Daewoong Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium (Unmicronized))

Adult dose

The initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily, most patients are adjusted at this dose. The dosage should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or longer, with a maximum daily dose of 20 mg. It can be taken at any time of the day, regardless of meals.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to individual treatment goals.

This medication should not be used in individuals allergic to certain ingredients. Patients with active liver disease or markedly elevated liver enzyme levels should not take this medication. Patients with muscle diseases or muscle-related problems should also avoid this drug. It is not indicated for patients taking cyclosporine or those with severe renal impairment, as well as pregnant or breastfeeding women. Women of childbearing potential should confirm a low likelihood of pregnancy before taking this medication and be fully aware of the risks to the fetus. High-dose use of this drug should be avoided in patients at risk of myopathy or rhabdomyolysis, including those with renal impairment, hypothyroidism, a history of genetic muscle disorders, or alcohol use disorder. This medication contains lactose and should not be given to patients with lactose intolerance or certain genetic metabolic disorders. Patients with a history of liver disease or excessive alcohol consumption should have regular liver function tests, and those with hypothyroidism or nephrotic syndrome should treat the underlying causes first. If symptoms such as myalgia, muscle weakness, or cramps occur, immediate consultation with a physician is required, and blood tests should be conducted if necessary to check for muscle damage. In cases of acute severe conditions or serious illnesses, discontinuation of this medication may be necessary. This medication can rarely induce severe muscle weakness or ocular myasthenia, so it should be stopped if relevant symptoms arise. Caution is needed when co-administered with certain drugs that may increase the risk of muscle damage. Regular kidney function tests are recommended during high-dose administration. Asian patients may have increased drug exposure, necessitating dosage adjustments. This medication is also used in pediatric patients, but any effects on growth and development are limited and require caution. Some patients may experience side effects such as headaches, dizziness, dyspepsia, myalgia, and if symptoms are severe, consultation with a physician is advised. Periodic testing is recommended due to possible liver function abnormalities or changes in kidney function. If there are severe skin reactions or allergic symptoms, immediate discontinuation of the medication and consultation with healthcare providers are necessary. Pregnant or breastfeeding women should not take this medication and should use appropriate contraception if planning for pregnancy. In case of overdose, there is no specific antidote, and treatment is based on symptoms with monitoring of liver and muscle function. This medication does not significantly affect the ability to drive or operate machinery, but caution is warranted as dizziness may occur. There may be drug interactions; therefore, patients should inform healthcare providers of any other medications they are taking.

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myasthenia, hepatitis, jaundice, fatal and non-fatal liver failure, acute renal failure, oliguria, thrombocytopenia, elevated transaminases, increased serum creatinine, dyspnea, severe allergic 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 is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle