Rosuvastatin Calcium 10mg Tablets

Adult dosage

The initial dose is 5 mg once daily, which can be adjusted to higher maintenance doses if greater reductions in LDL cholesterol are needed. The maintenance dose is usually 10 mg once a day, and most patients are controlled at this dosage. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. Dosage should be adjusted based on the individual treatment goals recommended for each patient.

This medication should not be administered to certain patients. For instance, it should not be used in patients who are allergic to it, have severe liver dysfunction, have muscle diseases, are taking certain immunosuppressants, have severe renal impairment, are pregnant or breastfeeding, and in fertile women who do not use adequate contraception. Additionally, the high-dose administration of this medication is prohibited for patients with a high risk of myopathy or rhabdomyolysis. Risk factors include moderate renal impairment, hypothyroidism, family history of muscle disease, and alcohol abuse. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should avoid it. Caution should be exercised when administering this medication to patients with abnormal liver function or those who consume alcohol excessively, and it is advisable to repeat liver enzyme tests before and during treatment. If symptoms such as myalgia, muscle weakness, or cramps occur, inform healthcare professionals immediately, and if necessary, check for muscle damage through blood tests. If symptoms are severe or blood test values are high, medication administration may need to be discontinued. Caution is also necessary for patients with acute severe illness or at risk of worsening renal failure, and the administration should be stopped if severe myasthenia gravis or ocular myasthenia occurs. This medication may interact with other drugs; therefore, it should be used with caution, especially when combined with specific antivirals, immunosuppressants, antifungals, antibiotics, and fibrates, as the risk of muscle damage may increase. Women who are pregnant or breastfeeding should not use this medication, and fertile women must ensure adequate contraceptive measures. In cases of overdose, there is no specific antidote, so treatment should be symptomatic, including liver function and muscle enzyme tests. Dizziness may occur during medication use; thus, caution should be observed when driving or operating machinery. Finally, rare but serious skin reactions, liver damage, neurological symptoms, and muscle inflammation may occur, so if any abnormal symptoms appear, consult healthcare professionals immediately.

Serious side effects

Allergic reactions including urticaria and angioedema, severe allergic reactions, severe swelling (edema), chest tightness, difficulty breathing, respiratory distress, respiratory problems, jaundice, liver dysfunction, hepatitis, Stevens-Johnson syndrome, severe skin reactions, immune-mediated necrotizing myopathy, rhabdomyolysis, serious neurological symptoms, severe myasthenia gravis, ocular myasthenia, severe edema or urination abnormalities, acute renal failure, oliguria, elevated blood creatinine levels

Mild side effects

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is also advisable to avoid extremely hot or cold places, maintaining a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink, round, film-coated tablet

Package unit

PTP - 28 tablets/PTP