Medication info
Kreloros 10mg (Rosuvastatin Calcium)

Kreloros 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)휴온스메디텍
Appearance
Pink round film-coated tablets
Packaging
28 tablets/PTP [(14 tablets/PTP×2)]
Approval status
Active

MFDS item code 201603585 · Approved 2016.06.20 · Insurance code 670401170

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 milligrams once daily, which can be taken at any time of the day, with or without food. If greater reductions in LDL cholesterol are needed, the maintenance dose can be adjusted, with a typical maintenance dose of 10 milligrams once daily. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, allowing for a maximum increase to 20 milligrams once daily at intervals of 4 weeks or more.
Children's dosage
The usual dosage range for children with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted based on individual treatment goals, with reevaluation every 4 weeks.

Ingredients

Manufacturer
(주)휴온스메디텍

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct to diet in cases of primary hypercholesterolemia and mixed dyslipidemia that are difficult to manage with diet and exercise alone. It is also beneficial for patients with homozygous familial hypercholesterolemia in conjunction with other therapies. This drug lowers total cholesterol and LDL-cholesterol levels, slowing the progression of atherosclerosis, and can also be used in pediatric patients who meet specific criteria. Additionally, it is utilized as an adjunct to the treatment of primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in patients at high risk for cardiovascular diseases. Thus, this medication is effectively used for cholesterol control and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

The initial dose is 5 milligrams once daily, which can be taken at any time of the day, with or without food. If greater reductions in LDL cholesterol are needed, the maintenance dose can be adjusted, with a typical maintenance dose of 10 milligrams once daily. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, allowing for a maximum increase to 20 milligrams once daily at intervals of 4 weeks or more.

Children's dosage

The usual dosage range for children with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted based on individual treatment goals, with reevaluation every 4 weeks.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to those with allergies to its components, severely impaired liver function, muscle disorders, or significantly reduced kidney function. It is also not recommended for women who are pregnant, breastfeeding, or of childbearing age without appropriate contraceptive measures. Specifically, high-dose administration is prohibited for patients at high risk of muscle disorders. This medication may affect liver health, so patients with a history of excessive alcohol consumption or liver disease should be cautious. Regular liver function tests should be conducted before and during treatment, and patients with hypothyroidism or nephrotic syndrome should treat those conditions first. Since muscle-related side effects may occur, symptoms such as muscle pain, weakness, or cramps should be reported to a doctor immediately. If serum creatine kinase (CK) levels rise significantly, treatment should be discontinued, and the dose can be adjusted and resumed if symptoms improve. In cases of acute severe conditions or serious physical illness, the use of this medication should be halted, and there is a rare risk of severe muscle weakness or ocular myasthenia. This medication can increase blood concentrations when taken with certain other medications, raising the risk of muscle damage, so it is essential to consult a doctor about concomitant use. Particularly, use with fibrate drugs is prohibited, and interactions with certain antivirals, antifungals, and antibiotics should be carefully managed. This medication contains lactose, so patients with lactose intolerance should not take it, and it is safest not to use it during pregnancy and breastfeeding. In cases of overdose, because there is no specific antidote, treatment should be symptomatic, along with assessments of liver function and muscle enzymes. Dizziness may occur when driving or operating machinery, so caution is advised, and during long-term use, interstitial lung disease or severe skin reactions may rarely occur, so any unusual symptoms should be immediately consulted with healthcare professionals. Finally, this medication may show higher concentrations in Asian individuals, indicating a need for dose adjustment.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, severe allergic reactions, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe muscle weakness, ocular myasthenia, respiratory distress, interstitial lung disease, jaundice, hepatitis, fatal and non-fatal liver failure, severe skin adverse reactions, acute renal failure, oliguria, thrombocytopenia, severe edema, severe allergic reaction, rhabdomyolysis

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • hepatitis
  • increase in transaminases
  • lupus-like syndrome
  • muscle rupture
  • hematuria
  • edema
  • depression
  • sleep disturbances
  • sexual dysfunction

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/PTP [(14 tablets/PTP×2)]

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.