Subaroadi Tablet 5 mg (Rosuvastatin Calcium (Unformulated))

Adult dose

This medication is an orally disintegrating tablet that should be placed on the tongue to dissolve and taken without water. The initial dose is 5 mg once daily, and the maintenance dose can be adjusted if greater LDL cholesterol reduction is needed. Most patients are controlled at a maintenance dose of 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, therapeutic goals, and patient response, with intervals of 4 weeks or more.

Child dose

This medication is an orally disintegrating tablet that should be placed on the tongue to dissolve and taken without water. The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily.

This medication should not be used in certain patients. For example, patients who are allergic to any component of this drug, those with severe liver impairment, and individuals with muscle disorders should not take this medication. Additionally, patients with severely impaired kidney function, as well as pregnant or nursing women, should not take this drug. Women of childbearing potential can only use this drug if they are highly unlikely to become pregnant and fully understand the risks to the fetus. Patients susceptible to muscle disease, such as those with moderate kidney impairment, hypothyroidism, a family history or genetic history of muscle disorders, or those who consume large amounts of alcohol should avoid high doses of this medication. This medication should be used cautiously in patients with a history of liver disease or excessive alcohol intake, and regular liver function tests before and during treatment are recommended. Muscle-related side effects, such as myalgia, myopathy, and rarely rhabdomyolysis, may occur, so any unusual symptoms related to muscles should be reported to healthcare professionals immediately. Especially if muscle pain is accompanied by fatigue or fever, prompt testing is necessary. In cases of acute renal failure or serious medical conditions, the use of this medication should be discontinued. Moreover, this medication can rarely cause severe muscle weakness or ophthalmoplegia, so if such symptoms occur, discontinue use immediately. This medication can interact with several other drugs, so inform healthcare professionals if you are taking other medications. In particular, co-administration with certain antiviral drugs, immunosuppressants, or fibrates can increase the risk of muscle side effects. When taking high doses, regular tests of kidney function are necessary, and Asian patients may need dosage adjustments due to increased systemic exposure. While on this medication, blood sugar levels can rarely increase or the risk of diabetes may rise, so patients with diabetes risk factors should regularly monitor their blood sugar. Pregnant or nursing women should not take this medication, and women of childbearing potential should use appropriate contraception, as this drug may harm the fetus or infant. In the event of overdose, there is no specific antidote, so treatment must be symptomatic, along with liver function and muscle enzyme testing. Dizziness may occur when driving or operating machinery, so caution is advised.

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, allergic reactions, severe rash accompanied by fever, blisters, desquamation, oral/ocular mucosal pain, Stevens-Johnson syndrome, jaundice, severe liver damage, hepatitis, acute kidney failure, oliguria, thrombocytopenia, increased blood creatinine, severe edema, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice), severe

Mild side effects

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

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

Appearance

White to yellowish round orally disintegrating tablet

Package unit

30 tablets/box [10 tablets/PTP × 3], 10 tablets/box [10 tablets/PTP × 1]