Medication info
Rosuvastatin Calcium 5 mg Tablets

Rosuvastatin Calcium 5 mg Tablets

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)인트로바이오파마
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201901250 · Approved 2019.02.26 · Insurance code 052401140

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be administered once daily at an initial dose of 5 milligrams, without regard to meals. If more reduction in LDL-cholesterol is needed, the maintenance dose should be adjusted, and most patients are controlled at a maintenance dose of 10 milligrams once daily. The maintenance dose can be adjusted according to LDL-cholesterol levels, treatment goals, and patient response, typically at intervals of 4 weeks or more, with a maximum of 20 milligrams per day.
Children's dosage
For pediatric patients with familial hypercholesterolemia (ages 10 to 17), the dosage range is once daily from 5 milligrams to 20 milligrams. The dosage should be adjusted individually based on recommended treatment goals over a 4-week period.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • mixed dyslipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • stroke
  • myocardial infarction
View approved original text

This medication is primarily used as an adjunct therapy for patients with primary hypercholesterolemia and mixed dyslipidemia that are not controlled by diet and exercise. It also helps to lower cholesterol levels in patients aged 10 years and older with familial hypercholesterolemia. It reduces total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis and aiding patients with dysbetalipoproteinemia in their dietary regimen. Furthermore, it is effective in reducing the risk of stroke, myocardial infarction, and vascular reconstruction in middle-aged individuals with cardiovascular risk factors. Overall, this medication is used to improve cardiovascular health in various conditions related to dyslipidemia.

Dosage and Administration

Adult dosage

This medication can be administered once daily at an initial dose of 5 milligrams, without regard to meals. If more reduction in LDL-cholesterol is needed, the maintenance dose should be adjusted, and most patients are controlled at a maintenance dose of 10 milligrams once daily. The maintenance dose can be adjusted according to LDL-cholesterol levels, treatment goals, and patient response, typically at intervals of 4 weeks or more, with a maximum of 20 milligrams per day.

Children's dosage

For pediatric patients with familial hypercholesterolemia (ages 10 to 17), the dosage range is once daily from 5 milligrams to 20 milligrams. The dosage should be adjusted individually based on recommended treatment goals over a 4-week period.

Precautions

This medication should not be used in certain patients. For instance, it should not be given to those with allergies to its components, unexplained liver dysfunction, muscle diseases, or severe renal impairment. Pregnant or nursing women, as well as fertile women who do not use appropriate contraception, are also advised against using this medication. Additionally, high doses should be avoided in patients prone to muscle diseases. This medication should be used cautiously in patients with poor liver function or those consuming excessive alcohol, and liver function tests should be repeated before and during treatment. If symptoms such as muscle pain or weakness appear, medical personnel should be informed immediately, and blood tests may be necessary to assess muscle damage. This medication can rarely cause severe skin reactions, liver damage, and muscle damage, so discontinuation is essential if such symptoms arise. Interactions may occur when taken with other medications, particularly certain antiviral agents, immunosuppressants, and fibrates, so caution is warranted. Pregnant or nursing women should not use this medication, and women of childbearing potential should use appropriate contraception. In case of overdose, there is no specific antidote; therefore, treatment should align with symptoms while monitoring liver function and muscle enzyme levels. This medication is not known to significantly affect driving or machine operation, but caution is necessary as dizziness may occur. Finally, regular check-ups and consultations with healthcare personnel are important for safe treatment while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, hepatic failure, severe edema, chest tightness, difficulty breathing, respiratory distress, severe muscle weakness, oculomotor weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, thrombocytopenia, acute kidney failure, oliguria

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, cough, diarrhea, hematuria, fatigue, numbness, paresthesia, discomfort in the chest, loss of appetite, abdominal bloating, fainting, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, depression, sleep disturbances (including insomnia and nightmares), sexual dysfunction, gynecomastia, memory decline, forgetfulness, amnesia, memory impairment, confusion

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is recommended to store it at room temperature between 1°C and 30°C. By storing it this way, the efficacy of the medication can be maintained and deterioration prevented.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.