Medication info
Itrex Rosuvastatin Calcium Tablet 10mg

Itrex Rosuvastatin Calcium Tablet 10mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Pink round film-coated tablet
Packaging
Domestic - 30 tablets/bottle, Export - 30 tablets/box [10 tablets/(Alu-Alu x 3)]
Approval status
Active

MFDS item code 201400287 · Approved 2014.01.22 · Insurance code 698502550

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For primary hypercholesterolemia, mixed dyslipidemia, type III primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, this medication can be taken at any time of the day, regardless of meals. The initial dosage is 5 milligrams once daily, and the maintenance dosage is typically adjusted to 10 milligrams once daily for most patients. The maintenance dosage should be adjusted at intervals of at least 4 weeks, and it may be increased up to a maximum of 20 milligrams once daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually according to therapeutic goals and for at least 4 weeks.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct to dietary changes when diet and exercise alone are inadequate for the control of primary hypercholesterolemia and mixed dyslipidemia patients. Additionally, it is prescribed as an adjunct therapy for patients with homozygous familial hypercholesterolemia along with other lipid-lowering treatments. It has been shown to effectively lower total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. It is also used as an adjunctive therapy in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia when their LDL cholesterol levels exceed certain criteria. This drug also aids patients with type III primary dysbetalipoproteinemia and is utilized to reduce the risk of stroke, myocardial infarction, and arterial revascularization in elderly patients at high cardiovascular risk. In summary, this medication is effectively used for various forms of hypercholesterolemia and for reducing the risk of cardiovascular diseases.

How to take

Adult dose

For primary hypercholesterolemia, mixed dyslipidemia, type III primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, this medication can be taken at any time of the day, regardless of meals. The initial dosage is 5 milligrams once daily, and the maintenance dosage is typically adjusted to 10 milligrams once daily for most patients. The maintenance dosage should be adjusted at intervals of at least 4 weeks, and it may be increased up to a maximum of 20 milligrams once daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually according to therapeutic goals and for at least 4 weeks.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any component of this drug, have active liver disease, have muscle disorders, take certain immunosuppressants, have severe kidney dysfunction, or are pregnant or breastfeeding should not take this medication. Furthermore, high doses are prohibited in patients at high risk of muscle damage. This medication contains lactose, so individuals with lactose intolerance or related genetic disorders should avoid it. Patients with a history of liver disease or excessive alcohol consumption should have regular liver function tests and use this drug with caution. If symptoms of myalgia or muscle weakness occur, patients should immediately inform their healthcare provider and undergo necessary examinations. This medication may increase blood sugar levels in some patients, so those at risk for diabetes should regularly monitor their blood sugar levels. Patients with certain genetic characteristics may have different drug responses, so dosage adjustments may be necessary. This drug can cause severe skin reactions, so if abnormal skin symptoms occur, it should be discontinued immediately. When used in conjunction with other medications, interactions may increase the blood concentration of this drug or the risk of side effects, so it is essential to inform the healthcare provider about any other medications being taken. The use of this medication during pregnancy or breastfeeding should be avoided as it may pose risks to the fetus or infant. In the case of overdose, there are no specific antidotes, so treatment should proceed based on the symptoms, and liver function and muscle enzyme levels should be monitored. This medication does not significantly impact driving or machinery operation, but caution is advised as dizziness may occur. Adverse reactions reported during drug use include headache, dizziness, dyspepsia, myalgia, skin rashes, etc., and if these symptoms are severe, medical consultation is necessary. The blood concentration of this medication may be higher in Asians, so caution is needed when determining dosage.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, rash, and urticaria, Stevens-Johnson syndrome, eosinophilia with systemic symptom drug reaction syndrome (DRESS), jaundice, hepatitis, severe muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, cough, dyspnea, polyneuropathy, memory loss, peripheral neuropathy, Stevens-Johnson syndrome, dyspnea, thrombocytopenia, acute renal failure, oliguria, blood concentration

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • thrombocytopenia
  • diarrhea
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  • ophthalmoplegia
  • hematuria
  • edema
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • memory disorders
  • confusion
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction

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 exposure to air or moisture. It is best to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Domestic - 30 tablets/bottle, Export - 30 tablets/box [10 tablets/(Alu-Alu x 3)]

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.