Rosustine 10 mg (Rosuvastatin Calcium)

Adult dosage

The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily, with most patients being adjusted to this dosage. The maintenance dosage should be appropriately adjusted based on LDL cholesterol levels, therapeutic targets, and patient response at intervals of 4 weeks or more, with a maximum daily increase to 20 mg possible. Elderly patients do not require dosage adjustment.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 mg to 20 mg once daily. The dosing should be adjusted according to the recommended therapeutic target for individual patients.

This medication should not be administered to certain patients. It should not be used by those allergic to any of its components, those with severely impaired liver function, individuals with muscle diseases, those taking certain immunosuppressants, patients with severe kidney impairment, pregnant or breastfeeding women, and fertile women who are not using appropriate contraception. High doses of this medication are particularly contraindicated for individuals at high risk of muscle disease. This medication contains lactose and should not be used by individuals with lactose intolerance or certain genetic metabolic disorders. This medication should be used with caution in individuals with a history of liver disease or those who consume alcohol excessively; it is recommended to repeat liver function tests before and during treatment. Patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome should first treat the underlying condition before taking this medication. Muscle-related side effects such as myalgia or muscle weakness have been reported, and patients should immediately notify their healthcare provider if muscle pain or weakness occurs, and undergo necessary testing. Patients with muscle-related risk factors should carefully consider the risks and benefits of treatment and be closely monitored for muscle symptoms during treatment. This medication should be discontinued in states where there is a risk of acute severe illness or worsening renal failure. The risk of muscle toxicity may increase when used in combination with certain specific medications, so patients should discuss concurrent medications with their healthcare provider. This medication may affect kidney function, and renal function testing may be necessary when used at higher doses. In Asians, the drug concentrations may appear higher, so caution is needed when determining the dose. In pediatric and adolescent patients, the impact on growth and sexual maturation has been limitedly assessed, so caution should be exercised. This medication contains certain dyes, and patients with allergic reactions should be cautious. Side effects may include headache, dizziness, dyspepsia, myalgia, and abnormal liver function, which are usually temporary and mild. However, rare but serious skin reactions or liver damage, muscle damage may occur, so any unusual symptoms should be reported to a healthcare provider immediately. This medication should not be used during pregnancy or while breastfeeding, and women of childbearing potential should use appropriate contraceptive methods. In the case of overdose, there is no specific antidote, and treatment should be symptomatic along with testing liver and muscle function. Caution is advised when driving or operating machinery, as dizziness and other symptoms may occur. Before taking this medication, patients must consult with their healthcare provider to inform about current medications and health conditions, and undergoing regular check-ups for safe treatment is important.

Serious side effects

Hypersensitivity reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, jaundice, hepatitis, acute renal failure, oliguria, severe edema, tightness in the chest, difficulty breathing, respiratory abnormalities with cough and fever, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice), serious neurological symptoms, severe edema.

Mild side effects

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

This medication should be stored in a tightly closed container to prevent contact with air and moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a longer period.

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP × 2 packs)