Rostazen Tablets 10mg (Rosuvastatin Calcium)

Adult dose

Administer once daily at any time of the day, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to the maintenance dose as needed. The maintenance dose is typically 10 mg once daily, adjusted based on LDL cholesterol levels, treatment goals, and patients' responses every 4 weeks or longer. The maximum dose is 20 mg daily.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual treatment goals over a period of at least 4 weeks.

This medication should not be used in certain patients. For example, patients who are allergic to this medication, those with severe liver dysfunction, those with muscle-related diseases, and patients with severe kidney impairment should not take this medication. Pregnant or nursing women should not use this medication, and women of childbearing age should only take it if they are confident that they are highly unlikely to become pregnant. Patients at high risk of muscle disorders should especially avoid high doses, and those with certain genetic lactose intolerance should avoid this medication due to its lactose content. Before starting or during treatment, regular liver function tests should be performed, and extra caution is needed for individuals who consume large amounts of alcohol or have a history of liver disease. If symptoms such as myalgia, muscular weakness, or cramps occur, it is important to inform a physician immediately, and muscle enzyme tests should be conducted to monitor the condition. This medication may interact with other drugs, so it is essential to consult with a physician or pharmacist if other medications are being taken. Particularly, when combined with some antiviral agents, immunosuppressants, or fibrates, the risk of muscle damage may increase. Headaches, dizziness, dyspepsia, skin rashes, and myalgia have been relatively commonly reported in clinical trials and post-marketing studies, and there is a rare risk of severe liver damage or serious skin reactions, so any unusual symptoms should be reported to a medical professional immediately. In case of overdose, there is no specific antidote, so immediate medical attention should be sought for symptomatic treatment, and monitoring of liver function and muscle enzyme levels is required. The effect of this medication on driving or operating machinery is unclear, but caution is advised due to possible dizziness. Finally, this medication may have higher blood concentrations in Asians, so care should be taken when determining the dosing.

Serious side effects

Allergic reactions including hives and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, severe muscle weakness, dyspnea, ophthalmoplegia, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, increased transaminases, immune-mediated necrotizing myopathy, severe skin reactions

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It should also be stored at room temperature between 1°C and 30°C, away from extremely hot or cold areas.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle