Medication info
Krelors 5mg (Rosuvastatin Calcium)

Krelors 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)휴온스메디텍
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 30 tablets/PTP[(10 tablets/PTP×3)]
Approval status
Active

MFDS item code 201604100 · Approved 2016.06.30 · Insurance code 670401450

Summary

Main use
Treatment of hypercholesterolemia and risk reduction of cardiovascular diseases
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time during the day regardless of meals. The initial dose is 5 milligrams once daily. The maintenance dose is 10 milligrams once daily, which can be adjusted based on LDL cholesterol levels and treatment goals at intervals of 4 weeks or more. The maximum daily dose is 20 milligrams.
Children's dosage
In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), dosing can range from 5 milligrams to 20 milligrams once daily. The dose should be adjusted based on the individual treatment goals of the patients, at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)휴온스메디텍

Efficacy & effects

Treatment of hypercholesterolemia and risk reduction of cardiovascular diseases

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dyslipidemia
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as an adjunct when diet and exercise alone do not adequately control hyperlipidemic conditions such as primary hypercholesterolemia and mixed dyslipidemia. It is also effective as an adjunct to diet and other therapies for patients with homozygous familial hypercholesterolemia. This drug helps lower total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. It is also used in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia to reduce blood cholesterol levels in conjunction with dietary therapy. It is employed as an adjunct to dietary therapy for patients with primary dysbetalipoproteinemia and reduces the risk of cardiovascular events such as strokes, myocardial infarctions, and revascularization in middle-aged patients with elevated high-sensitivity C-reactive protein levels. In summary, this medication is used for various hyperlipidemias and risk reduction of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication can be taken at any time during the day regardless of meals. The initial dose is 5 milligrams once daily. The maintenance dose is 10 milligrams once daily, which can be adjusted based on LDL cholesterol levels and treatment goals at intervals of 4 weeks or more. The maximum daily dose is 20 milligrams.

Children's dosage

In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), dosing can range from 5 milligrams to 20 milligrams once daily. The dose should be adjusted based on the individual treatment goals of the patients, at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For instance, it should not be administered to individuals who are allergic to this drug, have severely impaired liver function, have a muscle disease, are taking specific immunosuppressants, have severe renal impairment, are pregnant or breastfeeding, and fertile women who are not using appropriate contraception. Additionally, high-dose use is prohibited in patients at risk of muscle disease. Risk factors include moderate renal impairment, hypothyroidism, a family or personal history of muscle disorders, alcohol dependence, and combination with certain medications. This medication contains lactose and should not be given to patients with lactose intolerance or related genetic disorders. Patients with poor liver function or excessive alcohol consumption should undergo regular liver enzyme tests when using this drug, and patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome should treat the underlying conditions first. Should symptoms such as muscle pain, weakness, or cramps occur, notify a doctor immediately and verify muscle damage through blood tests. If symptoms are severe or blood test results are elevated, discontinuation of the medication may be necessary. In cases of acute severe illness, the use of this medication should be discontinued, as rare occurrences of muscle weakness or ocular muscle weakness may arise. Combining this drug with other medications could increase the risk of muscle disease, so combination with fibrate-class drugs should be avoided. This medication can affect liver and kidney functions; therefore, regular testing is necessary, and in Asian patients, drug concentration may be higher, necessitating dose adjustments. Common side effects include headaches, dizziness, dyspepsia, muscle pain, increases in liver enzyme levels, while serious side effects such as severe skin reactions or liver damage can occur rarely. Pregnant or breastfeeding women should not use this medication, and women who may become pregnant must use appropriate contraception. In cases of overdose, as there are no specific antidotes, treatment should be symptomatic, with tests for liver function and muscle enzymes as needed. Caution should be exercised as dizziness may occur while driving or operating machinery. The drug's blood concentration can vary depending on specific genotypes; hence, dose adjustments may be necessary based on patient condition. Immediate discontinuation and medical attention should be sought if severe skin reactions occur.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
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  • thrombocytopenia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • decreased appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • hematuria
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • increased transaminases
  • elevated AST
  • elevated ALT

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. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 30 tablets/PTP[(10 tablets/PTP×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.

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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.