Rosutinem Tablets 10mg (Rosuvastatin Calcium)

Adult dosage

The initial dose is 5 mg once daily. The maintenance dose is usually adjusted to 10 mg once daily for most patients, with appropriate adjustments made based on LDL-cholesterol levels and treatment goals at intervals of 4 weeks or more. The maximum dose can be increased to 20 mg once daily. The recommended initial dose for Asian patients is 5 mg, and dosing of 40 mg is contraindicated. Elderly patients and those with mild to moderate renal impairment do not need a dose adjustment.

Children's dosage

The usual dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is between 5 mg and 20 mg once daily. The dose should be adjusted based on the individual treatment goals of each patient.

This medication should not be used in certain patients. For example, it is contraindicated in patients with allergies to its ingredients, severely impaired liver function, muscle disorders, those taking certain immunosuppressants, patients with severe renal impairment, and women who are pregnant or breastfeeding, as well as those at high risk for muscle disorders. This drug contains lactose and certain colorants, so patients with lactose intolerance or allergies to specific colorants should take caution. Patients with a history of alcohol consumption or liver disease should undergo liver function tests before taking this drug and continue regular testing during treatment. Muscle pain, muscle weakness, and rarely severe muscle damage such as rhabdomyolysis may occur, so these symptoms should be reported to healthcare professionals immediately, and muscle damage should be monitored through blood tests. Particular attention should be paid to patients with decreased renal function, hypothyroidism, the elderly, and those with alcohol abuse, as they may be more susceptible to muscular adverse reactions. This drug can affect liver function, so if symptoms of liver dysfunction or abnormal test results occur, consult a healthcare professional immediately. Rarely, this drug may cause severe skin reactions or allergic reactions, so if symptoms such as rash, itching, or swelling occur, use should be discontinued immediately, and a hospital visit is necessary. This drug can interact with other medications, so if other medications are being taken, it is imperative to inform healthcare professionals, especially when combined with certain antivirals, immunosuppressants, antibiotics, and fibrates. Women who are pregnant or planning to become pregnant should consult with healthcare professionals before taking this drug and should use appropriate contraception. In case of overdose, there is no specific antidote, so contact a healthcare professional immediately for appropriate treatment and testing. Be cautious of dizziness that may occur while driving or operating machinery during the course of this medication. This medication is also used in children and adolescents, but growth and development should be regularly monitored.

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, severe swelling (edema), chest tightness, breathing difficulties, dyspnea, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia and systemic symptoms drug reaction syndrome (DRESS), immune-mediated necrotizing myopathy, rhabdomyolysis, acute renal failure, oliguria, severe edema, severe muscle weakness, ocular myasthenia, serious liver damage, fatal and non-fatal liver failure, cardiac

Mild side effects

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

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature. This will ensure the effectiveness of the medication is safely preserved.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP) X 3], 30 tablets/bottle