Donghwa Rosuvastatin Tablet 20 mg (Rosuvastatin Calcium)

Adult dosage

Adult patients with primary hypercholesterolemia can take this medication at any time during the day, regardless of meals. The initial dosage is 5 mg once daily, and the maintenance dose is usually 10 mg once daily, with most patients being managed at this dosage. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL cholesterol levels and treatment goals, with a maximum increase to 20 mg per day.

Children's dosage

In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), it can be administered once daily from 5 mg to 20 mg. Doses should be adjusted based on individual treatment goals at intervals of 4 weeks or more.

This medication should not be used in patients with known allergies to any of its ingredients or in patients with severely impaired liver function. It is also not safe to administer to patients with muscle-related diseases, severely impaired kidney function, or pregnant or breastfeeding women. Patients at high risk of muscle pain or myopathy should be particularly cautious, and dosage adjustments or avoidance of administration may be necessary. This medication contains lactose; therefore, patients with lactose intolerance should not take it. Patients with abnormal liver function or a history of alcohol abuse should undergo regular liver function tests, and those with hypothyroidism should receive appropriate treatment first. If symptoms such as myalgia, muscle weakness, or cramps occur, inform a physician immediately, and laboratory tests may be needed to check for muscle damage. If severe muscle damage is suspected, the administration of this medication may be discontinued. This drug may interact with certain medications; hence, it is essential to inform and consult healthcare professionals if taking other medications. In particular, when combined with certain antiviral agents, immunosuppressants, antibiotics, and fibrate agents, the risk of muscle damage may increase. Women who may become pregnant should use appropriate contraception, and this drug should not be used during pregnancy. During treatment with this medication, if any abnormal symptoms such as liver dysfunction, skin rash, or severe muscle pain occur, therapy should be stopped immediately and medical advice sought. In case of overdose, specific antidotes are not available; therefore, treatment should be symptomatic, including liver function and muscle enzyme testing. Caution is advised while driving or operating machinery as dizziness may occur. This medication may have increased systemic exposure in Asians; thus, dosage adjustments may be necessary. Before taking this medication, it is crucial to consult with a physician or pharmacist thoroughly and to take it as directed.

Serious side effects

Allergic reactions including urticaria, angioedema, severe myopathy, ophthalmoplegia, rhabdomyolysis, Stevens-Johnson syndrome, hypereosinophilia with systemic symptoms drug reaction syndrome, jaundice, hepatitis, acute renal failure, oliguria, severe edema, chest tightness, shortness of breath, asthma attacks, severe allergic reactions, severe skin reactions, severe neurological symptoms.

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash and hives
• myalgia
• weakness
• diarrhea

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at a temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/PTP [15 tablets/PTP x 2]