Rosuvastatin Calcium 10 mg (Rosuvastatin Calcium (unmicronized))

Adult dose

This medication is an orally disintegrating tablet that is placed on the tongue to dissolve and taken without water. The initial dosage is 5 mg once daily, and if more reduction of LDL cholesterol is necessary, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily, which is sufficient for most patients. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer.

Child dose

This medication is an orally disintegrating tablet that is placed on the tongue to dissolve and taken without water. For pediatric patients aged 10 to 17 years, it is administered once daily within a range of 5 mg to 20 mg. The dosage is adjusted individually according to the patient's condition.

This medication should not be administered to certain patients. For instance, it is contraindicated in patients with allergies to its components, severely impaired liver function, muscle diseases, and women who are pregnant or breastfeeding. Additionally, it should be avoided in patients with severely impaired kidney function, those with certain immunological disorders, or those taking specific medications. Care is particularly needed in cases of high-dose administration due to the increased risk of muscle damage. Liver function tests should be regularly conducted before and during treatment to monitor liver health, and any underlying causes for hypercholesterolemia should be treated before starting this medication if it is due to other conditions. Symptoms such as myalgia, muscle weakness, and muscle damage can occur, and if these symptoms appear, immediate consultation with a healthcare provider is essential. Especially if muscle symptoms are severe or if blood tests indicate high markers of muscle damage, discontinuation of the medication may be necessary. Patients who consume alcohol excessively, elderly patients, and those with certain genetic predispositions should also be cautious when taking this medication. Furthermore, this medication may interact with other drugs, so it is crucial to inform healthcare providers if other medications are being taken. Women of childbearing potential should use appropriate contraception while taking this medication, and if pregnancy is confirmed, discontinuation should occur immediately. Breastfeeding women are also advised against using this medication. In case of overdose, as there is no specific antidote, treatment should be symptom-dependent and monitoring of liver function and muscle damage should be conducted. Lastly, although there have been no reports that this medication directly affects driving or operating machinery, caution is advised as symptoms like dizziness may occur.

Serious side effects

Urticaria, angioedema, severe edema (swelling), chest tightness, difficulty breathing, Stevens-Johnson syndrome, jaundice, hepatitis, severe skin reactions, acute kidney injury, oliguria, increased serum creatinine, rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy, polyneuropathy, amnesia, peripheral neuropathy, severe muscle weakness, ocular myasthenia, severe neurological symptoms (e.g. seizures, confusion, visual disturbances, paralysis

Mild side effects

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage at room temperature between 1 and 30 degrees Celsius. Proper storage will safely maintain the effectiveness of the drug.

Appearance

White to yellowish round orally disintegrating tablets

Package unit

28 tablets/box [14 tablets/PTP × 2]