RotiJet Tablet 10/10 Milligrams

Adult dose

This medicine is administered once daily regardless of meals. For primary hypercholesterolemia, it is started at 10/5 mg once daily, with potential adjustments within the range of 10/5 mg to 10/20 mg as needed. After dosage adjustment, lipid levels should be checked at intervals of 4 weeks or longer, and the dose may be increased up to a maximum of 10/20 mg daily.

This medicine can rarely cause rhabdomyolysis, which may lead to a rapid decline in renal function. Patients with risk factors such as severe infections, hypotension, major surgery or trauma, severe metabolic disorders, and uncontrolled seizures should temporarily suspend or discontinue the use of this medicine. It should not be taken by patients who are allergic to any components of this medicine, those with severely impaired liver function, individuals with muscle disorders, certain patients with decreased kidney function, or women who are pregnant or breastfeeding. Additionally, caution is needed when prescribing to patients susceptible to myopathy or those taking certain drugs concomitantly. During treatment, if symptoms such as myalgia, muscle cramps, or muscle weakness occur, patients should immediately inform their doctor, and blood tests may be necessary to check for muscle damage. Liver function abnormalities may arise, so regular liver function tests should be conducted before and during treatment. This medicine should be administered with caution to patients with a history of alcohol dependence or liver diseases, and it is advisable not to administer it if liver function is severely impaired. Women who are pregnant or may become pregnant should use appropriate contraception during treatment and should discontinue use immediately if pregnancy is confirmed. Safety has not been well established in children and adolescents; therefore, it is not recommended for this age group. Caution is necessary when administering to the elderly, as the risk of myopathy may be increased. There may be interactions with other medications, so patients should inform healthcare professionals of any other medications they are taking. In the case of overdose, there is no specific antidote, and symptomatic treatment and supportive care are required while closely monitoring liver function and muscle damage.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusional states, visual disturbances, paralysis, urinary issues

Mild side effects

• Nasopharyngitis
• dyspepsia
• increased ALT
• edema
• myalgia
• headache
• acute pyelonephritis
• dry mouth
• increased liver enzymes
• abnormal liver function tests

This medicine may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is best to keep the medicine at room temperature between 1 to 30 degrees Celsius, away from excessively hot or cold conditions.

Appearance

Yellow, oblong film-coated tablet

Package unit

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