Rovetin Tablet 20 mg (Rosuvastatin Calcium)

Adult dose

Can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to a maintenance dose if needed. The maintenance dose is 10 mg once daily and should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or more. The dosage can be increased up to a maximum of 20 mg per day.

Child dose

Children with familial heterozygous hypercholesterolemia (ages 10 to 17) The typical dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted individually at intervals of 4 weeks or more.

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to any of its components, severely impaired liver function, muscle disorders, those taking cyclosporine, patients with severe kidney impairment, pregnant or nursing women, and those at increased risk for muscle-related disorders. This medication should be used with caution in patients who consume excessive alcohol or have a history of liver disease, and regular liver function tests should be conducted before and during treatment. Furthermore, if symptoms such as muscle pain or weakness occur, the healthcare provider should be notified immediately, and the medication may need to be discontinued if necessary. During treatment, rare muscle-related adverse reactions may occur, so symptoms such as muscle pain, weakness, or cramps should be reported immediately. Additionally, high doses may cause kidney function abnormalities, so renal function tests may be necessary. Due to certain genetic factors, the concentration in the body may increase, so dosage adjustments may be needed based on the patient's condition. Serious adverse reactions such as severe skin reactions may occur, so if symptoms such as rash, itching, or swelling arise, the medication should be discontinued immediately and the physician should be consulted. This medication can interact with other drugs, so if there are any other medications being taken, the healthcare provider must be informed. In particular, the risk of muscle adverse reactions may increase when used with certain antiviral agents, immunosuppressants, antibiotics, and fibrates. Women who are pregnant or planning to become pregnant should discuss this medication with their healthcare provider before use and should use appropriate contraception. Nursing women should also avoid this medication. In cases of overdose, since there is no specific antidote, treatment should be based on symptoms, along with liver function and muscle enzyme testing. Caution should be exercised, as dizziness may occur when driving or operating machinery. The drug concentration may be higher in Asians, so this should be considered when determining the dosage.

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions, hepatitis, jaundice, severe muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, severe allergic reactions, dyspnea, ocular muscle weakness, thrombocytopenia, serious neurological symptoms, acute renal failure, oliguria, edema.

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash
• myalgia
• weakness
• diarrhea

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is advisable to maintain the storage temperature between 1°C and 30°C.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle