Dongseong Rosuvastatin Tablets 5 mg (Rosuvastatin Calcium)

Adult dosage

Administer 5 mg once daily as the initial dose at any time during the day, irrespective of meals. If a greater reduction in LDL cholesterol is needed, the dose can be adjusted to a maintenance dose of 10 mg once daily. The maintenance dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient responses at intervals of 4 weeks or more, with the maximum dose up to 20 mg daily.

Children's dosage

The usual dosage range for pediatric patients aged 10 to 17 is 5 mg to 20 mg once daily. The dosage should be adjusted according to individual treatment goals with an interval of 4 weeks or more. For children under 10 years of age, safety and efficacy have not been established.

This medication should not be used in certain patients. For example, patients who are allergic to this drug, have severely impaired liver function, have muscle disorders, have severe renal impairment, or are pregnant or breastfeeding should avoid its use. Additionally, the risk of muscle-related side effects may increase when used with certain medications, so caution is needed when administering it concurrently. Patients who consume excessive alcohol or have a history of liver disease should undergo liver function tests before starting this medication and should have regular checks during treatment. If symptoms such as muscle pain or weakness occur, the doctor should be notified immediately, and blood tests should be performed to check for muscle damage if necessary. This medication contains lactose and is not suitable for patients with lactose intolerance. High doses may affect renal function; therefore, renal function tests are recommended for patients on high doses. If severe skin reactions or allergy symptoms occur during treatment, the medication should be stopped immediately, and a healthcare provider should be consulted. Women who could become pregnant should use appropriate contraceptive methods and should not use this medication during pregnancy. There is no specific antidote for overdose, so treatment should be symptomatic, and liver and muscle function tests are necessary. This medication may cause dizziness, so caution is advised when driving or operating machinery. Lastly, the effectiveness and side effects of this medication may vary according to certain genetic factors, and dose adjustments may be required based on the patient's condition.

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe allergic reactions, neurological symptoms (rarely including polyneuropathy, forgetfulness, peripheral neuropathy), dyspnea, interstitial lung disease, rhabdomyolysis, acute renal failure, oliguria, increased serum creatinine, severe edema, immune-mediated necrotizing myopathy

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is recommended to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

Pink round film-coated tablets

Package unit

30 tablets (15 tablets/PTP(AluAlu)*2), 30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle