Medication info
Kretrol Tablet 10/5 mg

Kretrol Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
White to almost white round film-coated tablet
Packaging
Blister - 30 tablets/blister [10 tablets/blister × 3], Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Active

MFDS item code 201601231 · Approved 2016.02.29 · Insurance code 654004740

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary and mixed) and prevention of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is taken once daily without regard to meals. The dosage range is 10/5 mg to 10/20 mg daily. The recommended starting dose is 10/5 mg daily. In cases where a more significant reduction in LDL cholesterol is required, the dose can be adjusted. After initiation of therapy or adjustment of dosage, lipid levels should be checked at intervals of at least 4 weeks, and adjustments made accordingly.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary and mixed) and prevention of the risk of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apolipoprotein B
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia or mixed dyslipidemia, while increasing good HDL cholesterol levels. It is also used in conjunction with lipid-regulating medications in patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia to contribute to the prevention of cardiovascular diseases. This medication serves as an adjunct to dietary management and is prescribed when dietary responses limiting saturated fat and cholesterol intake are insufficient. It is important to identify and treat other causes that may lead to dyslipidemia, such as diabetes or hypothyroidism, before starting the medication as needed. Regular lipid tests are necessary to monitor the treatment effects, especially in patients with acute coronary events, lipid levels should be checked at the time of admission or within 24 hours after admission. This medication is used to improve hypercholesterolemia and dyslipidemia.

How to take

Adult dose

This medication is taken once daily without regard to meals. The dosage range is 10/5 mg to 10/20 mg daily. The recommended starting dose is 10/5 mg daily. In cases where a more significant reduction in LDL cholesterol is required, the dose can be adjusted. After initiation of therapy or adjustment of dosage, lipid levels should be checked at intervals of at least 4 weeks, and adjustments made accordingly.

Precautions

This medication has been reported to rarely cause rhabdomyolysis, which can lead to serious kidney problems due to muscle tissue damage. Therefore, patients experiencing severe muscle pain or weakness, or those with risk factors such as severe infections, hypotension, major surgery, trauma, or serious metabolic disorders should temporarily discontinue or stop this medication. Patients allergic to components of this medication, those with active liver diseases, muscle disease patients, patients with severely impaired renal function, pregnant women, or nursing mothers should not take this medication. Moreover, patients with moderate to severe renal impairment, hypothyroidism, a family history of muscle disease, or those who are on specific medications that increase the risk of muscle damage should be particularly cautious when taking this medication. As this medication contains lactose, it should not be administered to patients with genetic issues such as lactose intolerance. Caution is also required in patients with a history of alcoholism or liver disease, moderate liver dysfunction, elderly patients, and those with risk factors for myopathy; special care is advised when combined with fibrate-type medications. If symptoms such as muscle pain, cramps, fatigue, or warmth occur while taking this medication, patients should notify their doctor immediately and be examined; in severe cases, the medication should be discontinued. Liver function abnormalities may appear, thus liver function tests should be conducted before and during treatment, and if liver enzyme levels increase significantly, the medication should be stopped. This medication may slightly raise blood glucose levels; however, the reduction of cardiovascular risks outweighs the potential risk of severe diabetes development, hence does not warrant discontinuation. It must be discontinued during pregnancy as it may be harmful to the fetus, and nursing mothers should avoid this medication as well. This medication is not recommended for children as its safety and efficacy have not been adequately established. Due to the risk of myopathy in the elderly, it should be used with caution. This medication may interact with other drugs, so patients should always inform their doctor or pharmacist of other medications they are taking, particularly with certain antibiotics, antivirals, anticoagulants, and fibrate-type drugs. There is no specific antidote for overdose; treatment is symptomatic, and liver function and muscle damage should be checked. Lastly, this medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, edema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, serious skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice, a very lethargic body, liver abnormality, sudden and severe headache, lightning headache, fainting

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • myalgia
  • swelling
  • elevated blood bilirubin
  • acneiform dermatitis
  • pruritus
Show 25 more
  • nasopharyngitis
  • arthralgia
  • dizziness
  • upper respiratory infections
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • diarrhea
  • flatulence
  • nausea
  • bronchitis
  • rhinitis
  • cystitis
  • onychomycosis
  • soft tissue inflammation
  • fatty liver
  • liver dysfunction

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, with a storage temperature maintained between 1 to 30 degrees Celsius in a cool, dry place. Proper storage will help maintain the effectiveness and safety of the medication for a longer duration.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

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.