Rosutero Tablet 10mg (Rosuvastatin Calcium)

Adult dose

The initial dosage is once daily 5 mg, and for patients needing greater reductions in LDL cholesterol, the maintenance dosage can be adjusted accordingly. The maintenance dosage is usually 10 mg once daily, and most patients are adjusted to this dosage. The maintenance dosage should be carefully adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or longer, with the maximum daily dose being 20 mg.

Child dose

The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is once daily 5 mg to 20 mg. Dosage should be adjusted based on the recommended therapeutic goals for individual patients

This medication should not be used in certain patient populations. For example, individuals with allergies to any component of this medication, those with severe liver impairment, those with muscular disorders, and patients with severely diminished renal function should not be administered this drug. Women who are pregnant, nursing, or potentially pregnant should consult a physician and ensure appropriate contraceptive measures before using this medication. Caution is especially warranted with high doses as they pose a greater risk of muscle-related issues. This medication contains lactose, so patients with genetic metabolic disorders such as lactose intolerance should not take it. Patients with a history of liver disease or those who consume a large amount of alcohol should undergo regular liver function tests before starting and during treatment with this medication. Individuals with hypothyroidism or nephrotic syndrome should first treat those conditions before use. If symptoms such as myalgia, muscle weakness, or cramps occur, the physician should be notified immediately, and muscle-related tests should be performed during treatment with this medication. If an acute serious condition arises, this drug should be discontinued. If symptoms of severe muscle weakness or ophthalmoplegia occur, use should be stopped immediately. When using this medication concurrently with other drugs, caution regarding drug interactions is advised, especially with drugs that may increase the risk of muscle toxicity. Regular testing of liver and kidney functions is recommended during treatment with this medication. This medication should not be used during pregnancy or breastfeeding, and women planning to become pregnant must consult a physician. In the case of an overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Caution is necessary when driving or operating machinery as dizziness may occur. Finally, this medication shows higher systemic exposure in Asians, so dose adjustments may be necessary.

Serious side effects

Allergic reactions including hives, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ophthalmoplegia, dyspnea, interstitial lung disease

Mild side effects

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is important to maintain a temperature between 1 and 30 degrees Celsius when storing the medication to ensure its effectiveness is preserved safely.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle