Rosuvastatin Calcium Tablets 5mg

Adult dose

This medication can be administered at any time of the day, irrespective of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer, with a maximum allowable increase to 20 mg daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the usual dosage range is 5 mg to 20 mg taken once daily. Dosage should be adjusted at intervals of 4 weeks or longer.

This medication should not be used in certain patients. For example, patients who are allergic to any component of this medication, have liver problems, have muscle diseases, or have severe renal impairment should not take this medication. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraceptive methods to reduce the likelihood of pregnancy. Additionally, high-dose administration is contraindicated in patients at high risk for muscle-related diseases. This medication may affect liver function; therefore, patients with a history of liver disease or those who consume alcohol excessively should regularly undergo liver function tests before and during treatment. Patients with hypothyroidism or nephrotic syndrome should treat the underlying condition before using this medication. If symptoms such as muscle pain or weakness occur, inform a doctor immediately, and if necessary, check for muscle damage through blood tests. If muscle-related adverse symptoms are severe, discontinuation of the medication may be considered. This medication may interact with certain drugs, so patients taking other medications should inform their doctor or pharmacist. When taken together with specific medications, the concentration of this medication may increase, raising the risk of side effects. It is important not to use this medication if you are pregnant or breastfeeding, as safety has not been established; women planning to become pregnant must consult before use. In case of overdose, special antidotes are not available, and treatment to manage symptoms is needed, while closely monitoring liver function and muscle enzyme levels. This medication does not significantly affect driving or machinery operation, but caution is advised as dizziness may occur. Lastly, this medication contains lactose, so patients with lactose intolerance should not take it, and in Asian patients, drug concentrations may appear higher, so dosage adjustments may be necessary.

Serious side effects

Hypersensitivity reactions including angioedema, hives, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, eosinophilia with systemic symptoms associated with drug reaction with eosinophilia and systemic symptoms (DRESS), severe muscle weakness, ocular muscle weakness, rhabdomyolysis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, interstitial lung disease, jaundice, hepatitis, severe cutaneous adverse reactions, serious allergic reactions, severe

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash
• and hives
• muscle pain
• weakness

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance

Yellow circular film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging × 2)