Medication info
Cretrol Tablets 10/20 mg

Cretrol Tablets 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
White to almost white round film-coated tablets
Packaging
Blister - 30 tablets/blister [10 tablets/blister × 3], Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Active

MFDS item code 201601233 · Approved 2016.02.29 · Insurance code 654004750

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed type) and dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily without regard to meals. The dosage range is 10/5 mg to 10/20 mg per day. The initial recommended dose is 10/5 mg once daily. For patients requiring a greater reduction in LDL-C, the dose may be adjusted. After starting treatment or adjusting the dosage, lipid levels should be checked at least 4 weeks apart, and adjustments should be made accordingly.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed type) and dyslipidemia

  • 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
View approved original text

This medication is used as an adjunct to diet for lowering elevated total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and for raising the level of HDL cholesterol, which is 'good' cholesterol. It is also applied to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia; it is administered when dietary modifications and non-pharmacological treatments are insufficient. Before treatment, secondary causes of dyslipidemia such as diabetes and hypothyroidism must be identified and treated if necessary. During treatment, cholesterol and triglyceride levels should be monitored regularly, and for patients with acute coronary events, it is vital to measure these levels upon admission or within 24 hours. This medication aids in cholesterol control and improves cardiovascular health alongside diet.

How to take

Adult dose

This medication is administered once daily without regard to meals. The dosage range is 10/5 mg to 10/20 mg per day. The initial recommended dose is 10/5 mg once daily. For patients requiring a greater reduction in LDL-C, the dose may be adjusted. After starting treatment or adjusting the dosage, lipid levels should be checked at least 4 weeks apart, and adjustments should be made accordingly.

Precautions

This medication helps lower blood cholesterol levels by inhibiting cholesterol synthesis in the liver. If symptoms such as muscle pain or weakness, fatigue, or fever occur during the use of this medication, the patient should inform their doctor immediately, as muscle damage may occur. Severe muscle damage can develop into a serious condition called rhabdomyolysis, which can lead to a rapid decline in kidney function; hence, careful monitoring is essential. Since this medication can affect liver function, liver function tests should be performed before starting treatment, and regular liver function tests should be conducted during treatment. Women who are pregnant or may become pregnant, and nursing mothers should not take this medication due to potential harm to the fetus or infant. This medication should not be administered to individuals with certain genetic disorders, severe liver disease, kidney disorders, or muscle diseases. Also, interactions may occur when used with other medications, so any current medications should be disclosed to a doctor or pharmacist. It is advisable to avoid alcohol while taking this medication, especially in individuals with a history of liver disease. Elderly patients or those with impaired kidney function are at higher risk of muscle injury and should take the medication under strict medical supervision. The safety and efficacy of this medication have not been established in children and is not recommended for use in this population. Patients should contact healthcare personnel immediately if they experience severe skin rashes, itching, swelling, or difficulty breathing during treatment. There is no specific antidote for overdose; treatment should be symptomatic, and liver and muscle function tests may be necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • muscle pain
  • edema
  • elevated blood bilirubin
  • itching
  • dermatitis
Show 26 more
  • pruritus
  • acneiform dermatitis
  • rhinitis
  • arthralgia
  • cough
  • diarrhea
  • weakness
  • fatigue
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • vomiting
  • gastritis
  • dry mouth
  • epigastric discomfort
  • belching
  • gastrointestinal disturbance
  • gastroesophageal reflux disease
  • tongue disease
  • diabetes

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. Maintain storage temperatures between 1°C and 30°C.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

Blister - 30 tablets/blister [10 tablets/blister × 3], Bottle - 30 tablets/bottle, Bottle - 300 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.