Medication info
Cres Tablet 20mg (Rosuvastatin Calcium)

Cres Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
알리코제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201505163 · Approved 2015.07.30 · Insurance code 656003940

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 milligrams once daily; the maintenance dose can be adjusted if greater reductions in LDL cholesterol levels are required. The maintenance dose is typically 10 milligrams once daily, which is sufficient for most patients. Maintenance doses should be adjusted suitably every 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, and can be increased to a maximum of 20 milligrams per day.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted according to the recommended treatment goals for each individual patient.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • stroke risk
  • myocardial infarction risk
View approved original text

This drug is used as an adjunct when diet and exercise are insufficient in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used with dietary therapy or other lipid-lowering therapy in patients with homozygous familial hypercholesterolemia to lower blood cholesterol levels and delay the progression of atherosclerosis, improving cardiovascular health. It is effective in reducing total cholesterol and LDL-cholesterol levels when added to the dietary therapy in pediatric patients aged 10 to 17 years with familial hypercholesterolemia. It is also utilized as an adjunct to diet in patients with primary dysbetalipoproteinemia. In particular, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged patients with elevated high-sensitivity C-reactive protein and additional risk factors for cardiovascular disease. Overall, this medication is used for the treatment of various types of hypercholesterolemia and to reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

The initial dose is 5 milligrams once daily; the maintenance dose can be adjusted if greater reductions in LDL cholesterol levels are required. The maintenance dose is typically 10 milligrams once daily, which is sufficient for most patients. Maintenance doses should be adjusted suitably every 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, and can be increased to a maximum of 20 milligrams per day.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted according to the recommended treatment goals for each individual patient.

Precautions

This drug should not be used in certain patients. For example, avoid administering this drug to patients with an allergy to it, severely impaired liver function, muscular disorders, significantly reduced kidney function, women who are pregnant or breastfeeding, and those taking specific medications. Additionally, patients should receive regular liver function tests and muscle-related tests before and during treatment. Caution is needed for patients with a history of alcohol consumption or liver disease. If symptoms such as myalgia or muscle weakness occur, consult a physician immediately. Since this drug may affect the liver and kidneys, patients with liver or kidney disease should use it more cautiously, and elderly patients or those with certain genetic predispositions should also exercise caution. Furthermore, this drug may interact with other medications, so any other medications being taken must be disclosed to healthcare professionals. The risk of muscle adverse reactions may increase when used with certain antivirals, antifungals, antibiotics, immunosuppressants, and lipid-lowering agents. Women with potential for pregnancy should use appropriate contraception while taking this medication, and it should be discontinued immediately if pregnancy is confirmed. It is also safer for breastfeeding women not to use this drug. In case of overdose, as there is no specific antidote, immediate appropriate treatment at a hospital is required, and liver function and muscle enzyme levels must be monitored. Finally, if symptoms such as dizziness or myalgia occur during this drug's use, caution should be taken when driving or operating machinery, and if an adverse reaction is suspected, consulting healthcare professionals immediately is essential.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reaction including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, jaundice, hepatitis, severe muscle weakness, dyspnea, severe edema, acute renal failure, oliguria, severe allergic reactions, severe skin reactions, respiratory issues, liver abnormalities (jaundice), severe neurological symptoms, severe edema or

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • thrombocytopenia
  • cough
Show 16 more
  • diarrhea
  • ocular myasthenia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hematuria

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. This will help to retain the drug's effectiveness longer.

Appearance and packaging

Appearance

Pink 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.