Hy’Ell 5 mg Tablet (Rosuvastatin Calcium)

Adult dose

The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is generally 10 mg once daily, which is adequate for most patients. The maintenance dose should be adjusted based on LDL cholesterol levels, therapeutic goals, and patient responses at intervals of 4 weeks or longer, with a maximum daily increase up to 20 mg.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The administration dose should be individually adjusted according to the recommended therapeutic goals for each patient. Doses should be adjusted at 4-week intervals or longer.

This drug should not be administered to certain patients. For instance, it should not be used in patients who have an allergy to this drug or have active liver diseases, muscle diseases, or severe renal impairment. The use of this drug is restricted in pregnant or nursing women, or in fertile women not using appropriate contraception. It should only be administered to women of childbearing potential after confirming a low likelihood of pregnancy. High-dose administration is prohibited in patients at high risk of muscle disorders, such as those with moderate to severe renal impairment, hypothyroidism, previous history of genetic muscle disorders, and those with alcohol dependence. Furthermore, this drug contains lactose and should not be administered to patients with lactose intolerance or certain genetic metabolic disorders. Liver function tests should be conducted regularly when administering this drug, and caution should be particularly taken with patients with a history of liver disease or those consuming excessive alcohol. Muscle-related side effects such as myalgia, myopathy, and rhabdomyolysis may occur, so patients should be advised to inform healthcare professionals immediately if they experience muscle pain or weakness. This drug may increase blood concentration when taken with other specific medications, which can elevate the risk of side effects; therefore, patients must consult healthcare professionals about concomitant medications. It should not be used during pregnancy or breastfeeding, and women planning pregnancy should use appropriate contraception. In cases of overdose, there is no specific antidote, so treatment should be based on symptoms while monitoring liver function and muscle enzyme levels. The effects of this drug on the ability to drive or operate machinery are unclear, but caution is advised due to the possibility of dizziness. Finally, this drug may show higher plasma concentrations in Asians, hence dose adjustment may be needed.

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe liver damage, severe swelling, hypertension, acute renal failure, oliguria, thrombocytopenia, severe muscle weakness, rhabdomyolysis, severe dermatological reactions, serious neurological symptoms, dyspnea, asthma attacks, severe allergic reactions.

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash
• weakness
• myalgia
• myopathy (including myositis)

This drug should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness and safety.

Appearance

Yellow circular film-coated tablets

Package unit

28 tablets (14 tablets/PTP * 2), 30 tablets/bottle, 90 tablets/bottle