Rosuzet Tablets 10/2.5 mg

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage is within the range of 10/2.5 mg to 10/20 mg per day. An initial dose of 10/2.5 mg or 10/5 mg is recommended. If a greater reduction in LDL cholesterol is needed, the dosage may be adjusted. Blood lipid levels should be checked at intervals of at least 4 weeks after administration or dosage adjustment, with a maximum daily dose of 10/2.

This medication can rarely cause muscle injury leading to rhabdomyolysis, which can result in a rapid decline in kidney function. Patients showing severe myopathy symptoms or those with conditions that may affect kidney function, such as severe infections, hypotension, major surgery, trauma, or metabolic disorders, should temporarily discontinue or stop using this drug. This medication should not be administered to patients who are allergic to the active ingredient or excipients, patients with liver disease or persistently elevated liver enzyme levels without known cause, patients with muscle diseases, those taking the immunosuppressant cyclosporine, patients with severe renal failure, pregnant or potentially pregnant women, nursing mothers, and those susceptible to myopathy. Patients at elevated risk of myopathy include those with moderate renal impairment, hypothyroidism, a history of genetic muscle disorders, a history of muscle toxicity from statins or fibrates, alcohol abuse, certain races (Asian descent), and those taking fibrate drugs concurrently. Additionally, this medication contains lactose and should not be given to patients with lactose intolerance or related genetic disorders. Caution should be exercised when administering this medication to patients with a history of alcohol abuse or liver conditions, and those with risk factors for myopathy should be closely monitored before and after treatment. If symptoms such as muscle pain, cramps, weakness, fatigue, fever, etc. occur during treatment, medical attention should be sought immediately for tests, and in severe cases, the medication should be discontinued. As liver function may be affected, liver function tests should be conducted before and during treatment, and if liver enzyme levels remain more than three times the normal limit, the dosage should be reduced or stopped. Pregnant or nursing women should not use this medication, and women of childbearing potential should use appropriate contraception during treatment. Safety in children has not been established, and this medication is not recommended for pediatric use. When administered to the elderly, caution should be taken considering the risk of myopathy, and any renal or liver function issues should be discussed with a healthcare professional before treatment. In cases of overdose, no specific antidote exists, requiring symptomatic treatment and monitoring of liver function and muscle enzyme levels. Finally, this medication may interact with other drugs, especially when taken with cyclosporine, fibrates, anticoagulants, etc., and should be carefully managed according to healthcare professional instructions.

Serious side effects

Angioedema, hypersensitivity reactions, urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, paleness, severe allergic reactions, severe rash with high fever, blistering, skin peeling, mucosal pain in mouth/eyes, severe skin adverse reactions, dyspnea or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, breathing difficulties, jaundice (yellowing of the skin or eyes), extreme lethargy, liver

Mild side effects

• Muscle pain
• itching
• constipation
• upper abdominal discomfort
• nasopharyngitis
• elevated C-reactive protein
• back pain
• headache
• dyspepsia
• nausea

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness and prevent degradation.

Appearance

White, oval film-coated tablets

Package unit

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