Medication info
Kairoutin Tablet 10mg (Rosuvastatin Calcium)

Kairoutin Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
한국코러스(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (15 tablets/PTP*2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201701549 · Approved 2017.03.31

Summary

Main use
Treatment to reduce high cholesterol levels and risk of cardiovascular disease
Who uses it
Adults · Children
Adult dosage
Administer once daily at a starting dose of 5 milligrams at any time of the day regardless of meals, and if necessary, adjust to a maintenance dose of 10 milligrams once daily, with a maximum increase to 20 milligrams once daily. Dose adjustments should be made at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response.
Children's dosage
For pediatric patients aged 10 to 17 years, administer once daily at a dose ranging from 5 milligrams to 20 milligrams, adjusted according to the recommended treatment goals and with intervals of 4 weeks or more.

Ingredients

Manufacturer
한국코러스(주)

Efficacy & effects

Treatment to reduce high cholesterol levels and risk of cardiovascular disease

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

This medication is used as an adjunct when dietary changes or exercise alone are insufficient to control dyslipidemia, such as primary hypercholesterolemia and mixed dyslipidemia. It is also helpful in patients with homozygous familial hypercholesterolemia when used alongside dietary therapy or other lipid-lowering therapies. In patients with hypercholesterolemia, it lowers total cholesterol and LDL-cholesterol levels, thereby slowing the progression of atherosclerosis. It is particularly useful for some pediatric patients aged 10 to 17 years and helps reduce cholesterol levels in patients with heterozygous familial hypercholesterolemia. This drug is also used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia and contributes to reducing the risk of stroke and myocardial infarction in high-risk groups by decreasing the risk of arterial revascularization and cardiovascular disease. In summary, this drug is effectively used in various types of hypercholesterolemia and to reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

Administer once daily at a starting dose of 5 milligrams at any time of the day regardless of meals, and if necessary, adjust to a maintenance dose of 10 milligrams once daily, with a maximum increase to 20 milligrams once daily. Dose adjustments should be made at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response.

Children's dosage

For pediatric patients aged 10 to 17 years, administer once daily at a dose ranging from 5 milligrams to 20 milligrams, adjusted according to the recommended treatment goals and with intervals of 4 weeks or more.

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to any of the components, those with severe liver dysfunction, muscle diseases, or severe kidney dysfunction should not take this medication. Women who are pregnant or breastfeeding, and women of childbearing potential not using appropriate contraception should also not take this medication, and women of childbearing age should be fully informed of the potential risks to pregnancy and the fetus. This drug requires special caution in patients at high risk of muscle damage, such as those with moderately or severely impaired renal function, hypothyroidism, those with a family history of muscle disease or past muscle toxic reactions, alcoholics, and those taking specific drugs concurrently. Moreover, since this drug contains lactose, patients with lactose intolerance or related genetic disorders should not take it. Before and during treatment with this drug, liver function tests should be conducted regularly to check liver status. Patients with a history of liver disease or excessive alcohol consumption require extra caution. If symptoms such as myalgia, muscle weakness, or cramps occur, inform a physician immediately, and in severe cases, discontinue the medication. Additionally, it is advisable to avoid tests for muscle damage after vigorous exercise. This drug may interact with other medications; therefore, if other medications are being taken, patients must inform their doctor or pharmacist and consult them. Particular care should be taken when combined with certain antiviral agents, immunosuppressants, antibiotics, or fibrates, as the risk of muscle damage may increase. Pregnant or breastfeeding women, or women planning to become pregnant should not take this medication, and if pregnancy is confirmed during treatment, it should be discontinued immediately. In case of overdose, as there is no specific antidote, treatment should be symptomatic while monitoring liver function and markers of muscle damage. This drug does not significantly impact the ability to drive or operate machinery; however, patients should be cautious as dizziness may occur. If severe skin reactions or allergic symptoms occur while taking this drug, it should be stopped immediately, and medical advice should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, severe swelling, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), jaundice, acute renal failure, oliguria, thrombocytopenia, increased transaminases, hepatitis, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, polyneuropathy, amnesia, peripheral neuropathy, severe muscle weakness, respiratory issues

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
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • arthralgia

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is essential to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP*2), 30 tablets/bottle, 100 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.