Rosuvastatin Calcium Tablets 5 mg (Undifferentiated)

Adult dose

Adult patients with primary hypercholesterolemia, etc., take an initial dose of 5 mg once daily at any time of day, regardless of meals. The maintenance dose is 10 mg once daily, with appropriate adjustments based on LDL-cholesterol levels and therapeutic goals at intervals of 4 weeks or more, with a maximum possible increase to 20 mg per day.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the dosage ranges from 5 mg to 20 mg taken once daily and adjusts based on therapeutic goals. Dosage adjustments should be made every 4 weeks.

This medication should not be used in specific patients. For example, it should not be administered to patients with allergies to any component of this medication, severe liver impairment, muscle disorders, patients taking certain immunosuppressants, patients with severely impaired kidney function, or women who are pregnant or breastfeeding. Moreover, high-dose administration is prohibited in patients at increased risk of muscle disorders. This medication contains lactose, so patients with lactose intolerance should not take it. This medication can affect liver function and muscles, therefore patients who consume a lot of alcohol or who have a history of liver disease should be cautious. It is recommended to repeatedly check liver enzymes before and during administration to monitor liver status. Symptoms such as muscle pain, weakness, or cramps should be reported to healthcare providers immediately, and if necessary, the medication should be discontinued. Patients at risk of serious muscle damage, such as those with kidney impairment, hypothyroidism, a history of muscle disorders, the elderly, or those who abuse alcohol should be closely monitored for muscle status before and after treatment. This medication can rarely cause serious skin reactions or liver damage; therefore, if symptoms like skin rashes or jaundice occur, the medication should be stopped immediately and a physician consulted. This medication can interact with other drugs, so if other medications are being taken, it is essential to inform the doctor or pharmacist. In particular, concomitant use with some antiviral agents, immunosuppressants, certain antibiotics, and fibrate-class medications may increase the risk of muscle damage. Women who are pregnant or planning to become pregnant should not take this medication and should use appropriate contraception. Similarly, its use is not recommended during breastfeeding. In the case of overdose, there are no specific antidotes, so treatment should be symptom-based, and liver function and muscle enzyme levels should be monitored periodically. This medication does not significantly affect the ability to drive or operate machinery; however, caution should be exercised as dizziness may occur rarely. Finally, this medication may present higher serum concentrations in Asians, necessitating potential dosage adjustments.

Serious side effects

Allergic reactions including hives and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, severe muscle weakness, dyspnea, ophthalmoplegia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute renal failure, oliguria, liver failure, severe edema, severe allergic reactions, severe skin abnormalities

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets (10 tablets/PTP × 3)