Rosuvastatin Calcium 10 mg Tablets

Adult dosage

Patients with primary hypercholesterolemia, mixed dyslipidemia, or dysbetalipoproteinemia should start at 5 mg once daily, at any time regardless of meals, and can be dosed at intervals of 4 weeks or longer up to 10 mg once daily if necessary. A maximum dose of 20 mg once daily can be reached.

Children's dosage

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) should receive between 5 mg and 20 mg once daily, adjusted individually, with titration at intervals of 4 weeks or longer.

This drug should not be used in certain patients. First, it must not be administered to patients who have allergies to its ingredients, severe liver dysfunction, muscle diseases, or severe kidney diseases. Pregnant or nursing women, or women of childbearing potential who are not using appropriate contraception should avoid using this drug. Additionally, patients at high risk for myopathy or rhabdomyolysis, such as those with poor kidney function, hypothyroidism, and those who have previously experienced muscle toxicity reactions, are prohibited from taking this medication in high doses. This drug contains lactose, thus, it should not be administered to patients with lactose intolerance or certain genetic metabolic disorders. When taking this drug, liver function and muscle status should be periodically monitored, especially in patients who consume large amounts of alcohol or have a history of liver disease. Symptoms such as muscle pain, muscle weakness, and cramps should be discussed with a doctor immediately, and the use of this drug may need to be discontinued if necessary. Furthermore, use of this medication should be discontinued in cases where serious muscle issues or deterioration of kidney function is suspected. Rarely, severe muscle weakness or ocular muscle weakness may occur, and if such symptoms appear, use should be stopped immediately. This drug may increase blood concentrations when taken with certain medications, which can heighten the risk of muscle damage, thus patients should consult their doctor or pharmacist if they are on other medications. Pregnant or nursing women should not use this medication, and women of childbearing age should ensure they use appropriate contraception. In the event of an overdose, there is no specific antidote, so treatment should be symptomatic, monitoring liver function and muscle enzyme levels. This drug is known not to significantly affect driving or machine operating abilities, however, caution is required as dizziness may occur. Lastly, while on this medication, severe skin reactions may arise, so should any symptoms such as skin rash, redness, or swelling occur, medical personnel should be notified immediately.

Serious side effects

Allergic reactions including urticaria, angioedema, rashes and urticaria, rhabdomyolysis, Stevens-Johnson syndrome, eosinophilia and systemic symptoms drug reaction syndrome (DRESS), jaundice, hepatitis, renal failure, acute renal failure, oliguria, difficulty breathing, dyspnea, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, severe allergic reactions, severe skin adverse reactions, severe edema or urinary issues

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• myalgia
• weakness
• diarrhea
• chest discomfort

This drug is sensitive to air and moisture; therefore, it should be stored in a tightly closed container. Additionally, it is important to store it at room temperature between 1 degree and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

Pink round film-coated tablets

Package unit

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