Medication info
Elosuva Tablet 10 mg (Rosuvastatin Calcium (Unprocessed))

Elosuva Tablet 10 mg (Rosuvastatin Calcium (Unprocessed))

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
(주)중헌제약
Appearance
Pink round film-coated tablet
Packaging
Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201400402 · Approved 2014.01.29 · Insurance code 053300640

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be administered once daily at any time without regard to meals. The initial dose is 5 mg once daily; if greater LDL cholesterol reduction is required, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, with most patients being managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is administered once daily within the range of 5 to 20 mg. There is no clinical data on administering doses higher than 20 mg in pediatric patients.

Ingredients

Manufacturer
(주)중헌제약

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • high-sensitivity C-reactive protein elevation
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of early coronary artery disease
  • stroke risk
View approved original text

This medication is used as an adjunct to diet and exercise in patients with primary hypercholesterolemia and mixed dyslipidemia when these measures are inadequate. It is also used in patients with homozygous familial hypercholesterolemia to help lower cholesterol levels in conjunction with diet or other lipid-lowering therapies. In patients with hypercholesterolemia, it reduces total cholesterol and LDL cholesterol, thereby delaying the progression of atherosclerosis. In pediatric patients with heterozygous familial hypercholesterolemia, it is also used as an adjunct to diet to reduce cholesterol levels. It is utilized as an adjunct to diet in patients with primary dysbetalipoproteinemia as well. Additionally, this medication contributes to the reduction of risks associated with stroke, myocardial infarction, and arterial revascularization procedures in certain high-risk groups. Therefore, this medication is effectively used for the treatment and risk reduction of various conditions related to hypercholesterolemia.

How to take

Adult dose

This medication can be administered once daily at any time without regard to meals. The initial dose is 5 mg once daily; if greater LDL cholesterol reduction is required, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, with most patients being managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is administered once daily within the range of 5 to 20 mg. There is no clinical data on administering doses higher than 20 mg in pediatric patients.

Precautions

This medication should not be administered to patients with certain allergies. It should also not be given to patients with severe liver dysfunction or unexplained elevations in liver enzymes. Patients with muscle disorders or muscle damage, and those taking cyclosporine, a specific immunosuppressant, should not use this medication. Patients with significantly reduced kidney function and women who are pregnant, breastfeeding, or of childbearing potential should consult a physician before taking this medication. In particular, high-dose administration is prohibited for patients at high risk of muscle disorders. Additionally, this medication contains lactose and should not be administered to patients with lactose intolerance or related genetic disorders. Caution is warranted for patients who have a history of excessive alcohol consumption or liver disease, and regular liver function tests should be conducted before and during treatment. If symptoms such as muscle pain or weakness occur, the physician should be notified immediately, and in severe cases, the medication should be discontinued. Additionally, caution is needed for patients with impaired renal function or hypothyroidism, elderly patients, and those with alcohol abuse, as they are at higher risk for muscle-related side effects. This medication may interact with certain drugs; patients taking other medications should inform their healthcare provider. In particular, the risk of muscle side effects may increase when used in combination with certain antiviral agents, immunosuppressants, antifungal agents, antibiotics, and fibric acid derivatives. During pregnancy, it may be harmful to the fetus, so proper contraception must be practiced, and women who are pregnant or planning to become pregnant should not use this medication. Nursing mothers should also avoid taking this medication, and if pregnancy is confirmed during treatment, it must be discontinued immediately. There are no specific antidotes for overdose, so treatment should be symptomatic along with liver and muscle function tests. This medication does not significantly affect driving or machine operation, but dizziness may occur, so caution is advised. Regular checks of liver and muscle health during treatment are important.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, severe swelling, tightness in the chest, difficulty breathing, respiratory distress, asthma attacks, Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular myasthenia, immune-mediated necrotizing myopathy, rhabdomyolysis, acute renal failure, oliguria, severe edema, pallor, severe rash with fever, blisters, blood

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, muscle pain, weakness, diarrhea, rash, hematuria, fatigue, numbness, sensory disturbances, chest discomfort, loss of appetite, abdominal bloating, fainting, generalized pain, muscle cramps, gout, erectile dysfunction, thrombocytopenia, amnesia, peripheral neuropathy, cough, increased serum creatinine, depression, sleep disturbances, sexual dysfunction, gynecomastia, cognitive impairment (memory decline, forgetfulness, confusion)

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

Storage

This medication should be stored in a tightly closed container that does not allow air or moisture to enter. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Bottle - 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.

Questions about this medicine

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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.