Medication info
Kirotin 5mg (Rosuvastatin Calcium)

Kirotin 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한국코러스(주)
Appearance
Yellow round film-coated tablet
Packaging
PTP packaging - 30 tablets/PTP [(15 tablets / PTP x 2)]
Approval status
Active

MFDS item code 201704835 · Approved 2017.06.27 · Insurance code 647204350

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For primary hypercholesterolemia, mixed dyslipidemia, and dysbetalipoproteinemia, the initial dose is 5 milligrams taken once a day at any time irrespective of meals. If necessary, the maintenance dose can be increased up to 10 milligrams once a day, and adjustments can be made to a maximum of 20 milligrams based on LDL cholesterol levels and patient response, with intervals of at least 4 weeks.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is once daily 5 milligrams to 20 milligrams. The dosage should be adjusted according to the individual patient's treatment goals with an interval of 4 weeks or more.

Ingredients

Manufacturer
한국코러스(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • dyslipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunct when diet and exercise alone do not adequately control primary hypercholesterolemia and mixed dyslipidemia patients. It also helps lower cholesterol levels in pediatric patients with homozygous familial hypercholesterolemia or those with heterozygous familial hypercholesterolemia when combined with dietary therapy. It lowers total cholesterol and LDL cholesterol to target levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and is also used as an adjunct in primary dysbetalipoproteinemia patients. Additionally, this medication contributes to reducing the risk of stroke, myocardial infarction, and artery re-stenosis in adult patients at high cardiovascular risk. Overall, this medication is effectively used in managing dyslipidemia and preventing cardiovascular disease.

Dosage and Administration

Adult dosage

For primary hypercholesterolemia, mixed dyslipidemia, and dysbetalipoproteinemia, the initial dose is 5 milligrams taken once a day at any time irrespective of meals. If necessary, the maintenance dose can be increased up to 10 milligrams once a day, and adjustments can be made to a maximum of 20 milligrams based on LDL cholesterol levels and patient response, with intervals of at least 4 weeks.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is once daily 5 milligrams to 20 milligrams. The dosage should be adjusted according to the individual patient's treatment goals with an interval of 4 weeks or more.

Precautions

This medication should not be used in patients with hypersensitivity to its components or those with active liver disease. Patients with muscle disorders or those taking cyclosporine, as well as patients with severe renal impairment, should not take this medication. Pregnant women, breastfeeding women, and women of childbearing potential should fully understand the risks of not being pregnant and the risks to the fetus before taking this medication. Patients at high risk for myopathy or rhabdomyolysis, for example, moderate renal impairment, hypothyroidism, or a family history of muscle disorders, should not take this medication at a 40mg dosage. Additionally, patients with genetic issues such as lactose intolerance should not take this medication. Patients who consume alcohol heavily or have a history of liver disease should undergo regular liver function tests before and during treatment with this medication. If symptoms of muscle pain or weakness occur, it is essential to inform the physician immediately, and blood tests may be necessary to determine the extent of muscle damage. In cases of severe muscle symptoms or abnormal blood test results, the use of this medication may need to be discontinued. This medication can cause side effects such as abnormal liver function, muscle pain, headache, digestive disturbances, so if symptoms persist or worsen, consult with healthcare professionals. There may be potential interactions when taken with other medications, so inform the healthcare provider of all medications being taken. Do not use this medication during pregnancy or breastfeeding, and if pregnancy is planned, proper contraception should be used. In case of overdose, there is no specific antidote, so seek medical attention immediately for appropriate treatment and monitor liver function and muscle levels. Dizziness may occur while taking this medication, so caution should be exercised when driving or operating machinery. Before taking this medication, always consult with a doctor or pharmacist to confirm the safe usage appropriate for your health condition.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, severe muscle weakness, respiratory distress, ophthalmoplegia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms related drug reaction syndrome (DRESS), immune-mediated necrotizing myopathy, acute renal failure, oliguria, fatal and non-fatal liver failure, severe skin reactions, severe allergic reactions, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • hives
  • muscle pain
  • weakness
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  • thrombocytopenia
  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • hematuria
  • edema
  • depression
  • sleep disturbance
  • 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 closed container to prevent air or moisture exposure. Additionally, it is best to store it at a temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

PTP packaging - 30 tablets/PTP [(15 tablets / PTP x 2)]

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.