Roxva Tablet 10mg (Rosuvastatin Calcium)

Adult dosage

For adult patients with primary hypercholesterolemia, this medication can be administered at any time without regard to meals. The initial dose is 5 milligrams once daily, and the maintenance dose is typically 10 milligrams once daily, with most patients regulated at this dosage. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, up to a maximum of 20 milligrams daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the typical dosage range is 5 to 20 milligrams once daily. The dosing should be adjusted based on the individual therapeutic goals recommended for each patient.

This medication should not be used by patients who are allergic to specific components. Patients with active liver disease or significantly elevated liver enzymes should not take this medication. Patients with muscle disease or muscle problems should avoid this drug, and patients with certain autoimmune diseases should also exercise caution. Patients taking cyclosporine or those with severely impaired kidney function should preferably not use this medication. Women who are pregnant or breastfeeding, as well as fertile women not using appropriate contraception, should not take this medication, and women of childbearing age may use it only if they are fully aware of the risks of pregnancy and fetal hazards. Patients at high risk for muscle diseases, such as moderate renal impairment, hypothyroidism, genetic history of muscle disease, alcohol dependence, Asians, and patients receiving fibrate medications should avoid high doses. This medication contains lactose and should not be taken by patients with lactose intolerance or related genetic conditions. Patients with a history of liver disease or who consume alcohol excessively should undergo regular liver function tests, and those with hypothyroidism or nephrotic syndrome should take this medication only after treating the underlying conditions. Muscle-related symptoms such as myalgia or myopathy, and in severe cases, rhabdomyolysis, may occur, so if any muscle-related symptoms appear, the patient should immediately notify a physician and undergo testing. In particular, if muscle enzyme levels rise significantly, the medication should be discontinued, and re-administration at a lower dose may be considered once symptoms and levels return to normal. In acute severe conditions, the administration of this medication should be stopped, and it should not be used if symptoms of severe myasthenia gravis or ocular myasthenia gravis are present, as it may exacerbate these conditions. Caution is also needed, especially when used in combination with certain medications, as there may be a higher risk of muscle-related side effects, particularly with gemfibrozil. Kidney function tests may be necessary with high-dose use. Asian patients may have higher concentrations of the medication, so dosage adjustment may be required. In children and adolescents, the evaluation of effects on growth and development is limited, so caution is advised. This drug may cause mild side effects such as headache, dizziness, gastrointestinal discomfort, rash, myalgia, weakness, hematuria, diarrhea, joint pain, fatigue, numbness, sensory disturbances, chest discomfort, decreased appetite, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, memory loss, peripheral neuropathy, cough, thrombocytopenia, increased transaminases, hepatitis, drug rash resembling lichen planus, lupus-like syndrome, muscle rupture, arthralgia, depression, sleep disturbances, and others. Rarely, severe liver damage, muscle diseases, severe skin reactions, and other abnormal symptoms may occur, so if any unusual symptoms appear, immediate consultation with healthcare personnel is essential. The medication should not be used during pregnancy or breastfeeding, and women planning pregnancy should use appropriate contraception. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle enzyme tests may be necessary. Caution is required when driving or operating machinery due to potential dizziness. This drug may interact with many other medications, so if taking other drugs, it is essential to consult with a physician or pharmacist. Particular caution is advised when used in combination with specific antiviral agents, immunosuppressants, antifungals, antibiotics, and fibrate medications.

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, jaundice, extreme fatigue, severe edemas, significantly reduced urine output, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, Stevens-Johnson syndrome, eosinophilia and systemic symptom drug reaction syndrome,

Mild side effects

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

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is recommended to keep it at room temperature between 1°C and 30°C. Storing it this way will maintain the effectiveness and safety of the medication.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle