Medication info

Ezistar Tablets 10/10 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)보령
Appearance
White to pale yellow, double convex rectangular tablets
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Expired

MFDS item code 201007220 · Notified 2010.11.26

This product's status changed to Expired on 2024.10.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of lipid levels by reducing LDL-cholesterol and increasing HDL-cholesterol in patients with hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This drug is administered once daily in the evening regardless of meals. For patients with primary hypercholesterolemia, the dosage ranges from 10/10mg to 10/40mg per day, with the generally recommended starting dose being 10/20mg per day. Patients who require less reduction in LDL-cholesterol may start at 10/10mg per day. After initiation or dosage adjustment, monitor blood lipid levels after an interval of 4 weeks or more.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Improvement of lipid levels by reducing LDL-cholesterol and increasing HDL-cholesterol in patients with hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
View approved original text

This drug is used as an adjunct to diet to reduce total cholesterol, LDL-cholesterol, Apo B, and triglycerides, and to increase HDL-cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. It can also be used in homozygous familial hypercholesterolemia patients in combination with or as an alternative to other lipid-lowering therapies. This drug is used together with an appropriate diet and is administered when dietary measures alone do not provide adequate effects. Before administration, it is important to identify and treat any secondary causes of dyslipidemia if necessary. Regular monitoring of blood lipid levels to assess treatment efficacy is recommended. This drug helps improve hypercholesterolemia and reduce the risk of atherosclerotic vascular disease.

How to take

Adult dose

This drug is administered once daily in the evening regardless of meals. For patients with primary hypercholesterolemia, the dosage ranges from 10/10mg to 10/40mg per day, with the generally recommended starting dose being 10/20mg per day. Patients who require less reduction in LDL-cholesterol may start at 10/10mg per day. After initiation or dosage adjustment, monitor blood lipid levels after an interval of 4 weeks or more.

Precautions

This drug may cause muscle-related side effects such as myopathy or rhabdomyolysis; therefore, if muscle pain or weakness occurs, you should consult your physician immediately. This drug should not be used in patients with allergies to its components or active liver disease, or in women who are pregnant or breastfeeding. Special caution should be taken when administering this drug to patients with impaired liver function, and if liver function tests show abnormal elevations, consult a physician. This drug may interact with other medications, so it is important to inform your healthcare provider of any other medications you are currently taking. Elderly patients or those with impaired kidney function should also use this drug with caution, and regular checks and monitoring are recommended. Women who plan to become pregnant should consult their physician before taking this drug, and if pregnancy is confirmed, they should stop taking it immediately. In addition to muscle-related adverse reactions, side effects such as headache, dyspepsia, and infections may occur; if symptoms persist or worsen, inform a healthcare provider. It is advisable to avoid taking grapefruit juice or specific medications during the use of this drug and consult a physician or pharmacist before taking them. In case of overdose, there is no specific antidote, so you should visit a medical institution immediately for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • rash
  • hypersensitivity reactions
  • pancreatitis
  • cholelithiasis
  • cholecystitis
  • eczema
  • itching
  • rash
Show 18 more
  • immune-mediated necrotizing myopathy
  • rhabdomyolysis
  • myopathy
  • weakness
  • facial paralysis
  • anaphylaxis
  • lupus-like erythema
  • polymyalgia rheumatica
  • dermatomyositis
  • vasculitis
  • purpura
  • thrombocytopenia
  • leukopenia
  • hemolytic anemia
  • positive antinuclear antibody
  • increased erythrocyte sedimentation rate
  • eosinophilia
  • arthritis

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, muscle pain, limb pain, fatigue, nausea, abdominal pain, constipation, epigastric pain, vomiting, chest pain, chest discomfort, weakness, sensory loss, sore throat, hematuria, itching, edema, thirst, facial edema, insomnia, gastritis, atrophic gastritis, dyspepsia, mucus stools, irritable bowel syndrome, nocturia, increased serum creatine phosphokinase (CPK), weight loss

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

Storage

This drug is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, to maintain the effectiveness of the drug, it is important to store it at a cool room temperature, between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White to pale yellow, double convex rectangular tablets

Package unit

30 tablets (10 tablets/PTPX3)

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.