Medication info
Klerato Tablet 10mg (Rosuvastatin Calcium)

Klerato Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201900602 · Approved 2019.01.23 · Insurance code 670501240

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
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 5mg once daily, and the maintenance dose is 10mg once daily. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response. The dose can be increased up to a maximum of 20mg per day.
Children's dosage
For pediatric patients aged 10 to 17 years, administer 5mg to 20mg once daily. The dosage should be adjusted individually at intervals of 4 weeks or more, and safety for patients under 10 years has not been established.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is primarily used as an adjunct to diet for patients with hypercholesterolemia and hyperlipidemia. It helps when dietary and exercise regimens alone are insufficient in patients with primary hypercholesterolemia and mixed hyperlipidemia. It is also used in conjunction with other treatments for patients with homozygous familial hypercholesterolemia. Additionally, it is effective in reducing total cholesterol and LDL cholesterol levels in pediatric patients with familial hypercholesterolemia who meet specific criteria. In adult patients at high risk of cardiovascular disease, it protects cardiovascular health by reducing the risk of stroke, myocardial infarction, and arterial revascularization. Thus, it is used to improve cholesterol levels and reduce the risk 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 5mg once daily, and the maintenance dose is 10mg once daily. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response. The dose can be increased up to a maximum of 20mg per day.

Children's dosage

For pediatric patients aged 10 to 17 years, administer 5mg to 20mg once daily. The dosage should be adjusted individually at intervals of 4 weeks or more, and safety for patients under 10 years has not been established.

Precautions

This medication should not be used in certain patients. For instance, individuals who are allergic to this medication, those with severe liver dysfunction, those with muscle disorders, certain kidney diseases, and women who are pregnant or nursing should not take this medication. In addition, caution is advised when using this medication in patients with impaired liver function or high alcohol consumption, individuals with hypothyroidism, elderly patients, and those with a family history of muscle-related diseases. During treatment with this medication, if symptoms such as muscle pain or weakness occur, it is important to inform a doctor immediately, and regular liver function tests or muscle-related examinations are recommended. This medication contains lactose, so individuals with genetic lactose intolerance should not take it. Furthermore, interactions may occur when taken with other medications, so it is crucial to inform your doctor or pharmacist of any other medications being taken. Women who are pregnant or may become pregnant should ensure proper contraceptive measures are in place before taking this medication, as taking it during pregnancy could pose risks to the fetus. In cases of overdose, there is no specific antidote, and treatment should be directed towards symptoms while monitoring liver function and muscle enzyme levels. Lastly, caution should be exercised when driving or operating machinery as dizziness may occur. Finally, this medication can occasionally cause serious skin reactions, liver damage, or muscle damage, so consult a healthcare professional immediately if any unusual symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe allergic reactions, rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myopathy, severe skin adverse reactions, dyspnea with cough and fever, acute renal failure, oliguria, generalized severe edema, blood

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • myalgia
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough

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 also recommended to store it at a temperature between 1 and 30 degrees Celsius to safely maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablets

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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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.