Rosuvastatin Calcium Tablet 10 mg

Adult dosage

Regardless of meals, 5 mg is administered once daily as the initial dose. If necessary, the maintenance dose can be adjusted to 10 mg once daily, with possible titration up to a maximum of 20 mg once daily at intervals of 4 weeks or longer, depending on patient response.

Children's dosage

Children and adolescents aged 10 to 17 years with heterozygous familial hypercholesterolemia are administered a dose of 5 to 20 mg once daily. Dosing should be adjusted according to recommended treatment goals at 4-week intervals or longer.

This medication should not be used in certain patients. For example, it is contraindicated in patients who are allergic to this medication, have severe liver dysfunction, muscle disorders, and severe kidney impairment. Special caution is needed when administering this medication to women who are pregnant, breastfeeding, or of childbearing age without appropriate contraception. It should only be used if the risk to the fetus is well explained and if there is a low possibility of pregnancy. The use of high doses of this medication is contraindicated in patients at high risk of muscle-related side effects, such as patients with moderate to severe renal impairment, hypothyroidism, or alcohol dependence. Since this medication contains lactose, patients with lactose intolerance or specific genetic metabolic disorders should avoid it. Patients who consume alcohol excessively or have a history of liver disease should undergo liver function tests before taking this medication and regularly check liver enzyme levels during treatment. Muscle pain, myopathy, and, rarely, severe muscle damage such as rhabdomyolysis may occur, so patients should immediately consult a physician if abnormal muscle symptoms arise, and blood tests should be performed to assess muscle damage. In cases of acute renal failure or severe conditions, this medication should be discontinued, and it should also be stopped if muscle weakness or ocular muscle weakness develops. Interactions may occur when used in combination with other drugs, especially with fibrates or certain antiviral agents, antifungals, and antibiotics, which may increase the risk of muscle side effects. Because the plasma concentration of this medication may be higher in Asians, dose adjustment may be necessary. In pediatric patients, the effects on growth and secondary sexual characteristics have been limitedly evaluated, so it should be used cautiously in children. This medication may rarely cause various side effects including liver dysfunction, skin rash, headache, dizziness, gastrointestinal symptoms, so any abnormal symptoms should be reported to healthcare professionals. This medication should not be used during pregnancy or breastfeeding, and women planning to become pregnant should use appropriate contraception. In case of overdose, there is no specific antidote, so symptomatic treatment and monitoring liver function and muscle enzymes are required. Caution is needed as dizziness may occur while driving or operating machinery. During the course of treatment, liver function, muscle status, and blood tests if necessary should be continuously monitored for safety.

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, paleness, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, jaundice, hepatitis, severe muscle weakness, ocular muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, severe edema, acute renal failure, thrombocytopenia, severe anemia

Mild side effects

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

This medication can be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is best stored at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication.

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)