Crelorba Tablet 20 mg (Rosuvastatin Calcium)

Adult dose

Starting at a dose of 5 mg once daily at any time of the day, regardless of food. If necessary, the dose may be increased to 10 mg once daily at intervals of 4 weeks or longer, based on LDL cholesterol levels and treatment targets, and may be titrated up to a maximum of 20 mg once daily.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, a dose of 5 mg to 20 mg is administered once daily. The dosage should be adjusted according to the individual treatment goals at intervals of 4 weeks or longer.

This medication should not be used by individuals who are allergic to certain components. People with active liver disease or unexplained elevated liver enzyme levels should also avoid this medication. Patients with muscle disease or those taking cyclosporine, as well as individuals with severely impaired kidney function, should avoid this medication. Women who are pregnant or breastfeeding and those of childbearing age who are not using adequate contraception should refrain from using this medication. Those at high risk for myopathy or rhabdomyolysis should particularly avoid high doses (40 mg), especially if they have impaired kidney function, hypothyroidism, or family history. This medication contains lactose, thus should not be taken by individuals with lactose intolerance or related genetic disorders. Those who consume alcohol excessively or have a history of liver disease should have regular liver function tests while on this medication. If symptoms such as muscle pain or weakness occur, notify your healthcare provider immediately, and consider discontinuing use as necessary. In cases of acute severe conditions or severe renal failure, discontinue this medication immediately. Rarely, this medication may lead to severe muscle weakness or ocular myasthenia, and it should be halted immediately if symptoms occur. When combined with other specific medications, the risk of muscle-related side effects may increase, so consult with your healthcare provider regarding concomitant medications. High-dose use may lead to temporary proteinuria, which may require kidney function tests. In Asians, the drug concentration may be higher, necessitating dosage adjustments. In children and adolescents, the effects on growth and secondary sexual characteristics should be considered when deciding on use. Adverse reactions such as interstitial lung disease, severe liver damage, and severe skin reactions have been reported rarely; discontinue if unusual symptoms occur and consult a healthcare provider. This medication can interact with certain drugs, so if you are taking other medications, be sure to inform your healthcare provider and exercise caution. Women who are pregnant or planning to become pregnant should avoid this medication and use suitable contraceptive methods. In cases of overdose, there is no specific antidote, and treatment and liver and muscle function tests should be conducted based on symptoms. Caution should be exercised when driving or operating machinery as dizziness may occur. Although no specific cancer risk has been reported with long-term use of this medication, ongoing observation for adverse reactions during treatment is necessary.

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, fatal and non-fatal liver failure, jaundice, hepatitis, severe myasthenia, ocular myasthenia, rhabdomyolysis, immune-mediated necrotizing myopathy, polyneuropathy, peripheral neuropathy, thrombocytopenia, edema, severe allergic reactions, severe skin reactions, respiratory distress, difficulty breathing

Mild side effects

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

This medication should be stored in a sealed container to protect it from air and moisture, ideally at room temperature between 1 to 30 degrees Celsius. By doing so, the effectiveness of the medication can be maintained for an extended period.

Appearance

Pink circular film-coated tablet

Package unit

30 tablets (10 tablets/PTP) x 3