Donghwa Rosuvastatin Tablets 10 milligrams (Rosuvastatin Calcium)

Adult dosage

This medication can be administered once daily at any time, regardless of meals. The initial dose is 5 milligrams once daily, and if greater reduction in LDL cholesterol levels is needed, it can be adjusted to a maintenance dose. The maintenance dose, which most patients are adjusted to, is 10 milligrams once daily. The maintenance dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Children's dosage

The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted according to the treatment goals recommended for individual patients.

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to any of its components, severely impaired liver function, muscle diseases, or severe renal disease. Women who are pregnant or breastfeeding, as well as fertile women not using appropriate contraception, should not use this medication. It can only be administered to women who might become pregnant if the potential risks to the fetus and the lack of probability to become pregnant are thoroughly explained. Additionally, a high dosage is contraindicated in patients at high risk for myopathy or rhabdomyolysis, as well as in patients with moderate to severe renal impairment, hypothyroidism, family history of such conditions, alcoholics, and Asian patients who should use caution when using this medication. This medication contains lactose, so it should not be given to patients with lactose intolerance or related genetic issues. Patients taking this medication should have regular liver function tests and muscle-related examinations, and report any symptoms such as muscle pain, weakness, fatigue, or fever to a healthcare professional immediately. Particularly, when used in combination with other medications, the risk of muscle damage may increase, so patients should discuss any concomitant medications with their healthcare provider. This medication may rarely cause severe skin reactions or liver damage, so if symptoms like rash, jaundice, or severe fatigue occur, patients should stop taking it immediately and consult a physician. Pregnant or breastfeeding women should not use this medication, and women planning to become pregnant should ensure appropriate contraception. In case of overdose, there are no specific antidotes, so treatment should be based on symptoms, and liver function and muscle enzyme levels should be monitored. Dizziness may occur during treatment, so caution should be exercised when driving or operating machinery. Finally, this medication may show higher plasma concentrations in Asians, so dosage adjustments may be necessary.

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, severe swelling, chest tightness, breathing difficulties, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver failure, acute renal failure, anuria, severe edema, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms, severe edema or urinary abnormalities, rhabdomyolysis

Mild side effects

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

This medication should be stored in a tightly sealed container to keep air and moisture out, at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its efficacy.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/PITP[15 tablets/PTPX2]