RosuMed Tablet 5 mg (Rosuvastatin Calcium)

Adult dosage

The initial dose is 5 mg once daily, and if further reduction of LDL-cholesterol is required, it can be adjusted to a maintenance dose. The maintenance dose is usually 10 mg once daily, with most patients being managed at this dosage. The maintenance dose may be adjusted based on LDL-cholesterol levels, treatment goals, and patient response, typically at intervals of 4 weeks or more, up to a maximum of 20 mg per day.

Children's dosage

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

This medication should not be administered to certain patients. For example, those with allergies to any component of this medication, severely impaired liver function, muscle diseases, those taking certain immunosuppressants, and patients with severe kidney dysfunction should not use this medication. Pregnant or breastfeeding women, or fertile women who do not use adequate contraception should also avoid this medication, and women of childbearing age may only take it if pregnancy risk is low and they have been adequately informed of the potential risks to the fetus. Special care should be taken with patients at high risk for muscle-related side effects, and the dosage should be adjusted according to the physician's instructions due to the increased risk of muscle damage with high-dose use. This medication contains lactose, so patients with lactase deficiency or certain genetic metabolic disorders should not take it. Patients with impaired liver function or those who consume alcohol heavily should have regular liver function tests before and during treatment with this medication, and patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome must first treat the underlying disease. Should symptoms such as myalgia, muscle weakness, or cramps occur, the patient should immediately report this to their doctor and undergo blood tests to check for muscle damage, with possible discontinuation of the medication in severe cases. This medication may interact with certain drugs, so patients taking other medications must inform their physician or pharmacist. The risk of muscle damage may increase with co-administration of specific antiviral drugs, immunosuppressants, antifungals, antibiotics, and fibrate-class drugs. Pregnant or breastfeeding women should not use this medication, and women planning to become pregnant must use appropriate contraceptive methods. In cases of overdose, there is no specific antidote, and treatment should be symptomatic with liver function and muscle enzyme testing. Lastly, patients should be cautious when driving or operating machinery while taking this medication, as dizziness may occur.

Serious side effects

• Hives, angioedema including hypersensitivity reactions → severe allergic reactions
• Severe swelling
• Chest tightness
• Difficulty breathing, shortness of breath
• Asthma attack
• Respiratory abnormalities accompanied by cough and fever
• Yellowing of skin or eyes (jaundice)
• Severe malaise
• Severe skin reactions (severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes accompanied by high fever)
• Stevens-Johnson syndrome

Mild side effects

Headache, dizziness, constipation, nausea, stomach pain, itching, rash, myalgia, weakness, hematuria, diarrhea, chest pain, cough, joint pain, fatigue, numbness, paresthesia, discomfort in the chest, loss of appetite, abdominal fullness, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disturbances (including insomnia and nightmares), sexual dysfunction, gynecomastia, memory decline, forgetfulness, amnesia, memory loss

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is safe to store at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/PTP[(15 tablets/PTP x 2 pieces)]