Medication info
EziSant Tablet 10/20 mg (Ezetimibe, Rosuvastatin)

EziSant Tablet 10/20 mg (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)보령
Appearance
Pink oval film-coated tablet
Packaging
30 tablets / box (10 tablets / PTP X 3)
Approval status
Active

MFDS item code 201601212 · Approved 2016.02.29 · Insurance code 641906340

Summary

Main use
Effectiveness in reducing LDL cholesterol and total cholesterol through the treatment of hypercholesterolemia (primary and mixed type), and increasing HDL cholesterol.
Who takes it
Adults
Adult dose
This medication is taken once daily, regardless of meals. The recommended starting dose for treating primary hypercholesterolemia is 10/5 mg daily, and dosing may be adjusted for patients requiring more significant reductions in LDL cholesterol. After initiating therapy or adjusting the dose, blood lipid levels should be monitored at intervals of more than 4 weeks, and the dose may be increased up to a maximum of 10/20 mg daily.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Effectiveness in reducing LDL cholesterol and total cholesterol through the treatment of hypercholesterolemia (primary and mixed type), and increasing HDL cholesterol.

  • Primary hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication helps reduce total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol. It is primarily used to support dietary treatment and is applied in conjunction with lipid-modifying therapy for patients at high risk of atherosclerotic vascular diseases. This medication should be administered alongside appropriate dietary regimens, such as limiting saturated fats and cholesterol, when non-pharmacological treatment does not yield sufficient results. It is important to identify other causes of dyslipidemia prior to treatment and address those causes if necessary. Additionally, various lipid levels should be checked during lipid testing, especially if triglycerides are elevated, accurate cholesterol concentration measurements are essential. This medication is used to effectively improve hypercholesterolemia and related diseases.

How to take

Adult dose

This medication is taken once daily, regardless of meals. The recommended starting dose for treating primary hypercholesterolemia is 10/5 mg daily, and dosing may be adjusted for patients requiring more significant reductions in LDL cholesterol. After initiating therapy or adjusting the dose, blood lipid levels should be monitored at intervals of more than 4 weeks, and the dose may be increased up to a maximum of 10/20 mg daily.

Precautions

This medication carries a risk of rhabdomyolysis, a rare side effect that can cause serious muscle problems. Acute renal failure may occur as a result, so if severe muscle pain or weakness occurs, medical personnel should be notified immediately. This medication should not be administered to patients with certain conditions. For instance, patients with hypersensitivity to this medication, active liver disease, muscle disorders, and serious kidney dysfunction should not use this medication. Furthermore, women who are pregnant or may become pregnant, as well as breastfeeding women, should not receive this medication. This medication may affect liver function, so it should be used cautiously in patients with a history of liver disease or alcohol addiction. Additionally, elderly patients and those with reduced kidney function are at an increased risk of developing myopathy and should be given this medication with caution. Regular liver function tests and muscle-related tests should be conducted while taking this medication, and especially if symptoms such as muscle pain, fatigue, or fever occur, the physician should be consulted immediately. This medication can interact with other drugs, so anyone currently taking medications must inform their healthcare provider. Special caution is required when used in conjunction with anticoagulants, fibrate drugs, certain antibiotics, and antifungals. This medication may be harmful to the fetus during pregnancy; thus, women of childbearing age should use appropriate contraception during treatment, and if pregnancy is confirmed, the medication should be discontinued immediately. The safety of this medication for children and adolescents has not been sufficiently established, so it is not recommended for use in pediatric patients. This medication may induce symptoms such as dizziness or headaches; therefore, caution should be exercised when driving or operating machinery while taking it. Finally, this medication contains lactose, so patients with lactose intolerance should not take it, and it is advisable to store it out of reach of children and not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention

Mild side effects

  • Pharyngitis
  • joint pain
  • headache
  • ALT elevation
  • AST elevation
  • myalgia
  • edema
  • elevated bilirubin levels
  • acneiform dermatitis
  • pruritus
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  • dizziness
  • upper respiratory infection
  • fatigue
  • numbness
  • dysesthesia
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • itching
  • dermatitis
  • skin burning sensation
  • skin disorders
  • alopecia
  • cough
  • sputum
  • runny nose
  • limb pain
  • chest pain
  • palpitations

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

Storage

This medication should be kept in a tightly closed container to avoid exposure to air and moisture. Additionally, it is important to maintain a temperature between 1 to 30 degrees Celsius when storing the medication. This will help preserve the medication's effectiveness for an extended period.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets / box (10 tablets / PTP 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.

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.