Rosumax Tablet 10mg (Rosuvastatin Calcium)

Adult dosage

The initial dose is 5mg once daily; if more LDL-cholesterol lowering is needed, the maintenance dose can be adjusted. The maintenance dose is 10mg once daily, and most patients are adjusted at this dose. The maintenance dosage can be appropriately adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and the patient's response, up to a maximum of 20mg daily.

Children's dosage

The usual dosage range is 5mg to 20mg once daily. The dosage should be individually adjusted according to the recommended treatment goals for each patient. Maintenance doses should be adjusted at intervals of 4 weeks or more.

This drug should not be administered to certain patients. For example, individuals allergic to this drug's components, those with severely impaired liver function, those with muscle diseases, those with significantly reduced kidney function, pregnant or nursing women, and fertile women who do not use effective contraception should not use this medication. Additionally, high doses of this drug are contraindicated in patients at risk of muscle diseases or rhabdomyolysis, and those with these risk factors should have careful evaluation and continuous monitoring before using this drug. Patients with a history of liver disease or excessive alcohol consumption should undergo liver function tests before starting this medication and receive regular liver enzyme tests during treatment. This medication can cause muscle pain, myopathy, and occasionally severe muscle rupture known as rhabdomyolysis; if symptoms such as muscle pain, weakness, or cramps arise during treatment, healthcare professionals should be notified immediately. This medication can also cause side effects such as liver function abnormalities, increased blood glucose, and rarely severe skin reactions, so any unusual symptoms should be discussed with a doctor immediately. Drug interactions may occur when used together with other medications, potentially increasing the blood concentration of this drug; therefore, it is crucial to inform the doctor or pharmacist of any co-administered medications, and some drugs should be avoided in combination. Women who are pregnant or planning to become pregnant should avoid taking this drug, and if pregnancy is confirmed during treatment, it should be discontinued immediately, and nursing mothers should also avoid using this medication for safety. There are no specific antidotes for overdose, so appropriate treatment and testing for liver function and muscle enzymes are needed based on symptoms. Caution is required when driving or operating machinery as dizziness may occur. This drug may present higher systemic exposure in Asians; therefore, dose adjustments may be necessary. Overall, this drug should be taken with careful observation of liver and muscle health, and it is essential to consult healthcare providers immediately in case of side effects.

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe renal failure, liver disease, rhabdomyolysis, severe allergic reactions, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, severe skin reactions, liver abnormalities (jaundice), severe neurological symptoms, edema, urination abnormalities, renal impairment, peripheral neuropathy, severe muscle weakness, respiratory distress, ocular muscle weakness, thrombocytopenia, jaundice, hepatitis

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• muscle pain
• weakness
• hematuria
• diarrhea

Store this medication in a tightly closed container to protect it from air and moisture. It is best to keep the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP x 2 packs)