Donghwa Rosuvastatin 5 mg Tablet (Rosuvastatin Calcium)

Adult dosage

This drug can be administered at any time during the day regardless of meals. The initial dose is 5 mg once daily. The maintenance dose is 10 mg once daily, and most patients are managed at this dose. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response and can be increased to a maximum of 20 mg once daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17): The usual dose range is 5 mg to 20 mg once daily. Dosage should be adjusted at intervals of 4 weeks or more.

This drug should not be used in certain patients. For instance, those who are allergic to this medication, have active liver disease, suffer from myopathy, or have severe kidney dysfunction should not take this drug. Women who are pregnant, breastfeeding, or may become pregnant should consult their doctor before use. Additionally, individuals with a history of muscle disorders or moderate to severe kidney dysfunction should avoid high doses, and those with genetically sensitive conditions to lactose contained in this medication should also refrain from use. This drug can affect liver function, so patients with a history of liver disease or those who consume alcohol heavily should have liver function tests before and regularly during treatment. If symptoms of muscle pain or weakness occur, they should immediately inform their healthcare provider, and in severe cases, discontinuation of the drug may be necessary. This drug may interact with other medications, so any other medications being taken should be disclosed to healthcare providers. Especially, when used in combination with certain antiviral drugs, immunosuppressants, antifungal agents, and fibrate drugs, the risk of muscle-related side effects may increase. Pregnant and breastfeeding women should not take this medication, and women who may become pregnant should use appropriate contraceptive measures. In the case of overdose, there is no specific antidote, so immediate medical attention should be sought for proper treatment, and liver function and muscle enzyme levels should be monitored. Lastly, this medication may cause dizziness, so caution is advised when driving or operating machinery.

Serious side effects

Angioedema and hypersensitivity reactions including urticaria, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, memory loss, peripheral neuropathy, severe muscle weakness, dyspnea, ocular myasthenia, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, hematuria, edema, acute renal failure, oliguria, elevated blood creatinine

Mild side effects

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

This medication should be stored in a sealed container to protect it from air and moisture. It is important to keep the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow, round, film-coated tablets

Package unit

30 tablets/PTP [15 tablets/PTP X 2]