Daiwoo Rosuvastatin Tablet 5 mg (Rosuvastatin Calcium (Unmicronized))

Adult dose

For adult patients with primary hypercholesterolemia and others, start at a dose of 5 mg once daily, and may increase to 10 mg at intervals of 4 weeks or more as needed. The maximum can be administered at 20 mg per day. It can be taken at any time of the day, regardless of meals.

Child dose

In children with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended dose is 5 mg to 20 mg once daily, adjusting the dosage at intervals of 4 weeks or more. For children under 10 years old, no data regarding safety and efficacy.

This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to it, have severe hepatic impairment, have muscle disorders, are taking certain immunosuppressants, have severe renal impairment, are pregnant or breastfeeding women, and in fertile women who do not use adequate contraception. Additionally, high-dose administration is contraindicated in patients at high risk for muscle disorders, and it should not be administered to patients with lactose intolerance. This medication should be used with caution in patients with weak liver function or those who consume alcohol excessively, and regular liver function tests should be conducted before and during treatment. If symptoms of muscle pain or weakness occur, notify healthcare professionals immediately. If necessary, blood tests should be conducted to check for muscle damage. In cases of acute severe illness or after surgery, administration of this medication may need to be discontinued. While taking this medication, there may be interactions with other drugs, so it is essential to inform healthcare professionals about any other medications being taken. Pregnant or breastfeeding women should not use this medication, and fertile women should use appropriate methods of contraception to prevent pregnancy. In case of overdose, there is no specific antidote, so symptomatic treatment and liver and muscle enzyme tests are required. This medication is known not to have a significant effect on driving or operating machinery; however, dizziness may occur, so caution is advised. Lastly, the plasma concentration of this medication may be higher in Asians, necessitating dose adjustment.

Serious side effects

Anaphylactic reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myasthenia gravis, jaundice, liver failure, acute renal failure, oliguria, tightness in the chest, dyspnea, respiratory distress, severe skin reactions, severe allergic reactions, severe edema or urination abnormalities

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is best to store it at room temperature between 1 degrees and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy longer.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle