Stavaster Tablet 5 mg (Rosuvastatin Calcium)

Adult dosage

Patients with primary hypercholesterolemia, mixed hyperlipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia should start at a dose of 5 mg once daily, at any time of day regardless of meals. If greater reduction in LDL-cholesterol is required, the maintenance dose may be adjusted, typically to 10 mg once daily, which is suitable for most patients. Dose adjustments should be made at intervals of at least 4 weeks.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17), administered once daily in the range of 5 mg to 20 mg, with the dosage adjusted individually according to treatment goals at intervals of at least 4 weeks.

This medication should not be administered to certain patients. For example, patients allergic to the components of this medication, those with liver dysfunction, muscle disorders, and patients on specific medications should not use this drug. Pregnant or breastfeeding women, as well as women of childbearing potential not practicing adequate contraception, should also avoid taking this medication, and it should only be given to women capable of becoming pregnant after fully explaining the high likelihood of not getting pregnant and the risks to the fetus. Additionally, patients vulnerable to muscle disorders should avoid high doses of this medication, and caution is required in patients with impaired renal function or hypothyroidism. Patients with a history of significant alcohol intake or liver disease should have their liver function tested regularly when taking this medication, and if symptoms like muscle pain or weakness occur, they should notify their healthcare provider immediately. If severe muscle pain occurs after exercise or if muscle-related levels are abnormally high in blood tests, discontinuation of this medication may be considered. This medication contains lactose, so patients with lactose intolerance should not take it. When taken with specific other medications, the drug concentration may increase, raising the risk of side effects; therefore, patients should consult their healthcare provider if they are taking other medications. During pregnancy and breastfeeding, safety has not been established, and use should be avoided, with women of childbearing potential required to use appropriate contraceptive methods. In the case of overdose, no specific antidote exists, so treatment should be based on symptoms while monitoring liver function and muscle levels. This medication does not appear to significantly affect driving or operating machinery, but caution is necessary as dizziness may occur. Finally, if severe skin reactions or signs of serious liver damage occur during treatment with this medication, it should be discontinued immediately, and consultation with a healthcare provider is necessary.

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, acute renal failure, oliguria, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction syndrome (DRESS), immune-mediated necrotizing myopathy, edema, dyspnea, polyneuropathy, amnesia, peripheral neuropathy, severe allergic reactions, severe skin abnormal reactions,

Mild side effects

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to keep the storage temperature between 1°C and 30°C room temperature. This will help maintain the medication's efficacy over time.

Appearance

Brown round film-coated tablets

Package unit

28 tablets/Alu-Alu (7 tablets/Alu-Alu x 4)