Rovatarin 5 mg (Rosuvastatin Calcium)

Adult dosage

The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, the maintenance dose can be titrated. The maintenance dose is usually 10 mg once daily, and most patients are adjusted to this dose. The maintenance dose should be suitably adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, and can be increased to a maximum of 20 mg per day.

Children's dosage

The typical dosage range is 5 mg to 20 mg once daily. The administered dose should be individually adjusted according to the recommended treatment goals in each patient. Dosage adjustments should be made at intervals of 4 weeks or more.

This medication should not be used in certain patients. For example, it should not be administered to those who are allergic to its components or have severely impaired liver function, muscle diseases, severe renal function impairment, are pregnant or breast-feeding women, or fertile women who do not use appropriate contraception. In addition, high-dose use of this medication is prohibited in patients at high risk for muscle-related diseases, which include moderate or severe renal function impairment, hypothyroidism, a history of genetic muscle diseases, and alcohol dependence. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should avoid taking it. Liver function and muscle status should be regularly monitored during the administration of this medication, especially in patients with a history of excessive alcohol intake or liver disease. If symptoms like muscle pain, weakness, or cramps occur, immediate notification to healthcare professionals is necessary, and the use of this medication may need to be stopped if required. In situations where there is a risk of acute severe condition or renal failure deterioration, administration of this medication should be discontinued. This drug can, though rarely, cause severe muscle weakness and ocular myasthenia, so if these symptoms occur, discontinuation of the drug is crucial. Coadministration with certain other medications may increase the risk of muscle toxicity, so consultation with a healthcare professional is recommended when using concomitant medications. Regular renal function tests are recommended for patients on high doses. As drug exposure may be higher in Asian patients, dose adjustments may be needed. For pediatric and adolescent patients, limited impacts on growth and maturation have been reported, so careful observation is needed. Rarely, during treatment with this drug, abnormal reactions such as skin rashes, allergic reactions, liver function abnormalities, and increased risk of developing diabetes may occur. Women who are pregnant or planning to become pregnant must consult healthcare professionals and use appropriate contraception, and discontinue the medication immediately if pregnancy is confirmed. In case of overdose, there are no specific antidotes, and treatment should be symptom-based with monitoring of liver function and muscle enzymes. Caution is necessary while driving or operating machinery, as dizziness may occur. Rare side effects such as interstitial lung disease have been reported with long-term use of this medication, so immediate medical attention is required if symptoms like dyspnea or persistent coughing appear. It is important to consult with a professional immediately upon any adverse symptoms while taking this medication.

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, jaundice, hepatitis, severe skin rash and blisters with high fever, severe allergic reactions, severe skin adverse reactions, difficulty breathing, dyspnea, severe muscle weakness, ocular myasthenia, rhabdomyolysis, polyneuropathy, exacerbation of severe renal failure, acute renal failure, oliguria, severe edema, headache, thunderclap headache, seizures, confusion, visual disturbances, coma.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, diarrhea, discomfort in the chest, loss of appetite, abdominal distension, fatigue, numbness, paresthesia, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, memory loss, peripheral neuropathy, cough, thrombocytopenia, hepatitis, increased transaminases, eosinophilia, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy.

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets (15 tablets/PTP x 2)