Medication info
Klerosh 10 mg (Rosuvastatin Calcium)

Klerosh 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
삼아제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/alu-alu X3)
Approval status
Active

MFDS item code 201001011 · Notified 2010.01.28 · Insurance code 645702150

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
It can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose can be adjusted as necessary for greater LDL cholesterol reduction. The maintenance dose is 10 mg once daily for most patients. The maintenance dose may be adjusted at intervals of 4 weeks or more according to LDL cholesterol levels, treatment goals, and patient response.
Child dose
The usual dose range is 5 mg to 20 mg once daily. The dosing should be adjusted individually according to the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
삼아제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct when diet and exercise alone do not adequately control primary hypercholesterolemia and mixed hyperlipidemia. It is also used as an adjunct to diet or other therapies in patients with homozygous familial hypercholesterolemia. It effectively lowers total cholesterol and LDL-C levels in hypercholesterolemic patients, delaying the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, helping those with high blood LDL-C levels. It plays a role in assisting dietary therapy for primary dysbetalipoproteinemia patients. Furthermore, in men over 50 years and women over 60 years with risk factors for cardiovascular disease, it helps reduce the risk of cardiovascular diseases such as stroke and myocardial infarction. This medication is used for hypercholesterolemia and reduction of cardiovascular disease risk.

How to take

Adult dose

It can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose can be adjusted as necessary for greater LDL cholesterol reduction. The maintenance dose is 10 mg once daily for most patients. The maintenance dose may be adjusted at intervals of 4 weeks or more according to LDL cholesterol levels, treatment goals, and patient response.

Child dose

The usual dose range is 5 mg to 20 mg once daily. The dosing should be adjusted individually according to the recommended treatment goals for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, those who are allergic to this medication, have severe liver disease, have muscle disorders, or have severely impaired kidney function may be at risk if they take this medication. Pregnant or nursing women, or fertile women not using proper contraception should also not take this medication. High-dose use is particularly prohibited in patients at high risk for muscle disorders. Additionally, this medication contains lactose and should not be administered to patients with lactose intolerance or related genetic conditions. It is important to periodically check liver function and muscle condition while taking this medication. Patients who consume large amounts of alcohol or have a history of liver disease require caution, and those with conditions like hypothyroidism or nephrotic syndrome must treat those conditions first. If symptoms such as myalgia, muscle weakness, or cramps appear, medical personnel must be informed immediately, and this medication may need to be discontinued if necessary. This medication may interact with other drugs, so patients should inform their doctor or pharmacist of any other medications they are taking. In particular, concurrent use with ciclosporin, fibrate drugs, or certain antibiotics and antifungals may increase the risk of muscle injury. Pregnant or nursing women should not use this medication, and fertile women must ensure proper contraception. There are no specific antidotes for overdose, so monitoring should be conducted through symptomatic treatment and tests for liver function and muscle enzymes. Lastly, this medication may cause dizziness, so caution is advised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms accompanying drug reaction syndrome (DRESS), jaundice, hepatitis, severe muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, acute kidney failure, oliguria, thrombocytopenia, increased serum creatinine levels, shortness of breath, ophthalmoplegia

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • sensory disturbances
  • discomfort in the chest
  • decreased appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture and kept in a cool place below 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/alu-alu X3)

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.