Medication info
Klerato 20mg (Rosuvastatin Calcium)

Klerato 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
Pink, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201901009 · Approved 2019.02.19 · Insurance code 670501330

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Irrespective of meals, the initial dose of 5 mg should be taken once daily at any time of the day. For patients requiring greater reduction in LDL cholesterol, a maintenance dose may be adjusted to 10 mg once daily for most patients. The maintenance dose may be adjusted according to LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or more, with a maximum dose of 20 mg once daily.
Children's dosage
In pediatric patients (aged 10-17 years) with heterozygous familial hypercholesterolemia, the medication is administered once daily at a dose ranging from 5 mg to 20 mg. The dosage may be adjusted over intervals of at least 4 weeks according to each individual patient's treatment goals.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • familial dyslipidemia
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is used for patients with hypercholesterolemia and dyslipidemia, particularly as an adjunct when diet and exercise are insufficient. It effectively lowers total cholesterol and LDL cholesterol in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, and combined dyslipidemia, delaying the progression of atherosclerosis. It is also used as an adjunct to therapy for patients with homozygous familial hypercholesterolemia. It can be safely used in patients aged 10 to 17 years who meet specific criteria for familial hypercholesterolemia. Additionally, it serves as an adjunctive dietary therapy for patients with primary dysbetalipoproteinemia. Lastly, it contributes to reducing the risks of stroke, myocardial infarction, and arterial revascularization in adults at high risk for cardiovascular disease.

Dosage and Administration

Adult dosage

Irrespective of meals, the initial dose of 5 mg should be taken once daily at any time of the day. For patients requiring greater reduction in LDL cholesterol, a maintenance dose may be adjusted to 10 mg once daily for most patients. The maintenance dose may be adjusted according to LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or more, with a maximum dose of 20 mg once daily.

Children's dosage

In pediatric patients (aged 10-17 years) with heterozygous familial hypercholesterolemia, the medication is administered once daily at a dose ranging from 5 mg to 20 mg. The dosage may be adjusted over intervals of at least 4 weeks according to each individual patient's treatment goals.

Precautions

This medication should not be used in certain patients. For example, individuals allergic to any components of the drug or those with severe liver dysfunction or muscle disorders should avoid it. Additionally, patients with significantly impaired kidney function, pregnant women, or breastfeeding individuals should also refrain from using this medication. Due to the risk of muscle problems, those predisposed to myopathy should be particularly cautious. Individuals with lactose intolerance should not take this medication. It is important to regularly monitor liver function and muscle condition during the treatment. Those who consume a lot of alcohol or have a history of liver disease should be especially careful. If symptoms of muscle pain or weakness occur, they should immediately inform their healthcare provider and undergo examination. Severe muscle damage or rhabdomyolysis may occur, so elderly patients or those with impaired kidney function will require dose adjustment and monitoring. This medication may interact with other specific drugs, so consultation with a healthcare professional is necessary. Pregnant women or those who may become pregnant must ensure appropriate contraception and can only use this medication when a low chance of pregnancy is determined. This medication can rarely cause serious side effects such as skin rashes, liver function abnormalities, kidney problems, and severe skin reactions, so any unusual symptoms should prompt immediate discontinuation of the drug and a visit to the hospital. In case of overdose, there is no specific antidote, and appropriate treatment should be received according to symptoms, along with liver and muscle function tests as needed. Caution should be taken when driving or operating machinery as dizziness may occur. Regular check-ups and consultations with healthcare providers during treatment with this medication are very important for safe therapy.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe allergic reactions, severe skin reactions, jaundice, hepatitis, severe liver damage and/or hyperbilirubinemia or jaundice, severe muscle weakness, ophthalmoplegia, immune-mediated necrotizing myopathy, rhabdomyolysis

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function test
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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, at a temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pink, round film-coated tablet

Package unit

30 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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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.