CMG Rosuvastatin Tablet 5 mg (Rosuvastatin Calcium)

Adult dose

The initial dose is 5 mg once daily, and if more significant reductions in LDL-cholesterol levels are needed, the maintenance dosage can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, with most patients adjusting to this dose. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient responses at intervals of 4 weeks or more, and can be increased to a maximum of 20 mg per day.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 mg to 20 mg once daily. The administered dose should be adjusted according to the recommended treatment goals for each individual patient.

This medication should not be used in certain patients. For instance, patients with allergies to its components, those with severe hepatic impairment, patients with muscular diseases, patients taking certain immunosuppressants, those with severe renal impairment, women who are pregnant or breastfeeding, and women of childbearing age who are not using appropriate contraception should not take this medication. Additionally, high-dose administration is prohibited in patients at risk for muscular diseases, and this medication contains lactose, so patients with genetic issues such as lactose intolerance should also avoid it. Before taking this medication, regular liver function tests and muscle-related tests should be conducted, and caution is required for patients who consume excessive alcohol or have a history of liver disease. Symptoms such as muscle pain, muscle weakness, fatigue, and fever should be reported to a physician immediately, and in severe cases, medication discontinuation may be necessary. This medication may interact with other drugs, so if you are currently taking any medication, be sure to inform your doctor or pharmacist. Particular caution should be observed when taken with certain antiviral drugs, immunosuppressants, antifungals, certain antibiotics, and fibrate drugs as the risk of muscular diseases may increase. Women who are pregnant or may become pregnant should not take this medication, and if pregnancy is confirmed while on this medication, it should be stopped immediately. It is also recommended that breastfeeding women refrain from taking this medication. There is no specific antidote for overdose, so treatment will depend on the symptoms, and liver function and muscle enzyme testing will be necessary. This medication is known not to significantly affect driving or machine operating abilities, however, caution is advised as dizziness may occur. Lastly, this medication may show higher blood concentration levels in Asians, thus dosage adjustments may be needed.

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, exfoliative skin reactions, pain in oral/ocular mucosa, severe skin adverse reactions, Stevens-Johnson syndrome, eosinophilia and drug reaction with eosinophilia and systemic symptoms (DRESS), shortness of breath or difficulty breathing, asthma attacks, respiratory impairments accompanied by cough and fever, skin

Mild side effects

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

This medication may be sensitive to air and moisture, thus it should be stored in a tightly sealed container. Moreover, it is best kept at room temperature between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets (15 tablets/PTP x 2 packs), 30 tablets/bottle