Roksba Tablet 5 mg (Rosuvastatin Calcium)

Adult dosage

Regardless of meals, the initial dose is 5 mg once daily at any time of the day. If a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted. The maintenance dose will usually be 10 mg once daily, which is the adjustment for most patients. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg per day.

Children's dosage

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to the therapeutic goals for each individual patient.

This drug should not be administered to certain patients. For example, individuals allergic to any component of this drug, those with severely impaired liver function, those with muscle disorders, and those with severely reduced kidney function should not take this medication. Additionally, pregnant or breastfeeding women, and women of childbearing potential who are not using appropriate contraceptive measures should consult with an expert before using this drug. This drug contains lactose, so it is not recommended for patients with lactose intolerance or related genetic disorders. It is important to regularly test liver function and muscle status when taking this drug. Particularly, individuals who consume alcohol heavily or have a history of liver disease should exercise additional caution and have their liver enzyme levels monitored regularly. If symptoms such as muscle pain or weakness occur, the healthcare provider should be notified immediately, and in severe cases, discontinuation of the medication may be necessary. This drug can interact with other medications; therefore, any current medications should be disclosed to the healthcare provider. Caution should be exercised, especially when used in combination with certain antiviral drugs, immunosuppressants, antifungals, and fibrate-class medications, as they may increase the risk of muscle damage. It is advisable not to take this drug during pregnancy, and women planning to become pregnant should use appropriate contraceptive methods. During breastfeeding, it is also advisable to avoid this medication as it may be excreted in breast milk. In case of overdose, there is no specific antidote, and treatment according to symptoms along with liver and muscle function tests is required. Patients may experience symptoms like dizziness during treatment, so they should be cautious when driving or operating machinery. Finally, this drug may present higher blood concentrations in Asians, so dosage adjustments may be necessary.

Serious side effects

Hives, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, hepatic failure, dyspnea, dyspnea (suspected interstitial lung disease symptoms included), difficulty breathing, severe muscle weakness, ophthalmoplegia, rhabdomyolysis, acute kidney injury, oliguria, severe edema, severe allergic reactions, serious neurological symptoms (headache, seizures,

Mild side effects

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

This drug is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 30 tablets/box [15 tablets/Alu-Alu*2]