mucosa, shortness of breath or respiratory difficulty, asthma attack, cough with fever accompanied respiratory abnormality, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, decreased urination.

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• muscle pain
• edema
• elevated bilirubin levels
• acneiform dermatitis
• itching

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This helps to preserve the medication's efficacy and safety over time.

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 3]