Medication info
Klerato 5 mg (Rosuvastatin Calcium)

Klerato 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201901008 · Approved 2019.02.19 · Insurance code 670501320

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if a greater decrease in LDL-cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, where most patients are adjusted to this dosage. The maintenance dosage should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient responses every four weeks or longer, with a maximum daily dosage of 20 mg.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the usual dosage range is 5 to 20 mg once daily. The dosing is adjusted according to the individual patient's treatment goals, and the dosage is

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dyslipidemia type familial
  • increased LDL-cholesterol
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol level
  • smoking
View approved original text

This medication is used as an adjunct treatment for patients with primary hypercholesterolemia and mixed hyperlipidemia when they are not adequately controlled by diet and exercise. It is also used in conjunction with other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia to enhance therapeutic effects. For patients with hypercholesterolemia, it helps lower total cholesterol and LDL-cholesterol levels to target levels, delaying the progression of atherosclerosis. It effectively reduces LDL-cholesterol and related markers as an adjunct to diet in patients with heterozygous familial hypercholesterolemia, particularly in children and adolescents. Additionally, it serves as an adjunct in patients with primary dysbetalipoproteinemia. Lastly, it contributes to reducing the risk of cardiovascular diseases in men aged over 50 and women aged over 60 with specific conditions. This medication is effectively used to improve various conditions related to hyperlipidemia.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if a greater decrease in LDL-cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, where most patients are adjusted to this dosage. The maintenance dosage should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient responses every four weeks or longer, with a maximum daily dosage of 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the usual dosage range is 5 to 20 mg once daily. The dosing is adjusted according to the individual patient's treatment goals, and the dosage is

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients who are allergic to this drug, those with severe liver dysfunction, patients with muscle diseases, and those with certain kidney disorders. Women who are pregnant or breastfeeding, or those who may become pregnant and are not using appropriate contraception, should not use this medication. Caution is particularly warranted for patients at risk of muscle damage. Symptoms such as muscle pain, muscle weakness, and in severe cases, rhabdomyolysis may occur, so if such symptoms arise, healthcare professionals should be immediately notified. There may be liver function abnormalities; therefore, regular liver function tests should be conducted before and during treatment. Excessive alcohol consumption or a history of liver disease while taking this medication requires caution. Patients with conditions such as hypothyroidism or nephrotic syndrome should first receive treatment for the underlying condition before using this medication. This medication may elevate blood sugar levels or increase the risk of developing diabetes in some patients; therefore, regular monitoring of blood sugar levels is necessary for patients requiring blood sugar management. Serious side effects such as interstitial lung disease and severe skin reactions (e.g., Stevens-Johnson syndrome) have been rarely reported; if symptoms like difficulty breathing, rash, or severe itching occur, immediate consultation with a doctor is necessary. There may be interactions when taking this medication alongside other drugs, so it is crucial to inform healthcare providers or pharmacists of any medications currently being taken. Exercise particular caution when taken with drugs that may increase the risk of muscle damage. Pregnant or breastfeeding women should not use this medication, and women who could become pregnant should use appropriate contraception. In case of an overdose, there is no specific antidote, so immediate hospital treatment must be sought, and liver function and muscle enzyme levels should be monitored. Dizziness may occur during the course of treatment, therefore care should be taken when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, pancreatitis, myopathy, rhabdomyolysis, severe muscle weakness, ophthalmoplegia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, polyneuropathy, memory loss, peripheral neuropathy, severe muscle weakness, cough, difficulty breathing, thrombocytopenia, acute renal failure, oliguria, elevated serum creatinine

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • asthenia
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • arthralgia
  • fatigue
  • numbness
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion

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

Storage

This medication must be stored in a tightly closed container to protect it from exposure to air and moisture. It is important to maintain the storage temperature between 1°C and 30°C to preserve the medication's efficacy and prevent deterioration.

Appearance and packaging

Appearance

Yellow 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.

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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.