Medication info
CreaGene Plus Tablet 10/5mg

CreaGene Plus Tablet 10/5mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
영진약품(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets (10 tablets/blister × 3)
Approval status
Active

MFDS item code 201601204 · Approved 2016.02.29 · Insurance code 642404090

Summary

Main use
Improvement of lipid levels in primary and mixed hypercholesterolemia and suppression of the risk of atherosclerotic cardiovascular disease
Who takes it
Adults
Adult dose
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5mg once daily is recommended. The dose may be increased as needed from 10/5mg to 10/20mg once daily. Blood lipid levels should be checked at intervals of 4 weeks or more after starting the medication or adjusting the dosage, and the dose should be adjusted accordingly.

Ingredients

Manufacturer
영진약품(주)

Efficacy & effects

Improvement of lipid levels in primary and mixed hypercholesterolemia and suppression of the risk of atherosclerotic cardiovascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
  • reduced HDL cholesterol
  • atherosclerotic cardiovascular disease due to hypercholesterolemia
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels, and increases HDL cholesterol in patients with primary hypercholesterolemia or mixed dyslipidemia. It is mainly used as an adjunct when dietary measures are insufficient, and is utilized to reduce the risk of atherosclerotic cardiovascular disease related to hyperlipidemia. Before administering, it is important to identify and treat other causes of dyslipidemia such as diabetes, hypothyroidism, liver and kidney diseases. Regular blood tests should be performed to monitor cholesterol levels during treatment, especially when triglycerides are very high; special measurement methods may be required in such cases. This medication safely and effectively regulates cholesterol levels, contributing to the prevention of cardiovascular diseases.

How to take

Adult dose

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5mg once daily is recommended. The dose may be increased as needed from 10/5mg to 10/20mg once daily. Blood lipid levels should be checked at intervals of 4 weeks or more after starting the medication or adjusting the dosage, and the dose should be adjusted accordingly.

Precautions

This medication has a rare risk of causing rhabdomyolysis, which can lead to acute renal failure. Therefore, if symptoms of severe myopathy occur, or if there are risk factors for renal failure such as severe infections, hypotension, major surgery, trauma, and severe metabolic disorders, this medication should be temporarily discontinued or stopped. Those with allergies to this medication's active ingredients or excipients, active liver disease, unexplained elevation of liver enzymes, myopathy, severe renal impairment, pregnant or nursing women, or patients at high risk for certain muscle disorders should not use this medication. It should be administered with caution in patients with a history of alcohol abuse or liver disease, severe liver dysfunction, decreased kidney function, hypothyroidism, the elderly, and those taking other lipid-lowering drugs due to an increased risk of muscle damage. If symptoms such as myalgia, muscle cramps, or muscle weakness occur during treatment, inform a doctor immediately and if needed, testing to assess muscle damage should be performed. Liver function tests should be conducted before and during treatment, and if symptoms of liver damage occur, use should be discontinued immediately. This medication may slightly elevate blood sugar levels; therefore, patients at risk for diabetes should regularly check their blood sugar levels. When co-administering with other medications, interactions may increase the blood concentration of this medication, thereby increasing the risk of side effects; hence, it is essential to consult with a physician or pharmacist regarding interactions with other medications taken. Women who are pregnant or may become pregnant should not take this medication and should use appropriate contraception while taking it. Safety in children and adolescents has not been sufficiently established, and it is not recommended for pediatric use. The elderly are at higher risk for muscle-related side effects and should use it with caution. There are no specific antidotes for overdose, thus symptoms should guide treatment and liver function and muscle enzyme tests should be monitored.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, facial swelling, chest pain, discomfort in the chest, cold sweat, renal failure, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), acute hepatitis, toxic hepatitis, liver toxicity, jaundice, hepatitis, acute renal failure, thrombocytopenia, renal dysfunction, hematuria, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), serious

Mild side effects

  • Nasopharyngitis
  • joint pain
  • headache
  • ALT elevation
  • AST elevation
  • myalgia
  • edema
  • increased blood bilirubin
  • acneiform dermatitis
  • pruritus
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  • dizziness
  • upper respiratory infections
  • itching
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • cough
  • phlegm
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia
  • anemia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and should be kept at room temperature between 1 and 30 degrees Celsius. Therefore, it is advisable to avoid direct sunlight and do not store it in excessively hot or cold areas.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets (10 tablets/blister × 3)

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.