Topstatin Tablet 5mg (Rosuvastatin Calcium)

Adult dosage

The initial dose is 5 mg administered once daily, and if a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted. The maintenance dose is often adjusted to 10 mg once daily, which is suitable for most patients. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and the patient's response, with a maximum daily increase up to 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), 5 mg to 20 mg is administered once daily. The dosing should be adjusted according to individual treatment goals.

It is very important not to administer this drug to certain patients. First, individuals who are allergic to any of the ingredients in this medication should not take it. Additionally, those with severely impaired liver function or unexplained elevated liver enzyme levels should also avoid this drug. Patients with muscle disorders or myopathy, as well as those taking certain immunosuppressants like cyclosporine, should avoid this medication. It is also safest not to administer it to individuals with severely reduced kidney function. Pregnant or nursing women, as well as women of childbearing age who do not use appropriate contraceptive methods, should not take this medication. Notably, patients at high risk of muscle disorders are prohibited from taking high doses, which include those with impaired kidney function, hypothyroidism, a history of genetic muscle diseases, or alcoholism. Caution is necessary for individuals with a history of liver disease or excessive alcohol consumption while taking this medication. Regular liver function tests should be performed before and during treatment, and in cases of hypercholesterolemia caused by hypothyroidism or nephrotic syndrome, the underlying cause should be treated first. If symptoms such as muscle pain, weakness, or cramps occur, medical staff should be informed immediately, and blood tests may be needed to check for muscle damage. If muscle-related symptoms are severe or if blood test results show significant increases, the medication should be discontinued. Additionally, care should be taken, as muscle damage tests may be affected after strenuous exercise. In cases of acute severe conditions such as severe infections, major surgery, or severe metabolic disorders, it is advisable to discontinue this medication. Rarely, it can cause myasthenia gravis or ocular myasthenia; therefore, if such symptoms appear, treatment should be halted. Caution is needed when used with other medications. Particularly, the co-administration with fibrate derivatives, which can increase the risk of muscle damage, is not recommended; monitoring or dose adjustments may be necessary when combined. Additionally, this drug's blood concentration may increase if taken with some antivirals, antifungals, or antibiotics, so consultation with a healthcare professional is essential. This drug can affect liver and kidney function, thus regular checkups are required. Liver enzyme levels and kidney function indicators should be periodically assessed during treatment, and if any abnormal signs are observed, medical staff should be notified promptly. Pregnant or nursing women should not take this medication, and women who could become pregnant must use appropriate contraceptive methods. If a pregnancy is planned or detected, the medication should be stopped immediately, and consultation with healthcare staff should be sought. In case of overdose, no specific antidote exists, so treatment should be symptomatic and liver function and muscle enzyme tests should be performed to manage the condition. Lastly, there may be dizziness while taking this medication, so caution should be exercised when driving or operating machinery.

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, severe muscle weakness, ocular myasthenia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute kidney failure, oliguria, severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa, difficulty breathing, asthma

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• muscle pain
• weakness
• diarrhea
• chest discomfort

This medication should be stored in a tightly closed container to protect it from air and moisture. Also, it is best to store the medication at a cool room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and safety.

Appearance

Yellow round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alux2), 30 tablets/bottle