Rosuvastatin Calcium 20 mg Tablet

Adult dose

Administer 5 mg once daily as the initial dosage, independent of food intake. The maintenance dose is 10 mg once daily, and the dosage may be adjusted up to a maximum of 20 mg once daily based on patient response at intervals of 4 weeks or more.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer once daily at a dosage range of 5 mg to 20 mg. The dosage should be individually adjusted according to therapeutic targets at intervals of 4 weeks.

This medication should not be administered to certain patients. For example, individuals allergic to this medication, those with active liver disease, muscle disorders, and severe renal failure should not take this medication. Pregnant or breastfeeding women, and fertile women not using appropriate contraception should also avoid this medication, and women of childbearing potential should only take it if they are aware of the risks to the fetus and have reduced the possibility of pregnancy. Patients at high risk for myopathy or rhabdomyolysis should be particularly cautious, and high doses of this medication are contraindicated. Risk factors include moderate renal impairment, hypothyroidism, a history of muscle disorders, alcohol dependence, certain ethnicities (Asians), and concomitant use with fibrate medications. This medication contains lactose, so patients with lactose intolerance or related genetic diseases should not take it. Patients with liver function impairment or a history of alcohol abuse should undergo regular liver function tests before and during treatment with this medication, and patients with hypercholesterolemia due to thyroid dysfunction or nephrotic syndrome should use this medication after treatment of the underlying disease. Muscle-related side effects such as myalgia, myopathy, and rarely rhabdomyolysis have been reported; therefore, if any muscle pain, weakness, or cramps occur during treatment, immediate consultation with a physician is necessary. Particularly, if there is a significant increase in muscle enzyme levels, discontinuation of the medication should occur. It is advisable to discontinue this medication during acute severe conditions or significant physical stress situations. This medication can rarely cause severe muscle weakness or ocular muscle weakness, and usage should be terminated if these symptoms emerge. The risk of muscle side effects can increase when used in conjunction with specific other medications; therefore, it is crucial to consult a doctor or pharmacist about concomitant medications. High doses may result in temporary proteinuria, necessitating renal function tests. Asian patients may require dosage adjustments due to potentially higher drug concentrations. Pediatric and adolescent patients should be monitored for growth and sexual development effects. While this medication is generally considered safe, it is important to consult healthcare professionals immediately if any abnormal symptoms are observed during treatment.

Serious side effects

Allergic reactions including urticaria and angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe allergic reactions, high fevers with severe rashes, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice, liver abnormalities, sudden and severe headaches, thunderclap headaches, seizures

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain storage temperatures between 1 and 30 degrees Celsius to ensure the drug's efficacy and safety are preserved over time.

Appearance

Pink, convex, round film-coated tablets

Package unit

30 tablets/bottle